louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01665495: Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
Official title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pericardial Effusion
Keywords: pericardial effusion
cardiac tamponade
pericardiocentesis
pericardial drainage
prevention
Lead sponsor: Maria Vittoria Hospital
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.

Detailed description: The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.

Eligibility criteria: Inclusion Criteria:

* adult patients
* pericardial effusion requiring pericardiocentesis
* non-malignant etiology

Exclusion Criteria:

* known neoplastic etiology
* known bacterial etiology

Primary outcomes:
measure: Recurrent pericardial effusion
timeFrame: 12 months
measure: Need for repeated pericardiocentesis
timeFrame: 12 months
measure: Need for cardiac surgery
timeFrame: 12 months
Secondary outcomes:
measure: Hospital stay
timeFrame: 12 months
measure: Disease-related hospitalization
timeFrame: 12 months
measure: Overall mortality
timeFrame: 12 months
Other outcomes:
measure: Complication rates
timeFrame: 12 months
Locations:
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Bolzano
country: Italy
facility: Ospedale Regionale San Maurizio
city: Milan
country: Italy
facility: Ospedale Niguarda
city: Rivoli
country: Italy
facility: Ospedale degli Infermi
city: Torino
country: Italy
facility: Cardiology Department, Maria Vittoria Hospital
city: Torino
country: Italy
facility: Cardiology Department, Ospedale San Giovanni Bosco
city: Torino
country: Italy
facility: Ospedale Mauriziano
Study officials:
affiliation: Cardiology Department, Maria Vittoria Hospital
name: Massimo Imazio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imazio M, Belli R, Beqaraj F, Giammaria M, Lestuzzi C, Hoit B, LeWinter M, Spodick DH, Adler Y; DROP Investigators. DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention: rationale and design of the DROP trial, a randomized, open-label, multicenter study. J Cardiovasc Med (Hagerstown). 2014 Jun;15(6):510-4. doi: 10.2459/JCM.0b013e3283621d26.
Clinical trial NCT01099995: Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
Official title: Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carbon Monoxide Poisoning
Keywords: domestic accident
coma
carbon monoxide
intoxication
acute domestic carbon monoxide poisoning
Lead sponsor: University of Versailles
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2010-04-08
Enrollment: 170
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.


Eligibility criteria: Inclusion Criteria:

* patients older than 15 years of age
* admitted for domestic CO poisoning within 12 hours after the end of CO exposure
* initial coma, regardless of consciousness at hospital admission
* carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively

Exclusion Criteria:

* poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke)
* suicide attempt
* pregnancy
* contraindications to HBO (circulatory collapse or pneumothorax)
* technical obstacles to HBO
* non domestic CO poisoning
* difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
* consent refusal

Primary outcomes:
measure: complete recovery
timeFrame: at one month
Secondary outcomes:
measure: persistent neurological sequels
timeFrame: at one month
measure: delayed neurological sequels
timeFrame: at one month
measure: the difference in carboxyhemoglobin levels before/after treatment completion
timeFrame: at 12 hours from randomization
measure: serious adverse events
timeFrame: at one month
Other outcomes:
Locations:
city: GArches
country: France
facility: Raymond Poincaré Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Djillali Annane, MD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Claude Raphael
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03250195: Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Official title: Non-invasive Detection of Male Infertility With FDG-PET/MRI (Spectroscopy and DWI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to examine the value of the new MRI techniques (spectroscopy and DWI), and FDG-PET in prognostication of male infertility.

Detailed description: The diagnostic workup of male infertility includes medical history, physical examination and semen analysis. In severe cases further workup includes testicular ultrasound, analysis of genes and hormones and in a few cases testicular biopsies are necessary.

Ultrasound is the first choice of imaging, but new MRI and PET techniques can provide additional information.

Research indicates that new MRI techniques can measure the activity of the testicular sperm cell production non-invasively and FDG-PET can measure the testicular metabolism with a radioactively marked glucose analog (FDG). These imaging modalities are combined in a PET/MRI and we wish to perform a PET/MRI in 10 men with normal sperm counts and 10 men with low sperm counts in order to evaluate whether a PET/MRI can distinguish testicles with and without sperm cell production. We hope that this new non-invasive technique can replace the need for invasive biopsies and will be able to target the harvesting of sperm cells in fertility treatment.

Eligibility criteria: Inclusion Criteria:

18-40 year old males referred to fertility treatment at Rigshospitalet, Denmark. 10 men with a normal sperm count and 10 men with no sperm cells in the ejaculate will be included. The patients shall be able to understand the patient information and be able to give informed consent.

Exclusion Criteria:

Severe claustrophobia Age: less than 18 or above 40 Severe obesity (\> 140 kg) Pacemaker or other electronic in-operated devices Non-MR compatible metallic devices Malignant testicular tumors suspected at clinical examination or ultrasound Infectious testicular diseases

Primary outcomes:
measure: SUVmax (maximum standardized uptake value)
timeFrame: 1 year
measure: Testicular metabolite concentrations measured by MRI spectroscopy.
timeFrame: 1 year
measure: Testicular apparent diffusion coefficient
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Louise Risør
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371695: Serum IGF-II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
Official title: Phase 1 of Serum IGF II and Cancer: Can IGF II Levels be Used to Monitor and Screen Patients Specifically for Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia II
Cervical Intraepithelial Neoplasia III
Keywords: IGF-II levels
Lead sponsor: Onconix, Inc
Sponsor class: INDUSTRY
First posted: 2011-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: university clinic

Brief summary: The purpose of this study is to determine whether Insulin-like Growth Factor II is elevated sufficiently to detect Cervical Intraepithelial Neoplasia II (CIN II), Cervical Intraepithelial Neoplasia III (CIN III), and cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 75 years
* Female
* Normal medical history
* Medical history of a single type of cancer confirmed by biopsy or equivalent criteria
* Squamous cell carcinoma of organs other than cervix
* Adenocarcinoma
* Medical history of inflammatory disease
* May be pregnant
* Pap smear positive for Cervical Intraepithelial Neoplasia II or III
* Squamous cell cervical cancer confirmed by biopsy
* Informed consent
* Willingness to submit a blood sample by venipuncture
* Willingness to submit a second blood sample if necessary

Exclusion Criteria:

* Age \< 18 or \> 75 years
* Medical history of cancer other than cervical cancer, Non-islet-cell tumor hypoglycemia, Growth hormone deficiency, Acromegaly, Hepatoma, inflammatory disease in addition to confirmed CIN and cervical cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences
state: Georgia
Study officials:
References:
Clinical trial NCT00863395: Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Official title: Recalcitrant Pruritus in Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cutaneous T-Cell Lymphoma
Keywords: pruritis
itch
CTCL
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to define the mechanisms that underlie the refractory pruritus (itch) in Cutaneous T-Cell Lymphoma (CTCL).

Detailed description: Little is known about the fundamental cause of pruritus in CTCL, however we do know the malignant CD4+ T-cells of CTCL accumulate in the epidermis and are in close proximity to the neural, immune and vascular systems that influence and regulate the biology of the skin. The close proximity of malignant CD4+ T-cells with the key mediators in the itch process could result in the pruritus experienced by patients with CTCL. To accomplish this we are collecting and examining skin biopsies for CTCL patients and healthy controls to identify itch-associated local biomarkers of the disease. In addition to these skin biopsies, we are retrospectively examining existing paraffin-embedded skin biopsy tissue blocks from CTCL patients. We are performing comparative and quantitative immunohistochemical analyses on the samples. This study will help to determine which components in the skin are potential key players in the manifestation and maintenance of recalcitrant pruritus in patients with CTCL.

Eligibility criteria: Inclusion Criteria:

* Patients with CTCL

Exclusion Criteria:

* None

Primary outcomes:
measure: Collection of biopsies from pruritic CTCL patients, non pruritic CTCL patients and controls and analysis of a panel of itch-associated local biomarkers in an attempt to characterize and quantify the components in the skin involved.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05777395: Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
Official title: Comparison of Maitland Oscillatory Mobilizations With Kaltenborn Sustained Stretch Mobilizations in Cervicogenic Headache Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with Maitland oscillatory mobilizations and the second will receive Kaltenborn sustained stretch mobilizations with conventional physical therapy. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Cervicogenic headache is a common headache that causes disability and affects everyday activities. Headache related disorders are the second most common reason for years lived with disability all over the world. According to the latest International Headache Society model, cervicogenicheadache (CGH) is a secondary headache having C1-C2 dysfunction. There is marked limitation in cervical ROM specially rotation. Treatment indicated involves use of electrotherapy and thermal modalities. In addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. C1-C2 dysfunction. Maitland mobilizations for cervical spine have been found to be effective in treating CGH patients. Maitland mobilizations uses oscillatory mobilizations and has four grades. Kaltenborn, on the other hand, applies sustained stretches and has 3 grades.So, the study will be focusing on comparing the effectiveness of these two mobilizations on cervicogenic headache patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-45 years
* Both males and females
* Unilateral headache with no shift of side
* C1-C2 dysfunction
* Headache with neck stiffness
* Headache at least once a month in the last 3 months
* Positive flexion rotation test (Rotation restriction is greater than 10 degrees)
* Headache with a score of at least 4 in the Numeric pain rating scale

Exclusion Criteria:

* Cervical spondylosis
* Headache of non-cervical origin
* Dizziness or visual disturbance
* Cervical radiculopathy/ nerve root involvement/ disc herniation
* Cervical instability/ fracture
* Vertebrobasilar insufficiency
* Thoracic outlet syndrome
* Cervical spine surgery
* Cervical spondylolisthesis
* Spinal infection or tumors
* Osteoporosis
* History of trauma
* Metabolic disorders
* Rheumatoid Arthritis
* Inflammatory Arthritis

Primary outcomes:
measure: Pain intensity
timeFrame: 2 weeks
measure: Cervical range of motion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT01761695: Chronic Myelod Leukemia Registry at Asan Medical Center
Official title: Prospective Observational Cohort Registry for Patients With Chronic Myeloid Leukemia at Asan Medical Center
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Leukemia, Chronic Myeloid
Myeloid Leukemia, Chronic, Accelerated Phase
Myeloid Leukemia, Chronic, Chronic Phase
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed and/or treated with chronic myeloid leukemia at Asan Medical Center, Seoul, Korea

Brief summary: The investigators would like to propose a prospective longitudinal observational cohort study for patients who will be diagnosed and/or treated for chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, to use the acquired data for fundamentals of other retrospective analysis.

Detailed description: 1. Acquisition of informed concent form
2. Data acquisition from medical record including

   * demographic / disease-associated factors
   * details of treatment, and its results
   * complications during treatment
   * genetic data
   * survival outcome (upto 30 years)
3. Accumulation of data for 30 years
4. Use of data for other retrospective analysis (including Asan Medical center Cell Banking basic data)

Eligibility criteria: Inclusion Criteria:

* All patients who are diagnosed and/or treated as chronic myeloid leukemia at Asan Medical Center
* 15 years of age and over
* All patients who give written consent according to guidelines at Asan Medical Center committee on human research

Exclusion Criteria:

* Patients who refuse to give consent to registering

Primary outcomes:
measure: Overall survival
timeFrame: 30 years
Secondary outcomes:
measure: Event-free survival
timeFrame: 30 years
measure: Failure-free survival
timeFrame: 30 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Assistant Professor
name: Dae-Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069795: Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
Official title: Utilization of Speech Analysis as a Diagnostic Tool to Objectively Evaluate Early Signs of Mild Traumatic Brain Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Keywords: concussion, athlete, speech analysis
Lead sponsor: Forte Sports Medicine and Orthopedics
Sponsor class: OTHER
Collaborators: name: Waveform Communications LLC
First posted: 2014-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. The aim of this study is to investigate this possibility using the Cobweb automated application system for acoustic processing.

Detailed description: Concussions affect cognitive and fine muscle motor control, and these changes will be reflected in the acoustic characteristics of the vowels being produced. The methods to identify and analyze the acoustics of vowels will greatly extend the detailed understanding of vowels produced after a concussion. The identification of the changes in formant frequencies, pitch, and duration will provide the means to use these parameters as an automated diagnostic tool. The waveform assessment of the athlete's speech production has a high probability of showing brain abnormalities immediately after a suspected or diagnosed concussion at the venue of the athletic sport. The aim of this study assessment is to investigate this possibility using the Cobweb system and greatly enhance the ability to diagnose a concussion in a timely manner to remove the athlete from practice or play.

Eligibility criteria: Inclusion Criteria:

* All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
* Ages 6 -21

Exclusion Criteria:

* Patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed.
* Patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials.
* Non-native speakers who cannot read the materials or produce the stimuli consistently.
* Patients who cannot read the materials or produce the stimuli consistently due to their age.

Primary outcomes:
measure: Change in formant frequencies
timeFrame: 2 months
Secondary outcomes:
measure: Changes in duration of speech production
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Forte Sports Medicine and Orthopedics
name: Terry G Horner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550795: Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Official title: Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Detailed description: Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Eligibility criteria: Inclusion Criteria:

* ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

* uncontrolled cardiovascular disease
* history of chronic pain
* smoker
* previous history of steroid administraion
* neoajuvant chemotherapy

Primary outcomes:
measure: Postoperative Nausea (Numeric Rating Scale for Nausea)
timeFrame: Changes from baseline in postoperative nausea at 30 min
Secondary outcomes:
measure: Postoperative Vomiting (Number of Participants With Vomiting)
timeFrame: Changes from baseline in postoperative nausea at 30 min
measure: Rhodes Index Score
timeFrame: assessed at 6 and 24 hour after operative end
Other outcomes:
Locations:
Study officials:
References: