louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00605605: Vascular Endothelial Protection Effects of Dextromethorphan
Official title: Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Smoking
Inflammation
Keywords: endothelial function
atherosclerosis
smoking
inflammation
antioxidant
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2008-01-31
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Detailed description: Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

Eligibility criteria: Inclusion Criteria:

* healthy male volunteers who are currently smoking

Exclusion Criteria:

* personal history of hypertension or diabetes mellitus
* family history with
* documented premature cardiovascular events
* cardiovascular-associated sudden death
* total cholesterol \> 240 mg/dL
* triglyceride \> 200 mg/dL
* low-density lipoprotein \> 160 mg/dL.

Primary outcomes:
measure: Endothelial function
timeFrame: 1, 2, 3 and 6 month
Secondary outcomes:
measure: Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa
timeFrame: 1, 2, 3 and 6 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: Assiatant Professor of National Cheng Kung University Medical Center
name: Ping-Yen Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04588805: Incidence Rate of Perioperiative VTE in Colorectal Cancer Patients : a Multicenter Prospective Observational Cohort Study
Official title: Incidence Rate of Perioperiative Venous Thromboembolism(VTE) in Colorectal Cancer Patients : a Multicenter Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incidence Rate of Perioperiative Venous Thromboembolism(VTE) in Colorectal Cancer Patients
Keywords: Venous Thromboembolism
Colorectal Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients prepare for radical colorectal surgery in colorectal surgery wards

Brief summary: This is a multi-centered, prospective, observational study aimed at observing the Incidence Rate of Perioperiative VTE in Colorectal Cancer Patients


Eligibility criteria: Inclusion Criteria:

* Patients in colorectal surgery ward Clinical diagnosis of colorectal cancer Prepare for radical colorectal surgery.

Exclusion Criteria:

* Patients prepare for emergency surgery Clinical diagnosis of benign colorectal disease Patients who have joined other clinic studys

Primary outcomes:
measure: ncidence Rate of Perioperiative VTE
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wei Q, Wang Y, An YB, Yang ZY, Liu YS, Zhang X, Gu ZC, Yao HW; CRC-VTE investigators. Rationale and design of a prospective, multicenter, cohort study on the evaluation of postoperative Venous ThromboEmbolism incidence in patients with ColoRectal Cancer (CRC-VTE trial). Transl Cancer Res. 2022 May;11(5):1406-1412. doi: 10.21037/tcr-21-1860.
Clinical trial NCT03106805: Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion
Official title: Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contraception Behavior
Keywords: intrauterine device
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals


Eligibility criteria: Inclusion Criteria:

Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.

Exclusion Criteria:

1. Known uterine anomalies.
2. Women with previous ectopic pregnancy.
3. Presence of postpartum pyrexia.
4. Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
5. Retained products of conception.
6. History of previous uterine perforation.
7. Anticipation of difficulty of subsequent follow-up with the women.
8. Women with uncontrolled diabetes and hypertension.
9. Women who wish to use other contraceptive methods.

Primary outcomes:
measure: The number of participants use the device
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
affiliation: Assiut University
name: Ahmed Abbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.
Clinical trial NCT01689805: Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis
Official title: Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Filaggrin
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atopic dermatitis who are followed-up at the Skin and Allergy Hospital in Helsinki for at least one year can be included in the study.

The control population consists of non-atopic persons without any other skin disease (samples for the control population are applied for from a sample collection of the National institute for health and welfare).

Brief summary: Atopic dermatitis is a common disease which affects about one million people in Finland at some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin and a defect in skin barrier function. The filaggrin protein plays a central role in the skin barrier function and studies indicate that about 30% of patients with atopic dermatitis have a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation in the filaggrin gene affects the clinical treatment outcome in patients with atopic dermatitis. If a mutation predisposes to a worse response to treatment, this could be examined and those patients with the mutation could be given extra treatment support for their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic population is studied in the control group.


Eligibility criteria: Inclusion Criteria (patients with atopic dermatitis):

* Age at least 18 years
* Clinical diagnosis of atopic dermatitis
* Need for follow-up at the Skin and Allergy Hospital
* Patient gives signed informed consent to participate in this study
* Patients parents and grandparents are of Finnish origin

Inclusion Criteria (Controls):

* No history of atopy or skin disease
* Age at least 18 years

Primary outcomes:
measure: Filaggrin mutation
Secondary outcomes:
measure: Response to treatment
timeFrame: 12 months
measure: Serum IgE
timeFrame: 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics
Study officials:
affiliation: Skin and Allergy Hospital, Helsinki University Central Hospital
name: Anita Remitz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05062005: ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma
Official title: Induction Chemotherapy+Chemoradiotherapy vs. Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 447
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: This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years old;
2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);
4. No distant metastasis;
5. Have not received anti-cancer treatment in the past;
6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
7. Adequate hematologic, hepatic and renal function.

Exclusion Criteria:

1. The purpose of treatment is palliative;
2. Diagnosed with other malignant tumors at the same time;
3. Malignant tumor history;
4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
5. Combined serious illness.

Primary outcomes:
measure: FFS (Failure-free Survival)
timeFrame: 3 year
Secondary outcomes:
measure: OS (Overall Survival)
timeFrame: 3 year
measure: LRFS (Locoregional Recurrence-free Survival)
timeFrame: 3 year
measure: DMFS (Distant Metastasis-free Survival)
timeFrame: 3 year
measure: AE (Adverse events)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guang Dong
Study officials:
References:
Clinical trial NCT01350505: Toileting at Night in Older Adults: Light to Maximize Balance, Minimize Insomnia
Official title: Toileting at Night in Older Adults: Light to Maximize Vision, Minimize Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Balance
Insomnia
Aging
Keywords: Postural Balance
Sleep Initiation and Maintenance Disorders
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2011-05-09
Enrollment: 21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Intervention model description: The order of the interventions were randomized to the four visits.
Primary purpose: BASIC_SCIENCE

Brief summary: To examine the change in balance that occurs in older individuals when exposed to different colored lights at night.


Eligibility criteria: Inclusion Criteria:

* Aged 55-85
* Stable health
* Normal color vision

Exclusion Criteria:

* Alcohol abuse
* Depression
* Sleep disorders
* Smoking
* Use of illegal drugs

Primary outcomes:
measure: Change in Balance
timeFrame: 13 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Jamie M Zeitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McBean AL, Najjar RP, Schuchard RA, Hall CD, Wang CA, Ku B, Zeitzer JM. Standing Balance and Spatiotemporal Aspects of Gait Are Impaired Upon Nocturnal Awakening in Healthy Late Middle-Aged and Older Adults. J Clin Sleep Med. 2016 Nov 15;12(11):1477-1486. doi: 10.5664/jcsm.6270.
Clinical trial NCT01644305: Plasma Levels of GDF-9 and GDF-15 in Patients With Polycystic Ovary Syndrome.
Official title: 1. Association of Plasma GDF-9 or GDF-15 Levels With Bone Parameters in Polycystic Ovary Syndrome. 2. Plasma GDF-15 Levels and Their Association With Hormonal and Metabolic Status in Women With Polycystic Ovary Syndrome Aged 25-35.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-07-19
Enrollment: 85
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital Endocrinology Outpatient Clinic

Brief summary: The purpose of this study is to determine the plasma levels of GDF-9 and GDF-15, and their association with bone and cardiovascular parameters in patients with Polycystic Ovary Syndrome.


Eligibility criteria: Inclusion Criteria:

* Female patients at ages 25-35 diagnosed with polycystic ovarian syndrome and idiopathic hirsutism

Exclusion Criteria:

* acute infectious disease, a thyroid, pituitary, nutritional, inflammatory, hepatic, renal, or neoplastic disorder; history of cardiovascular disease or pulmonary embolism; a family history of coronary artery disease; smoking history; hypertension; diabetes mellitus; use of oral contraceptives, anti-androgens and drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs.

any medication known to affect hormonal or metabolic parameters.

Primary outcomes:
measure: The association of GDF 9 AND GDF 15 with bone and cardiovascular parameters in women with polycystic ovary syndrome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Education and Research Hospital
Study officials:
References:
citation: Berberoglu Z, Aktas A, Fidan Y, Yazici AC, Aral Y. Association of plasma GDF-9 or GDF-15 levels with bone parameters in polycystic ovary syndrome. J Bone Miner Metab. 2015 Jan;33(1):101-8. doi: 10.1007/s00774-013-0560-8. Epub 2014 Jan 16.
Clinical trial NCT06362005: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus
Official title: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Lichen Planus, Oral
Keywords: seleinum
Antioxidant
Glutathione-S-transferases
Reactive oxygen species
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Sphinx university
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus.

Detailed description: The signs and symptoms of the oral lichen planus lesion. 2-The associated oral symptoms. 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis .

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of OLP

Exclusion Criteria:

1. lichenoid reaction from medication ' .
2. any systemic autoimmune disease
3. Pregnancy
4. smokers

Primary outcomes:
measure: to assess a visual analog scale (VAS)of the oral lichen planus lesion
timeFrame: baseline, 1, 3 and 6 months after treatment
Secondary outcomes:
measure: to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis
timeFrame: baseline, 1, 3 and 6 months after treatment
measure: Biochemical evaluation of salivary Glutathione level using (ELISA)
timeFrame: baseline, 1, 3 and 6 months after treatment
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar university ,faculty of Dental Medicine
Study officials:
References:
Clinical trial NCT00969605: Adaptive Support Ventilation in the Weaning of COPD
Official title: Adaptive Support Ventilation for Faster Weaning in COPD: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: weaning
adaptive support ventilation
COPD
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both as pressure support (PSV) and pressure controlled (PCV) ventilation. Weaning with ASV shows promising results mainly in post-cardiac surgery patients. The aim of this randomized controlled study was to test the hypothesis that weaning with ASV could reduce the weaning duration in patients with chronic obstructive pulmonary disease (COPD) when compared with PSV.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* On invasive mechanical ventilation for at least 24 hours because of hypoxemic and/or hypercapnic respiratory failure

Exclusion Criteria:

* Mechanical ventilation less then 24 hours (self extubation or death),
* Having a tracheotomy and
* COPD coexisted with severe cardiac or neurologic diseases.

Primary outcomes:
measure: Weaning duration
Secondary outcomes:
measure: Weaning success
measure: Length of stay in the ICU
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
Study officials:
affiliation: Izmir Dr Suat Seren Chest Diseases and Chest Surgery Education and Research Hospital
name: Cenk Kirakli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04224805: The Use of Bone-borne Guides in Orthognathic Surgery Cases
Official title: Evaluation of the Use of Bone-borne CAD/CAM Surgical Guides in Orthognathic Surgery Cases Requiring Le Fort I Osteotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentofacial Deformities
Keywords: Le Fort
Orthognathic surgery
Virtual surgical planning
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.

Detailed description: Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.

Eligibility criteria: Inclusion Criteria:

* Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion Criteria:

* Patients with severe asymmetry

Primary outcomes:
measure: Error of superimposition
timeFrame: 2 weeks
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 3 months
measure: Procedure duration
timeFrame: 1 day
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References: