louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06219772: Assessment of Dynamic Balance in Idiopathic Scoliosis Compared to Normal Subjects
Official title: Assessment of Dynamic Balance in Females With Adolescent Idiopathic Scoliosis Compared to Normal Subjects: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Scoliosis
Keywords: adolescent idiopathic scoliosis
dynamic balance
Cobb angle
stability index
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2024-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent idiopathic scoliosis and normal subjects

Brief summary: The purpose of this study is to assess dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

Detailed description: Adolescent idiopathic scoliosis (AIS) is one of the most common forms of scoliosis. It is a three-dimensional deformity of the spine and trunk with a lateral deviation of ≥ 10°, which can occur during the growing years from 10 years to puberty, with an apparent gender dominance rising with age and severity with a female to male ratio of 1.5:1 to 10:1.

Dynamic balance is the ability to maintain and regain the center of gravity within the base of support in response to outside perturbations or voluntary movements. It has been reported that AIS is associated with trunk imbalance and could negatively influence the sensorimotor control of posture and decrease postural balance capabilities, which increases susceptibility to injuries and impacts the individual's ability to engage in daily living activities.

Previous research reported that postural stability control in adolescents with idiopathic scoliosis is as good as in healthy individuals, and others found that AIS patients have poorer static balance control than age-matched patients without AIS. So the current study will be conducted to investigate the dynamic balance in females with adolescent idiopathic scoliosis compared to normal subjects.

Eligibility criteria: Inclusion Criteria:

1. Females with age between 10-20 years.
2. Idiopathic scoliosis will be diagnosed based on clinical examination and radiological measures.
3. Cobb's angle will be between 20° and 40°.
4. Their BMI from 18 to 24.9 kg/m2.
5. They must be willing to participate in the study.

Exclusion Criteria:

1. History of previous back surgery.
2. Neurological deficit.
3. Current lower extremity symptoms.
4. Symptoms of vertigo or dizziness.
5. No other disorders in the vertebral column (disc prolapse, spondylosis, fracture).

Primary outcomes:
measure: Dynamic balance
timeFrame: Through study completion, an average of 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Ayoub Elimy
Study officials:
affiliation: King Khalid University, Saudi Arabia
name: Ghada MR Koura, Ass. prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00858572: STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders
Official title: A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AML
CML
MDS
Myeloproliferative Disorders
Keywords: Synta
STA-9090
AML
CML
MDS
myeloproliferative disorder
hematologic malignancy
ganetespib
Lead sponsor: Synta Pharmaceuticals Corp.
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.


Eligibility criteria: Inclusion Criteria

* Males and females 18 years or older
* Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol
* Must have acceptable organ function during screening as defined in the protocol

Exclusion Criteria

* Pregnant or breast-feeding women
* Patients must meet the washout periods for prior chemotherapies and radiation
* History of stroke within 6 months of treatment
* Poor venous access for study drug administration
* Treatment with chronic immunosuppressants
* Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

Primary outcomes:
measure: To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies
timeFrame: Feb 2011
measure: To assess preliminary evidence of anti-neoplastic activity
timeFrame: Feb 2011
measure: To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion
timeFrame: Feb 2011
Secondary outcomes:
measure: To assess changes in biomarkers following study drug administration
timeFrame: Feb 2011
measure: To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters
timeFrame: Feb 2011
measure: To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib)
timeFrame: Feb 2011
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: San Antonio
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00191672: A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer
Official title: A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic breast cancer
* Disease that can be measured by the physician or radiologic test.
* May have had one chemotherapy treatment for advanced or metastatic disease.
* Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment.
* Patients may have received prior hormone therapy or immunotherapy.

Exclusion Criteria:

* Patients with only non-measurable disease
* Cancer that has spread to the brain
* A patient who received a taxane with metastatic disease.
* Pregnancy
* Patients who received prior gemcitabine

Primary outcomes:
measure: Estimate the response rate of two regimens separately.
Secondary outcomes:
measure: Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status
measure: Nature of toxicities experienced on each arm of the study
Other outcomes:
Locations:
city: Nashville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Tennessee
city: Katy
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04692272: Xbox Kinect, Sleep Quality, Anxiety and Functional Capacity in Older Adults
Official title: Effects of Xbox Kinect Exercise Training on the Sleep Quality, Anxiety and Functional Capacity in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Anxiety
Aging
Exercise
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to examine the effects of Xbox Kinect exercise training program on the sleep quality, anxiety and functional capacity in older adults. Older adults were randomized into two groups. The XBOX group performed exercise with Xbox Kinect during 60 min, three times/week for 6 weeks. The CONTROL group did not exercise. Pittsburgh Sleep Quality Index was used to evaluate sleep quality, anxiety symptoms by the State-Trait Anxiety Inventory, and the functional capacity was analyzed using following tests: Chair Stand Test, 8-Foot Up and Go Test, and 6-min Walk Test.


Eligibility criteria: Inclusion Criteria:

1. ability to perform exercises with Xbox Kinect and/or physical/functional tests and to answer the questionnaires;
2. score ≥ 24 on the Mini-Mental State Examination

Exclusion Criteria:

(a) using psychiatric drugs or beta-blockers;

1. functional limitations
2. exercise regularly

(e) smoking (b) previous experience with Xbox Kinect games.

Primary outcomes:
measure: Change from Baseline Sleep Quality at 6 weeks
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Change from Baseline Anxiety at 6 weeks
timeFrame: up to 24 weeks
measure: Change from Baseline strength at 6 weeks
timeFrame: up to 24 weeks
measure: Change from Baseline agility/dynamic balance at 6 weeks
timeFrame: up to 24 weeks
measure: Change from Baseline aerobic endurance at 6 weeks
timeFrame: up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Evangelista de Lima B, Passos GS, Youngstedt SD, Bandeira Santos Junior LC, Goncalves Santana M. Effects of Xbox Kinect exercise training on sleep quality, anxiety and functional capacity in older adults. J Bodyw Mov Ther. 2021 Oct;28:271-275. doi: 10.1016/j.jbmt.2021.07.029. Epub 2021 Aug 6.
Clinical trial NCT01780272: A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
Official title: A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-01-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
* Currently treated with any anti-diabetic treatment (incl. diet and exercise) except insulin with a stable dose for more than 4 weeks prior to screening
* Body mass index below 35 kg/m\^2

Exclusion Criteria:

* Severe hypoglycaemic event during the past 6 months or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Any other chronic disorder or severe disease by clinical information (including chronic obstructive pulmonary disease (COPD), sleep apnoea and epilepsy) which, in the opinion of the investigator might jeopardise subject's sleep, safety or compliance with the protocol, or subjects with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial
* Use of antidepressants, antipsychotics, hypnotics, sedatives or other drugs known to influence sleep within 12 weeks prior to screening

Primary outcomes:
measure: The number of electroencephalogram (EEG) identified arousals
timeFrame: During the first four hours (0-4 hours) after reaching sleep stage N2
Secondary outcomes:
measure: Time spent in the different sleep stages (% of total sleep time): Sleep stage N1, Sleep stage N2, Sleep stage N3 and Rapid Eye Movement (REM) sleep
timeFrame: During the first four hours (0-4 hours) after reaching sleep stage N2
measure: Total sleep time
timeFrame: 0-8 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jennum P, Stender-Petersen K, Rabol R, Jorgensen NR, Chu PL, Madsbad S. The Impact of Nocturnal Hypoglycemia on Sleep in Subjects With Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2151-7. doi: 10.2337/dc15-0907. Epub 2015 Sep 25.
Clinical trial NCT06895772: Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD
Official title: Analysis of Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With Crohn's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn&#39;s Disease (CD)
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CD patients or healthy individuals

Brief summary: The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge gap. Additionally, this research holds significant importance for understanding the etiology of Crohn's disease and predicting treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients with Crohn's disease undergoing endoscopic examination
* Healthy individuals with no symptoms undergoing colonoscopy without any lesions detected
* Patients undergoing small intestinal endoscopy due to symptoms but with negative examination results.
* Age between 18 and 80 years.
* Patients or authorized family members sign the relevant informed consent forms.

Exclusion Criteria:

* Patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases.
* Patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases.
* Patients who have taken probiotics or antibiotics within the past week.
* Patients with psychiatric disorders or other conditions that prevent them from cooperating with the study.
* Patients participating in other clinical trials that may interfere with the results of this study.

Primary outcomes:
measure: The characteristics of the intestinal microbiota in Crohn's disease
timeFrame: 12 months
Secondary outcomes:
measure: Contrast the characteristics of the intestinal microbiota in Crohn's disease and healthy individuals
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of shandong university
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02816372: Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
Official title: Ultra Protective Ventilation Without Extracorporeal Circulation in Severe ARDS Patients (VT4ARDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Despite the use of protective ventilation, neuromuscular blocking agent and prone position, ARDS mortality remains high (30%-50%) in observational studies, and pneumothorax rate in randomized controlled trial remains stable (10%). The driving pressure (the ratio of tidal volume over respiratory system compliance) has recently been strongly associated with ARDS mortality, suggesting that tidal volume reduction below 6ml/kg may offer mortality benefit. While extracorporeal CO2 removal technique are currently under investigation in association with tidal volume reduction


Eligibility criteria: Inclusion Criteria:

* invasive mechanical ventilation
* ARDS (Berlin definition) with PaO2/FiO2 ratio ≤ 150 mm Hg

Exclusion Criteria:

* Age below 18 year
* planned duration of invasive mechanical ventilation \< 48 hours
* ARDS criteria present for more than 24 hours
* known or suspected intracranial hypertension
* known or suspected COPD
* chronic respiratory failure under long term oxygen or non-invasive ventilation
* pneumothorax or broncho-pleural fistula
* morbid obesity with body weight \>1 kg/cm height
* sickle cell disease
* recent bone marrow transplantation, aplasia following chemotherapy
* burn injury on more than 30% of body surface
* severe hepatic cirrhosis (Child-Pugh score C)
* extracorporeal circulation life support
* pregnancy
* advance directives to withhold or withdraw life-sustaining treatment
* previous inclusion in present study
* patient under an exclusion period following inclusion in another biomedical study
* patient deprived of freedom, minor, subject under a legal protective measure
* lack of affiliation to social security as required by French regulation
* lack of written informed consent by patient or next of kin

Primary outcomes:
measure: Change in driving pressure
timeFrame: Baseline and 24 hours following inclusion
Secondary outcomes:
measure: Rate of patients who achieved tidal volume reduction equal to 4 ml/kg predicted body weight
timeFrame: 48 hours following inclusion
measure: Rate of pneumothorax
timeFrame: Day 90
measure: Change in right ventricule/left ventricule area
timeFrame: Baseline and 24 hours following inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT00855972: Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
Official title: Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-03-05
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile fibromyalgia, and at what dose it does so.

Detailed description: In this pilot dosage-finding and efficacy study, we will experimentally test whether LDN reduces the symptoms of JPFS. We will recruit 40 children with JPFS. Participants will be screened via the JPFS criteria of Yunus and Masi. The study will be an open-label test of various doses of LDN to determine whether LDN reduces JPFS symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep.

The protocol is designed to take 18 weeks. There are a total of 10 study visits, taking place approximately every 2 weeks.

Eligibility criteria: Inclusion Criteria:1. Generalized musculoskeletal aching for over 3 months duration 2. Moderate-severe pain in 5 of 11 tender points 3. Age 7 - 17 4. Male or female Exclusion Criteria:1. Diagnosed rheumatic or autoimmune condition contributing to pain 2. Abnormal laboratory results (Rf, ANA, ESR) 3. Use of opioid analgesics in the last 6 months 4. Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening. 5. Current or previous psychiatric disorder requiring hospitalization 6. Inability to operate Palm OS® handheld device for self-reports 7. Inability to understand English 8. Inability to attend sessions at Stanford lab every 3 weeks 9. Pregnancy or planned pregnancy, or breastfeeding 10. Abnormal liver functioning tests

Primary outcomes:
measure: Self Reported Pain
timeFrame: duration of trial
measure: Self-reported fatigue
timeFrame: duration of trial
measure: Overall Fibromyalgia Symptom report
timeFrame: duration of trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Jarred Younger
role: SUB_INVESTIGATOR
affiliation: Stanford University
name: Sean Mackey
role: PRINCIPAL_INVESTIGATOR
References: