louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02614820: The Safety, Efficacy and Tolerability of Remote Ischemic Preconditioning as a Therapy to DMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: Ischemic preconditioning
sefety
efficacy
DMD
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2015-11-25
Enrollment: 100
Sex: MALE
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Duchenne muscular dystrophy (DMD) is an X chromosome recessive hereditary disease and mainly characterized by progressive muscle weakness and atrophy. Glucocorticoid is the only proven effective medicine,while side effects limit its use. Recent studies have shown that the vascular density in the DMD patients' muscle is decreased,so muscle are in ischemic and anoxic. Remote ischemic preconditioning(RIPC) can improve the capable of resistanting ischemia and hypoxia and maybe a potential therapy for DMD patients.

Methods: 100 patients (aged 2 to 6 years)will be divided into two groups(treatment and control groups) randomly. Treatment group will receive an RIPC stimulus (inflation of a blood pressure cuff on the bilateral thighs to 150 mm Hg for four 5-minute intervals) while control group will receive a similar stimulus (inflation of a blood pressure cuff on the bilateral thighs to 40 mm Hg for four 5-minute intervals). Serum kinase level ,Blood levels of myoglobin, Evaluation of motor function(Four steps test;6-minute walking test) and MRI of lower limbs）at 0 days, 3 days, 3months ,6months.

Purpose：

1. To evaluate the safety and tolerability of remote ischemic preconditioning for DMD patients
2. To identify the effectiveness of remote ischemic preconditioning for DMD patients.


Eligibility criteria: Inclusion Criteria:Genetic analysis of DMD; from 2 to 6 years old ;without other diseases .

-

Exclusion Criteria: other congenital diseases;upper respiratory infection, gastroenteritis, vaccination, trauma.

-

Primary outcomes:
measure: Serum CK value
timeFrame: 0 day
measure: Serum CK value
timeFrame: 3 days
measure: Serum CK value
timeFrame: 3 months
measure: Serum CK value
timeFrame: 6 months
measure: Serum myoglobin values
timeFrame: 0 day
measure: Serum myoglobin values
timeFrame: 3 days
Secondary outcomes:
measure: Serum myoglobin values
timeFrame: 3 months
Other outcomes:
measure: Serum myoglobin values
timeFrame: 6 months
measure: 6-minute walking test
timeFrame: 0 day
measure: 6-minute walking test
timeFrame: 3 days
measure: 6-minute walking test
timeFrame: 3 months
measure: 6-minute walking test
timeFrame: 6 months
measure: T2 values
timeFrame: 0 day
measure: T2 values
timeFrame: 3 days
measure: T2 values
timeFrame: 3 months
measure: T2 values
timeFrame: 6 months
Locations:
city: BeiJing
country: China
facility: Shiwen wu
Study officials:
References:
Clinical trial NCT01671020: Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
Official title: Open-label, Randomized, Crossover Clinical Trials for Single Oral Dose of 60mg Fimasartan and Single IV Infusion of 30mg Fimasartan to Evaluate the Absolute Bioavailability of Kanarb® Tablet (Fimasartan) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: fimasartan
absolute bioavailability
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Open-label, randomized, crossover clinical trials for single oral dose of 60mg fimasartan and single IV infusion of 30mg fimasartan to evaluate the absolute bioavailability of Kanarb® tablet (fimasartan) in healthy subjects


Eligibility criteria: Inclusion Criteria:

* age: 20 - 55 years
* body weight: standard weight(Broca's index, Possible range is plus or minus 20percent)
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* abnormal diet which could affect drug absorption or metabolism
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day
* participation in a clinical trial during the last 90 days prior to the start of the study

Primary outcomes:
measure: AUCinf, AUC, Cmax, Tmax, half-life; t1/2z, AUCt, Vdss, Cl,
timeFrame: PO : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr, IV : 0.25, 0.5, 0.75, 1, 1.08, 1.17, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48hr
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
affiliation: Division of Clinical Pharmacology
name: Jae-Gook Shin, M.D, Ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04125420: Hypersensitivity Reactions During Anesthesia
Official title: Hypersensitivity Reactions During Anesthesia: A Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 940
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing surgery at Mayo Clinic Florida

Brief summary: Researchers are trying to study the natural history of allergic reactions during anesthesia and its causes and risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients over age 18 undergoing surgery at Mayo Clinic Florida

Exclusion Criteria:

* Minors under age 18
* Unable to consent

Primary outcomes:
measure: Incidence.
timeFrame: 2-3 years
Secondary outcomes:
measure: Risk factors
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Alexei Gonzalez Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05374720: Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
Official title: Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Salpingectomy
Hysterectomy
Primary Ciliary Dyskinesia
Ectopic Pregnancy
Keywords: miscarriage
tubal cilia
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women

Detailed description: Primary Ciliary Dyskinesia (DCP) is a rare genetic disease (1 in 15,000 individuals at birth), which manifests itself in chronic respiratory infections (bronchopneumopathies and rhinosinusitis type) associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of sperm mobility. However, there is very little data in the literature on the structure and function of tubal cilia in women with DCP.

Before considering a study of tubal cilia in patients with DCP, it seems necessary to specify in DCP patients or not DCP, the molecular and morphological composition of tubal cilia and to look for ciliary abnormalities in case of GEU

Eligibility criteria: Inclusion Criteria:

* Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)
* Major patients ( \>18 years)

Exclusion Criteria:

* Patient not willing to participate in the study

Primary outcomes:
measure: morphological of tubal cilia
timeFrame: through study completion, an average of 6 week after surgery
measure: Molecular difference in tubal cilia between patients with or without GEU salpingectomy
timeFrame: through study completion, an average of 6 week after surgery
measure: molecular tubal cilia
timeFrame: through study completion, an average of 6 week after surgery
measure: functional composition of tubal cell by video microscopy
timeFrame: through study completion, an average of 6 week after surgery
measure: functional composition of tubal cell by video microscopy
timeFrame: through study completion, an average of 6 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
state: Val-deMarne
Study officials:
affiliation: Centre Hospitalier Intercommunal Créteil
name: Rana i MITRI-FRANGIEH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977520: Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
Official title: Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Printing, Three-Dimensional, Simulation Training
Lead sponsor: Beijing Luhe Hospital
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years-80 years;
* Hunt-Hess grade: 0-4;
* Without other stroke, brain trauma and other neurological disease;
* Without cerebral hernia;
* Cystic aneurysm.

Exclusion Criteria:

* Age: less than 18 years or above 80 years;
* Hunt-Hess grade is 5;
* With serious previous disorder of multiple organ;
* Acute cerebral hernia;
* Aneurysms were fusiform or serpentine expansion.

Primary outcomes:
measure: time of operation
timeFrame: 1 to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Luhe hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03818620: Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
Official title: DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Cancer
Skin Diseases
Lead sponsor: Barco NV
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be considered for enrollment in the study when they have a lesion that is accessible to the Barco Digital Dermatoscope, are able to give informed consent and are over 18 years old.

Brief summary: This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.


Eligibility criteria: Inclusion Criteria:

* The patient has a lesion that is accessible to the Barco Digital Dermatoscope
* Patient gives informed consent
* Men or women of any ethnic group aged ≥ 18 years

Exclusion Criteria:

* Men or women of any ethnic group aged \< 18 years
* Patients not willing or able to read, understand and sign the study-specific informed consent form

Primary outcomes:
measure: Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
timeFrame: 3.5 years
Secondary outcomes:
measure: Comparison of new device to standard dermoscopy
timeFrame: 2 years
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ / KU Leuven
Study officials:
affiliation: UZ / KU Leuven
name: Marjan Garmyn, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Gent
name: Lieve Brochez, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328120: Faslodex 500mg Multiple Dose Tolerability Study in BC Patients
Official title: An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Breast Cancer
Keywords: Advanced breast cancer
Faslodex
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-19
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Postmenopausal woman who fulfils any one of the following criteria:
* Histological or cytological confirmation of breast cancer
* Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion Criteria:

* Having received any one of the following therapy for advanced or recurrent breast cancer
* 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

Primary outcomes:
measure: The primary objective of this study is to assess the tolerability of 500mg fulvestrant
timeFrame: assessed when all patients have been in the study for 6 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: each visit
measure: Time to progression
timeFrame: assessed when all patients have been in the study for 6 months
measure: ORR
timeFrame: assessed when all patients have been in the study for 6 months
measure: Clinical benefit rate
timeFrame: assessed when all patients have been in the study for 6 months
measure: Time to response
timeFrame: assessed when all patients have been in the study for 6 months
measure: duration of response and changes in serum tumour markers
timeFrame: assessed when all patients have been in the study for 6 months
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Nagoyata
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Breast Cancer Established Brands Team Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06772220: Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Official title: Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson&Amp;#39;s Disease
Keywords: Parkinson&amp;#39;s disease
Parkinson disease
homocysteine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants with elevated homocysteine levels at the first study visit will take B vitamins for 3 months, and then have a follow-up visit. Study participants with normal homocysteine levels at the first study visit will not take the B vitamins, and will also have a follow-up visit 3 months later.
Primary purpose: TREATMENT

Brief summary: This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
2. Currently treated with levodopa at a minimum dose of 300 mg/day
3. Montreal Cognitive Assessment (MOCA) ≥15
4. Demonstrated capacity to provide informed consent.
5. 40-90 years of age
6. Estimated glomerular filtration rate ≥60
7. Absence of uncontrolled hypertension in medical history
8. Absence of insulin use

Exclusion Criteria:

-

Primary outcomes:
measure: Hyperhomocysteinemia and B vitamin deficiency
timeFrame: baseline measurement
measure: Hyperhomocysteinemia and B vitamin deficiency
timeFrame: baseline measurement
measure: Hyperhomocysteinemia and B vitamin deficiency
timeFrame: baseline measurement
Secondary outcomes:
measure: Hyperhomocysteinemia and cognitive assessments
timeFrame: From enrollment to the end of treatment at 3 months
measure: Hyperhomocysteinemia and measurement of neurofilament light in plasma
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
affiliation: Oregon Health & Science University (OHSU)
name: Joseph Quinn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851720: Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Official title: Randomized Trial for Pain Management in Low-grade Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Headaches Associated With Subarachnoid Hemorrhage (SAH)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Headaches associated with subarachnoid hemorrhage (SAH) cause severe pain. Headache management is complex, requiring a balance between pain control and preservation of neurological assessment. Sufficient pain control can be achieved with narcotics, however, these carry numerous undesirable side effects. Most critically, all narcotics can result in respiratory depression and sedation. For patients who present without neurological defects but debilitating pain, management is particularly challenging. The sedative effect of narcotics confounds the management of these patients by interfering with the neurological examination. Pain management is also a significant concern for patient's families as they observe suffering without full understanding of the importance of preserved mental status. In order to control the pain associated with SAH headaches, the use of narcotics is often required despite the risks. This standard therapy involves an IV bolus dose delivered by the provider regularly as needed for pain control. A common approach to reduce pain in other patient populations, including acute pain relief following major spine surgery, is patient controlled analgesia (PCA). With the PCA method, patients deliver low doses of narcotics through a pain pump with preset maximal doses and frequency of delivery. We hypothesize that this approach to pain relief for SAH headaches will result in lower pain scores, greater patient and family satisfaction scores, and increased patient safety with lower narcotic doses minimally interfering with neurological assessment.


Eligibility criteria: Inclusion Criteria:

* Age\>18-75
* Glasgow Coma Scale (GCS) 13 or greater
* Hunt and Hess grade I, II conditions
* Admitted within 2 days of initial SAH event \>6/10 pain on presentation

Exclusion Criteria:

* Aphasia
* Head trauma within the past 30 days
* Need for craniotomy
* h/o obstructive sleep apnea or respiratory disease
* h/o opioid tolerance
* evidence of vasospasm
* h/o liver disease

Primary outcomes:
measure: Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References: