louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02329028: Feasibility of Mini-EEG in the Prehospital Setting
Official title: Feasibility of Mini-EEG in the Prehospital Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Coma
Keywords: Emergency Care, Prehospital
Electroencephalography
Coma
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 23
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: Unconscious patients in the prehospital field

Brief summary: The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.

The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)


Eligibility criteria: Inclusion Criteria:

* Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria:

* Cardiac arrest
* Traumatic unconsciousness
* Transient unconsciousness

Primary outcomes:
measure: Signal interpretability
timeFrame: 60 min
measure: Device ease-of-use
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Tapani Salmi, MD, Ph.D.
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Johannes Björkman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04337528: Osteopathic Thrust and Muscle-energy Manipulations on Sacroiliac Joint Dysfunction
Official title: Biomechanical Effects of Osteopathic Thrust and Muscle-energy Manipulations in Sacroiliac Joint Dysfunction of Athletes or Runners
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Disorder
Keywords: osteopathy
baropodometry
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Thrust technique Group 2: Muscle-energy technique Group 3: Placebo
Primary purpose: TREATMENT

Brief summary: This study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.

Detailed description: The thrust manipulation applies a high velocity and intensity push in a specified direction to correct the position or movement of the sacroiliac joint.

The muscle-energy technique consists of the therapist correcting the sacroiliac joint while the participant is applying active resistance.

For the placebo manipulation, participants will receive a false manipulation over the affected joint, without producing movement at the sacroiliac joint.

Eligibility criteria: Inclusion Criteria:

* Amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction.

Exclusion Criteria:

* Low back pain
* Vertebral bone pathology
* Radicular neurological condition
* Fracture or recent surgical intervention in the lumbosacral or pelvic region
* Anatomical short leg with a difference greater than 0.5 cm
* Pregnant
* Fear of manipulation technique

Primary outcomes:
measure: Change in Weight Distribution
timeFrame: throughout study completion, an average of 1 month
measure: Center of Gravity Displacement
timeFrame: throughout study completion, an average of 1 month
measure: Center of Pressure Displacement
timeFrame: throughout study completion, an average of 1 month
measure: Change in Plantar support
timeFrame: throughout study completion, an average of 1 month
measure: Foot Plantar Pressure
timeFrame: throughout study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalupe
country: Spain
facility: UCAM Research Center for High Performance Sport
state: Murcia
Study officials:
affiliation: UCAM Research Center for High Performance Sport
name: Linda H Chung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815628: Next-Generation-Sequencing Approach to Neutropenic Sepsis
Official title: Next-Generation-Sequencing Approach to Neutropenic Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Febrile Neutropenia
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: Noscendo GmbH
First posted: 2023-04-18
Enrollment: 400
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: 400 neutropenic patients with febrile neutropenia

Brief summary: The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.

Detailed description: The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER (Platform for digital pathogen diagnostics from Noscendo GmbH) in neutropenic patients with FN (Febrile neutropenia) is to provide further evidence of the efficacy of an NGS (Next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Informed consent
* Neutropenia defined as \<500 ANC (Absolute neutrophil Count)/µl or \<1000 WBC (White bloddcell Count)/µl if ANC is not available
* Fever (with an onset \< 24h) or Sepsis (with an onset \<24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection.

Exclusion Criteria:

* Age \< 18 years
* Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available
* Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time
* Death is deemed imminent and inevitable

Primary outcomes:
measure: Evaluation of the performance of a NGS-based
timeFrame: Baseline
Secondary outcomes:
measure: Average process time for NGS-based measurements
timeFrame: Baseline
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Dessau-Rosslau
country: Germany
facility: Hospital Dessau
city: Essen
country: Germany
facility: University Hospital of Essen
city: Frankfurt am Main
country: Germany
facility: University Hospital of Frankfurt
city: Leipzig
country: Germany
facility: University Hospital of Leipzig
city: Magdeburg
country: Germany
facility: University Hospital of Magdeburg
Study officials:
References:
Clinical trial NCT02245828: A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
Official title: A Randomized, Double-blind, Placebo-controlled First-in-human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: healthy subjects, inhaled
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-09-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
3. Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2.
4. Oxygen saturation (O2) at screening must be ≥ 95% on room air.
5. FEV1 ≥ 90% predicted.

Exclusion Criteria:

1. 1. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.
2. History of asthma or reactive airway diseases.
3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.
4. History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
5. Women of child-bearing potential

Primary outcomes:
measure: Safety and tolerability
timeFrame: 39 days
Secondary outcomes:
measure: AUCinf
timeFrame: 39 days
measure: AUClast
timeFrame: 39 days
measure: AUCtau
timeFrame: 39 days
measure: Cav
timeFrame: 39 days
measure: Cmax
timeFrame: 39 days
measure: T1/2
timeFrame: 39 days
measure: Tmax
timeFrame: 39 days
Other outcomes:
Locations:
city: Mid Glamorgan
country: United Kingdom
facility: Novartis Investigative Site
state: Wales
Study officials:
References:
Clinical trial NCT05482828: Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness
Official title: Effect of Jaeumgeonbi-Tang on Chronic Subjective Dizziness: A Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Subjective Dizziness
Keywords: Chronic subjective dizziness
Oxidative stress
Lead sponsor: Korea Health Industry Development Institute
Sponsor class: OTHER_GOV
First posted: 2022-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the safety and efficacy of JGT (Jaeumgeonbi-Tang). A randomized, double-blind, parallel-group, placebo-controlled clinical trial was conducted and changes in symptoms and quality of life of the patients were evaluated.

Detailed description: This study's protocol was designed to assess the efficacy of JGT (Jaeumgeonbi-Tang) for chronic subjective dizziness.

* This design of the study is a randomized, double-blind, parallel-group, placebo-controlled design.
* Symptoms and quality of life of chronic subjective dizziness patients will be evaluated.
* Dizziness severity and quality of life of the patients will be evaluated using DHI (Dizziness Handicap Inventory) (1) before treatment (baseline), (2) after 2 weeks, and (3) after 4 weeks of JGT treatment.
* Blood samples of the patients will be gathered before and after JGT treatment for pathophysiological analysis.

Eligibility criteria: \[Inclusion Criteria\]

* Chronic subjective dizziness patients, aged from 20 to 65
* DHI (Dizziness Handicap Inventory) score ≥ 24
* Those who can fully comprehend the general protocol of this study and voluntarily agree to participate

\[Exclusion Criteria\]

* Inner ear disease (benign paroxysmal positional vertigo, vestibular neuritis, Meniere's disease, etc.)
* Dizziness secondary to specific diseases such as hypoglycemia, recent stroke (within the last 6 months), or heart disease.
* Use of medications that could influence the result of the study (anticonvulsants, sedatives, antidepressants, sleeping pills, prostate medicine, Parkinson's drug, dementia drug, etc.)
* Pregnancy, breastfeeding, or plans of becoming pregnant
* Functional dyspepsia (persistent, recurring abdominal pain, or discomfort)
* Other allergic diseases
* Ineligibility for other reasons in the opinion of the research clinician (when the physician determines that there are significant physical or mental defects that the patient cannot understand and follow the protocol)

Primary outcomes:
measure: Dizziness handicap Inventory
timeFrame: Change from Baseline DHI score at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Daejeon Korean Medicine Hospital of Daejeon Unversity
Study officials:
affiliation: Daejeon University
name: Yoo HoRyong, KMD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06638528: Effects of Walking Apnea At High Lung Volume on Hypoalgesia
Official title: Effects of Walking Apnea At High Lung Volume on Hypoalgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Hypoxemia
Hypercapnia
Apnea
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.

  * History of epilepsy.
  * Pregnant
  * Pharmacological treatment.
  * Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)]
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT06327828: Methimazole in Graves' Disease - Comparing the Computer-aided Treatment DigiThy Versus Usual Care
Official title: Guiding Methimazole Therapy in Graves' Disease - a Randomised Controlled Trial Comparing a Computer-aided Treatment (Digital Thyroid, DigiThy) Versus Usual Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Graves Disease
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Graz University of Technology
First posted: 2024-03-25
Enrollment: 52
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: The goal of this clinical trial is to compare two methods of guiding methimazole therapy in patients with Graves' disease: methimazole dose adjustments based on a new semi-automated computer-guided treatment (based on a mathematical model) or based on the treating physician's decision (i.e. usual care). The main question it aims to answer is whether semi-automated computer-guided treatment is not inferior to usual care in terms of safety, the time it takes to achieve euthyroidism and the methimazole dose required.


Eligibility criteria: Inclusion Criteria:

* Active Graves' hyperthyroidism \[Thyroid-stimulating hormone \<0.1 mU/L, elevated free thyroxine levels (fT4) above the upper limit of normal and positive Thyrotropin receptor antibody (TRAb) according to local laboratory results\], measured within the last month prior to the inclusion date
* Patients not yet receiving antithyroid treatment, or having received antithyroid treatment continuously for less than 4 weeks, or relapse or recurrence of Graves' hyperthyroidism defined as patients previously having received and discontinued treatment with antithyroid drugs for at least 4 weeks)
* Age 18 years or older
* Provision of written informed consent

Exclusion Criteria:

* Previous treatment with radioactive iodine
* Ongoing antithyroid treatment for more than one month
* Pregnancy
* Treatment with propylthiouracil

Primary outcomes:
measure: The primary aim is to compare semi-automated computer-guided treatment with usual care in terms of their performance indices
timeFrame: 18 months
Secondary outcomes:
measure: Comparison in terms of cumulative methimazole dosing
timeFrame: 18 months
measure: Comparison based on free thyroxine (fT4) target range
timeFrame: 18 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Stefan Pilz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771728: A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis
Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bacterial Vaginosis
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: BGI, China
First posted: 2021-02-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis

Detailed description: Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 55 years old, with history of sexual activity,
2. Amsel criterion for diagnosing BV
3. Sign informed consent

Exclusion Criteria:

1. History of systemic organic diseases or psychiatric diseases
2. Planning for or during pregnancy, lactation, menstruation
3. within 5 days of onset of the disease, any antibiotics has been used
4. Long-term use of contraceptives or immunosuppressant
5. Anaphylactic constitution or allergic to known ingredients of research drugs
6. No same fixed partner (RSP) before and after treatment

Primary outcomes:
measure: Cure rate of BV
timeFrame: 14 days after treatment
Secondary outcomes:
measure: Recurrence of BV
timeFrame: The first month after treatment
measure: Recurrence of BV
timeFrame: 5-7 days after third menstruation after treatment
measure: Recurrence of BV
timeFrame: 5-7 days after sixth menstruation after treatment
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Peking University Shenzhen Hosptal
state: Guangdong
Study officials:
affiliation: Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
name: Ruifang Wu, M.D.
role: STUDY_DIRECTOR
References: