louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00286780: Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia
Official title: A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: AT101
AT-101
cancer
lymphoctic
lukemia
Rituximab
Lead sponsor: Ascenta Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-02-06
Enrollment: 19
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: This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CLL as defined by the NCI-working group
* Previous treatment with standard systemic chemotherapy or immunotherapy.
* Disease progression or relapse after treatment.
* Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
* ECOG performance status ≤ 2
* Adequate liver and renal and bone marrow function

Exclusion Criteria:

* Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
* Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
* Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
* Active secondary malignancy or history of other malignancy within the last five years
* Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
* Patients who are contraindicated for treatment with rituximab
* Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
* T-CLL or other T-cell malignancy

Primary outcomes:
measure: Safety of AT-101 in combination with rituximab
timeFrame: 5 months for each patient; 20 months entire study
Secondary outcomes:
measure: Preliminary efficacy of AT-101 in combination with rituximab
timeFrame: 5 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Moores Cancer Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Thomas Kipps, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02232880: Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation
Official title: Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Keywords: hypertension
inflammation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-09-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 test whether abatacept, a drug approved by the Food and Drug Administration to treat rheumatoid arthritis, may help blood pressure medications to work better. This will be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. We expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
* having a systolic blood pressure \>150 mmHg in the clinic and daytime average \>150 mmHg on ambulatory blood pressure monitoring

Exclusion Criteria:

* Medical history of secondary cause of hypertension, severe obesity (BMI \>35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
* Inability to return for abatacept treatment and follow-up for 24 weeks.
* Inability to understand or complete study-related assessments.
* Current abuse of drugs or alcohol.
* Receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
* Evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (HIV)
* Risk for tuberculosis
* Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin \< 8.5 g/dL, white blood cell count \< 3000/mm3, platelets \< 100,000/mm3, creatinine \> 2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase \> 2 times the ULN.

Primary outcomes:
measure: Change in Systolic Blood Pressure From Randomization to End of Treatment
timeFrame: 6 months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: 6 months
measure: Change in Brachial Artery Reactivity
timeFrame: 6 months
measure: Change in Inflammatory Markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: David G Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329780: Retrospective Comparison of Lap and Robotic-Assisted RYGB and SG
Official title: Retrospective Multicenter Comparison of Laparoscopic and Robotic-Assisted Roux-en-Y Gastric Bypass and Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 1872
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who meets all inclusion and exclusion criteria and who have undergone a primary bariatric procedure.

Brief summary: A retrospective, multicenter, comparative chart review study comparing laparoscopic and robotic-assisted Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)


Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of procedure
* Undergone either laparoscopic or robotic-assisted Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
* Meets qualification for primary bariatric procedure per American Society for Metabolic and Bariatric Surgery guidelines

Exclusion Criteria:

* Subject who underwent bariatric procedure as an emergency procedure
* Subject who underwent bariatric procedure as an revisional bariatric procedure
* Subject who underwent bariatric procedure as an secondary procedure

Primary outcomes:
measure: Perioperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
References:
Clinical trial NCT04866680: Personalized Circulating DNA Follow-up in Melanoma (PERCIMEL)
Official title: Personalized Circulating DNA Follow-up in Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Keywords: Circulating tumour DNA
immunotherapy
targeted therapy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PERCIMEL is an open multicentric study. The purpose of this study is to assess the interest of molecular analysis on circulating tumor DNA in the follow-up of the disease.


Eligibility criteria: Inclusion Criteria:

* locally advanced, operable melanoma
* treated by immunotherapy or anti-BRAF and anti-MEK targeted therapies (stage IIIb, IIIc) or exclusive immunotherapy (stage IV) in an adjuvant situation.

Exclusion Criteria:

* second cancer
* woman who is pregnant, likely to be pregnant or breastfeeding

Primary outcomes:
measure: Studying the tumor molecular abnormalities resulting from circulating tumor DNA (ctDNA) to predict the resistance to treatment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Dijon
country: France
facility: CGFL
city: Dijon
country: France
facility: Chu Dijon
city: Lille
country: France
facility: Chru Lille
city: Mulhouse
country: France
facility: Ghr Mulhouse Sud Alsace
city: Reims
country: France
facility: Institut Godinot
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy
Study officials:
References:
Clinical trial NCT05125380: Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia
Official title: Evaluation of an Human Papillomavirus (HPV) Based Screening Algorithm for Low and Middle Income Countries, by Self-sampling in Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
STI
Human Papilloma Virus
Microbiota
Keywords: LMIC Lowe Middle income country
Screening
Vaginal microbiota
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
name: Armauer Hansen Research Institute, Ethiopia
name: Adama Hospital Medical College, Ethiopia
First posted: 2021-11-18
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The whole cohort is offered an HPV self-sample. The HPV high risk positive women gets randomised into two arms VIA or VIA/VILI at the triage step.
Primary purpose: PREVENTION

Brief summary: The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC).

Specific aims are the following:

* To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV.
* To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort.
* To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN).
* To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer


Eligibility criteria: Inclusion Criteria:

* Can give consent, Age above 18

Exclusion Criteria:

* Women who have undergone hysterectomy

Primary outcomes:
measure: Sensitivity and specificity of VIA and VIA/VILI as triage test
timeFrame: 12 weeks
Secondary outcomes:
measure: Prevalence of STI other than HPV
timeFrame: 8 weeks
measure: Vaginal Microbiota composition
timeFrame: 24 months
Other outcomes:
Locations:
city: Ādama
country: Ethiopia
facility: Adama and Geda Health Center
Study officials:
affiliation: Armauer Hansen Research Institute
name: Adane Mihret, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00406380: Effect of Avastin in Juxtafoveal Telangiectasias
Official title: Does Avastin Change Evolution in Juxtafoveal Telangiectasias?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Telangiectasis
Keywords: Telangiectasias
Leakage
Bevacizumab
Telangiectasias secondary to Branch Retinal Vein Occlusion (BRVO)
Idiopathic juxtafoveal retinal telangiectasias
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Evaluation of efficacy of Intravitreal Injection of Bevacizumab in patients with Yuxtafoveal Telangiectasias

Detailed description: After diagnose Yuxtafoveal telangiectasias secondary to Branch Retinal Vein Occlusion and with Idiopathic Ethiology by clinical signs and Fluorescein angiogram (FA)findings we treated patients with Intravitreal Injection of Bevacizumab (2.5mg/0.1ml). We performed a complete ophthalmological evaluation and at baseline and follow-up (1 and 3 months) we evaluate ETDRS Best Corrected visual acuity (BCVA), fluorescein angiogram (FA) and Optical Coherence Tomography (OCT)findings. We found an improvement in visual acuity and reduction of FA leakage and decrease retinal thickness in OCT.

Eligibility criteria: Inclusion Criteria:

* Patients with Telangiectasias secondary to Branch Retinal Vein Occlusion
* Patients with Idiopathic Juxtafoveal Retinal Telangiectasias

Exclusion Criteria:

* Diabetic Retinopathy and Diabetic Macular Edema
* Hypertensive Retinopathy
* Choroidal Neovascularization

Primary outcomes:
measure: Best corrected Visual Acuity
measure: Fluorescein Angiogram: Leakage
measure: Optical Coherence Tomography: Retinal thickness
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Veronica Kon-Jara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01966380: Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
Official title: An Open Randomised, Prospective, Crossover, Proof of Concept (Design Validation) Clinical Investigation to Caompare the Performance and Safety of Wound Dressing(Leia) Compared to and Hydroactive Surgical Dressing on Low to Highly Exuding Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Leg Ulcer
Diabetic Foot Ulcer
Pressure Ulcer
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2013-10-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic foot ulcer.


Eligibility criteria: Inclusion Criteria:

* Low to highly exuding chronic wound(wound history \> 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer
* Male of female, 18 years and above
* Signed Informed Consent Form

Exclusion Criteria:

* Pregnancy or lactation
* Wound size not suitable for the wound dressing size
* Known allergy/hypersensitivity to any of the components in the dressing

Primary outcomes:
measure: Absorption of Wound Exudates.
timeFrame: 2-3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska clinical trial center
Study officials:
References:
Clinical trial NCT02321865: Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
Official title: Dose Adjustment Study of NPC-02 in Patients With Zinc Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Zinc Deficiency
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.


Eligibility criteria: Inclusion Criteria:

* The serum zinc concentrations are under the nomal level before registration
* Able to taking a tablet

Exclusion Criteria:

1. Heavy hepatitis
2. Malignant tumor
3. Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
4. The serum albumin under 2.8 g/dL
5. Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
6. Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
7. Pregnant, suspected pregnant, lactating, patients who wish to have a child
8. Patient who participated in other clinical trials within 12 weeks before registration
9. Unsuitable as a target of this clinical trial judged by doctor

Primary outcomes:
measure: The ratio of the patients who could maintain target serum zinc concentration
timeFrame: approx. 12-24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
Study officials:
References:
citation: Katayama K, Hosui A, Sakai Y, Itou M, Matsuzaki Y, Takamori Y, Hosho K, Tsuru T, Takikawa Y, Michitaka K, Ogawa E, Miyoshi Y, Ito T, Ida S, Hamada I, Miyoshi K, Kodama H, Takehara T. Effects of Zinc Acetate on Serum Zinc Concentrations in Chronic Liver Diseases: a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial and a Dose Adjustment Trial. Biol Trace Elem Res. 2020 May;195(1):71-81. doi: 10.1007/s12011-019-01851-y. Epub 2019 Aug 7.
Clinical trial NCT02187965: Impact of Muscle Fat Accumulation on the Genomic Profile of Skeletal Muscle in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intermuscular Adipose Tissue Quantification
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: normal weight and obese older adults

Brief summary: Subjects were asked to come to the Purdue facilities after an overnight fast on 2 different testing days for 2.5 hours each day. On one day the subjects participated in blood pressure and body weight measurements as well as a muscle biopsy from the thigh. On the second day the subjects underwent an MRI and MRS scan of the thigh and calf.


Eligibility criteria: Inclusion Criteria:

* 60-80 years old, men and women, normal body weight or obese,

Exclusion Criteria:

* Certain medical conditions could have placed them at risk

Primary outcomes:
measure: MRI
timeFrame: 1 day
Secondary outcomes:
measure: genomic profile
timeFrame: 1 day
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT03227965: Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation
Official title: Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Keywords: cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Cancer is a well known complication about long term transplantation. Cancer outcomes are due to the immunosuppressive treatment that prevents transplanted people from rejection. By lowering the effectiveness of the immune system, immune cells are no longer able to seek and destroy cancer cells.

The goal here is to study immunes cells population of people that were transplanted 10 years ago and are now treated either by a corticosteroid - azathioprine association, or only by cyclosporine A.


Eligibility criteria: Inclusion Criteria:

* Patients over 18
* Patients with kidney transplantation for 10 year
* Patients with stable renal function (less than 20% creatinine variation during the last 12 months)
* Patients treated either by a corticosteroid - azathioprine association or cyclosporine A
* Patients giving his agreement
* Patients legally free

Exclusion Criteria:

* Patients under 18
* Patients under legal protection
* Pregnant women, or of age to get pregnant

Primary outcomes:
measure: Immune cells study
timeFrame: 12 months
Secondary outcomes:
measure: bacteria study
timeFrame: 12 months
measure: cancer incidence
timeFrame: 12 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
Study officials:
References:
Clinical trial NCT06910865: Study of the Radio-clinical Correlation of Endolymphatic Hydrops
Official title: Study of the Radio-clinical Correlation of Endolymphatic Hydrops
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endolymphatic Hydrops
Keywords: Endolymphatic Hydrops
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥18 years) presenting vestibular dilation on MRI

Brief summary: In patients presenting with symptoms of endolymphatic hydrops, signs of vestibular dilation are often found on MRI. Some patients present with these radiological signs without vestibular clinical signs, or signs other than those of hydrops. No study has yet investigated the radiological-clinical correlation of endolymphatic hydrops by selecting patients based on their imaging findings and then comparing them to the symptoms presented.


Eligibility criteria: Inclusion Criteria:

* Adult subject (≥18 years)
* Subject presenting vestibular dilation on MRI

Exclusion Criteria:

* Subjects who have expressed opposition to the reuse of their data for scientific research purposes.
* Subjects under legal protection
* Subjects under guardianship or curatorship

Primary outcomes:
measure: Nystagmus observed on videonystagmoscopy
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Study officials:
References: