louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00465309: Protective Ventilation With Carbon Dioxide (CO2) -Removal Technique in Patients With Adult Respiratory Distress Syndrome (ARDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Respiratory Distress Syndrome
Keywords: Respiratory Insufficiency
CO2 removal
protective ventilation
ARDS
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Regione Piemonte
First posted: 2007-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 30% of ARDS patients ventilated according to NIH protocol presents morphological (CT) and functional (Stress Index\>1) conditions of hyperinflation even with Plateau pressure (Pplat) \< 30 cmH2O; values of Pplat lower than 26 cmH2O were associated with more a condition of more protective ventilation.

In patients at risk of hyperinflation, use of alternative techniques such as CO2-removal my allow the reduction of Tidal Volume (Vt) and Pplat.

Detailed description: Aim of the study was to verify the efficacy of CO2-removal technique in reducing Vt and consequently Pplat to obtain a Stress Index value equal to 1.

Eligibility criteria: Inclusion Criteria:

* ARDS patients with Pplat \>= 26 during NIH protective ventilation protocol

Exclusion Criteria:

* Age \< 18 years
* Brain injury and patients with intracranial pressure \> 20 mmHg
* Pregnancy
* Immunodepressed patients
* Patients already enrolled in other trials
* Renal replacement therapy
* BMI \> 40
* Contraindication anticoagulation treatment
* Morphological abnormalities of femoral veins
* NYHA III-IV
* Burns BSA\>30%
* Hepatic failure (grade C Child)

Primary outcomes:
measure: pulmonary inflammatory mediator reduction
timeFrame: within the first 72 hours after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine,S. G. Battista Hospital
city: Turin
country: Italy
facility: University of Turin, Department of Anesthesia and Intensive Care Medicine
Study officials:
affiliation: University of Turin, Italy
name: V. M. Ranieri, MD
role: STUDY_DIRECTOR
affiliation: University of Turin, Italy
name: P. Terragni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
Clinical trial NCT04479709: The Urinary Microbiome in Patients Receiving Intradetrusor Botox Injections
Official title: The Urinary Microbiome Before and After Treatment With Intradetrusor Onabotulinum Toxin A Injection for Overactive Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: Overactive bladder
Urinary microbiome
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing intradetrusor botox injection with botox 100 U

Brief summary: An altered urinary microbiome (UM) may explain the symptoms in overactive bladder (OAB) patients who were previously considered to have "idiopathic" OAB. To date, most research on the relationship between OAB and the UM has focused on differentiating between the UM of a normal bladder and that of an OAB bladder. There is currently a paucity of data on the way that OAB therapy impacts the UM. One of the few studies to evaluate the UM pre- and post-OAB treatment focused on how management with solifenacin affected the UM, but no studies have evaluated how intravesical onabotulinumtoxin A injections (IOI) affects the UM. Understanding IOI's impact on the UM is particularly interesting because despite both anticholinergics and IOI exerting antimuscarinic affects on the bladder, IOI is often successful when anticholinergics are not. This raises the question of what other mechanisms of action IOI may have in the bladders of OAB patients - one hypothesis is that it might stabilize the UM in those select patients who suffer from OAB due to an altered UM. The primary objective of this study is therefore to determine the UM profiles of OAB patients before and after treatment with IOI.


Eligibility criteria: Inclusion Criteria:

- Women undergoing intradetrusor botox injection with botox 100 U

Exclusion Criteria:

* Current UTI
* History of recurrent UTI
* History of antibiotic exposure for any reason (including if response is "unknown")
* Antibiotic exposure for any reason other than post-procedure prophylaxis during the four-week follow-up period.

Primary outcomes:
measure: Urinary Microbiome
timeFrame: 08/2020 - 08/2021
Secondary outcomes:
measure: Urinary Microbiome by response
timeFrame: 08/2020 - 08/2021
measure: Urinary tract infection
timeFrame: 08/2020 - 08/2021
measure: Adverse events
timeFrame: 08/2020 - 08/2021
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
Study officials:
References:
citation: Palm KM, Abrams MK, Sears SB, Wherley SD, Alfahmy AM, Kamumbu SA, Chakraborty NN, Mahajan ST, El-Nashar SA, Henderson JW, Hijaz AK, Mangel JM, Pollard RR, Al-Shakhshir H, Retuerto MA, Steller KM, Elshaer M, Ghannoum MA, Sheyn D. The Response of the Urinary Microbiome to Botox. Int Urogynecol J. 2024 Jan;35(1):237-251. doi: 10.1007/s00192-023-05703-1. Epub 2024 Jan 2.
Clinical trial NCT05575609: Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
Official title: Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes mellitus
anthropometric measurements
balance
Diabetes Mellitus, Type 1
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with T1DM will be selected from Abu El-Rish Hospial, Cairo University. Sample size estimation will be carried out based on a pilot study to determine the recruited number of participants. Participants will be recruited according to the following criteria.

Brief summary: Type 1 diabetes mellitus is the most common chronic metabolic disorder in children. Diabetic children who take proper nutrition and good care attain normal growth status. Factors affecting growth in diabetic patients include gender, age at diagnosis, duration of disease, glycemic control, and puberty status. Moreover, diabetes mellitus has negative impact on vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced balance.

Detailed description: Limited literature is available regarding the relation between anthropometric measurements and balance in children with diabetes mellitus. Therefore, the current study will be conducted to investigate the relation between anthropometric measurements (weight, height and body mass index) and balance in children with diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as controlled T1DM.
* Age ranges from 7 to 11 years.
* From both sexes.
* Duration of the disease 3 to \< 5 years.
* Same socioeconomic level.

Exclusion Criteria:

* Other hormonal diseases (hypothyroidism or hyperthyroidism).
* Hereditary sensory and autonomic neuropathy
* Significant visual disorders.
* Subjects participating in regular sports activities.
* History of fracture or surgery in the lower extremities in the past 12 months.

Primary outcomes:
measure: balance
timeFrame: baseline assessment
measure: weight anthropometric measurement
timeFrame: baseline assessment
measure: height anthropometric measurement
timeFrame: baseline assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Amira Mahmoud Abd-elmonem
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: Mohamed E Mohamed, B.S.C
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo university, faculty of physical therapy
name: Asmaa O Sayed, Phd
role: STUDY_CHAIR
affiliation: Cairo University
name: SHaima A Mohamed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01553409: Effect of Blood Donation on Blood Pressure, Iron Metabolism, Oxidative Stress
Official title: Prospective Observational Study on the Effects of Blood Donation on Blood Pressure, Iron Metabolism and Oxidative Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Ferritin
Phlebotomy
Blood donation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female and male from 18 years to 65 years, who are able and want to donate blood for the first time or after one year break to the last blood donation

Brief summary: The investigators want to investigate the effects of blood donation to blood pressure, to iron metabolism and oxidative stress.

There are results of other studies that show, that there is a positive effect of blood donation to high blood pressure, iron metabolism and oxidative stress.

Detailed description: The regular application flow of blood donation at that blood bank of Charité is not disturbed. There are only some more questions and measurement of blood pressure, iron metabolism, fat metabolism and oxidative stress.

No extra puncture of the vein is necessary.

Eligibility criteria: Inclusion Criteria:

* first time donating blood or after a break of 12 months to last blood donation
* voluntary attending blood donation and study
* fulfilling the criteria of the blood donation center

Exclusion Criteria:

* criteria of the blood donation center (e. g. low haemoglobin, fever, acute infection, having spent in tropical countries for the last months,general bad health condition,...)
* missing informed consent to the study

Primary outcomes:
measure: blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Blutspende Campus Mitte
Study officials:
affiliation: Charite University
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University
name: Abdulgabar Salama, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807009: Role of Core Exercise in Treatment of Fibromyalgia Patients
Official title: Effect of Core Exercise on Health Status, Pain in Fibromyalgia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia syndrome
core exercise
aerobic exercise
pressure pain threshold
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: core exerscie
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Detailed description: Fibromyalgia (FM) is a chronic non-degenerative disease of unknown etiology without effective medical treatment that mostly affects women. At present, the diagnostic and classification criteria are still under debate. As a result, the treatments for FM are also under investigation. No single treatment has achieved a reduction in the symptoms. Its occurrence increases with age. Exercise is one of the treatment approaches where effectiveness in the management of FM is supported by stronger evidence. Besides, recent reviews found that exercise has a positive effect on pain, physical function and health-related quality of life .with no associated adverse effects. Among the different exercise modalities available, core stability training has shown its effectiveness by improving static and dynamic balance, functionality and risk of falls, pain and quality of life. so This study will be conducted to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Eligibility criteria: Inclusion Criteria:

* 1. Patient referred from rheumatologist with a history of widespread bilateral musculoskeletal pain both above and below the waist for a minimum of three months and pain in at least 11 of 18 specific tender points 2. moderate or greater tenderness reported on digital palpation with 4 kg/cm2 of force 3. 21_43 years old patients

Exclusion Criteria:

- 1. presence of other systemic, somatic, or psychiatric diseases. 2. pregnant or were planning a pregnancy during the study period. 3. patients with acute disease including high fever and uncontrolled medical conditions (such as severe infection and cardiovascular disease including unstable angina.

4. surgical history for previous 6 months.

Primary outcomes:
measure: pressure pain thresholds
timeFrame: up to 8 weeks
Secondary outcomes:
measure: pain intensity
timeFrame: up to 8 weeks
measure: health status
timeFrame: up to 8 weeks
measure: function state
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Engy Ashraf Gamal Mohamed
Study officials:
References:
Clinical trial NCT03710785: Effect of Neck Extension Exercise Using 8 Channel Surface Electromyography
Official title: Analysis of Abnormal Muscle Activities on Forward Neck Posture Syndrome Patients and Effect of Neck Extension Exercise Using 8 Channel Surface Electromyography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Syndrome
Keywords: 8 Channel Surface Electromyography
Forward Neck Posture Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Analysis of Abnormal Muscle Activities on Forward Neck Posture Syndrome Patients and Effect of Neck Extension Exercise Using 8 Channel Surface Electromyography

Detailed description: In this study, the investigators investigate the muscle contraction according to posture change in patients with forward neck posture syndrome which was not revealed by 8 channel surface electromyography and provide accurate evaluation of forward neck posture syndrome in comparison with normal group and to be used as basic research data for the development of 8 channel electric stimulation therapy device.

Eligibility criteria: Inclusion Criteria:

* Healthy adults over the age of 20 who do not have any underlying disease that does not appeal to forward neck posture syndrome 2) Among adults who complained of chronic pain over three months, patients aged 20 years and over who were diagnosed with forward neck posture syndrome in a simple x-ray of the lumbar spine

Exclusion Criteria:

* Patients with severe neurological disorders (procedural hypertrophy), previous cervical surgery, impaired eye diseases, spinal deformations, rehabilitation for strengthening spinal muscles within the last three months and pregnant women

Primary outcomes:
measure: Change from 8 Channel Surface Electromyography at 4 weeks
timeFrame: when patient enrolled and after 4 weeks
Secondary outcomes:
measure: Change the angle of cervical vertebrae from plain x-ray at 8 weeks
timeFrame: when patient enrolled and after 8 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jusuk Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00759785: A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)
Official title: A Study to Establish Proof-of-Biology for MK-0646 in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.


Eligibility criteria: Inclusion Criteria:

* Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
* Participant is female and ≥18 years of age

Exclusion Criteria:

* Participant is pregnant, breastfeeding or planning to become pregnant while in the study
* Participant has received prior chemotherapy, biological therapy or radiation
* Participant has participated in a clinical trial in the last 30 days
* Participant has a history of drug or alcohol abuse in the last year
* Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C
* Participant has poorly controlled diabetes mellitus

Primary outcomes:
measure: Percentage of Participants Demonstrating a Decrease in the Growth Factor Signature (GFS)
timeFrame: Up to 12 Days Post-dose
Secondary outcomes:
measure: Percentage of IGF1R Positive Participants With a Decrease in GFS by Cohort
timeFrame: Up to 12 Days Post-dose
measure: Percentage of IGF1R Negative Participants With a Decrease in GFS by Cohort
timeFrame: Up to 12 Days Post-dose
measure: Change From Baseline in IGF1R Membrane H-Score After a Single Dose of Dalotuzumab
timeFrame: Baseline and Up to 12 Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00520585: Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes
Official title: Study of Influence of Atorvastatin on the Repolarisation Phase of Cardiomyocytes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heterogeneity of Cardiomyocytes Repolarisation
Autonomic Changes of Cardiomyocytes Repolarisation
Keywords: atorvastatin
repolarisation
cardiomyocytes
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2007-08-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate influence of atorvastin on the repolarisation phase of cardiomyocytes. If there is any, it could be a part of positive "non-lipid" effect of statins in therapy of ischaemic heart disease.

Study hypothesis: atorvastin will decrease heterogeneity of repolarisation of cardiomyocytes in comparison with placebo

Detailed description: The group will consist of 40 healthy volunteers. The study will be mono-centric. The repolarisation phase of cardiomyocytes will be evaluated using long - term 12-lead digital ECG monitoring. There will be 3 single ECG recordings - randomly after 20 mg of atorvastin, 80 mg of atorvastatin and placebo, respectively.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* age 18 - 45 years

Exclusion Criteria:

* no chronic active disease
* no concomitant pharmacotherapy, excluding hormonal contraception
* abnormal ECG, echocardiography, laboratory findings
* known hypersensitivity or myopathy due o statin
* pregnancy, lactation, breast implants
* skin disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Brno, Department of Cardiology, Brno, Czech Republic
name: Ondrej Toman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925585: Vaginal Tactile Imaging for Pelvic Floor Prolapse
Official title: Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-10-06
Enrollment: 119
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for pelvic floor surgery

Brief summary: The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.


Eligibility criteria: Inclusion Criteria:

1. Subject is female of 21 years or older, and
2. No prior pelvic floor surgery, and
3. One of the following:

Normal pelvic floor conditions, or POP Stage I affecting one or more vaginal compartment, or POP Stage II affecting one or more vaginal compartment, or POP Stage III affecting one or more vaginal compartment, or POP Stage IV affecting one or more vaginal compartment

Exclusion Criteria:

1. Active skin infection or ulceration within the vagina
2. Presence of a vaginal septum;
3. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
4. Ongoing radiation therapy for pelvic cancer;
5. Impacted stool;
6. Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
7. Severe hemorrhoids;
8. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
9. Current pregnancy.

Primary outcomes:
measure: Tissue elasticity change after the surgery measured as a gradient in tactile image. Unit of measure: mmHg/mm
timeFrame: pre-surgery and post-surgery (4-6 months after surgery) measurements
measure: Pelvic floor muscle strength change after the surgery measured as a pressure dynamic feedback during muscle contractions. Unit of measure: mmHg
timeFrame: pre-surgery and post-surgery (4-6 months after surgery) measurements
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The Pelvic Floor Institute
state: Florida
city: Princeton
country: United States
facility: Princeton Urogynecology PU
state: New Jersey
city: Allentown
country: United States
facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Falls Church
country: United States
facility: Inova Health System Foundation
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
References: