louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00985699: S8516-S8736-S9125-S9240 Research Study of Genes in Tissue Samples From Patients With B-cell Non-Hodgkin Lymphoma
Official title: Pharmacogenomics of Oxidative Stress-Related Genes in Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: non-Hodgkin lymphoma
cutaneous B-cell non-Hodgkin lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-28
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on S8516 S8736 S9125 S9240 consenting to banking

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at genes in tissue samples from patients with B-cell non-Hodgkin lymphoma.

Detailed description: OBJECTIVES:

* To determine if toxicity following treatment for lymphoma varies according to genetic polymorphisms in oxidative stress-related genes (i.e., SOD2, CAT, GPX1, GSTM1, and GSTP1).
* To assess whether these genetic polymorphisms are associated with progression-free survival and/or overall survival in these patients treated for lymphoma.

OUTLINE: Previously collected samples are used for biomarker analysis.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of aggressive B-cell non-Hodgkin lymphoma

  * Previously treated with curative intent using anthracycline-based therapies
* Previously collected paraffin-embedded diagnostic tissues from clinical trials that were collected as part of SWOG treatment protocols (S8516, S8736, S9125, S9240, and S9349) available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Association of polymorphisms in oxidative stress-related genes with overall survival and/or progression-free survival
timeFrame: retrospectively
measure: Association of polymorphisms in these genes with rate of grade 4-5 hematologic toxicity
timeFrame: retrospectively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Margaret M. Briehl, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00002099: Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Official title: Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: Didanosine
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lentinan
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the tolerance and side effects of a combination of lentinan and didanosine (ddI) in comparison with ddI alone. To determine whether the combination of lentinan and ddI produces a significant immunorestorative effect within the study observation period (6-12 months) as measured by an increase in one or more of the following: neutrophil count and activity, T-cell subsets, and a decrease in p24 antigen.

Detailed description: Patients are treated with daily oral ddI for 6 weeks, then are randomized to ddI in combination with intravenous lentinan or placebo (administered once weekly) for 26 weeks. Patients who are already stabilized on 400 mg/day ddI will proceed directly to randomization. Following completion of the combination therapy, patients may be offered 26 additional weeks of therapy on an optional basis.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Absolute CD4 count of 200 - 500 cells/mm3.
* No active opportunistic infection or Kaposi's sarcoma.

Prior Medication:

Allowed:

* Prior ddI for no longer than 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Lymphoid malignancy.
* Pancreatitis.
* Peripheral neuropathy.
* Critical illness.

Concurrent Medication:

Excluded:

* Antiretroviral agents other than ddI.
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.
* 1-Thyroxine.

Concurrent Treatment:

Excluded:

* Radiotherapy.

Prior Medication:

Excluded within 1 month prior to study entry:

* Antiretroviral agents other than ddI (patients may have received prior ddI for no longer than 3 months total).
* Steroids.
* Cytotoxic agents.
* Immunosuppressive agents.
* Immunomodulators.

Prior Treatment:

Excluded:

* Radiotherapy within 1 month prior to study entry. Active IV drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: HIV Research Group
state: California
Study officials:
name: Pearce D
role: STUDY_CHAIR
References:
Clinical trial NCT04667299: Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment
Official title: Bismuth-Metronidazole Triple Versus Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 270
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: This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (PPI+bismuth+ metronidazole+ amoxicillin) for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria: Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have not received Helicobacter pylori eradication treatment before.

Exclusion Criteria:

* Have received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: At least 4 weeks after completion of therapy
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori metronidazole-resistant strains
timeFrame: At least 4 weeks after completion of therapy
measure: Eradication rate of Helicobacter pylori metronidazole-susceptible strains
timeFrame: At least 4 weeks after completion of therapy
Other outcomes:
measure: Adherence rate
timeFrame: At least 1 weeks after completion of therapy
measure: Frequency of adverse events
timeFrame: At least 1 weeks after completion of therapy
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Taotao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03510299: Videoscope Guided Flexible LMA Insertion
Official title: Videoscope Guided Flexible LMA Insertion : Comparison With Blind Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ideal Position of LMA Flexible
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Laryngeal Mask Airway Flexible (LMA Flexible) is useful in various surgery because of its unique design. The flexometallic tube allows it could be used in head and neck related surgery but also make insertion more difficult. The ideal position of LMA Flexible is important because in most case, the surgery requiring LMA Flexible allows movements of the stem or patient's head during operation without dislodgement of LMA Flexible. Several studies have examined different techniques like assisting LMA Flexible with rigid introducers or lifting epiglottis with direct laryngoscope. But there is no study using videolaryngoscope (VL) for LMA Flexible insertion. The investigator hypothesized that McGrath(McGRATH™ MAC video laryngoscope;Aircraft Medical Ltd, UK.), one kind of the VL, assisted insertion would increase the success rate of LMA Flexible insertion by lifting epiglottis and securing a view while LMA Flexible is seated. The aim of this study was to investigate the efficacy of the McGrath VL assisted insertion of LMA Flexible compared with the standard method of digital manipulation technique in regard to the ideal anatomical position and sealing pressure in anesthetized adult patients.


Eligibility criteria: Inclusion Criteria:

* ASA (American society of anesthesiologist) physical status classification system I and II,
* scheduled to elective general anesthesia with the use of LMA

Exclusion Criteria:

* suspected difficult airway
* a history of a recent upper airway tract infection
* gastroesophageal reflux
* body mass index \> 30 kg/m2

Primary outcomes:
measure: Ideal positioning rate of LMA flexible
timeFrame: 3 minute after LMA flexible insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Suweon
country: Korea, Republic of
facility: Jiyoung Yoo
state: Kyunggido
Study officials:
References:
Clinical trial NCT02042599: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Official title: Pharmacokinetic Study of 48-hour Sevoflurane Inhalation Using a Disposable Delivery System (AnaConDa©) in ICU Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Kidney Injury
Keywords: Pharmacokinetics
Sevoflurane
Acute kidney injury
Sedation
ICU patients
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Describing a pharmacokinetic model of 48-h sevoflurane sedation in ICU patients with acute kidney failure

Detailed description: Prospective clinical monocentric study in ICU with sedated ventilated patients (presenting acute kidney failure) with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility criteria: Inclusion Criteria:

- Adult patients ventilated more than 48 h Stable respiratory and hemodynamic conditions Consent of patients or family Arterial line AKIN score = 3

Exclusion Criteria:

* BMI \<30 Sevoflurane anaphylaxia

Primary outcomes:
measure: Determination of plasmatic concentrations of sevoflurane before using AnaConda® system
timeFrame: at 5min, 60 min, 24 hrs and just before the end of sedation.
Secondary outcomes:
measure: Determination of plasmatic concentrations of HFIP and fluoride
timeFrame: at 5min, 15 min, 60 min and just before the end of sedation. And 5 min, 10 min, 30 min, 120 min and 360 min after the end of sedation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sébastien PERBET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06261099: Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients
Official title: The Effect of Telerehabilitation-Based Early Upper Extremity Training on Upper Extremity Function and Proprioception in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: telerehabilitation
Upper Extremity
rehabilitation
Proprioception
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective double-blind, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic.

Detailed description: After the sociodemographic data of the participants are recorded, Mini Mental Test (MMT) will be applied to evaluate the cognitive status. Upper extremity functions of patients eligible for the study will be evaluated with the Fugl-Meyer Upper Extremity Scale (FM-UE), proprioception evaluation will be evaluated with the Laser-pointer Assisted Angle Reproduction Test, activities of daily living will be evaluated with the Modified Barthel Index, and reaching performance will be evaluated with the Reaching Performance Scale. Characteristics of the patients participating in the study and all outcome measurements before and after treatment will be evaluated by a blinded physiotherapist. A researcher blinded to the exercise groups and evaluation results will perform the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 30-65, with a history of stroke within the last month,
* Mini Mental Score ≥ 24, 1-10 after discharge. on the day,
* patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable

Exclusion Criteria:

* Flaccid hemiplegia detected by anamnesis and physical examination,
* Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale,
* patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease

Primary outcomes:
measure: Mini Mental Test
timeFrame: six weeks
measure: Fugl Meyer Motor Function Scale
timeFrame: six weeks
measure: Laser-pointer Assisted Angle Reproduction Test
timeFrame: six weeks
measure: Modified Barthel Index
timeFrame: six weeks
measure: Reaching Performance Scale
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Güler Ertuğrul
state: İ̇zmi̇t
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Merkez
Study officials:
References:
Clinical trial NCT06977399: The Application Value of Spectral CT in the Accurate Staging of Liver Cancer
Official title: The Application Value of Spectral CT in the Accurate Staging of Liver Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Spectral CT was used to prospectively collect medical images and clinical data related to liver cancer, evaluate the effect of image quality in the diagnosis of liver cancer, and evaluate the application value in the accurate staging of liver cancer, so as to provide a more accurate clinical basis for diagnosis, promote the development of individualized treatment, and ultimately improve the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

1. Undergo a contrast-enhanced Quark Spectral CT scan of the lower abdomen/pelvis within 1 week before treatment.
2. Age \> 18 years.
3. Patients suspected of having liver cancer.
4. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Severe cardiac, pulmonary, or renal insufficiency.
2. Allergy to iodine-based contrast agents.
3. Inability to cooperate with the CT examination.
4. Poor image quality of the Quark Spectral CT scan.
5. Women who are pregnant or breastfeeding.

Primary outcomes:
measure: Pathological TNM staging
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT01440699: Study of Allogenic Adipose-derived Stem Cells in Crohn's Fistula
Official title: Phase I Study of Dose Escalation of Human Allogenic Adipose-derived Stem Cells (ALLO-ASC) to Evaluate Safety and Efficacy in Patients With Crohn's Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Crohn
Keywords: Crohn's fistula
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adipose-derived stem cells have properties of differentiation to various types of cells, immunomodulatory effects. adipose-derived stem cells (ASCs) show also low immunogenicity.

Anterogen has developed ANTG-ASC(Autologous ASC) which has shown good efficacy and safety in Phase I and II study on the patients with Crohn's fistula.

However, Crohn's patients are sometimes not fat enough to extract fat tissue for culturing ASCs. Therefore the investigators have planned to study allogenic ASCs for safety and efficacy in patients with Crohn's fistula.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Crohn's disease
* Crohn's fistula which has been lasted at least for 3 months
* Negative for beta-HCG pregnancy test

Exclusion Criteria:

* Medical history with Variant Creutzfeldt Jacobs Disease
* Allergic to anesthetics or bovine protein or fibrin glue
* autoimmune disease other than Crohn's disease
* Infectious disease
* Sepsis or active tuberculosis
* pregnant or breast feeding woman
* Inflammatory Bowel disease other than Crohn's disease
* active crohn's disease with CDAI score \> 200
* malignant tumor
* fistula's diameter \> 2 cm

Primary outcomes:
measure: General safety (Laboratory screening, adverse effects, immunological response, local tolerance)
timeFrame: Week8
Secondary outcomes:
measure: Proportion of patients with sustained efficacy
timeFrame: Month 8
measure: Proportion of patients with adverse effects
timeFrame: at month 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Keonghee Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yeonsei Medical Center
Study officials:
affiliation: Yeonsei Medical Center
name: TI Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02045199: Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Cracked Heel in Diabetic Patients With Polyneuropathy
Keywords: Diabetic Neuropathies
Diabetes Mellitus
Diabetic Foot
Diabetes Complications
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus with neuropathy,
* Cracked open heel with at least one fissure Grade 2,

Exclusion Criteria:

* Open wound, skin infection, haemorrhagic crack on feet,
* Major static disorder ,
* Ulceration and history of ulceration,
* Active haemorrhagic crack,
* Hyperkeratotic disease
* Diabetic arteriopathy,

Primary outcomes:
measure: Complete healing of target fissure on the heel
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Liege
country: Belgium
city: Angers
country: France
city: Bron
country: France
city: La Rochelle
country: France
city: Laval
country: France
city: Mantes la Jolie
country: France
city: Muret
country: France
city: Nanterre
country: France
city: Nice
country: France
city: Nieuls sur Mer
country: France
city: Paris
country: France
city: Pessac
country: France
city: Pringy
country: France
city: Rillieux
country: France
city: Saint Orens de Gameville
country: France
city: Seysses
country: France
city: Suresnes
country: France
city: Tierce
country: France
Study officials:
affiliation: Pierre Fabre Médicament
name: Eric Garrigue, MD
role: STUDY_DIRECTOR
References: