louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02445261: Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing
Official title: The Effects of Mobile Phone on Umbilical Artery Doppler and Fetal Cardiotogogrphy in Normal and Gowth Restricted Fetuses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Artery Doppler
Fetal Heart Rate Tracing
Keywords: MOBILE PHONE ON AND IN AND
UMBILICAL ARTERY DOPPLER
FETAL CARDIOTOCOGRAPHY
GROWTH RESTRICTED FETUS
NORMAL GROWTH FETUS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Women were instructed not to use the mobile phones for 24 hours before carrying out the initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace recording was done followed by umbilical artery Doppler ultrasound using high resolution ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of spontaneous decelerations.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 40 years pregnant between
* singleton fetus
* 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120 women with normally growing fetuses. Group (B) included 70 women with growth-restricted fetuses.

Exclusion Criteria:

* presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios

Primary outcomes:
measure: umbilical artery doppler
timeFrame: 5 minutes after hanging up the mobile phone
Secondary outcomes:
measure: fetal heart rate tracing
timeFrame: 10 minutes after phone is in the dialing mode for
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maged
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed M Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706961: Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Official title: Effect Of Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the effect of power walking on quality of life in Post CABG population undergoing phase 2 cardiac rehabilitation


Eligibility criteria: Inclusion Criteria:

* Male and Female subject
* Age will be from 50 to 70
* Four weeks after CABG surgery patient are eligible to participate
* Patient able to walk on Treadmill with Cardiac symptoms stable or absent
* Appropriate HR response to exercise

Exclusion Criteria:

* Those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.

Primary outcomes:
measure: Heart Quality of Life questionnaire
timeFrame: 4th weeks
Secondary outcomes:
measure: Six Minute Walk Test (6MWT)
timeFrame: 4th week
measure: BORG Rating of Perceived exertion
timeFrame: 4th Week
measure: Pulse rate
timeFrame: 4th Week
measure: Liebowitz Social Anxiety Scale
timeFrame: 4th Week
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Women Institute of Rehabilitation Sciences (WIRS) and Jinnah International Hospital
state: Khyber PkahtoonKhwa
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078661: Safety and Efficacy of PG101 for Dry Eye Syndrome
Official title: A Single Center, Randomized, Double-Masked, Placebo Controlled Study Evaluating the Safety and Efficacy of 0.25% PG101 and 1.0% PG101 in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Syndrome
Keywords: Keratoconjunctivitis sicca
Dry eye
Lead sponsor: Rhodes Pharmaceuticals, L.P.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-03-05
Enrollment: 72
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: To evaluate the safety and efficacy of 0.25% PG101 and 1.0% PG101 topical gel suspension compared to placebo when administered two times daily for 14 days in subjects diagnosed with dry eye syndrome

Detailed description: The topical product PG101 is expected to be efficacious in treating the symptoms of dry eye such as discomfort, dryness, grittiness, burning, stinging, photophobia, lid friction, mucus discharge and hyper-tearing. Two concentrations (0.25% and 1.0%) are included in the study to determine if there is a dose response effect.

Eligibility criteria: Inclusion Criteria:

* Be male or female of any race, at least 18 years of age
* Have provided verbal and written informed consent
* Be able and willing to follow instructions, including participation in all study assessments and visits
* Have a reported history of dry eye syndrome
* Have a history of use or desire to use eye drops for dry eye
* If a woman of childbearing potential, have a negative pregnancy test at Visit 1 and be using an adequate method of birth control throughout the study period
* Have a best corrected visual acuity of +0.70 logMAR or better in both eyes

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment or may interfere with study parameters
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1
* Be a woman who is pregnant, nursing or planning a pregnancy
* Have a known allergy and/or sensitivity to the test article or its components
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1

Primary outcomes:
measure: At least one dry eye ocular symptom
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: At least one dry eye ocular sign measure.
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye
state: Massachusetts
Study officials:
affiliation: Andover Eye
name: Gail Torkildsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05714761: Postpartum Continuous Glucose Monitoring (CGM) Study
Official title: Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
oral glucose tolerance test
glucose sensor
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2023-02-06
Enrollment: 50
Sex: FEMALE
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 research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).


Eligibility criteria: Inclusion criteria:

* include diagnosis of gestational diabetes during a current or recent pregnancy
* age 18 or older.

Exclusion criteria:

* include known pregestational diabetes,
* known skin adhesive allergy which would prevent subject from wearing a CGM,
* chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.

Primary outcomes:
measure: Number of Participants With at Least 72 Hours of CGM Data Downloaded.
timeFrame: Postpartum days 10-20
Secondary outcomes:
measure: Specificity
timeFrame: up to 12 weeks postpartum
measure: Sensitivity
timeFrame: up to 12 weeks postpartum
measure: Positive Predictive Value (PPV)
timeFrame: up to 12 weeks postpartum
measure: Positive Likelihood Ratio (PLR)
timeFrame: up to 12 weeks postpartum
measure: Negative Predictive Value (NPV)
timeFrame: up to 12 weeks postpartum
measure: Negative Likelihood Ratio (NLR)
timeFrame: up to 12 weeks postpartum
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Grenye O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02203461: Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication
Official title: Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Keywords: ART, HIV, insulin resistance
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: MUC Research GmbH
First posted: 2014-07-30
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.

Detailed description: The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age 18-40 years
* Informed consent and willingness in study participation
* Birth control during study period

Exclusion Criteria:

* Participation in other clinical trials
* Contraindication or known allergy to study medication
* Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others
* Known alcohol or nicotine abuse
* HIV infection
* History of pharmaceutical study in the last 4 weeks
* BMI \< 18 \> 25
* Long-term or regular medication
* Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder
* Dependence to study center or coordinator
* Inmates or psychiatric treatment

Primary outcomes:
measure: Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
timeFrame: Day 14
Secondary outcomes:
measure: Changes in metabolic parameters
timeFrame: Day 14
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Klinikum rechts der Isar (TUM)
state: Bavaria
Study officials:
affiliation: University Hospital Klinikum rechts der Isar, Technische Universitaet Muenchen
name: Christoph D Spinner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05201261: the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level
Official title: the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Combined Spinal Epidurai Anesthesia
Lower Extremity Surgery
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery under spinal anesthesia. Inclusion criteria: (1) Elective lower extremity surgery; (3) ASA (American Society of Anesthesiologists) Grading: ⅰ - ⅲ.

Brief summary: Spinal anesthesia technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. How to provide perfect nerve block effect for operation, provide good postoperative analgesia, and prevent unnecessary extensive block leading to other complications and related risks has always been the focus of anesthesiologists. Doses and the relationship between the anesthesia plane great individual differences, and previous research on the patient's own condition such as height, weight, 6 to the anesthesia plane have different results, the influence of clinical work often refer patients height adjustment of drug doses, this research attempts to evaluate ultrasound was used to assess spinal vertebral body in the plane of the length and width of subarachnoid and anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective lower limbs surgery
* ASA: grade I to III

Exclusion Criteria:

* There are contraindications to spinal anesthesia
* Allergic to local anesthetics
* Patient refused

Primary outcomes:
measure: The length of lumbar cone
timeFrame: 1year
measure: The width of subarachnoid space was measured by ultrasound
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06340061: The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
Official title: The Aim of This Study is to Investigate the Correlation Between the Severity of Glaucoma and Corneal Biomechanics as Well as Anterior Chamber Parameters.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Glaucoma
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients

Brief summary: The ocular biomechanical differences between the normal control group and primary glaucoma patients, including those treated with conventional medication, laser therapy, and surgery, were compared. Additionally, an investigation was conducted to explore the relationship between anterior chamber parameters, corneal biomechanics, and the severity of glaucoma


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of primary glaucoma.
* Must be able to cooperate to complete the inspection.

Exclusion Criteria:

* Secondary glaucoma.
* Corneal disease (E. g., keratitis, corneal scarring) that the investigator believes may affect the examination.
* trauma
* congenital eye malformations

Primary outcomes:
measure: IOP
timeFrame: through study completion, an average of 2 years.
measure: bIOP
timeFrame: through study completion, an average of 2 years.
measure: ACD
timeFrame: through study completion, an average of 2 years.
measure: ACW
timeFrame: through study completion, an average of 2 years.
measure: SSI
timeFrame: through study completion, an average of 2 years.
measure: VF
timeFrame: through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
Study officials:
affiliation: Henan Provincial People's Hospital, Henan Eye Hospital
name: Qian Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600261: iCam Clinical Validation Study
Official title: iCam Clinical Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Disease
Keywords: without eye disease
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects shall be recruited from the practice of the principal investigator (PI).

Brief summary: Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Detailed description: Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Able and willing to complete the required examination

Exclusion Criteria:

* Spherical Equivalent outside -12 diopter to +15 diopter
* Without lens
* Inability to fixate

Primary outcomes:
measure: proportion of clinically useful images
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Livermore
country: United States
facility: Livermore Optometry Group
state: California
city: San Jose
country: United States
facility: Buena Vista Eye Care
state: California
Study officials:
References:
Clinical trial NCT03251261: Detection of Cytomegalovirus Virus in Neonates
Official title: Illumigene CMV Clinical Trial Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CMV
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 1615
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Saliva swab specimens from all neonates up to 21 days of age may be collected and tested

Brief summary: To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs


Eligibility criteria: Inclusion Criteria:

* Saliva swab specimens from neonates up to 21 days of age
* Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.
* Flocked-nylon swabs

Exclusion Criteria:

* Samples other than saliva swab from patients up to 21 days of age.
* Swabs other than flocked-nylon.
* Swabs in a viral transport media not defined in the Investigational Use Only package insert
* Multiple specimens from the same patient.
* Specimens received in the laboratory in unsatisfactory containers or condition.

Primary outcomes:
measure: Qualitative detection of CMV to aid in the diagnosis of CMV
timeFrame: within 30 days of sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Randwick
country: Australia
facility: The Prince of Wales Hospital
state: New South Wales
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital / British Columbia Women's Hospital
state: British Coloumbia
city: Via Massarenti 19
country: Italy
facility: Ospedale Sant'Orsola
state: Province Of Bologna
Study officials:
affiliation: Meridian Bioscience
name: Julie M Kesler
role: STUDY_DIRECTOR
affiliation: Meridian Bioscience
name: Ken Kozak
role: STUDY_CHAIR
References:
Clinical trial NCT00237861: Effectiveness of Atypical Versus Conventional Antipsychotics in Treating Schizophrenia
Official title: Effectiveness of Atypical Vs Conventional Antipsychotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-10-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia.

Detailed description: At seven participating hospitals, acutely exacerbated patients with schizophrenia were randomly assigned to treatment with antipsychotic from the atypical class vs antipsychotic from the conventional class. Medication choice within class, dose, concomitant medications, and other prescribing decisions were left to the community prescriber. Patients were followed for one year after discharge.

Eligibility criteria: Inclusion Criteria:

* hospitalized for schizophrenia

Exclusion Criteria:

* none

Primary outcomes:
measure: PANSS
measure: Retention.
Secondary outcomes:
measure: EPS, TD.
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References: