louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01201161: Ranibizumab for Diabetic Traction Retinal Detachment
Official title: The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Retinal Detachment
Keywords: Diabetic Retinopathy
Retinal detachment
Vitreous Hemorrhage
Preoperative Ranibizumab
pars plana vitrectomy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 19
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: TREATMENT

Brief summary: The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.


Eligibility criteria: Inclusion Criteria:

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events

Primary outcomes:
measure: amount of intraoperative intra-ocular bleeding
timeFrame: one week
Secondary outcomes:
measure: visual acuity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of São Paulo
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo Jorge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173861: Effectiveness of a Cancer Center Based Physical Activity Intervention
Official title: Effectiveness of a Cancer Center Based Physical Activity Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Physical Activity
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: Examine the effectiveness of cancer center-based physical activity counseling on physical activity rates and quality of life in breast cancer survivors.

Hypothesis: Participants in the intervention group will indicate greater step counts and quality of life at the end of the intervention compared to the control group


Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer within the last 5 years
* Over the age of 18 years
* female

Exclusion Criteria:

* Non-ambulatory
* Poor cognitive function
* Contraindications for exercise as determined by the PAR-Q

Primary outcomes:
measure: Effectiveness of a cancer center based physical activity intervention for increasing physical activity in breast cancer survivors.
timeFrame: 8 weeks
Secondary outcomes:
measure: Effectiveness of a cancer center based physical activity counseling intervention on increasing quality of life in breast cancer survivors.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Kristina H Karvinen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776861: A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Official title: A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 150
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 with advanced breast cancer who have already received and continue to use immunotherapy, or are planned to receive immunotherapy, and have been recommended for radiotherapy following evaluation by a multidisciplinary team (MDT) in the early stage and have completed radiotherapy, are registered and followed up in this study.

Brief summary: A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

Subjects are eligible for inclusion in the study only if all the following criteria apply:

1. Men or women who are 18 years of age or older on the day of signing the informed consent;
2. Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;
3. Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;
4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;
5. Patients with a traceable medical history during treatment;
6. Subjects who are able to sign an informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;
2. Have not signed the informed consent form;
3. Pregnant or lactating women;
4. Other conditions deemed unsuitable for inclusion in the study by the investigator.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT00314561: The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome
Official title: The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome: A Prospective, Randomized, Open-label, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: Rosiglitazone
Pioglitazone
FMD
PWV
atherosclerosis
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2006-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pioglitazone and rosiglitazone are used in the treatment of diabetic patients. Thiazolidinediones increase insulin sensitivity and show favorable effect blood glucose levels and lipid profiles. The effect of these two different thiazolidinediones on atherosclerotic and inflammatory markers has not been compared in prospective manner. The purpose of this prospective, randomized, open-label, crossover trial is to compare the effect of pioglitazone and rosiglitazone on atherosclerotic and inflammatory markers in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with at least 3 metabolic syndrome criteria of Asian-Pacific ATP III guideline: fasting blood glucose ≥ 110 mg/dl, systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, triglyceride ≥ 150 mg/dl, HDL-cholesterol \< 40 mg/dl for men and \< 50 mg/dl for women.
* Age: 18 years and above

Exclusion Criteria:

* Hypertensive patients with the use of ACE inhibitor or ARB
* Hyperlipidemic patients with the use of statin or fenofibrate
* Patients with any contraindications to the treatment of thiazolidinediones
* Pregnant or lactating patients
* Chronic alcohol or drug abuse
* Hepatic dysfunction
* Renal dysfunction
* Heart failure (EF \< 50%)
* Expected life expectancy of \< 1 year

Primary outcomes:
measure: The effect on flow-mediated dilation (FMD) and pulse wave velocity (PWV)
Secondary outcomes:
measure: The effect of atherosclerotic and inflammatory markers such as adiponectin, IL-6, TNF-α, hsCRP.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Dong Sup Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01761461: Phase III Randomized Trial of Adjuvant Chemotherapy With S-1 vs S-1/Oxaliplatin ± Radiotherapy for Completely Resected Gastric Adenocarcinoma : The ARTIST II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 547
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The optimal regimen for adjuvant treatment has not been established in GC yet. We plan to compare TS-1, TS-1/oxaliplatin with or without RT in D2 resected gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Histologically proven gastric or gastroesophageal adenocarcinoma
2. ≥ D2 lymph node dissection, curative gastrectomy
3. Stage II, III (AJCC 2010) with any N (any stage with N0 will be excluded)
4. Age \> 19
5. ECOG 0-2
6. No distant metastasis
7. Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl, transfusion allowed)
8. Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
9. liver functions (serum bilirubin ≤ 1.5mg/dl, AST/ALT ≤ 3 times(normal value)
10. Written informed consent
11. Possible oral intake (food, drug)

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the study

  1. Active infection requiring antibiotics
  2. Pregnant, lactating women
  3. Concurrent systemic illness not appropriate for chemotherapy
  4. Resection margin (+) at permanent pathology
  5. Pathologic stage I or IV (Ia or Ib according to AJCC 2010)
  6. Inadequate surgery including D0, D1 resection, dissected LNs less than 12
  7. Paraaortic lymph node (+), pathologically proven
  8. women of potential childbearing not employing adequate contraception

Primary outcomes:
measure: The primary endpoint of the study is disease-free survival (DFS).
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00822861: Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
Official title: A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.

Detailed description: The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.

Eligibility criteria: Inclusion Criteria:

* Men and women 18 to 65 years of age
* Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
* History of episodic wheeze and shortness of breath
* Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value
* Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.

Exclusion Criteria:

* Significant acute or chronic medical or psychiatric illness
* Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks
* Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).

Primary outcomes:
measure: Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
timeFrame: 7 and 24 hrs post-allergen challenge
Secondary outcomes:
measure: Safety and tolerability.
timeFrame: Throughout the study
measure: Plasma and sputum pharmacokinetic profile at the two highest dose levels.
timeFrame: Dose level 3 and 4
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: Topigen Pharmaceuticals Inc.
name: Rene Pageau, B.Pharm M.Sc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01160861: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
Official title: A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MEMP1972A in Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase Ib, randomized, blinded, placebo-controlled, multiple-ascending dose study in patients with seasonal or perennial allergic rhinitis to investigate the safety, tolerability, and pharmacokinetics (PK) of MEMP1972A.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of allergic rhinitis
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug

Exclusion Criteria:

* History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
* History of anaphylaxis, hypersensitivity or drug allergies
* Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
* Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
* Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody

Primary outcomes:
measure: Incidence and nature of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
timeFrame: Throughout study or until early discontinuation
measure: Incidence, nature, and severity of adverse events
timeFrame: Throughout study or until early discontinuation
Secondary outcomes:
measure: Pharmacokinetic parameters of MEMP1972A (maximum plasma concentration, total serum clearance, volume of distribution, half-life)
timeFrame: Throughout study or until early discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Jeffrey Harris, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Gauvreau GM, Harris JM, Boulet LP, Scheerens H, Fitzgerald JM, Putnam WS, Cockcroft DW, Davis BE, Leigh R, Zheng Y, Dahlen B, Wang Y, Maciuca R, Mayers I, Liao XC, Wu LC, Matthews JG, O'Byrne PM. Targeting membrane-expressed IgE B cell receptor with an antibody to the M1 prime epitope reduces IgE production. Sci Transl Med. 2014 Jul 2;6(243):243ra85. doi: 10.1126/scitranslmed.3008961.
Clinical trial NCT01705561: Evaluation of Attitudes About Fertility
Official title: Evaluation of Attitudes of Premenopausal Latin American Patients With Breast Cancer Towards the Risk of Loss Their Fertility by Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: fertility
chemotherapy
breast cancer
latin american women
pre menopausal
Lead sponsor: Grupo de Estudios Clínicos Oncológicos Peruano
Sponsor class: OTHER
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2012-10-12
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with diagnosis of breast cancer in pre menopausal status

Brief summary: * Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy.
* Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.

Detailed description: Eligibility criteria:

* Latin American women with evidence of cancer diagnosis at premenopausal status
* Over 18 years
* Agree to sign the informed consent
* No evidence of infertility.

Eligibility criteria: Inclusion Criteria:

* women with breast cancer diagnosis in premenopausal
* over 18 years
* signed informed consent

Exclusion Criteria:

* Evidence of infertility at diagnosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Oncosalud
Study officials:
affiliation: Grupo de Estudios Clínicos Oncológicos Peruano
name: HENRY L GOMEZ, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233061: Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities? (ACTIVOB)
Official title: Does Obesity Influence Women Cardiorespiratory Fitness and Daily Physical Activities?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity; cardiorespiratory fitness; oxygen uptake; household activities; physical activity; sedentary; intensity; obese women
Lead sponsor: Laboratory of Movement, Condorcet, Tournai, Belgium
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women OBESE group VS Women NON-OBESE group
Primary purpose: DIAGNOSTIC

Brief summary: Many obese individuals experience difficulties in executing household activities. In this study, we investigate the cardiorespiratory fitness (CRF) of obese vs. non-obese women, and the impact of obesity on cardiorespiratory functioning during daily household activities.

Detailed description: Methods: On 48 sedentary female subjects will be assessed by cardiorespiratory exercise testing with evaluation of peak oxygen uptake (⩒O2), heart rate (HR) and maximal cycling power output. Next, cardiorespiratory functioning will be assessed during household activities such as ironing (A1), cleaning floor (A2), walking and climbing stairs (A3).

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI = weight in kilograms/(height in meters) x (height in meters)) as: healthy obese (OB group (OB); BMI between 30 to 39.9 kg.m-2; n = 20), and healthy non obese (NO group (NO); BMI between 18.5 to 24.9 kg.m-2; n = 28).

Exclusion Criteria:

* comorbidities (other than obesity) :

  1. history of systemic hypertension or antihypertensive medication, diabetes mellitus, cardiovascular or respiratory disease, systemic disease, smoking;
  2. any drugs;
  3. BMI \>40 kg.m-2;
  4. having a regular physical activity.

Primary outcomes:
measure: Comparison of relative peak oxygen consumption between obese and non-obese women , mesured with indirect calorimetry
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tournai
country: Belgium
facility: LAboratoire de l'effort et du mouvement
state: HAinaut
Study officials:
References: