louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01429324: Near Infrared Spectroscopy (NIRS)
Official title: Validation of Near Infrared Spectroscopy (NIRS) Neuro-monitoring During Deep Hypothermic Circulatory Arrest for Aortic Arch Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Arch Surgery
Keywords: Near infrared spectroscopy
neuromonitoring
aortic arch surgery
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 20
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: Mayo Clinic and affiliated hospitals

Brief summary: This study is designed to assess the feasibility of evaluating cerebral saturation during critical periods of deep hypothermia circulatory arrest and Selective Antegrade Cerebral Perfusion.


Eligibility criteria: Inclusion Criteria:

* Is male or female
* Is of any race or ethnicity
* Is greater than or equal to eighteen (18) years of age
* Weighs greater than or equal to 40 kilogram
* Is not known to be pregnant
* Understands English
* Is undergoing aortic arch surgery with planned deep hypothermia circulatory arrest, either with or without select antegrade cerebral perfusion
* Is able and willing to provide informed consent

Exclusion Criteria:

* Is less than eighteen (18) years of age
* Weighs less than 40 kilogram
* Is known to be pregnant
* Does not understand English
* Has known sensitivity to adhesives
* Is unable or unwilling to provide informed consent

Primary outcomes:
measure: Evaluate brain tissue oxygenation assessing the number and percentage of subjects from whom regional data could be collected during 90% of the aortic arch surgery, and the registration rate during deep hypothermic circulatory arrest.
timeFrame: At the end of the surgical case approximately 6 to 8 hours
Secondary outcomes:
measure: Determine whether there are unilateral or global differences in cerebral tissue oxygenation detected during selective antegrade cerebral perfusion
timeFrame: At the end of the surgical case approximately 6 to 8 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic and affiliated hospitals
name: James J Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306824: Berlin Atrial Fibrillation Registry
Official title: Berlin Cohort Study on Oral Anticoagulation in Patients With Atrial Fibrillation and Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Atrial Fibrillation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Center for Stroke Research Berlin
name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2014-12-03
Enrollment: 1080
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 with known atrial fibrillation and acute ischemic stroke or transient ischemic attack

Brief summary: Investigator-initiated prospective multicentre hospital-based registry to uncover the proportion of self-reported anticoagulation in stroke patients with atrial fibrillation and assessing the proportion of stroke, intracranial bleeding and all-cause death in the short (at 3 months), mid-term (at 12 months) as well as long term (at 24 months) after ischemic stroke or transient ischemic attack in an unselected urban population in Germany. In addition, annual follow-up is planned yearly up to 5 years after enrollment.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke or transient ischemic attack (with clinical deficit on admission or corresponding brain MRI lesion)
* Age ≥ 18 years
* Known atrial fibrillation or ECG recording documenting atrial fibrillation during the in-hospital stay for acute ischemic stroke or transient ischemic attack
* Written or oral informed consent
* Willingness to take part in the planned follow up examinations

Exclusion Criteria:

* Life expectancy \< 1 year (before stroke)
* Assumed post-stroke life expectancy \< 1 month according to stroke severity
* Chronic anticoagulation for reasons other than atrial fibrillation

Primary outcomes:
measure: Patient self-reported persistence to oral anticoagulants (novel oral anticoagulants or vitamin K antagonists) in stroke patients with AF at 12 months after ischemic stroke or TIA
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Wuerzburg University Hospital
name: Karl Georg Haeusler, MD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tutuncu S, Olma M, Kunze C, Dietzel J, Schurig J, Fiessler C, Malsch C, Haas TE, Dimitrijeski B, Doehner W, Hagemann G, Hamilton F, Honermann M, Jungehulsing GJ, Kauert A, Koennecke HC, Mackert BM, Nabavi D, Nolte CH, Reis JM, Schmehl I, Sparenberg P, Stingele R, Volzke E, Waldschmidt C, Zeise-Wehry D, Heuschmann PU, Endress M, Haeusler KG. Off-label-dosing of non-vitamin K-dependent oral antagonists in AF patients before and after stroke: results of the prospective multicenter Berlin Atrial Fibrillation Registry. J Neurol. 2022 Jan;269(1):470-480. doi: 10.1007/s00415-021-10866-2. Epub 2021 Oct 31.
Clinical trial NCT04496024: Ofloxacin Concentration-toxicity Relationship in the Elderly
Official title: Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ofloxacin
Bone and Joint Infection
Therapeutic Drug Monitoring
Adverse Drug Reactions
Keywords: ofloxacin
Bone and Joint Infection
therapeutic drug monitoring
Adverse Drug Reactions
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections
* Indication for oral switch to ofloxacin

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient under guardianship or curators or deprived of public rights
* Any liver or biliary injury
* Any contraindications to ofloxacin

Primary outcomes:
measure: Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
timeFrame: day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Youssef BENNIS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Jean Philippe LANOIX, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03163524: Behavioural Insights to Improve Take up of SRH Services (Uganda)
Official title: Applying Behavioural Insights to Improve Take up of Sexual and Reproductive Health Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: family planning
reproductive health
m-health
Lead sponsor: Marie Stopes International
Sponsor class: OTHER
Collaborators: name: Ideas42
First posted: 2017-05-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomised controlled trial to test the impact of a modified e-coupon service, delivered through SMS, on uptake of sexual and reproductive health services among women calling a free hotline in Uganda.

Detailed description: The overall goal of the proposed research project is to increase uptake of sexual and reproductive health (SRH) services among clients who call into Marie Stopes Uganda's free hotline. The study seeks to achieve this goal by using behavioural economics to design interventions to increase redemptions of e-coupons distributed to hotline clients. The intervention will include modifying the text message sent to e-coupon recipients as well as sending follow-up texts reminding clients to use their coupons. The impact of the intervention will be evaluated using a randomized controlled trial (RCT). The intervention will be implemented and data will be collected regularly over a period of approximately 12 months. Strict confidentiality procedures in line with Marie Stopes International's best practices will be put into place to ensure that information made public or otherwise distributed outside the principle investigators and other key personnel cannot be linked to any individual respondents. Results from the study will be published in a report, among other outputs, and the outcomes will be shared within MSI as well as with the wider SRH community.

Eligibility criteria: Inclusion Criteria:

* Callers to the call centre who are over the age of 18, receive an e-coupon, and consent to participate in the research.

Exclusion Criteria:

* Callers who are below the age of 18, non-recipients of e-coupons, and those who receive e-coupons but do not consent to participate in the study.

Primary outcomes:
measure: Increase in e-coupon redemption in MSU centres
timeFrame: 6 months
measure: Increase in SRH service uptake in MSU centres
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Marie Stopes Uganda call centre
Study officials:
affiliation: Marie Stopes International
name: Patricia Aujo
role: PRINCIPAL_INVESTIGATOR
affiliation: Ideas42
name: Andrew Fertig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ideas42
name: Karina Lorenzana
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes International
name: Andrew Gidudu, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00213824: A Study of the Expression of Nogo and Reticulon Genes in Skeletal Muscle of Patients With Amyotrophic Lateral Sclerosis
Official title: A Study of the Expression of Nogo and Reticulon Genes in Skeletal Muscle of Patients With Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Nogo gene
reticulon genes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University Hospital, Strasbourg, France

Brief summary: This is a study of the expression of nogo and reticulon genes in the skeletal muscle of patients with amyotrophic lateral sclerosis (ALS).


Eligibility criteria: Inclusion Criteria:

* Patients with definite ALS
* Males or females
* Age \> 18

Exclusion Criteria:

* Patients with other neuromuscular affections

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique Neurologique, Service des Maladies du Système Nerveux et du Muscle, Hôpital Civil, Hôpitaux Universitaires
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Yon-Andoni Echaniz-Laguna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732224: To Compare the Efficacy of Combined Tenofovir Plus Telbivudine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B
Official title: A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spontaneous Reactivation of Hepatitis B
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.


Eligibility criteria: Inclusion Criteria:

* Reactivation of CHB characterized by a rise in ALT level \>5 times upper limit of normal along with HBV DNA level \>10\^5 copies/ mL (\> 1.8 X 10\^4 IU/mL).

Exclusion Criteria:

1. Superinfection with other viruses (hepatitis E, A, D, or C)
2. other causes of chronic liver failure
3. coexistent hepatocellular carcinoma (HCC)
4. portal vein thrombosis
5. coexistent renal impairment
6. pregnancy
7. coinfection with human immunodeficiency virus (HIV)
8. patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.

Primary outcomes:
measure: Survival
timeFrame: 1 and 3 months
Secondary outcomes:
measure: Reduction in HBV DNA.
timeFrame: 7 days, 15 days, 1 month and 3 month
measure: Drug(s) related adverse effects/ side effects
timeFrame: 1 and 3 months
measure: Improvement in CTP and MELD scores
timeFrame: 1 and 3 months
measure: Alteration of renal functions
timeFrame: 1 and 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences (ILBS).
name: Shiv Kumar Sarin, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176924: Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams
Official title: Effect of tDCS Along With Relaxation Technique on Anxiety Level in Students Preparing for Competitive Exams: A Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Anxiety, tDCS, Relaxation, Competitive Exam Students, 2mA, CSAI-2R
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety is one of the most significant obstacles to academic success. When stress is interpreted negatively or becomes overwhelming, it causes anxiety before and during examinations, which in turn impacts students' academic performance. The difficulty in managing severely associated anxiousness enhances the demand for NIBS. It is a unique approach that has the potential to alleviate anxiety by modifying cortical excitability whereas Relaxation breaks the vicious cycle of pain caused by muscular stress, circulatory illness, and metabolic by-products alterations. The main purpose is to evaluate whether tDCS along with Relaxation technique reduces the anxiety level in competitive exam students. Total 46 students are recruited and randomly allocating in experimental and control group. The subjects in the experimental group are going to receive 9 tDCS sessions (2mA, anode placed on the DLFPC of left side and cathode on right supraorbital cortex for 20 min) along with relaxation technique. Subjects in the control group are going to receive 9 sessions of relaxation. The CSAI-2R scale is used as an Outcome Measure. Samples completed the CSAI-2R scale before and following the intervention. The data will be analyzed using SPSS 26.0 software.


Eligibility criteria: Inclusion Criteria: • Both male and female students.

* Competitive Exam students only.
* Age group between 15 years to 18 years.
* Willingness to take part in the research.

Exclusion Criteria: • Seizure disorder

* Non-Corporative students
* Skin irritation

Primary outcomes:
measure: CSAI- 2R (Competitive State Anxiety Inventory-2R)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: MMIPR
state: Haryana
Study officials:
References:
Clinical trial NCT04039724: Pharmacokinetics of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
Official title: Clinical Trial to Compare the Pharmacokinetics and Safety/Tolerability of HCP1305 and Co-administration of HCP0605, HGP0816 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-07-31
Enrollment: 61
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Detailed description: The purpose of this study is to investigate the pharmacokinetics and safety/tolerability after administration of HCP1305 and co-administration of HCP0605, HGP0816 in healthy male volunteers

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteer, age 19\~45 years
2. Weight is not less than 55kg, no more than 90kg and Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Subjects who judged ineligible by the investigator.

Primary outcomes:
measure: AUClast
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
measure: Cmax
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Secondary outcomes:
measure: AUCinf
timeFrame: pre-dose(0h), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
measure: Tmax
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
measure: T1/2
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
measure: Cl/F
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
measure: Vz/F
timeFrame: pre-dose(0hours), post-dose 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 22, 48, 72, 96, 144 hours
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT00001424: Evaluation and Natural History of Children With Cancer and AIDS
Official title: Evaluation and Natural History of Children With Cancer and AIDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Cancer
HIV Infections
Leukemia
Lymphoma
Keywords: AIDS
Children
Human Immunodeficiency Virus
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Patients enrolled in this study will not receive investigational therapy. Any treatments rendered will be standard and based on appropriate medical care. Should a patient become eligible for an experimental therapy protocol, the normal process of enrollment and informed consent will be followed.

Detailed description: This protocol will enable the Pediatric Branch to follow selected children with cancer or HIV infection who are not immediately eligible for protocol enrollment but who are likely, within the next year, to become candidates for protocol entry. It will also enable the Pediatric Branch to follow children who present with either clinical findings that constitute important educational experiences for the NCI trainees or who have unique or unusual medical problems that are likely to benefit from the research expertise of the NCI.

Eligibility criteria: Children with cancer (or a precancer syndrome) or HIV infection, between the age(s) of 3 months to 30 years, who are evaluated by the Pediatric Branch and are found to be not immediately eligible for an ongoing protocol but are likely to become a candidate for a future protocol.

Children with cancer (or a precancer syndrome) or HIV infection, who present with disease manifestations of special interest to Pediatric Branch investigators, because they are likely to shed light on disease.

Patients who, when evaluated by the Branch, are determined to likely never become eligible for a Pediatric Branch protocol are not eligible for this protocol.

No patients younger than 3 months of age or older than 30 years of age are eligible for this protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References: