louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05277233: Cardiovascular Risk After Preeclampsia
Official title: Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman 5-15 years after pregnancy

Brief summary: Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.


Eligibility criteria: Inclusion Criteria:

* Women
* 18-60 years
* 5-15 years postpartum

Exclusion Criteria:

* Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
* Pregnancy and/or active breastfeeding
* Glaucoma disease, epilepsy
* In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR \< 30 ml/min)

Primary outcomes:
measure: Myocardial perfusion
timeFrame: Day 2
Secondary outcomes:
measure: Cardiac fibrosis
timeFrame: Day 2
measure: Immune cell phenotypes
timeFrame: Day 1
measure: Concentration of N-terminal prohormone of brain natriuretic peptide
timeFrame: Day 1
measure: Concentration of brain natriuretic peptide
timeFrame: Day 1
measure: Urinary protein
timeFrame: Day 1
measure: Advanced glycation end products
timeFrame: Day 1
measure: Body fat mass
timeFrame: Day 1
measure: Body fat-free mass
timeFrame: Day 1
measure: Hand grip strength
timeFrame: Day 1
measure: Systolic blood pressure
timeFrame: Day 1
measure: Diastolic blood pressure
timeFrame: Day 1
measure: Pulse wave velocity
timeFrame: Day 1
measure: Flow-mediated dilation
timeFrame: Day 1
measure: Reactive hyperemia index
timeFrame: Day 1
measure: Choroidal thickness
timeFrame: Day 1
measure: Macular volume
timeFrame: Day 1
measure: Arterial dilation induced by retinal flicker stimulation
timeFrame: Day 1
measure: Venous dilation induced by retinal flicker stimulation
timeFrame: Day 1
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912533: A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: JCR Pharmaceuticals Co., Ltd.
First posted: 2016-09-23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).


Eligibility criteria: Inclusion Criteria:

* Patients being treated with erythropoiesis stimulating agent.

Exclusion Criteria:

* Patients having complication or history of a cardiovascular / lung / brain infarction.
* Patients having a pronounced hemorrhagic lesion.

Primary outcomes:
measure: Measure adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: Hemoglobin level
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
Clinical trial NCT01642433: Prazosin for Smoking Cessation
Official title: Prazosin as a Novel Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nicotine Dependence
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
First posted: 2012-07-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The most likely outcome of smoking cessation attempts is relapse, underscoring the need to advance novel treatments. Preclinical research shows that the noradrenergic system is critical for modulating drug-seeking behavior and recent findings indicate that the α1-adrenergic antagonist prazosin reduces nicotine self-administration and reinstatement. Presently, data on prazosin's effects on nicotine-related behaviour in humans is lacking. An efficient method for screening novel smoking cessation medications is to integrate human laboratory paradigms in the context of brief, randomized trials of smoking cessation that include smokers motivated to quit. This study aims to provide an initial test of prazosin for smoking cessation by implementing a brief, randomized trial that will include both human laboratory and clinical phenotypes. This approach will allow an efficient but sensitive method for medication screening that maximizes clinical validity.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 10 cigarettes per day for past year
* Baseline Fagerstrom Test for Nicotine Dependence (FTND) score of greater than or equal to four
* Willing to engage in two practice quit attempts
* Willingness to forgo other medication based treatments during the trial

Exclusion Criteria:

* Current illicit drug use
* Current treatment with psychiatric medications other than selective serotonin re-uptake inhibitors (SSRIs)
* Lifetime diagnosis of post-traumatic stress disorder (PTSD)
* Significant medical/neurological illness
* Baseline BP outside of normal range
* Current use of tobacco aids
* Current use of medications that could interact with prazosin
* Pregnancy or nursing

Primary outcomes:
measure: Short-term smoking cessation
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830633: Trial to Evaluate Laparoscopy-assisted Nerve-preserved Total Mesorectal Excision (LNTME) Versus Open TME for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: laparoscopy
rectal cancer
pelvic autonomic nerve
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine: (1) whether laparoscopy-assisted nerve-preserved total mesorectal excision (LNTME) is as safe as open TME for rectal cancer, and (2) whether LNTME is more effective for protection of pelvic autonomic nerve function from surgical impairing when comparing to open TME.


Eligibility criteria: Inclusion Criteria:

1. Male patients
2. From 18 years old to 60 years old
3. Normal sexual function
4. Tumor located in rectum (defined as 5- to 12-cm from the anal verge)
5. Pathological confirmed rectal cancer
6. Preoperative T stage ranging from T1 to T4a according to the 7th Edition of AJCC Cancer Staging Manual
7. Tumor size \< 5 cm
8. ASA score was I-II
9. Informed consent was written

Exclusion Criteria:

1. Distant cancer metastasis
2. History of abdominal surgery
3. With other type of malignancy
4. Preoperative voiding dysfunction
5. Preoperative sexual dysfunction
6. Refusing to attend this trial

Primary outcomes:
measure: Postoperative complications including bleeding, anastomotic leakage, postoperative infection, organ dysfunctions.
timeFrame: postoperative 30 days
measure: The postoperative sexual function assessed by IIEF questionnaire
timeFrame: postoperative one year
measure: The postoperative voiding function assessed by IPSS questionnaire.
timeFrame: postoperative one year
Secondary outcomes:
measure: Operative time
timeFrame: an expected average of 180 minutes
measure: Postoperative deaths
timeFrame: postoperative 30 days
measure: The length postoperative hospital stay
timeFrame: an expected average 8 days
measure: C-reactive protein
timeFrame: postoperative 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: He Y, Zhu Z, Liu S, Liu L, Hu B, Wan X, Huang Q. [Effect of anastomotic reinforcing sutures on the incidence of anastomotic leakage after laparoscopic radical resection of rectal cancer: a prospective randomized controlled trial]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Apirl 25;21(4):431-436. Chinese.
Clinical trial NCT00166933: Minimal Erythema Dose of UV-B in Normal Population of Taiwan
Official title: Minimal Erythema Dose of UV-B in Normal Population of Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Volunteers
Keywords: minimal erythema dose
UVB
normal
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: There is no previous study on the minimal erythema dose of UVB irradiation in Chinese people. We will investigate the correlation of skin phototype, constitutive skin color, facultative skin color and minimal erythema dose in Taiwanese.

Detailed description: The skin phototype will be obtained from a structuralized questionaire. The constitutive skin color and facultative skin color will be obtained by chromameter. The minimal erythema dose will be obtained by physician's assessment.

Eligibility criteria: Inclusion Criteria:

10-65 years old normal healthy volunteers

Exclusion Criteria:

Age under 10 years old or older than 65 years old People with a past history of photo-sensitivity People who had been treated with phototherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chia-Yu Chu
Study officials:
affiliation: Department of Dermatology, National Taiwan University Hospital
name: Chia-Yu Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05582733: Effects of Cervical Spine Manipulation
Official title: Effects of Cervical Spine Manipulation on Upper Trapezius Active Versus Conventional Techniques.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Pain
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: Riphah International University
First posted: 2022-10-17
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching.
Primary purpose: TREATMENT

Brief summary: To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point. it was a randomized control trial including 66 patients at physiotherapy OPD of railway rehabilitation center from August 2019 to December 2019, Railway General Hospital Pakistan and Max Rehab and decompression center Max health Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method.

Detailed description: To determine the immediate effects of cervical spine manipulation on pressure pain sensitivity on upper trapezius trigger point and neck ranges of motion. A randomized control trial of 66 patients was conducted from August 2019 to December 2019 at physiotherapy OPD of railway rehabilitation center, Railway General Hospital Pakistan and Max Rehab and decompression center Maxhealth Hospital G8 Islamabad. The subjects were randomly divided into two groups (group control and experimental) by free envelope method. Control was treated with Manual Pressure release followed by stretching while in experimental received cervical spine manipulation (chin hold) kaltenborn followed by stretching. Structural questionnaire was used for pre and post assessment. Outcomes were measured by algometry and inclinometer before and after the application of respective techniques. The data was analyzed at baseline and immediately after the intervention on IBM SPSS-21.

Eligibility criteria: Inclusion Criteria:

* 1.presence MTrps in upper trapezius
* limited side bending and rotation
* both gender
* age between 25 to 45

Exclusion Criteria:

* Malignancy, infection, trauma, bone deformities.
* Acute Disc Protrusion
* Positive VBI
* Positive Sharp purser test
* History of whiplash injury

Primary outcomes:
measure: changes from the baseline in Algometer values
timeFrame: Baseline and 3 weeks
measure: changes from the baseline in Inclinometer values
timeFrame: Baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Dr. Abdul Gaffoor
Study officials:
affiliation: ghafoor.sajjad@riphah.edu.pk
name: Abdul Ghafoor Sajjad, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00842933: Adrenal Insufficiency in Septic Shock
Official title: An Open-label, Prospective, Randomized, Controlled Clinical Trial of the Use of Reduced Duration Versus Standard Duration Steroid Replacement Therapy for Acute Adrenal Insufficiency in Patients With Septic Shock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Septic Shock
Acute Adrenal Insufficiency
Keywords: Septic shock
Acute adrenal insufficiency
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2009-02-12
Enrollment: 32
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: Randomized controlled trial evaluating the duration of steroid replacement therapy in patients with adrenal insufficiency and septic shock. Patients will be randomized to receive either hydrocortisone 50 mg IV every six hours for seven days (control) or hydrocortisone 50 mg IV every six hours until 24 hours after achievement of hemodynamic stability (MAP \> 65 mm Hg off of vasopressors).


Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years of age or older
* Patients who sign informed consent or are represented by a legally authorized representative to provide consent on behalf of the patient
* Patients with septic shock meeting the ACCM/SCCM consensus conference definitions for septic shock

Exclusion Criteria:

* Patients with documented allergic or anaphylactic reactions to corticosteroids
* Patients who have received steroid therapy within 6 months of presentation
* Patients who have received steroids during their hospital admission, with the exception of a single dose of dexamethasone
* Patients who have received etomidate in the preceding 12 hours
* Patients who have had a prior adrenalectomy or a known history of adrenal disease (documented adrenal insufficiency or Cushing syndrome).
* Documented Human Immunodeficiency Virus (HIV) infection
* Pregnancy
* Allergies to adrenocorticotropic hormone (ACTH) or corticosteroids
* Administration of additional medications which may suppress the hypothalamic-pituitary axis:

  * Ketoconazole
  * Aminoglutethimide
  * Mitotane
  * Megestrol acetate
  * Suramin

Primary outcomes:
measure: The primary outcome measure for this study is the number of hours receiving steroid dosing.
timeFrame: 7 days
Secondary outcomes:
measure: A secondary outcome measure will be the difference between daily glucose levels, insulin requirements, and length of stay in the ICU.
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital, Houston, TX
name: Laura J Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06843733: Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes
Official title: Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People with Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Executive Dysfunction
Mild Cognitive Impairment (MCI)
Keywords: Feasibility study
Mixed reality
Mild cognitive impairment
Executive Dysfunction
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.


Eligibility criteria: Inclusion Criteria

* Healthy group: 1) MoCA score \> 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.
* MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.

Exclusion Criteria:

* Uncontrolled high blood pressure (more than 140/90 mmHg)
* Hemodialysis
* Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.
* History of neurological disorder, such as stroke or other neurodegenerative disorder
* Taking medicine which affected to functional movement.
* Unable to follow study protocol.
* Uncorrected visual or hearing impairment.
* Positive screening for contraindication of TMS which will be confirmed by TMS screening questionnaire such as uncontrolled seizures.

Primary outcomes:
measure: Visual attention and task switching
timeFrame: before and immediately after intervention
measure: Inhibitory control
timeFrame: before and immediately after intervention
measure: Single-task performance
timeFrame: before and immediately after intervention
measure: Dual-task performance
timeFrame: before and immediately after intervention
measure: Cortical outcomes
timeFrame: before and immediately after intervention
measure: Usability
timeFrame: immediately after Mixed reality exergaming
measure: Motivation
timeFrame: immediately after Mixed reality exergaming
measure: Adverse side effects
timeFrame: immediately after Mixed reality exergaming
Secondary outcomes:
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Faculty of Physical Therapy, Mahidol University
state: Nakhon Pathom
Study officials:
References:
Clinical trial NCT04510233: Ivermectin Nasal Spray for COVID19 Patients
Official title: Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid19
Keywords: COVID19
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.

Detailed description: Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.

However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.

Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.

Eligibility criteria: Inclusion Criteria:

* mild to moderate severity who are confirmed to be positive for SARS COV 2.

Exclusion Criteria:

* patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm

Primary outcomes:
measure: PCR of SARS-Cov2 RNA
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tanta Univesity faculty of Medicine
name: Kamal Okasha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018733: Biological Aspects of Depression and Antidepressant Drugs
Official title: Biological Aspects of Depression and Antidepressant Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will be measuring changes in depressive symptoms over a 7 week time period. Double-blind placebo controlled trial using the pharmacologic agents Paroxetine or Desipramine.


Eligibility criteria: * Diagnosis of major depressive disorder Ham-D Score \> 18
* English speaking with ability to read and sign an informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
Study officials:
name: Steve Brannan, M.D.
name: Cheryl Gonzalez, M.D.
References: