louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04938050: Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
Official title: Diagnostic Accuracy of a Specialized Pro Forma in Assessing Morbidly Adherent Placenta With Correlation to Intra-operative Findings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbidly Adherent Placenta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 21
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 21 pregnant females during their late 3rd trimester between (34 0/7: 37 0/7 weeks gestation)

Brief summary: This study objective is to assess the accuracy of a specialized pro forma in suggesting the probability of Morbidly Adherent Placenta, its extent and its correlation with intraoperative findings.


Eligibility criteria: Inclusion Criteria:

* Age group 28:42 years.
* Pregnant women in their late third trimester (34 0/7 weeks: 37 0/7 weeks).
* With a single living fetus in the current pregnancy.
* A previous delivery by at least 1 cesarean section or history of uterine surgery including (surgical evacuation, myomectomy or endometrium ablation)
* Having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment.

Exclusion Criteria:

* Cases with a non-previa placenta, posterior low lying placenta or posterior previa placenta.
* Maternal chronic medical disorders( diabetes mellitus, hypertension)
* Patients presented with severe attack of bleeding.
* Patients presented with rupture of membrane.
* Emergency delivery regardless the cause.

Primary outcomes:
measure: Clinical significance of ultrasound signs in morbidly adherent placenta(most sensitive US sign)
timeFrame: June 2021- July 2022
measure: Accuracy of our specialized pro forma in assessing extent of morbidly adherent placenta(focal , diffuse)
timeFrame: June 2021- July 2022
measure: Accuracy of our specialized pro forma in assessing depth of invasion of placenta accreta spectrum (accrete, increta and percreta)
timeFrame: June 2021- July 2022
Secondary outcomes:
measure: 1- Correlation between US signs and intraoperative findings including morbidity and mortality
timeFrame: June 2021- July 2022
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university Kasr Alainy OBGYN hospital
Study officials:
References:
Clinical trial NCT00586950: 123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
Official title: Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Fatty Acids, Unsaturated
Radioisotopes
Hemodialysis
Single Photon Emission Computed Tomography
Keywords: Myocardial Free Fatty Acid metabolism
High risk patients
End-stage renal failure
Cardiovascular events
prognosis
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Toho University Ohashi Medical Center
First posted: 2008-01-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Defined Population

Brief summary: The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.


Eligibility criteria: Inclusion Criteria:Adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease

* Hypertension
* Diabetes mellitus
* Hyperlipidemia
* Obliterative arteriosclerosis in the lower extremities
* Smoker
* Family history of juvenile coronary artery disease
* History of ischemic stroke
* History of heart failure requiring hospitalization
* Within 3 months after initiation of hemodialysis therapy
* Dialysis hypotension

Exclusion Criteria:Hemodialysis patients who meet any one of the following conditions will be excluded.

* Peritoneal dialysis
* Severe valvular disorder requiring treatment
* Diagnosis of hypertrophic cardiomyopathy(HCM) or dilated cardiomyopathy(DCM) before start of dialysis
* History of revascularization(PCI, CABG) or prior diagnosis of myocardial infarction
* Hypersensitivity to BMIPP or its analogue
* Judged unsuitable for the study for any other reasons by physicians.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
Study officials:
affiliation: Asahikawa Medical College
name: Kenjiro Kikuchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564950: Influence of Periodontitis and Coronary Heart Disease on Galectin-3
Official title: Influence of Periodontitis and Coronary Heart Disease on Galectin-3 in Serum and Saliva
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 155
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38)

Brief summary: The aim of this study was to analyze the association between serum and salivary Galectin-3 levels in patients with periodontitis. Furthermore, the objective was to determine if the periodontitis influenced serum and salivary Galectin-3 levels

Detailed description: Healthy controls (n=38), patients with CHD (n=39), periodontitis (n=40), and a combination of periodontitis + CHD (n=38) were enrolled in the present study. The analyzed sample undergo a demographical, clinical and periodontal evaluation and serological analyses including Endothelin-1 (ET-1) and for serum and salivary Galectin-3 levels.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 16 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Changes of Clinical Attachment Level (mm)
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
References:
Clinical trial NCT02660450: Relationship Between Aerobic Prescription Methods
Official title: Relationship Between Methods of Aerobic Prescription: Heart Rate vs. VO2 Load vs. Self Selected
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2016-01-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Current literature report 3 ways to prescribe and control aerobic training. Such models require comparison to determine if they really provide the same impact training in a prescription. The aim of this study is to compare the results of different methods of prescription of aerobic training, ie VO2 workload, heart rate (HR), and load self adjusted by perceived effort (PSE) as well as psychological responses activation, and feel depending on the stimuli offered.

Detailed description: 36 subjects will undergo two sessions. On the first visit, a maximum aerobic exercise test will be carried on treadmill to determine the maximum oxygen intake and maximum heart rate. Second, the subjects are placed (in a blinded fashion) in 3 situations of moderate effort (60 to 65%) for a total of 5 min and 3 min interval between conditions. In situation 1) will be used to speed regarding the particular metabolic demand from the maximum oxygen intake; In the second situation the reserve of heart rate will be used as reference for prescription aiming to achieve 60-65%; On the last visit will be shown to subjects a perceived effort characterized as moderate and asked to adjust their speed according to the application effort. The final will be recorded each time the FC and the speed and perception of effort that the subject was.

Eligibility criteria: Inclusion Criteria:

* 18 at 45 years
* Risk stratification low
* Physically active by American College of Sports Medicine criteria

Exclusion Criteria:

* Use of ergogenic resources
* Use of sympatholytic drugs
* Use of stimulants

Primary outcomes:
measure: Response of Heart Rate and perceived Effort through prescriptions for oxygen uptake
timeFrame: Acute Change in 5 minutes of moderate aerobic exercise
measure: Response of Heart Rate through prescriptions for self selected workload based in perceived effort
timeFrame: Acute Change in 5 minutes of moderate aerobic exercise
measure: Response of velocity and Perceived Effort through Prescription of Heart Rate
timeFrame: Acute Change in 5 minutes of moderate aerobic exercise
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06851650: Efficacy of Adding Early Scapular Muscles Strengthening Exercise After Rotator Cuff Repair on Scapula Kinematics
Official title: Early Strengthening of Lower Trapezius and Serratus Anterior Muscles in an Accelerated Rehabilitation Program After Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Rotator Cuff Repair Rehabilition
Supraspinatus Tear
Keywords: Rotator cuff repair Rehabilition, scapular upward rotation, scapular strengthen exercise
accelerate rehabilitation protocol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the effect of accelerate rehabilitation protocol(adding scapular strengthen exercises (lower trapezius and serratus anterior) from week 1) after arthroscopic rotator cuff repair on scapular upward rotation during shoulder elevation.

Detailed description: the study will consist of 2 group Both groups will participate in an accelerated rehabilitation program starting the first week after surgery till week 12, but they will follow different protocols. Accelerated rehabilitation protocol with Early Strengthening of Scapular stabilizer muscle (LT and SA) and GH Active range of motion protocol will be starting gradual active ROM for GH from week 3 post operative till week 12 and gradual scapular muscles strengthening exercises (serratus anterior, lower trapezius) from day 1 while Accelerated rehabilitation protocol with Delay strengthening of Scapular stabilizer muscles and Active GH range of motion protocol will start active ROM for GH and scapular activation exercises (protraction, retraction, and depression) from week 6 till week 12. Patients will wear the sling for the first 6 weeks or as the physician recommends and remove it only during the session and home program.

7 The outcomes will be measured 3 times, at week 3 as a baseline for assessment, then reassess at weeks 6, and 12

Eligibility criteria: Inclusion Criteria:

1. Patients after arthroscopic rotator cuff repair.
2. Both gender between age 30 to 50 years
3. Small and medium supraspinatus tear

Primary outcomes:
measure: Upward rotation of the scapula
timeFrame: At week 3 and week 9 and week 12 after arthroscopic rotator cuff repair
Secondary outcomes:
measure: glenohumeral shoulder elevation
timeFrame: At week 3 and week 9 and week 12 after arthroscopic rotator cuff repair
Other outcomes:
Locations:
city: Alexsandria
country: Egypt
facility: Wengat Hospital
Study officials:
References:
Clinical trial NCT00833950: Phase Out in Tinnitus Patients
Official title: Phase Out Treatment for Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinnitus
Keywords: Tinnitus
Phase Out
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.

The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.


Eligibility criteria: Inclusion Criteria:

* consult ENT department UZA with tinnitus
* pure tone tinnitus or narrow band noise tinnitus
* unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
* frequency tinnitus \> 1kHz
* cochlear origin tinnitus
* tinnitus duration 3 months or longer
* age 18y or more
* patient being able to cooperate
* patiënt able to fill in VAS
* normal MRI pontine angle

Exclusion Criteria:

* depression: BDI \> 21
* pulsatile tinnitus
* pregnancy
* epilepsy

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 3x/week
Secondary outcomes:
measure: Score on Tinnitus Questionnaire
timeFrame: week 0, week 3, week 6
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp university Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT01112150: Effect of Normatec Pump for Relief of Leg Edema
Official title: Effect of Normatec Pump for Relief of Leg Edema: Short- Intermediate- and Longer-term Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edema
Heart Failure
Pulmonary Hypertension
Keywords: Edema
Heart failure
Pulmonary hypertension
Edema in legs
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesize that leg edema will decrease rapidly when using the NormaTec pump, patients will lose weight, will feel better, will be less prone to infections in their legs and to congestion of the liver. Temporary elevation of intravascular fluid volume by the mobilized edema fluid returned to the intravascular space by pumping may increase cardiac output and renal perfusion and in addition it may distend the right atrium and ventricle thus inducing BNP secretion. Both mechanisms may promote excess fluid removal by the kidneys.


Eligibility criteria: Inclusion Criteria:

* hemodynamically stable adult patients with pronounced leg edema from any etiology, on optimal medical therapy (such as diuretics, ACE-I or ARBs, digoxin).
* documentation of right heart failure by Echo or other modality (CT, MRI, right heart catheterization) and hemodynamic data from Echo is required and an elevated pulmonary artery pressure (\> 35 mmHg) is expected in such cases.

Exclusion Criteria:

* patients in sepsis,
* hemodynamically unstable,
* during an acute attack of pulmonary edema,
* with renal failure (creatinine \> 2 mg%),
* with DVT,
* psychiatric or noncompliant patients, and
* patients who will not sign the informed consent form will be excluded from the study.

Primary outcomes:
measure: Weight Loss
timeFrame: 5 days
Secondary outcomes:
measure: Leg circumference
timeFrame: 5 Days
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Ceter
Study officials:
References:
Clinical trial NCT00850850: Physostigmine After General Anesthesia
Official title: The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Anesthesia Recovery Period
Keywords: PACU
Physostigmine
Recovery
Postanesthesia Nursing
Wakefulness
General anesthesia
General Anesthetics
Postoperative Period
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recovery after general anaesthesia is often prolonged in the elderly. This group is particularly exposed to post-operative confusion. This has negative personal consequences as well as consequences for the postoperative care for these patients.

The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative confusion.

Detailed description: The researchers wish to investigate the use of physostigmine in the elderly patients (age \> 60 yrs, ASA I-III) in the postoperative recovery-phase after general anesthesia.

Apart from the beneficial effects for the patient, the lessened amount of time in the PACU will release caregiving resources and thereby increase the efficacy of the PACU.

Eligibility criteria: Inclusion Criteria:

* Scheduled for surgical acute or elective operation
* General anesthesia.
* ASA physical status I-III
* Age \> 60 years

Exclusion Criteria:

* Asthma and chronic pulmonary diseases
* Glaucoma
* Diabetics
* Any history of neurological and psychiatric disorder
* Parkinson's disease
* Disorders of the gastrointestinal and urogenital tracts

Primary outcomes:
measure: The readiness to be released from the PACU (assessed by the normal guidelines) It should be noted that for safety reasons the patients remained in the PACU for at least 60 minutes
timeFrame: 60 minutes
Secondary outcomes:
measure: Pain, shivering and nausea will also be registered on the standardized form as well as a multiple of physiological measurements. A follow-up will be performed after 12 hours from release from the PACU
timeFrame: 6 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Frank Pott, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01269450: Progesterone and Second Trimester Bleeding
Official title: The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Antepartum Bleeding
Preterm Birth
Keywords: second trimester vaginal bleeding
late abortion
preterm birth
progesterone
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Working hypothesis and aims:

To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.

The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.


Eligibility criteria: Inclusion Criteria:

* Viable pregnancy
* Gestational age between 13 to 26 weeks
* Vaginal bleeding from uterine origin
* Singleton pregnancy
* Normal clotting tests
* Hemodynamically stable woman

Exclusion Criteria:

* Water leak
* Signs of preterm labor
* Fetal malformations incompatible with life
* Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
* Past preterm birth

Primary outcomes:
measure: Incidence of spontaneous preterm birth - before 37 weeks.
timeFrame: 3 years
Secondary outcomes:
measure: Maternal and fetal outcomes
timeFrame: 3 years
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
city: Hadera
country: Israel
facility: dEP ob/gyn, Hillel Yaffe Medical Center.
city: Nazareth
country: Israel
facility: Dep. OB/GYN, The Nazareth Hospital, E.M.M.S
Study officials:
affiliation: HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel
name: RAED SALIM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salim R, Hakim M, Zafran N, Nachum Z, Romano S, Garmi G. Double-blind randomized trial of progesterone to prevent preterm birth in second-trimester bleeding. Acta Obstet Gynecol Scand. 2019 Oct;98(10):1318-1325. doi: 10.1111/aogs.13641. Epub 2019 Jun 1.