louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06434103: Clinical Study of SHR-A1921 Combined With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
Official title: An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

1. Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
2. Aged 18-75 at the time of signing the informed consent;
3. Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
4. At least one measurable lesion consistent with RECIST v1.1;
5. ECOG PS score: 0-1;
6. The organ function level is good;

Exclusion Criteria:

1. Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
2. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
3. Previous or co-existing malignant neoplasms;
4. The presence of any active or known autoimmune disease;
5. Have clinical symptoms or diseases of the heart that are not well controlled;
6. People with past or current interstitial pneumonia/interstitial lung disease;
7. Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
8. Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;

Primary outcomes:
measure: DLT
timeFrame: 21 days after the first dose
measure: ORR based on RECIST v1.1 assessment.
timeFrame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Secondary outcomes:
measure: Adverse event
timeFrame: All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years
measure: DCR based on RECIST v1.1 assessment
timeFrame: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00903903: Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography
Official title: Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Synovitis
Keywords: active synovitis
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Arthritis patients who visited the Rheumatology out patient clinic in Taichung Veterans General Hospital

Brief summary: The purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Intra- and inter-observer reliability of this method will also be determined.


Eligibility criteria: Inclusion Criteria:

* patients with at least one painful swollen peripheral joint observed by a rheumatologist, including:

  * shoulder joints
  * elbow joints
  * wrist joints
  * metacarpophalangeal (MCP) AND
  * proximal interphalangeal (PIP) joints of hands, ankle joints, subtalar joints, mid-tarsal joints, MTP and PIP joints of feet

Exclusion Criteria:

* patients with active infection
* patients with concurrent malignant disease
* patients with a history of traumatic, septic, or cystal arthritis
* previous joint surgery, or isotopic synovectomy within the past 12 months before the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT00200603: Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy
Official title: Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Calcium phosphate ceramic
tibial osteotomy
osteoarthritis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 50
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 aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.


Eligibility criteria: Inclusion Criteria:

* knee osteoarthritis eligible for tibial valgus osteotomy
* \> 18 y.o

Exclusion Criteria:

* prior tibial osteotomy
* history of local infection
* rheumatoid and other inflammatory arthritis

Primary outcomes:
measure: Radiological healing and stability of the osteotomy measure at 3, 6, 12 and 24 months after surgery
Secondary outcomes:
measure: Knee and iliac crest painSurgical complicationsFonctional results
Other outcomes:
Locations:
city: Nantes
country: France
facility: Gouin François
Study officials:
affiliation: Nantes UH
name: François Gouin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02603003: the"Fuzheng" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs
Official title: A Study on the"Fuzheng"Therapy Promoted Immune Reconstitution to Improve the Survival of Early-stage Lung Cancer After Surgical Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer(NSCLC)
Keywords: Circulating tumor cells(CTCs)
Traditional Chinese Medicine(TCM)
Myeloid-derived suppressor cells(MDSCs)
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Detailed description: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Complete resection was accepted in IIa \~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
3. Age from 18 Years to 70 Years;
4. The liver and renal function were normal,and no other disease.
5. Patients compliance is good ang can understand the situation of this study and signed informed consent

Exclusion Criteria:

1. Patients without clear pathological diagnosis;
2. The expected survival period is morn than 6 months;
3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
4. Patients with pregnancy or lactation;
5. Persons with a history of less control.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: The progression disease is assessed based on CT or PET-CT every six months from date of randomization and the endpoints is the date of first documented progression or date of death due to lung cancer,assessed up to Two years.
Secondary outcomes:
measure: Circulating Tumor Cell
timeFrame: 24months
measure: Overall survival
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03142503: The DIET Trial - Dietetic Intervention in Psoriatic Arthritis
Official title: Effectiveness of a Dietary Intervention Program on Disease Activity, Metabolism and Oxidative Stress in Patients With Psoriatic Arthritis and Psoriasis Activity: A Clinical, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Psoriatic
Metabolic Syndrome
Keywords: psoriatic arthritis
psoriasis
body composition
DXA measurements
spondyloarthritis
diet therapy
adipose tissue
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Psoriasis (Ps) and psoriatic arthritis (PsA) are associated with increased risk of metabolic syndrome (MetS), body fatness and cardiovascular risk. Additionally, oxidative stress and inflammation are also contributing mechanisms on Ps and PsA. However, little is known about the influence of diet and micronutrients on the main outcomes of these diseases. The aim of the investigators is to evaluate the effectiveness of an intervention diet program on disease activity, metabolic profile and oxidative stress inpatients with Psoriasis and Psoriatic Arthritis.


Eligibility criteria: Inclusion Criteria:

* patients with psoriatic arthritis, according to the Classification Criteria of Psoriatic Arthritis (CASPAR)

Exclusion Criteria:

* lack of written informed consent;
* age \< 18 years old;
* history of gastrointestinal, endocrine, pulmonary, kidney, hepatic, and neuromuscular diseases, as well as HIV-positive;
* pregnant or breast-feeding women;
* previous history of cancer;
* use of steroids, protein supplements, vitamins, multivitamins, or antioxidants.
* Specific medications to PsA and physical activity were required to be stable for the last 3 months to be included in the study

Primary outcomes:
measure: Disease activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Fat Mass
timeFrame: 12 weeks
measure: Lean Mass
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
measure: Glycation markers
timeFrame: 12 weeks
measure: Anti-inflammatory marker
timeFrame: 12 weeks
measure: Lipidic Peroxidation
timeFrame: 12 weeks
measure: Inflammatory markers
timeFrame: 12 weeks
measure: Cutaneous activity
timeFrame: 12 weeks
measure: Articular activity
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Leite BF, Morimoto MA, Gomes CMF, Klemz BNC, Genaro PS, Shivappa N, Hebert JR, Damasceno NRT, Pinheiro MM. Dietetic intervention in psoriatic arthritis: the DIETA trial. Adv Rheumatol. 2022 Apr 6;62(1):12. doi: 10.1186/s42358-022-00243-6.
Clinical trial NCT02245503: Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (BPH)
Official title: Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 7391
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BPH recruited at urologist offices

Brief summary: The objectives of this post marketing surveillance study were to document the comorbidity and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia).


Eligibility criteria: Inclusion Criteria:

* Indication for the treatment with ALNA according to its summary of product characteristics (SPC)

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency cannot be included in the study

Primary outcomes:
measure: Collection of information on concomitant diseases
timeFrame: day 1
measure: Collection of information on concomitant treatment
timeFrame: day 1
Secondary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02339103: Study of Heat and Intravenous Fluids for Exogenous Rewarming
Official title: Study of Heat and Intravenous Fluids for Exogenous Rewarming (SHIVER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: arteriovenous anastomoses
accidental hypothermia
rewarming
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two novel active rewarming techniques in mildly hypothermic people. Volunteers will undergo 3 cooling trials in a circulating bath at 14 degrees celsius and will then be rewarmed with either shivering alone, warmed iv fluids (IVF), or water perfusion pads applied to the hands and feet. The investigators hypothesize that both heated IVF and water perfusion pads to the arteriovenous anastomoses (AVAs) will prove to provide significantly superior rewarming rates than shivering alone.


Eligibility criteria: Inclusion Criteria:

* Any healthy male or female over 18 years of age

Exclusion Criteria:

* No heart/blood pressure/cholesterol medications.
* No history of Raynaud's disease or any other condition (including asthma) that could be aggravated by cold-water immersion

Primary outcomes:
measure: Rate of rewarming
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Christensen ML, Lipman GS, Grahn DA, Shea KM, Einhorn J, Heller HC. A Novel Cooling Method and Comparison of Active Rewarming of Mildly Hypothermic Subjects. Wilderness Environ Med. 2017 Jun;28(2):108-115. doi: 10.1016/j.wem.2017.02.009. Epub 2017 May 12.
Clinical trial NCT01431703: The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Official title: The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Lesion
Keywords: narrow band imaging
learning curve
colorectal
differential diagnosis
with colorectal lesion
NBI with magnification
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-09-09
Enrollment: 326
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: academic hospital endoscopist of digestive department

Brief summary: It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

Detailed description: It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.

Eligibility criteria: Inclusion Criteria:

* Ages 16 to 85
* Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions

Exclusion Criteria:

* Unwilling to consent
* Had surgery of colorectal tumors
* Using NSAIDS
* Diagnosed or suspected IBD
* Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease

Primary outcomes:
measure: Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions
timeFrame: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03467503: Healthy Diet for Healthy Moms and Babies
Official title: Healthy Diet for Healthy Moms and Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Obesity
Pregnancy, High Risk
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 34
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to collect baseline information on dietary habits and metabolic risk factors, and to examine the effects of a dietary intervention focusing on fiber and antioxidant rich berries on the development of gestational diabetes, maternal glucose and lipid control and inflammation in obese pregnant women at risk of developing diabetes. With the ongoing epidemic of obesity, the prevalence of gestational diabetes is significantly increasing and the goal of this research is to identify optimal dietary strategies that can reverse this condition or control the rise in blood glucose among those with already developed diabetes.


Eligibility criteria: Inclusion Criteria:

* BMI \> or = 30, \<20 weeks gestation and singleton pregnancy with the following options: previous history of gestational diabetes and/or family history of diabetes

Exclusion Criteria:

* • Twin or multiple pregnancy

  * Chronic pre-pregnancy conditions (CHD, cancer, diabetes)
  * Gastrointestinal conditions
  * Anemia
  * Allergic to berries and fiber
  * Vegetarian food habits or special diets
  * Not proficient in English and/or unable to provide consent

Primary outcomes:
measure: Gestational weight gain
timeFrame: 20 weeks
measure: Gestational glycemia
timeFrame: 20 weeks
measure: Maternal serum lipids
timeFrame: 20 weeks
measure: Maternal inflammation
timeFrame: 20 weeks
Secondary outcomes:
measure: Maternal biomarkers of atherosclerosis
timeFrame: 20 weeks
measure: Maternal dietary intakes
timeFrame: 20 weeks
Other outcomes:
measure: Maternal metabolomics
timeFrame: 20 weeks
Locations:
city: Las Vegas
country: United States
facility: University of Nevada at Las Vegas
state: Nevada
Study officials:
affiliation: University of Nevada at Las Vegas
name: Arpita Basu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basu A, Feng D, Planinic P, Ebersole JL, Lyons TJ, Alexander JM. Dietary Blueberry and Soluble Fiber Supplementation Reduces Risk of Gestational Diabetes in Women with Obesity in a Randomized Controlled Trial. J Nutr. 2021 May 11;151(5):1128-1138. doi: 10.1093/jn/nxaa435.
Clinical trial NCT00409903: The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.
Official title: The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in healthy individuals - during baseline conditions and after activation of the sympathetic nervous system.


Eligibility criteria: Inclusion Criteria:

* Both genders.
* Age 18 - 65 years.
* Body mass index less or equal to 30 kg/m2.
* Women must use oral hormonal anticonception, use intrauterine anticonceptive device, be sterilized/hysterectomized or be postmenopausal.

Exclusion Criteria:

* History or clinical signs of heart, lung, kidney, or endocrine organ disease.
* Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
* Abnormal screening of the urine regarding: albumin and glucose
* Malignant disease.
* Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
* Alcohol abuse.
* Smoking.
* Drug use or abuse.
* Known intolerance or allergy to eprosartan or sodium nitroprusside.
* Blood donation within 1 month of the start of the study.

Primary outcomes:
measure: Heart rate
measure: Fractional sodium excretion
measure: Plasma levels of noradrenaline
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Department of Medical Research, Holstebro Hospital, Denmark
name: Erling B Pedersen, MD, professor
role: STUDY_CHAIR
References: