louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01051206: The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery
Official title: The Effect of 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Coagulation in Patients Medicated With Antiplatelet Agents Prior to Off-Pump Coronary Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Occlusive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-01-18
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).


Eligibility criteria: Inclusion Criteria:

* Eighty patients undergoing OPCAB, who were exposed to anti platelet agents until 5 days prior to surgery were randomly allocated to infuse HES 130/0.4 up to 30 ml/kg and followed crystalloid infusion or infuse crystalloid only during perioperative period,

Exclusion Criteria:

Patient who has

* Valvular disease of heart
* MI within 3 months,patient under 40% of left ventricle preoperative output
* left main artery stenosis
* anemia (hemoglobin \< 12 g/dl), coagulopathy (Platelet \< 100/nl, activated partial thromboplastin time, aPTT) \> 80sec, serum creatinine \> 1.2 mg/dl, respiratory disease(asthma, COPD, PaO2 \< 70 mmHg, pulmonary hypertension or pulmonary edema, etc)
* not consented to this trial

Primary outcomes:
measure: TEG, hemoglobin, platelet count, prothrombin time (PT), partial prothrombin time (aPTT), blood loss, amount of transfusion, urine output, comparing the record data of IV fluid consumption
timeFrame: Preoperative thromboelastography (TEG) and other coagulation variables were measured and follow up data were collected at immediate postoperatively and 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05685706: Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty
Official title: Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cases Who Received TKA/THA
Keywords: Total hip/knee arthroplasty
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration patients who take Total hip and knee arthroplasty

Brief summary: Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis.

Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.


Eligibility criteria: Inclusion Criteria:

1. Primary degenerative arthritis of the knee or hip
2. Those who have undergone artificial knee or hip replacement surgery
3. Follow up surgery for at least 1 year
4. Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery

Exclusion Criteria:

1. Previous hip surgery
2. Previous spine surgery
3. Contracture after hip fusion surgery
4. Scoliosis over 10 degrees combined with neuropathy
5. Patients with flexion contracture after knee joint surgery
6. Rheumatoid arthritis lesions

Primary outcomes:
measure: The Forgotten Joint Score-12 (FJS-12)
timeFrame: Post-operative at 24th month
measure: EQ-5D
timeFrame: Post-operative at 24th month
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References:
Clinical trial NCT02167906: Impact of Hand Osteoarthritis on Arterial Stiffness
Official title: Impact of Hand Osteoarthritis on Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
* Patients with radiographic hand OA defined according to the Kellgren
* Lawrence criteria (≥ 2).
* Steady dose of statins for at least one month.
* Subject affiliated to a social security scheme
* Written informed consent

Exclusion Criteria:

* Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
* History of arterial hypertension treated and / or uncontrolled (SBP \> 140 mmHg and DBP (diastolic blood pressure) \> 90 mmHg)
* Diabetes (fasting blood glucose \> 7 mmol/L)
* Obesity (BMI \> 35 kg/m²)
* Chronic renal failure defined by a glomerular filtration rate \<60 ml/min/1,73m ².
* Patient with uncontrolled cardiovascular disease or a personal history of cardiovascular events (myocardial infarction and angina, occlusive arterial disease, stroke)
* Pregnant or breastfeeding, or premenopausal and not taking an effective contraception

Primary outcomes:
measure: carotid-femoral arterial stiffness
timeFrame: within the first 15 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
References:
Clinical trial NCT00783406: Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Official title: A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.


Eligibility criteria: Inclusion Criteria:

* Post-bronchodilator FEV1/ FVC ratio of \<0.7.
* Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
* Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
* Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion Criteria:

* Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
* History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Primary outcomes:
measure: To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
timeFrame: up to 8 days post dose
measure: To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
timeFrame: up to 24 hours post dose
Secondary outcomes:
measure: To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
timeFrame: up to 24 hours post dose
measure: To investigate the exposure/response relationship of PF-00610355.
timeFrame: up to 8 days post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06550206: Toddlers' Responses to Strangers
Official title: The Malleability of Social Group Understanding in Infancy and Early Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Social Behavior
Lead sponsor: University of California Santa Cruz
Sponsor class: OTHER
Collaborators: name: New York University
name: University of Maryland, College Park
First posted: 2024-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 24
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample from the larger Santa Cruz area

Brief summary: The study will assess if toddlers show differences in stranger wariness according to race, temperament, social network diversity, and neighborhood diversity.

Detailed description: This study is investigating 13- to 24-month-old toddlers' reactions to meeting new people from familiar and unfamiliar racial backgrounds! Participation involves a 1-hour one-time visit to the researcher's lab, located on the UC Santa Cruz campus.

The study itself will take about 20 minutes, but will ask for a 1-hour visit to make sure child participants feel comfortable in the new space. The study will video record as child participants interact with two adults, who will play with the child and offer toys. Parent participants will also be asked to complete two surveys, one demographic survey and one social network survey, so that investigators can better understand how the people children see in their daily lives relate to how participants react to strangers from different racial backgrounds.

Eligibility criteria: Inclusion Criteria:

* typically developing
* age 13-24 months

Exclusion Criteria:

- any known developmental delays

Primary outcomes:
measure: Social Wariness
timeFrame: Through study completion, an average of 10 years
measure: Social Preference
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz
country: United States
facility: Social Science 2 Building
state: California
Study officials:
affiliation: University of California Santa Cruz
name: Hyesung Hwang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang HG, Filippi CA, Morales S, Fox NA, Woodward A. Children's social wariness toward a different-race stranger relates to individual differences in temperament. Dev Sci. 2023 Nov;26(6):e13390. doi: 10.1111/desc.13390. Epub 2023 Mar 24.
Clinical trial NCT00984906: Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers
Official title: Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained.
* Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
* Age: 6 years or above.

Exclusion Criteria:

* Any severe chronic respiratory disease other than asthma or COPD.
* Acute respiratory infection.
* Concurrent participation in a clinical drug study.
* Inability to perform repeatable spirometric measurements.
* Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).

Primary outcomes:
measure: Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
timeFrame: 1 Day
Secondary outcomes:
measure: Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.
timeFrame: 1 Day
measure: Handling of the devices in the subpopulation of asthmatic children
timeFrame: 1 Day
measure: Acceptability of the inhalers in the subpopulation of asthmatic children
timeFrame: 1 Day
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Jorvi hospital
city: Helsinki
country: Finland
facility: Skin and Allergy hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Satu Lähelmä, M.Sc.(Pharm)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05440006: A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
Official title: Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects over 18 years;
2. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
3. Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

Exclusion Criteria:

1. Subjects with evidence of disease or major surgery;
2. History of drug allergy;
3. Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
4. Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
5. Those who have heavy smokers, alcoholics or drug abuse
6. Lactating female subjects or fertile female subjects
7. Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: day 1 to day 10
measure: Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)
timeFrame: day 1 to day 10
measure: Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )
timeFrame: day 1 to day 10
Secondary outcomes:
measure: The incidence and severity of adverse events/serious adverse events
timeFrame: from ICF signing date to approximate day 23
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
Study officials:
References:
Clinical trial NCT04484506: Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma
Official title: A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NK/T Cell Lymphoma Nos
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Peking University International Hospital
name: Hebei Medical University Fourth Hospital
name: Jiangxi Provincial Cancer Hospital
First posted: 2020-07-23
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with radiotherapy for patients with newly diagnosed ENKTL.


Eligibility criteria: Inclusion Criteria:

* patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
* age 14-80 years
* no prior chemotherapy or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* at least one measurable lesion
* adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelets ≥ 100 ×10\^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)
* expected survival of more than three months

Exclusion Criteria:

* invasion of lymphoma to central nervous system
* pre-existing coagulation disorder
* other concomitant neoplasms
* severe infection
* positive HIV antibody
* HBV DNA titer higher than 10\^4 copies /ml in HBsAg-positive patients post antiviral therapy
* pregnant or lactating women
* women of childbearing age unwilling to take contraceptive measures during the study period

Primary outcomes:
measure: Complete response rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 3-year
measure: Overall survival
timeFrame: 3-year
measure: Adverse events
timeFrame: 1-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
References:
Clinical trial NCT03349606: Cocaine Use Disorder and Cortical Dopamine
Official title: Imaging of Cortical Dopamine Transmission in Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Dependence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: \[C-11\]FLB 457 d-amphetamine
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to use \[C-11\]FLB 457 and amphetamine (oral, 0.5 mg/kg) to measure cortical dopamine transmission in cocaine dependent individuals and healthy controls

Detailed description: This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with \[C-11\]FLB 457, in cortical regions of interest in subjects who have a history of cocaine dependence. We hypothesize that cocaine dependence is associated with decreases in dopamine in the prefrontal cortical regions compared to controls. This may explain the impulsivity and cognitive deficits that underlie relapse in this disorder.

Eligibility criteria: Subjects with Cocaine Dependence INCLUSION CRITERIA

1. Males or Females 18-40
2. Fulfill Diagnostic and Statistical Manual (DSM-IV) Diagnosis for Cocaine Dependence
3. Medically Healthy MAJOR EXCLUSIONS

1. Major medical, psychiatric, co-morbid drug \& alcohol use disorders 2. Pregnancy or lactation, 3. Contraindications to MRI 4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year 5. Family History of a psychotic illness or manic episode in first-degree relatives

Healthy Subjects INCLUSION CRITERIA

1. Males or Females 18-40
2. Absence of present or past psychiatric conditions (including alcohol or drug dependence)
3. A negative urine drug screen
4. Medically Healthy

MAJOR EXCLUSIONS

1. Any medical, psychiatric, co-morbid drug \& alcohol use disorders
2. Pregnancy or lactation,
3. Contraindications to MRI
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Family History of a psychotic illness or manic episode, or drug and alcohol Abuse/Dependence in first-degree relatives

Primary outcomes:
measure: Percent change in Binding potential (BPnd)
timeFrame: Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of PIttsburgh PET Facility
state: Pennsylvania
Study officials:
References: