louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02294110: Effect of Diabetes Mellitus on Success of Spinal Anesthesia
Official title: Phase IV Study of Diabetes Mellitus for Spinal Anesthesia Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: failure
spinal anesthesia
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-11-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who undergoes surgery with spinal anesthesia

Brief summary: Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia failure. However, that opinion was not determined in a trial. Thus the investigators aimed to investigate the effect of diabetes mellitus on spinal anesthesia.

Detailed description: The investigators will include all of the patients who will undergo surgery with spinal anesthesia. The investigators will observe the patients with or without diabetes mellitus. And the investigators will examine the effect of diabetes mellitus on failure of spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* surgery with spinal anesthesia

Exclusion Criteria:

* heart failure
* coronary artery disease

Primary outcomes:
measure: sensorial loss with pin prick test
timeFrame: intraoperative 5 th minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D.
name: dilek yazıcıoğlu, M.D.
role: STUDY_CHAIR
References:
citation: Hoppe J, Popham P. Complete failure of spinal anaesthesia in obstetrics. Int J Obstet Anesth. 2007 Jul;16(3):250-5. doi: 10.1016/j.ijoa.2006.12.005. Epub 2007 May 16.
Clinical trial NCT02343510: Detection of Chlamydia DNA by Polymerase Chain Reaction in Primary Tubal and Ovarian Cancers Tissues : a Pilot Study
Official title: Detection of Chlamydia DNA by Polymerase Chain Reaction ( PCR ) in Tumours Tissue of Primary Tubal and Ovarian Cancers : a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Fallopian Tube
Keywords: Fallopian tubal cancer, high grade serous , ovarian cancer
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathology blocks of patients with primary tubal cancer and with high grade serous ovarian cancer and normal tubes.

Brief summary: PCR for chlamydia DNA is done in paraffin blocks of cases of primary tubal cancer and is compared to cases of high grade serous ovarian cancer and normal tubes .

Detailed description: The investigators shall review the early cancer detection unite pathology records for the past 10 years , for cases diagnosed with primary Fallopian tube cancers , cases of high and low grade serous ovarian cancer and cases underwent hysterectomy and salpingectomy for non oncological reasons. Paraffin blocks for suitable selected patients will be examined histologically to confirm the primary diagnosis . Chlamydia DNA in these paraffin blocks of the Fallopian tubes and ovarian tissues will be examined using PCR techniques . The possible correlation between the presence of Chlamydia DNA and the ovarian serous tumours and primary tubal cancer will be analyzed statistically .

Eligibility criteria: Inclusion Criteria:

* any patient with primary tubal cancer and high grade serous cancer and normal tubes.

Exclusion Criteria:

* clinical pelvic inflammatory disease
* salpingectomy for ectopic

Primary outcomes:
measure: Presence of chlamydia DNA in tubal and ovarian tissues
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Presence of concomitant tubal cancer with high grade serous ovarian cancer
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
Clinical trial NCT03089710: Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
Official title: The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Detailed description: Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in prone position surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Eligibility criteria: Inclusion Criteria: meet both of

1. Patients receiving scheduled prone position spine surgery
2. BMI 18.5\~30 kg.m-2

Exclusion Criteria:

1. age younger then 20 yrs or elder than 80 yrs
2. pregnant women
3. patients in intensive care units
4. patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
5. patients with ongoing infection
6. patients allergic to voluven

Primary outcomes:
measure: Change of cardiac index after fluid loading
timeFrame: 3hr
Secondary outcomes:
measure: pulse pressure variation(PPV)
timeFrame: 3hr
Other outcomes:
measure: stroke volume variation(SVV)
timeFrame: 3hr
measure: plethysmographic variation index(PVI)
timeFrame: 3hr
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
References:
Clinical trial NCT04921410: AI Driven Biofeedback Wearable
Official title: Artificially Intelligent Biofeedback Sleeve for Prevention and Rehabilitation of Traumatic Knee Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: injury
prevention
biofeedback
knee
wearable
rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to conduct a comprehensive clinical and biomechanical screening of high school, collegiate-level, recreational, and Olympic/professional-level athletes with the goal of identifying individual functional and performance deficits that lead to future injury.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 12 - 65 years old.
* Athlete at High School, Collegiate, Recreational, Olympic / Professional level.

Exclusion Criteria:

* Indidividual under 12 or over 65 years old.
* Lower extremity injury in the past 6 months.
* History of neurological disease, vestibular or visual disturbance.
* Any other pathology that would impair motor performance.

Primary outcomes:
measure: 3D Motion
timeFrame: 8-16 weeks
measure: Rate / Incidence of Knee Injury
timeFrame: 8-16 weeks
Secondary outcomes:
measure: Landing force
timeFrame: 8-16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Clifton Haider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03963310: Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis
Official title: Evaluation and Follow-up of Optic Neuritis Not Related to Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Optic Neuritis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen at the Adolphe de Rothschild Foundation for the first onset of an optic neuritis not related to multiple sclerosis and clinically isolated syndrome

Brief summary: The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution.

This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.


Eligibility criteria: Inclusion Criteria:

* First onset of an optic neuritis lasting for less than 1 month
* With a brain MRI that does not meet the MS criteria

Exclusion Criteria:

* Contra-indication to MRI
* Pregnant or lactating woman
* History of known ipsilateral optic neuritis
* Ophthalmologic comorbidity in the ipsilateral eye that may interfere with the interpretation of the examinations

Primary outcomes:
measure: Visual acuity (ETDRS scale)
timeFrame: 1 year
measure: Thickness of the layers of the retina with Optical Coherent Tomography(OCT),
timeFrame: 1 year
measure: Standard Humphrey Visual Field Test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A. de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Romain DESCHAMPS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697814: Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Official title: Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadotropic Hypogonadism
Prolactinoma
Keywords: Hypogonadotropic hypogonadism
Prolactinoma
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. Clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open label clinical trial of CC to evaluate its effects in reverting persistent HH in male patients with prolactinomas under dopaminergic agonist treatment.


Eligibility criteria: Inclusion Criteria:

* a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least 2 months)
* serum total testosterone less than 300ng/dl with normal or low LH and FSH levels after discontinuing testosterone replacement for at least 2 months.

Exclusion Criteria:

* impossibility to attend scheduled visits and irregular compliance to DA treatment.

Primary outcomes:
measure: assess the effects of CC treatment on testosterone levels in male patients with prolactinomas and persistent HH on dopaminergic agonist therapy
timeFrame: 10 days, 4, 8 and 12 weeks
Secondary outcomes:
measure: Assess the effects of CC on sexual function, fertility, body composition, lipid and glucose metabolism, and quality of life were also evaluated.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Neuroendocrine Unit - Escola Paulista de Medicina (UNIFESP)
state: SP
Study officials:
affiliation: Neuroendocrine Unit
name: Julio Abucham, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02424214: Artificial Oocyte Activation Comparing Tow Different Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oocyte Fertilization
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Al Baraka Fertility Hospital
name: Banon IVF Center Assiut, Egypt
First posted: 2015-04-22
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

Detailed description: The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.

Eligibility criteria: Inclusion Criteria:

* previous fertilization failure
* poor quality Oocytes
* poor sperms

Exclusion Criteria:

* normal patients

Primary outcomes:
measure: Pregnancy rate ( % )
timeFrame: 9 months
Secondary outcomes:
measure: Blastocyst rate ( % )
timeFrame: 9 months
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Al Barka fertility center
city: Assiut
country: Egypt
facility: Banon Fertility Center
city: Sohag
country: Egypt
facility: Ibnsina IVF center
Study officials:
References:
citation: Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.
Clinical trial NCT04887714: Physiological Impact of Cloth Mask During Exercise
Official title: Physiological Impact of Cloth Mask During Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Mask wearing during the Covid-19 pandemic has been proven substantially effective in containing the spread of infection, with cloth masks being the most universally used. However, cloth masks may be uncomfortable and have physiological repercussion during exercise. This study aims to investigate the impact of cloth masks during exercise.


Eligibility criteria: Inclusion Criteria:

* healthy individuals
* active, non-active and athletic individuals;

Exclusion Criteria:

* preexisting chronic conditions
* obesity
* physical limitation precluding exercise.

Primary outcomes:
measure: perceived exertion ratings
timeFrame: immediately after the intervention
measure: perceived exertion ratings
timeFrame: during the intervention
Secondary outcomes:
measure: oxygen consumption
timeFrame: immediately after the intervention
measure: spirometry/lung function (VeVCO2 Slope)
timeFrame: during the intervention
measure: spirometry/lung function (PetCO2)
timeFrame: during the intervention
measure: spirometry/lung function (OUES)
timeFrame: during the intervention
measure: spirometry/lung function (flow-volume loop)
timeFrame: during the intervention
measure: blood lactate
timeFrame: immediately after the intervention
measure: oxygen saturation
timeFrame: immediately after the intervention
measure: vertical jump
timeFrame: immediately after the intervention
measure: heart rate recovery
timeFrame: immediately after the intervention
measure: Scale of Measuring Subjective Perceptions to maskwearing
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: General Hospital - School of Medicine - University of Sao Paulo
Study officials:
References:
Clinical trial NCT01746914: Morphofunctional Lung Analysis by PET and CT After Lung Transplantation
Official title: Morphofunctional Lung Analysis by Positron Emission Tomography and Computed Tomography After Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder Related to Lung Transplantation
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung Transplantated patients

Brief summary: 72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology.

Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.

Detailed description: Pulmonary transplantation is considered as a lifesaving procedure in end-stage pulmonary disease. However morbidity and mortality after lung transplantation are still significant.

Primary graft dysfunction (PGD) is the main cause of early death. PGD is similar to acute lung injury (ALI)/ acute respiratory distress syndrome (ARDS): oxygenation is compromised, pulmonary compliance is decreased, chest Rx shows several infiltrates, and alveolar damage is present.

25% of patients develops PGD within 72 hours from transplantation and 30 days mortality is eight times higher in patients who develop PGD.

72 hours after lung transplantation, patients, whose clinical condition allow to bring them to nuclear medicine department, will undergo pulmonary computed tomography (CT) to study lung morphology and measure lung recruitability and positron emission tomography (PET) to study lung functionality and estimate lung inflammation.

Aim of this study is to investigate the onset of PGD and other complications and to determine 72 hours and 90 days mortality after lung transplantation.

Eligibility criteria: Inclusion Criteria:

* lung transplantation
* ≥ 18 years

Exclusion Criteria:

* \< 18 years
* patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit

Primary outcomes:
measure: Number of patients alive
timeFrame: up to 90 days from transplantation
Secondary outcomes:
measure: incidence of complications other than primary graft dysfunction
timeFrame: 72 hours and 90 days
measure: incidence of primary graft dysfunction
timeFrame: 72 hours and 90 days after transplantation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Milan
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Hospital
name: Franco Valenza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02988414: Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
Official title: Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Septicemia
Keywords: Sepsis
Infection
Culture
Sequencing
Non-invasive
NGS
Lead sponsor: Karius, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2016-12-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are at least 18 years of age, have been admitted to Duke University Hospital, and have a positive blood culture.

Brief summary: Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. A positive blood culture
3. A suitable residual blood sample collected within 24 hours of the positive blood culture OR
4. A blood sample obtained for the study obtain within 48 hours of the positive blood culture

For Endocarditis Cohort:

1. All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria

Exclusion Criteria:

1. Inability to understand instructions and comply with study-related procedures
2. Any condition that in the opinion of the treating physician will prevent the subject from completing the study

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Vance G Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References: