louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00742352: PET FDG Assessment of Change in Atherosclerotic Plaques After Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients at the Tel-Aviv Sourasky Medical Center Lung cancer patients at the Tel-Aviv Sourasky Medical Center

Brief summary: The purpose of this study is to determine whether chemotherapy induces regression in atherosclerotic plaques in oncologic patients already undergoing PET FDG as part of their routine assessment.We will use PET FDG to assess whether the inflammation in atherosclerotic plaques is affected by chemotherapy and anti angiogenic therapy.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 65 diagnosed with metastatic breast cancer
* Men over the age of 65 diagnosed with lung cancer

Exclusion Criteria:

* Patients under the age of 65
* Patients diagnosed with chronic inflammatory disease or chronic infection
* Patients taking steroids and NSAIDS on a regular basis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT05026632: NPI-002 Intravitreal Implant for the Delay of Cataract Progression
Official title: Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cataract
Lead sponsor: Nacuity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.


Eligibility criteria: Inclusion Criteria:

1. Indicated for vitrectomy
2. Natural Lens in place at time of vitrectomy
3. Some cataract present as assessed pre-operatively

Exclusion Criteria:

1. Previous intraocular surgery in study eye.
2. Clear zonular weakness or defects / coloboma.
3. Not on stable dose of medications for other conditions.
4. Need for oral corticosteroids during study participation.
5. Evidence or history of uveitis, or ocular ischemia.
6. Current smoker
7. Use of supplemental oxygen
8. Evidence or history of proliferative diabetic retinopathy.
9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.
10. Sensitivity to thiol compounds.
11. Participation in another clinical trial.

Primary outcomes:
measure: Lens Densitometry
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
Study officials:
affiliation: Nacuity Pharmaceuticals
name: Jami R Kern, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06896032: Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis
Official title: Effect of Retro-walking Versus Forward-walking Training Using Underwater Treadmill on Pain and Function in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis (Knee OA)
Osteoarthritis
Keywords: Knee Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retro walking and forward walking training exercise
Primary purpose: TREATMENT

Brief summary: The purpose of this study Will investigate and compare the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA

Detailed description: In the current study, Sixty subjects from both genders, the dominant side only will be involved. They will be divided in to three equal groups: group A (experimental1), group B (experimental 2), group C (control), they will be signed a consent form to share in this study which aimed to investigate the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA

Eligibility criteria: Inclusion Criteria:

1. 60 patients with chronic knee OA.
2. Age ranges from 40-60 years old of both genders.
3. body mass index (BMI) 25- 35kg/m2.
4. The degree of osteoarthritis was mild or moderate and have a Kellgren- Lawrence radiographic grade of of1-3.
5. unilateral knee osteoarthritis involvement.

Exclusion Criteria:

1. hydrophobia.
2. pregnancy.
3. infection.
4. psychiatric disorder.
5. haemorrhagic diathesis.
6. cardiac pacemaker.
7. all Subjects with deformity of hip, knee \& ankle.
8. any CNS or PNS involvement.
9. recent steroidal or intraarticular injections (3 months).
10. systemic inflammatory disease and bone malignancy.

Primary outcomes:
measure: Pain intensity
timeFrame: up to three monthes
measure: knee disability
timeFrame: up to three months
Secondary outcomes:
measure: knee range of motion
timeFrame: up to three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: cairo U
city: Cairo
country: Egypt
facility: cairo U
Study officials:
References:
Clinical trial NCT06864832: Efficacy of Therapeutic Exercise (Mirror Image Exercise) in Adolescent With Chronic Low Back Pain, Through Corrective of Postural Changes
Official title: Efficacy of Therapeutic Exercise (Mirror Image Exercise) in Adolescent With Chronic Low Back Pain, Through Corrective of Postural Changes; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will include two groups. The study group will receive mirror-image postural exercise on the 3D postural analysis. The control group will receive a traditional exercise program.


Eligibility criteria: Inclusion Criteria:

* Having chronic mechanical low back pain.
* Having a significant translational and/or rotational deformity of the lumbar spine according to the posture index scale.
* Having normal x-ray

Exclusion Criteria:

* Severe cardiovascular disease.
* Previous spinal surgery.
* Abdominal hernia.
* True leg length discrepancy.
* Severe respiratory disease.
* Pregnancy.
* Associated pathologies of lower limbs that may interfere with the posture such as foot, knee, and hip deformities.

Primary outcomes:
measure: Pain Intensity
timeFrame: 1-3 months
measure: Postural Alignment
timeFrame: 1-3 months
measure: Functional Disability
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT00674232: Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
Official title: Misoprostol for Treatment of Incomplete Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Abortion
Keywords: incomplete abortion
spontaneous miscarriage
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 311
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.


Eligibility criteria: Inclusion Criteria:

* past or present history of vaginal bleeding during pregnancy
* open cervical os
* evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound)
* surgical evacuation of the uterus would be advised as course of action if misoprostol was not available
* generally in good health
* woman lives or works within one hour of study site
* woman willing to provide contact information for follow up purposes
* informed consent given

Exclusion Criteria:

* contraindications to study drug
* uterine size larger than 12 weeks LMP
* signs of severe infection

Primary outcomes:
measure: complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
timeFrame: one week after initial treatment
Secondary outcomes:
measure: side effects
timeFrame: measured at follow up visit one week after initial treatment
measure: acceptability
timeFrame: measured at follow up visit one week after initial treatment
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: Hospital del Dia, CEMOPLAF
city: Quito
country: Ecuador
facility: Hospital Gineco-obstetrico Isidro Ayora
city: Caracas
country: Venezuela
facility: Hospital Maternidad Concepcion Palacios
Study officials:
affiliation: Gynuity Health Projects
name: Melanie Peña, MPH, MA
role: STUDY_DIRECTOR
affiliation: Gynuity Health Projects
name: Jill Durocher
role: STUDY_DIRECTOR
References:
citation: Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.
Clinical trial NCT01291732: Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.


Eligibility criteria: Inclusion criteria:

1. Healthy male volunteers,
2. Chinese or Japanese ethnicity

Exclusion criteria:

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
2. Any evidence of a clinically relevant concomitant disease
3. Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Primary outcomes:
measure: Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
timeFrame: up to 21 days
measure: Changes in 12-lead ECG (electrocardiogram)
timeFrame: up to 21 days
measure: Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
timeFrame: up to 21 days
measure: Occurrence of Adverse events
timeFrame: up to 21 days
Secondary outcomes:
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: 10 days
measure: Tmax (maximum measured concentration of the analyte in plasma)
timeFrame: 10 days
measure: AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: 10 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 1283.5.82001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01029132: Characteristics of Treatment Responders to Galantamine
Official title: Characteristics of Treatment Responders to Galantamine Administration in the Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Alzheimer's disease
Galantamine
Treatment response
Efficacy
Adverse Event
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2009-12-09
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the characteristics of treatment responders to galantamine.

Detailed description: The purposes of this study are:

1. to investigate the characteristics of treatment responders to galantamine by examining the clinical response of galantamine in patients with mild to moderate AD for 52 weeks.
2. to examine the specific cognitive sub-domains that are more sensitive to galantamine administration.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
2. Korean version Mini-Mental State Examination scores between 10 and 26
3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months
4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia
4. Clinically active cerebrovascular disease; History of seizure disorder
5. Other physical conditions that required acute treatment.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K)
timeFrame: baseline, 4w, 13w, 26w, 39w, 52w
Secondary outcomes:
measure: Seoul-Activities of Daily Living (S-ADL) Seoul-Instrumental Activities of Daily Living (S-IADL) Korean version Neuropsychiatric Inventory (K-NPI)
timeFrame: baseline, 4w, 13w, 26w, 39w, 52w
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, PhD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138332: Biomarkers in Young Patients With Acute Myeloid Leukemia
Official title: Stat3 Signaling Pathway Aberrancies in Pediatric AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-07
Enrollment: 20
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
* Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.

OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* One of the following karyotypes:

  * t(8;21) and WT c-kit
  * t(8;21) and mutant c-kit
  * Normal karyotype

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors
measure: Association of constitutive and/or increased pY-Stat3 and c-kit genotype
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Texas Children's Cancer Center
name: Michele S. Redell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06112132: National Observatory of Children Hospitalized for Bronchiolitis
Official title: National Observatory of Children Hospitalized for Bronchiolitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2023-11-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children hospilalized for bronchiolitis

Brief summary: This study is an observational, multicenter and prospective study for surveillance of case of hospitalised children for bronchiolitis associated or not to RSV or other viruses (isolated or associated with RSV)

Detailed description: The aim of this surveillance is to observe and describe the cases hospitalized for bronchiolitis in the 2023/2024 season in the context of routine immunization with Nirsevimab.

Eligibility criteria: Inclusion Criteria:

* Children under 12 months of age
* In one of the 6 study sites
* From October 15, 2023
* For acute bronchiolitis defined according to current national and international recommendations
* Hospitalized from the pediatric emergency department.

Exclusion Criteria:

- Refusal to participate by patient relative or legal representative

Primary outcomes:
measure: Number of patients hospitalized for bronchiolitis
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of RSV vs non-RSV associated to bronchiolitis hospitalizations
timeFrame: 1 year
measure: Proportion of other viruses associated to bronchiolitis hospitalizations.
timeFrame: 1 year
measure: Proportion of patients immunized with Nirsevimab among children hospitalized for bronchiolitis
timeFrame: 1 year
measure: Proportion of demographics and clinical characteristics of patients hospitalized for bronchiolitis overall
timeFrame: 1 year
measure: Proportion of demographics, clinical and viral characteristics of patients hospitalized for bronchiolitis requiring ventilation support
timeFrame: 1 year
measure: Length of hospital stay of children with bronchiolitis overall in France
timeFrame: 1 year
measure: Length of hospital stay of children with bronchiolitis in France according to immunization status with Nirsevimab
timeFrame: 1 year
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Levy Corinne
role: STUDY_DIRECTOR
affiliation: CHU Montpellier, Service Urgence et Post-urgences pédiatrique
name: Jeziorski Eric
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184232: Treatment of Recurrent Bladder Cancer With Dendritic Cells
Official title: Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Dendritic cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
First posted: 2019-12-03
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of recurrent bladder cancer with dendritic cells


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of pTa bladder cancer;
* Patient who require repetitive transurethral resection;
* Expression of muc-1/wt-1 by the tumor;
* EGOC 0-3;

Exclusion Criteria:

* any medical condition which can be associated with the high risk for the patient;
* pregnancy/lactation;
* chronic infections, including hepatitis B/C, tuberculosis, HIV

Primary outcomes:
measure: Efficacy evaluation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: Head of the chair, Belarusian State Medical University
name: Alexander V Prokharau, Dr
role: STUDY_DIRECTOR
References: