louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04226534: A Psychophysiological Database of Maximal Effort Tests.
Official title: Constructing a Psychophysiological Database Towards the Optimization of the Methodological Approach During, and Training Advice After Maximal Effort Tests.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is first to construct a database containing psychophysiological data from athletes performing a maximal effort test. Second, the investigators want to use the data to optimize the methodological approach during, and trainings advice after maximal effort tests.

Detailed description: The lab (and research group) of Human Physiology and Sports Physiotherapy of the Vrije Universiteit Brussel performs exercise tests in both trained and untrained populations. The aim of the maximal effort test is to evaluate endurance capacity and provide recommendations to monitor training load. Until now, this is done by objective parameters such as heart rate, speed, time, power, etcetera. Researchers already presented a method to quantify training intensity distribution in elite endurance athletes based on the rating of perceived exertion. However, during pilot testing and everyday experience, these cut-off values are not always applicable to each individual athlete, nor are they the same for different sports. Therefore, the investigators want to investigate the possible relation between the exercise intensity, and objective and subjective parameters. Thereafter, the investigators want to provide recommendations to a new way of methodological approach during, and trainings advice after maximal effort tests.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Trained
* No medication influencing heart rate or physical performance

Exclusion Criteria:

* Disease
* injury
* medication influencing (maximal) heart rate or exercise performance

Decision made after sports medical evaluation, comprising personal and family history, physical examination and resting electrocardiogram (ECG).

Primary outcomes:
measure: Ergospirometry
timeFrame: Up to one hour
Secondary outcomes:
measure: blood samples
timeFrame: Up to one hour
measure: Rating of perceived effort
timeFrame: Up to one hour
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel, Human Physiology and Sports Physiotherapy
name: Luk Buyse, Msc. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05975034: Investigation of the Use of a Probiotic Supplement in People With Long COVID
Official title: Investigation of the Use of a Probiotic Supplement in People With Long COVID
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Symprove UK
name: Biomesight
First posted: 2023-08-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomised trial
Primary purpose: TREATMENT

Brief summary: This study is a double-blinded randomised trial to assess the efficacy of a probiotic supplement in alleviating symptoms in people with Long COVID.

Detailed description: 240 participants with Long COVID will be randomly assigned to either a probiotic or placebo group in a 1:1 ratio for twelve weeks. Participants will track symptoms using an app for three weeks before the study, and for the last three weeks of the treatment. Participants will answer online questionnaires about their symptoms at 0, 4, 8, and 12 weeks. A subgroup of 60 participants will attend the laboratory for blood tests, cognitive function tests and gut microbiome analysis at 0 and 12 weeks. This group will also wear activity trackers for two weeks before the study, and for the final two weeks of the study.

Eligibility criteria: Inclusion Criteria: Long COVID defined as National Institute for Health and Care Excellence (NICE) criteria for Long COVID (Persistent symptoms at least 12 weeks after a confirmed or suspected Covid-19 infection).

-

Exclusion Criteria: Significant co-morbidities - no pre-existing diagnosis of hypertension, diabetes, cerebrovascular, cardiovascular or peripheral vascular disease, coagulopathy or haematological disorder or current or recent cancer.

-

Primary outcomes:
measure: Fatigue severity scale (FSS)
timeFrame: 12 weeks
measure: FACIT fatigue scale
timeFrame: 12 weeks
measure: EQ-5D-5L
timeFrame: 12 weeks
measure: Ability to Participate in Social Roles and Activities - PROMIS Short Form 8a
timeFrame: 12 weeks
measure: Ecological Momentary Assessment (EMA) app
timeFrame: 12 weeks
Secondary outcomes:
measure: IBS-SSS
timeFrame: 12 weeks
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 12 weeks
measure: MRC Dyspnoea scale
timeFrame: 12 weeks
measure: International. Physical Activity Questionnaire (short form)
timeFrame: 12 weeks
measure: Accelerometery data
timeFrame: 12 weeks
measure: Cambridge Neuropsychological Test Automated Battery (CANTAB)
timeFrame: 12 weeks
measure: 16S rRNA sequencing
timeFrame: 12 weeks
measure: Analysis of inflammatory markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
Study officials:
affiliation: Sheffield Hallam University
name: Caroline Dalton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01747434: Complaints and Presumptive Diagnosis in a Danish Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptoms on Admission
Presumptive Diagnosis on Admission
Final Diagnosis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 10070
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all acute admissions to a Danish Emergency Department in 2010

Brief summary: Acute patients in Denmark are often admitted to Emergency Departments by their General Practitioner with a presumptive diagnosis.

The aim of this study is to evaluate the diagnostic value of the pre-admission presumptive diagnosis and to assess if the presumptive diagnosis could be replaced by a number of symptom-based groups.


Eligibility criteria: Inclusion Criteria:

* all acute patients admitted to emergency department

Exclusion Criteria:

-

Primary outcomes:
measure: action diagnosis
timeFrame: 0-48 hours after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Kolding Hospital Emergency Department
Study officials:
References:
citation: Carter-Storch R, Olsen UF, Mogensen CB. Admissions to emergency department may be classified into specific complaint categories. Dan Med J. 2014 Mar;61(3):A4802.
Clinical trial NCT02647034: Stress Ventricular Function in Evaluating Patients With Pulmonary Hypertension
Official title: Using the Stress Ventricular Function Assessment to Evaluate the Long-term Prognosis and Treatment Outcome in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspnea
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspicious for pulmonary hypertension

Brief summary: This study investigated clinical parameters, laboratory data, imaging studies to evaluate patients with suspected pulmonary hypertension.

Detailed description: Left and right ventricular ejection fraction (LV/RV EF) at rest and immediately after exercise treadmill test (ETT) were measured by nuclear medicine study in consecutively symptomatic patients with suspected pulmonary hypertension, along with other clinical variables were correlated with right heart catheterization parameters.

Eligibility criteria: Inclusion Criteria:

* patients suspicious for pulmonary hypertension.

Exclusion Criteria:

* pregnant, lactating, CAD history

Primary outcomes:
measure: All-cause mortality
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital and National Taiwan University College of Medicine
Study officials:
affiliation: National Taiwan University Hospital and National Taiwan University College of Medicine
name: Mei-Fang Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04487834: Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Official title: Effects of Simethicone and Vivatlac Baby in Infantile Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infantile Colic
Lead sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 87
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Detailed description: Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.

Eligibility criteria: Inclusion Criteria:

* diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

* previous treatment with probiotic or synbiotic
* previous treatment with antibiotics

Primary outcomes:
measure: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline
timeFrame: Three weeks
measure: Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent
timeFrame: Three weeks
measure: Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Koziegłowy
country: Poland
facility: GP Practice Pro Familia
city: Poznan
country: Poland
facility: Medical University in Poznań
Study officials:
affiliation: University of Applied Sciences in Kalisz, Poland
name: Hanna Krauss, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.
citation: Piatek J, Bernatek M, Krauss H, Wojciechowska M, Checinska-Maciejewska Z, Kaczmarek P, Sommermeyer H. Effects of a nine-strain bacterial synbiotic compared to simethicone in colicky babies - an open-label randomised study. Benef Microbes. 2021 Jun 15;12(3):249-257. doi: 10.3920/BM2020.0160. Epub 2021 Mar 26.
Clinical trial NCT01447134: RGD-K5 in Head and Neck Cancer Patients
Official title: Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Neoplasms
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified.

Brief summary: 1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
2. Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

Detailed description: This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients (including nasopharyngeal cancer)
* Age equals or more than 20 years old
* Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
* Willing to sign the informed consent

Exclusion Criteria:

* Patient who is pregnant or lactating;
* Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
* Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
* Unable to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02817334: A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
Official title: A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Near-infrared fluorescence
Indocyanine green, ICG
breast cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2016-06-29
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Detailed description: Indocyanine green, ICG (ICG-fluorescence)

* ICG is the most commonly used fluorophore which approve by FDA.
* NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
* Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

* New method for the localization and resection of non-palpable breast lesions.
* The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Eligibility criteria: Inclusion Criteria:

* nonpalpable breast tumor \< 5cm in patients with breast cancer.
* consented patients with more than 18 years
* Eastern Cooperative Oncology Group Performance status 0 or 1
* patients who need breast biopsy as treatment for breast cancer.

Exclusion Criteria:

* nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
* inflammatory cancer of breast or patients who need MRM
* pregnancy
* history of severe allergy to ICG(Indocyanine Green)
* iode hypersensitiveness

Primary outcomes:
measure: detection rate
timeFrame: one day
Secondary outcomes:
measure: determine the pathological stability
timeFrame: one day
Other outcomes:
measure: Side effects and availability Side effects and availability Side effects and availability side effects and availability
timeFrame: following up a week to 3 month
measure: side effects and availability
timeFrame: following up a week to 3 month
measure: side effects ans availability
timeFrame: following up a week to 3 month
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: So-Youn Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01075334: Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Infertility
Keywords: sperm
male infertility
Carnitine
food supplementation
insemination
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.


Eligibility criteria: Inclusion Criteria:

* infertility
* at least one abnormal sperm quality parameter
* female age \< 35
* normal ovarian reserve

Exclusion Criteria:

* known allergy to one of the food additives planned for treatment

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 3 Insemination cycles
Secondary outcomes:
measure: Sperm quality parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare-Zedek IVF and infertility unit
Study officials:
References:
citation: Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. doi: 10.1016/s1472-6483(10)61082-6.
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
Clinical trial NCT01782534: Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection
Official title: Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diagnosed AD patients in Our hospital From August 2001 to August2007

Brief summary: The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.

Detailed description: Clinical data were collected from 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug.2007, and the related factors for death within 5 years after the onset of dissection, which include Gender, age, history of smoking, hypertension, diabetes, renal insufficiency (azotemia), low admission diastolic blood pressure (\<70mmHg), Stanford typing (Stanford A or B), long-acting calcium channel blocker treatment,ACEI /ARB treatment, endovascular stent and surgical aortic replacement,were statistically analyzed by univariate and multivariate binary logistic regression.

Eligibility criteria: Inclusion Criteria:

* Stanford type A dissection
* Stanford type B dissection

Exclusion Criteria:

Primary outcomes:
measure: death after 5 years after the onset of dissection
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Central South University
name: Zhishan SUN, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05301634: Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection
Official title: Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intraoperative Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.


Eligibility criteria: Inclusion Criteria:

* ASA I, II or III
* patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

Exclusion Criteria:

* Patient's refusal
* Allergy to local anesthetics.
* Preoperative cerebrospinal fluid leak.
* Preoperative cardiac arrythmias.
* Seizure disorders.
* Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.

Primary outcomes:
measure: Mean arterial blood pressure
timeFrame: at the time of mucosal dissection
Secondary outcomes:
measure: Intraoperative need for magnesium sulphate
timeFrame: the entire duration of surgery
measure: Intraoperative need for fentanyl
timeFrame: the entire duration of surgery
measure: Intraoperative need for nitroglycerine
timeFrame: the entire duration of surgery
measure: Postoperative need of pethidine
timeFrame: 24 hours postoprative
measure: Postoperative pain assessed by Numeric pain score
timeFrame: 24 hours postoprative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini hospital
Study officials:
References: