louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005376: Premature Birth and Its Sequelae in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To establish in children born prematurely a set of links between lung function in late infancy and lung function at school age, between lung function at school age and that in adolescence, and between lung function in adolescence and that in adulthood in order to evaluate pulmonary outcomes of neonatal therapeutic strategies and to relate these strategies to lung health in adult life.

Detailed description: BACKGROUND:

Effective perinatal treatment strategies during the past 20 years have increased the survival of low birth weight infants. Accompanying this increased survival has been a 4-6 fold increase in the number of children surviving with bronchopulmonary dysplasia, although the birthweight specific incidence has remained constant or declined. Limited data currently available indicate that individuals who had BPD as infants have, as childrearing adults, impaired lung growth as well as both fixed and reversible airways obstruction.

The study was part of an Institute-initiated program on Collaborative Projects in Women's Health. The concept was developed by the NHLBI staff and given concept clearance at the February 1992 National Heart, Lung, and Blood Advisory Council. The Request for Applications was released in April 1992.

DESIGN NARRATIVE:

The study was part of a four-grant collaborative project on women's health. Based on available data, Dr. Mary Ellen Wohl hypothesized that bronchopulmonary dysplasia (BPD) morbidity was related to impaired lung growth in the first year of life, did not improve during adolescence and was accentuated in females because of their intrinsically smaller lungs. To test this hypothesis, she measured lung size and airway function in teenagers and young adults, previously studied at school age, who were born, 1) at term, 2) prematurely, 3) developed respiratory distress syndrome of the newborn (RDS) or 4) developed BPD. Children born from 1987-89 previously studied at 10 months of age by novel lung function function methods developed in this laboratory were restudied at school age. Techniques of measuring total respiratory system compliance and resistance and of obtaining forced expiratory flow at functional residual capacity were applied to cohorts of born premature infants at 10-18 months of age to assess outcome of current perinatal strategies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01590576: Population-based Estimates of Medical Comorbidities in Women With Lower Urinary Tract Symptoms or Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Pelvic Organ Prolapse
Keywords: women
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-05-03
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low urinary tract symptoms

Brief summary: The purpose of this study is to investigate the comorbidities of lower urinary tract symptoms or pelvic organ prolapse in a nationwide population-based data in Taiwan during the study period of 2001-2010, a total of 10 years.


Eligibility criteria: Inclusion Criteria:

* all cases with lower urinary tract symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT05942976: Enthesis Differences in Rheumatoid Arthritis and Axial Spondyloarthropathy
Official title: Ultrasonographic Differences in Entheses in Rheumatoid Arthritis and Axial Spondyloarthropathy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Rheumatoid Arthritis
Enthesitis
Enthesopathy
Keywords: Axial Spondyloarthritis,
Rheumatoid Arthritis
Enthesitis
Ultrasound
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria, axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria and healthy controls with no history of rheumatic diseases.

Brief summary: The aim of this study is to investigate the sonographic differences in entheses in patients with Rheumatoid arthritis and Axial Spondyloarthropathy.

Detailed description: After recording the demographic data of the patients; 5 enthesis regions 5 enthesis sites were evaluated bilaterally as ''tricipital tendon (TT), quadricipital tendon (QT), proximal patellar tendon (PPT), distal patellar tendon (DPT), achilles tendon (AT)'' will be sonographically evaluated and the presence of hypoechogenicity , tendon thickness increase, power Doppler activity, erosion, presence of entezophyte/calcification will be investigated. The differences between the groups will then be compared.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis patients identified according to the 2010 American College of Rheumatology /Europan Leage Against Rheumatism classification criteria,
* axial Spondyloarthrtis patients identified according to the Assessment of Spondyloarthritis classification criteria
* healthy controls with no history of rheumatic diseases.

Exclusion Criteria:

* history of limb trauma and surgery in the last 3 months,
* metabolic disease (diabetes mellitus, hypothyroidism),
* malignant neoplasm,
* limitation of range of motion in the extremity,
* those who have received corticosteroid injections in the last 3 months,
* uncontrollable fibromyalgia.

Primary outcomes:
measure: Ultrasound enthesis differences between the groups
timeFrame: 2 months
measure: The relationship between ultrasound findings and disease parameters
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Resarch Hospital
Study officials:
References:
Clinical trial NCT00820976: Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML
Official title: A Phase III, Randomized Multicenter Study of Induction With or Without Granulocyte Colony-Stimulating Factor in AML
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AML
Keywords: G-CSF
AML
survival
Lead sponsor: Turkish Leukemia Study Group
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 260
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery following induction chemotherapy are widely accepted. However, their impact on response and survival has not been clarified yet. Male gender has been claimed to be a susceptibility factor for development of leukemia and shorten survival but effect of sex has not been analyzed in clinical trials utilizing G-CSF.

Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy was assessed in this prospective randomized Phase III multicenter trial. Patients were randomized to receive induction therapy consisting of either cytosine arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over 0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).

After achievement of CR, all patients received first consolidation course of Ara-C 1 gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor they were randomized to receive second course of consolidation either high dose Ara-C 3 gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed AML
* Age over 16
* Performance status greater than 60
* Previously untreated
* Peripheral blood white blood cell (WBC) count of less than (\<) 0.5 x109/L, and/or marrow leukemic blasts\< 20 % at 7th day of remission induction treatment

Exclusion Criteria:

* Previously treated
* Acute promyelocytic leukemia
* Age equal or younger than 15

Primary outcomes:
measure: response to induction
timeFrame: 3 year
measure: overall survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Beksac M, Ali R, Ozcelik T, Ozcan M, Ozcebe O, Bayik M, Paydas S, Buyukasik Y, Ilhan O, Ozkalemkas F, Gurman G, Uysal A, Akan H, Soydan EA, Tunali A. Short and long term effects of granulocyte colony-stimulating factor during induction therapy in acute myeloid leukemia patients younger than 65: results of a randomized multicenter phase III trial. Leuk Res. 2011 Mar;35(3):340-5. doi: 10.1016/j.leukres.2010.07.005. Epub 2010 Jul 29.
Clinical trial NCT02726776: Suspension Syndrome
Official title: Suspension Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circulatory Collapse
Circulatory Failure
Syncope, Vasovagal, Neurally-Mediated
Orthostatic Hypotension
Lead sponsor: Institute of Mountain Emergency Medicine
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 18-50 years
* ASA class 1
* Signed informed consent

Exclusion Criteria:

* Age \<18 or \>50 years
* ASA class \>1
* Informed consent not signed

Primary outcomes:
measure: Heart rate
timeFrame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
measure: Blood pressure
timeFrame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Secondary outcomes:
measure: Change in maximal Diameter of superficial femoral vein
timeFrame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
measure: Change in interbeat-interval
timeFrame: Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
Other outcomes:
Locations:
Study officials:
affiliation: Barts Heart Centre, London
name: Peter Paal, MD, MBA
role: STUDY_DIRECTOR
affiliation: Eurac, Institute of mountain emergency medicine
name: Hermann Brugger, MD
role: STUDY_DIRECTOR
References:
citation: Pasquier M, Yersin B, Vallotton L, Carron PN. Clinical update: suspension trauma. Wilderness Environ Med. 2011 Jun;22(2):167-71. doi: 10.1016/j.wem.2010.12.006. Epub 2010 Dec 23.
citation: Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.
Clinical trial NCT05955976: Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle
Official title: Study to Compare the Characteristics of Hoffa Adipose Tissue and Intramuscular Adipose Tissue in the Quadriceps Muscle
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteo Arthritis Knee
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 40 and 85 years that have a scheduled surgery for a total knee prosthesis and have a confirmed diagnosis of knee ostheoarthritis.

Brief summary: Over the last few years, it has been suggested that Knee Ostheoarthritis (KOA) incidence and progression could potentially be related to skeletal muscle characteristics. In particular, weakness of the quadriceps muscle would be a key determinant of KOA. However the mechanisms underpinning the influence of skeletal muscle in the pathophysiology of ostheoarthritis (OA) are poorly understood.

Crosstalk between skeletal muscle and structures around and in the joint is of interest. In physical deconditioning and aging, it has been reported that skeletal muscle can be replaced by adipose tissue. Several factors involved in the development of OA but also of adipose tissue may be involved in these muscular changes. Of interest, in patients with KOA, quadriceps weakness is an ubiquitous clinical finding. Infiltration of adipose tissue in skeletal muscle has been shown to affect muscle strength and mobility and be linked to cartilage volume loss and the occurrence/progression of KOA.

The main objective of this study is to compare the characteristics of the Hoffa tissus and the intamuscular fat (IMF) tissus in the quadriceps muscle in patients with gonarthrosis requiring total knee prosthesis.

This is a single-centre study based on a collection of surgical waste and is categorized as Research Not Involving Human subjects.


Eligibility criteria: Inclusion Criteria:

* Adult patient, aged between 40 and 85 years
* Patient having a confirmed diagnosis of knee ostheoarthritis
* Patient undergoing a surgery for a total knee prosthesis for knee ostheoarthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): adipose tissue size differences
timeFrame: 4 months
measure: Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps): lipid levels
timeFrame: 4 months
measure: Comparison between Hoffa tissue and intramuscular fat tissue (quadriceps):fibrotic tissue
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT00999076: Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens
Official title: Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atypical Mycobacteria
Mycobacterium Infections
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AFB-smear positive sputum

Brief summary: The aim of the study is to evaluate the polymerase chain reaction (PCR)-Reverse Blot Hybridization Assay (REBA) for identification of nontuberculous mycobacteria (NTM) species in acid-fast bacilli (AFB) smear-positive respiratory specimens.


Eligibility criteria: Inclusion Criteria:

* Patients with AFB-smear positive sputum

Exclusion Criteria:

* Non-applicable

Primary outcomes:
measure: Results of REBA for identification of NTM species
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won-Jung Koh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00152776: Treating Climacteric Symptoms With a Complex Homeopathic Remedy
Official title: Treatment of Climacteric Symptoms With Ovaria Comp - A Prospective Randomized Placebo Controlled Doubleblind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Anxiety Disorders
Depression
Keywords: menopausal symptoms
complementary medicine
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Wala GmbH
First posted: 2005-09-09
Enrollment: 102
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ovaria comp. is effective in relieving climacteric symptoms.

Detailed description: Complementary treatments for climacteric symptoms are used by many women although their efficacy and safety is mostly unproven.

The use of the complex homeopathic remedy Ovaria comp. for the relief of climacteric symptoms will be examined in this three-armed intervention trial and measured with the menopause rating scale II before and after each study phase of 12 weeks. Participants will receive the verum during two treatment phases of 12 weeks and the placebo during one treatment phase of 12 weeks in different sequences and are stratified for post- and perimenopausal status.

Eligibility criteria: Inclusion Criteria:

* Climacteric symptoms\>=3 Points in Menopause Rating Scale (MRS) II
* Communication possible

Exclusion Criteria:

* Hormone replacement therapy within 2 weeks prior to study inclusion
* Other complementary treatments 7 days before and during the study
* Climacteric symptoms caused by operation, chemotherapy or hormonal therapy of cancer
* Allergy to components of the remedy, especially bee poison

Primary outcomes:
measure: Climacteric symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Climacteric symptoms (vegetative, psychological, urogenital subscales of the MRS II)
timeFrame: 12 weeks
measure: Follow-up for another 12 weeks of treatment or after cross-over to the placebo group
timeFrame: 12+12 weeks
measure: Follow-up for cross-over to placebo after 24 weeks of treatment
timeFrame: 12+12+12 weeks
measure: Diurnal profile of cortisol level before and after treatment phases
timeFrame: 12+12+12 weeks
measure: Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS-D) before and after treatment period
timeFrame: 12+12+12 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Complementary and Integrative Medicine
state: Baden-Württemberg
Study officials:
affiliation: Heidelberg University
name: Cornelia U von Hagens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Hagens C, Schiller P, Godbillon B, Osburg J, Klose C, Limprecht R, Strowitzki T. Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial. Climacteric. 2012 Aug;15(4):358-67. doi: 10.3109/13697137.2011.597895. Epub 2011 Oct 23.
Clinical trial NCT05655676: 89Zr-labeled NY008 PET Imaging in Patients
Official title: 89Zr-labeled NY008 PET Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 10
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: This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma


Eligibility criteria: Inclusion Criteria:

1. Older than 18 years old, male or female;
2. Patients diagnosed with relapsing or refractory multiple myeloma；
3. LVEF≥50%；
4. ECOG score 0\~2；

Exclusion Criteria:

1. Life expectancy of less than 3 months;
2. Participated in other clinical research within 1 month;
3. Recovery from major trauma (including surgery) within 28 days prior to study treatment;
4. Patients with systemic or locally severe infections, or other serious coexisting diseases;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Patients with allergies or allergies to any component of the imaging agent or antibody;
10. Patients who cannot undergo PET/CT imaging scan;
11. Syphilis, HBV, HCV, or HIV positive subjects;
12. Male and female subjects of reproductive age cannot take effective contraceptive measures;
13. Pregnant or lactating women;
14. Patients with a history of mental illness or related conditions;
15. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Evaluation of tissue distribution of 89Zr-NY008
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
Study officials:
References: