louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01392716: A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
Official title: An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-75 years of age
* Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma
* \>/=1 measurable lesion
* No prior treatment (no corticosteroids or radiotherapy)

Exclusion Criteria:

* Transformed follicular lymphoma
* Cerebral or meningeal lymphomaotus localization
* Uncontrolled concurrent infection

Primary outcomes:
measure: Overall objective complete response rate
timeFrame: Day 50
measure: Overall objective partial response rate
timeFrame: Day 50
Secondary outcomes:
measure: Progression-free survival
timeFrame: 7 years
measure: Overall survival
timeFrame: 7 years
measure: Duration of response
timeFrame: 7 years
measure: Safety: Incidence of adverse events
timeFrame: 7 years
measure: Level of biological marker bcl2 in peripheral blood and bone marrow
timeFrame: 7 years
Other outcomes:
Locations:
city: Angers
country: France
city: Besancon
country: France
city: Bordeaux
country: France
city: Clamart
country: France
city: Creteil
country: France
city: Le Mans
country: France
city: Lyon
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Poitiers
country: France
city: Rouen
country: France
city: Tours
country: France
city: Vandoeuvre-les-nancy
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01391416: Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients
Official title: Prevalence Of Hyperhomocysteinemia In Thai CKD Patients And Relationship To Cardiovascular Events: Subgroup Analysis From Thai SEEK Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Hyperhomocysteinemia
Keywords: Hyperhomocysteinemia
Chronic kidney disease
Lead sponsor: Bangkok Metropolitan Administration Medical College and Vajira Hospital
Sponsor class: OTHER_GOV
First posted: 2011-07-12
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Ninety eight subjects from CKD stages 3-4 were randomly sampling from Thai- SEEK study database. Thai-SEEK study is a community-based cross-sectional survey that was conducted between August 2007-june 2008 in four regions of Thailand (i.e Northern, Northeastern, Central and Southern) and Bangkok (Metropolitan).

Brief summary: It is well recognized that patients with chronic kidney disease (CKD) have an increased risk for cardiovascular disease (CVD) and hyperhomocysteinemia appears to be a predictor of future CVD events. Hyperhomocysteinemia has been reported to bo of high prevalence in patients with CKD. The investigators aim to study the prevalence of hyperhomocysteinemia in Thai CKD patients by using Thai Screening and Early Evaluation of Kidney Disease (SEEK) study database and their relationship to CVD.

Detailed description: Ninety eight subjects were sampling from Thai SEEK study database Traditional Traditional risk factors of CVD such as total cholesterol, triglyceride, age, sex, history of smoking and blood pressure levels were examined and recorded. Stored sera of these subjects were analyzed for the total homocysteine (tHcy) level. Analysis of variance was used to evaluate the different of mean tHcy among groups

Eligibility criteria: Inclusion Criteria:

* CKD stages 3-4 from Thai SEEK Study

Exclusion Criteria:

* CKD stage 5

Primary outcomes:
measure: Level of Homocysteine
timeFrame: 3 months
Secondary outcomes:
measure: Association of cardiovascular event to the level of homocysteine
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Renal Unit,Department of Medicine,Faculty of Medicine,Vajira Hospital,University of Bangkok Metropolis
name: Thananda Trakarnvanich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27.
Clinical trial NCT01521416: Cost of Illness Associated With Influenza in the UK
Official title: The Cost of Illness Associated With Influenza in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Illness
Influenza
Cost
UK
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 1
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients coded within the relevant database (GPRD and HES) as having acute respiratory events that could be related to an infection between 2001 and 2009.

Brief summary: The objective of this study is to describe the burden associated with influenza in the UK, from both primary and secondary care perspectives, and to stratify the burden by the annual degree of mismatch between predicted and actual virus strains.

Detailed description: This is a retrospective, cross sectional, exploratory, observational study using database analysis and therefore there is no patient or user group involvement.

Eligibility criteria: Inclusion Criteria:

* Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.
* Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.

Exclusion Criteria:

Not Applicable

Primary outcomes:
measure: Incidence of influenza-related events
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Number of confirmed influenza infections
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Assessment of resource use
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Evaluation of patient outcomes, treatments and costs (type and duration)
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Cause of deaths
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Incidence of influenza-related events in High Risk groups
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
measure: Incidence of complications and exacerbations
timeFrame: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06327516: Lysophosphatidylglycerol in Asthma Pathogenesis
Official title: Lysophosphatidylglycerol in Asthma Pathogenesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: asthma
lysophosphatidylglycerol
Treg
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma who visited or were hospitalized in the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital, who met the asthma diagnostic criteria proposed in the Bronchial Asthma Prevention and Treatment Guidelines and healthy controls without history or symptoms of chronic respiratory disease, allergic status or other conditions that could affect the outcome.

Brief summary: The study aims to investigate the relationship between the small molecule metabolite lysophosphatidylglycerol and asthma clinical features and explore its involvement in asthma pathogenesis.

Detailed description: This study screened LPG as a asthma marker by performing metabolomics of the included asthma patients and normal controls, explored the relationship between LPG and clinical features of asthma (including acute exacerbation, asthma control state, asthma treatment steps，lung function, and inflammatory signals including eosinophils, FeNO and total IgE), and further performed in vitro tests to investigate the specific mechanism of LPG's involvement in asthma inflammation through its influence on Treg function.

Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of asthma.

Exclusion Criteria:

1. Combined with chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypopnea syndrome, malignant tumor
2. Combined with acute and chronic respiratory failure
3. Combined with severe cardiovascular disease
4. Pregnant woman.

Primary outcomes:
measure: lipidomics
timeFrame: when enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: None Selected
Study officials:
affiliation: Peking University Third Hospital
name: Chun Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05770258: The Novel Electrolyzed Water Spray Treatment Mild Periodontitis
Official title: A Novel Electrolyzed Water Spray Reduces the Gingival Discomfort as Well as Gingival Redness, Swelling and Bleeding of Patients With Mild Periodontitis: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Electrolyzed water device
Hydroxyl radical
Tap water
Spray
Periodontitis
gingival redness
gingival swelling
gingival bleeding
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-15
Enrollment: 12
Sex: ALL
Minimum age (years): 36
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether spraying the tooth of patients by use of the novel electrolyzed water spray will produce improvement in the condition of mild periodontitis.

Detailed description: In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat mild periodontitis.

Eligibility criteria: Inclusion Criteria:

* mild periodontitis accompanied by gingival discomfort.
* Patient \> 18 years old.
* Systemically healthy individuals

Exclusion Criteria:

* severe periodontitis.
* 80 years or older.
* Patients who take Anticoagulants or Antiplatelet Agents
* Pregnant or breastfeeding women

Primary outcomes:
measure: A discomfort or itching scale made by modifying the Numeric Pain Rating Scale (NPRS)
timeFrame: 10 days
Secondary outcomes:
measure: A gingival signs scale made by modifying the Numeric Pain Rating Scale (NPRS).
timeFrame: 10 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT05410158: Comparative Study of Ketamine Added to Bupivacaine in PECS Block Versus Topical Wound Instillation on Post Operative Analgesia in Modified Radical Mastectomy Surgery
Official title: Comparative Study of Ketamine Added to Bupivacaine in PECS Block Versus Topical Wound Instillation on Post Operative Analgesia in Modified Radical Mastectomy Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Ketamine, Pecs Block, Topical Wound Instillation , Modefied Radical Mastectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparative study of ketamine added to bupivacaine in PECS block versus topical wound instillation on post operative analgesia in modified radical mastectomy surgery


Eligibility criteria: Inclusion Criteria:

- 1) female patients aged 18 - 60 years, 2) American Society of Anesthesiologists (ASA) class \| , \|\| , \|\|\| 3) With body weight of 50 - 90 kg . 4) female patients diagnosed with cancer breast and scheduled for modified radical mastectomy .

5) patients not known to be allergic to any of the medications used in the study.

Exclusion Criteria:

- 1) patients with known allergy to the study drugs . 2) patients with significant cardiac, respiratory, renal or hepatic disease . 3) patients with drug or alcohol abuse . 4) patients with psychiatric illness that would interfere with perception and assessment of pain.

5) Patients with a history of bleeding diathesis; opioid dependence; sepsis; prior surgery in the supraclavicular, infraclavicular or axillary regions.

Primary outcomes:
measure: - The primary outcome measure in this study will be the total dose of morphine consumption during the 48 hours Postoperatively.
timeFrame: july 2022 - feb 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02587858: NBIAready: Online Collection of Natural History Patient-reported Outcome Measures
Official title: NBIAready: Online Collection of Natural History Patient-reported Outcome Measures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurodegeneration With Brain Iron Accumulation (NBIA)
Keywords: NBIA
PKAN
brain iron
Neurodegeneration with Brain Iron Accumulation
Hallervorden Spatz Syndrome
Pantothenate Kinase Associated Neurodegeneration
PLAN
INAD
PLA2G6-associated neurodegeneration
BPAN
Beta-propeller Protein-associated neurodegenration
WDR45
PLA2G6
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2015-10-27
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The PKAN group consists of international individuals diagnosed with PKAN. The PLAN group consists of international individuals diagnosed with PLAN. The BPAN group consists of international individuals diagnosed with BPAN.

Brief summary: The purpose of this study is to learn more about Neurodegeneration with Brain Iron Accumulation (NBIA) Disorders. Data is being collected on three types of NBIA disorders:

Pantothenate Kinase-Associated Neurodegeneration (PKAN), PLA2G6-associated Neurodegeneration (PLAN) and Beta-propeller Protein-associated Neurodegeneration (BPAN). The study will (1) collect information about how symptoms and findings in NBIA change over time and (2) identify measures of NBIA that can be used in future clinical trials. Participants will follow links to a secure website every 6 months for a period of 5-10 years to electronically complete a set of rating scales as related to their NBIA disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PKAN, PLAN or BPAN confirmed by gene testing and/or clinical features.
* Ability to access a computer with internet services or a phone approximately once every 6 months for up to 10 years to enter data.

Exclusion Criteria:

* Individuals who are not fluent in reading and communicating in English.

Primary outcomes:
measure: Document the natural history of NBIA and identify new markers of disease progression.
timeFrame: 5-10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Susan J Hayflick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04459858: The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear
Official title: GTA-The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear - a Comparative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Critical Shoulder Angle (CSA)
Greater Tuberosity Angle (GTA)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated for traumatic or degenerative rotator cuff lesion at the University Hospital Basel between January 2015 and January 2019.

Brief summary: This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Detailed description: A tear of the rotator cuff is one of the most common disorders of the shoulder. It is assumed that a large Critical Shoulder Angle (CSA) is associated with the occurrence of rotator cuff tears. This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

Eligibility criteria: Inclusion Criteria:

* Patient after an arthroscopic rotator cuff repair
* 1 to 4 years postoperative
* Presence of pre-operative radiography of the shoulder

Exclusion Criteria:

* Massive irreparable cuff tear
* Chronically retracted tendons and atrophic rotator cuff muscles Partial arthroscopic repair
* Absence of pre-operative radiography in neutral rotation

Primary outcomes:
measure: Change in Constant Score
timeFrame: 1 year (before surgery and 1 year after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Mohy Taha, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00336258: US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status
Official title: US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Cancer
Keywords: Deep Vein Thrombosis
Cancer
US- Doppler
Procoagulant Microparticles
Asymptomatic
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with an advanced stage of the disease, hospitalized in the oncology department.

Brief summary: The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease.

An attempt will be made to determine whether there is a correlation between this prevalence and various clinical and laboratory parameters.

Detailed description: The association between malignancy and venous thromboembolism(VTE) is well known. VTE is one of the most common complications seen in cancer patients Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

There are recommendations for hospitalized cancer patients who are bedridden with an acute medical illness to receive prophylaxis, but in practice this is not clear cut.It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis). Hematological coagulation tests, including procoagulant microparticles will be performed for the evaluation of coagulation profile, in order to evaluate the possible correlation between the prevalence of asymptomatic DVT and these laboratory parameters.

Eligibility criteria: Inclusion Criteria:

* Cancer patients with an advanced stage of the disease, hospitalized in the oncology department.
* WHO performance status of 3( i.e. spends more than half his/her time in bed or seated) - or 4 ( i.e. completely confined to bed or to chair) : for at least a week; according to the treating physician, the poor performance status results from advanced malignancy.
* Patient is asymptomatic for lower extremity DVT according to the treating physician

Exclusion Criteria:

* major surgery during more than a month, from the time of investigation
* anticoagulant therapy for more than one month, from the time of investigation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Ministry of Health, Israel
name: Nira Beck-Razi
role: PRINCIPAL_INVESTIGATOR
References: