louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02175524: The Association Between Areca-nut Chewing Habit and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral and Esophageal Cancer
Metabolic Syndrome.
Keywords: nut chewing
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with oral and oesophageal carcinoma.

Brief summary: The purpose of this study is going to determine the odds ratio of metabolic syndrome (MS), the habit of areca nut chewing, antioxidant, and inflammatory status in oral and esophageal patients. The current study was designed as a case-control study. Patients proved to be oral and esophageal cancer and had the habit of areca nut chewing are defined as case group. Patients proved to be oral and esophageal cancer and did not have the habit of areca nut chewing are defined as control group. The participants' age, blood pressures, and smoking habits will be recorded. Body weight, height, waist, and hip circumferences will be measured. Fasting venous blood samples will be obtained to determine hematological parameters \[i.e., serum creatinine, total cholesterol, triacylglycerol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, malondialdehyde, superoxide dismutase, glutathione peroxidase, catalase, and inflammatory markers (C-reactive protein, tumor necrosis factor-alpha, and interleukin-6)\]. Logistic regression analyses are going to perform to examine the relationship between areca nut chewing and MS in this population. If we can make sure the relationship between areca nut chewing and MS, the clinicians and nutritionists can teach people to quit areca nut chewing in order to avoid the possibility of developing metabolic syndrome and cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Patients proved to be oral and esophageal cancer will be recruited.

Exclusion Criteria:

* Subjects with diabetes mellitus, liver, renal diseases, or undergoing statin therapy.
* Taking antioxidant vitamins supplements.

Primary outcomes:
measure: Metabolic syndrome
timeFrame: Up to 1 week
Secondary outcomes:
measure: Antioxidant activity
timeFrame: Up to 1 week
measure: Inflammatory status
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital
Study officials:
References:
Clinical trial NCT01052324: The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
Official title: The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Disc Herniation
Cervical Spinal Stenosis
Cervical Spine Damage
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. It can be used for conscious sedation during awake nasotracheal fiberoptic intubation. Target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. The aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cervical spine surgery
* Age 20-65
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

* Patients' refusal
* allergy to any drug used
* unable to cooperate
* Severe hepatic or renal disease
* coagulation disorder
* chronic use of opioids or sedatives
* increase risk of pulmonary aspiration.

Primary outcomes:
measure: EC50 of remifentanil for preventing persistent cough and defensive movement using Dixon's up-and-down method
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Yuen Hee Shim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00555724: Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
Official title: A Phase 1, Open Label, Dose Escalation Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Subjects With Relapsed or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Relapsed
refractory
solid tumor
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 40
Sex: ALL
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: Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older at the time of informed consent
* Relapsed or refractory solid tumors following standard therapy.
* ECOG Performance Status 0 or 1.

Exclusion Criteria:

* History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c \>6% at screening.
* History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
* Known central nervous system or brain metastases.
* Prior anti-IGF-1R therapy of any kind.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To evaluate the safety and tolerability of BIIB022
timeFrame: ongoing
Secondary outcomes:
measure: To evaluate pharmacokinetics
timeFrame: ongoing
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
References:
citation: von Mehren M, Britten CD, Pieslor P, Saville W, Vassos A, Harris S, Galluppi GR, Darif M, Wainberg ZA, Cohen RB, Leong S. A phase 1, open-label, dose-escalation study of BIIB022 (anti-IGF-1R monoclonal antibody) in subjects with relapsed or refractory solid tumors. Invest New Drugs. 2014 Jun;32(3):518-25. doi: 10.1007/s10637-014-0064-y. Epub 2014 Jan 24.
Clinical trial NCT04991324: Cholecalciferol Comedication in IBD - the 5C-study
Official title: Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Patient will be recruited by their regularly visit. Patients will be randomly assigned to be supplemented with monthly capsules (monthly group), weekly capsules (weekly group) or no supplementation (control group).
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.

Detailed description: Monthly supplementation: Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.

Weekly supplementation: Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.

Control: Usual treatment without vitamin D supplementation. All 3 groups: In a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin D supplementation or not.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Crohn disease or ulcerative colitis

Exclusion Criteria:

* hypercalcaemia

Primary outcomes:
measure: fecal calprotectin
timeFrame: every 2 months during 6 months
Secondary outcomes:
measure: (OH)-vitamin D serum value
timeFrame: every 2 months during 6 months
Other outcomes:
measure: disease activity score
timeFrame: every 2 months during 6 months
measure: medication adherence
timeFrame: every 2 months during 6 months
Locations:
city: Basel
country: Switzerland
facility: Clarunis
Study officials:
affiliation: Pharmaceutical Care Research Group
name: Samuel Allemann, Prof.
role: STUDY_CHAIR
affiliation: Clarunis
name: Petr Hrúz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818324: Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Official title: Long Term Administration Study of OPC-12759 Ophthalmic Suspension in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients


Eligibility criteria: Inclusion Criteria:

1. Out patient;
2. Ocular discomfort severity is moderate to severe;
3. Corneal-conjunctival damage is moderate to severe;
4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5 seconds or less;
5. Best corrected visual acuity of 0.2 or better in both eyes.

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis scicca;
2. Ocular hypertention patient or glaucoma patient with ophthalmic solution;
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study;
4. Anticipated use of contact lens during the study;
5. Patient with punctal plug;
6. Any history of ocular surgery within 12 months;
7. Female patients who are pregnant, possibly pregnant or breast feeding;
8. Known hypersensitivity to any component of the study drug or procedual medications;
9. Receipt of any investigational product within 4 months.

Primary outcomes:
measure: Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
timeFrame: Baseline, Week2, Week4, Week28, Week52
Secondary outcomes:
Other outcomes:
measure: Change From Baseline (CFB) in Lissamine Green Conjunctival Staining (LGCS) Score
timeFrame: Baseline, Week2, Week4, Week28, Week52
Locations:
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Tohoku region
country: Japan
city: Tokai region
country: Japan
Study officials:
affiliation: OPCJ-DDO
name: Eiji Murakami
role: STUDY_CHAIR
References:
Clinical trial NCT00529724: Body Weight Gain, Parkinson, Subthalamic Stimulation
Official title: Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease
Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

Detailed description: Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :

* Clinical examination
* Autoevaluation dietary questionnaire
* Biological tests
* Study in calorimetry chamber (only in Clermont-Ferrand centre)
* Heart rate recorded during 7 days in usual conditions of life
* Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
* Acute Ldopa challenge (in both conditions of dopa and stim)
* Apathy evaluation
* Body weight, and body compositions measurements

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 70 years old
* Diagnosis of Parkinson' disease established for 5 years at least
* Ldopa effect \> 50 %
* Hoehn and Yarh score \> 2.5 in On phase

Exclusion Criteria:

* Metabolism disorder
* Biological analysis abnormal

Primary outcomes:
measure: heart rate recorded during 7 days in usual conditions of life
timeFrame: 7 days in usual conditions of life
measure: energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
timeFrame: 14 days in usual conditions of life
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
name: Franck Durif, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864224: A Pilot Implementation Study of GLA:D Back
Official title: A Pilot Implementation Study of GLA:D Back
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 190
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: English speaking adults greater than 18 years of age.

Brief summary: GLA:D Back is a program developed in Denmark to help people with persistent low back pain. This pilot study will assist in contextualizing Danish content into an English version of the program.

Detailed description: GLA:D Back is a program developed in Denmark to help people with persistent low back pain. Unfortunately, all materials developed for the program are in Danish. In this pilot, the investigators will translate the Danish materials into English, then use them to conduct an English training session for community clinicians in Edmonton, Alberta, Canada. Interested clinicians will then implement the program in their communities and provide feedback to contextualize the program for use in English. Specifically, surveys, interviews and focus groups will be used to help fine-tune the printed content of the course (e.g. manuals), it's training materials (e.g. lectures) and processes related to REDCap data collection (e.g. surveys).

Eligibility criteria: Inclusion Criteria:

* Patients must have persistent low back pain of at least 1 month's duration.

Exclusion Criteria:

* Participating currently in a supervised exercise or rehabilitation program or enrolled in another interventional clinical trial.
* Patients with nerve root involvement, suspected serious pathology, unstable trauma to the spine, aspects of pregnancy or other conditions that would prevent participation or disallow trial completion within the prescribed time period.
* Persons with conditions that require a specialist consult are suspected of needing a specialist consult, or have conditions that would be aggravated or worsened if treated by the interventions in this study.

Primary outcomes:
measure: Implementation
timeFrame: 6 months
Secondary outcomes:
measure: Patients enrolled
timeFrame: 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT04983524: Propolis Versus Calcium Hydroxide on Post-Operative Pain in Patients With Necrotic Pulp
Official title: Evaluation of the Effect of Propolis Versus Calcium Hydroxide, Intracanal Medicaments on Post-Operative Pain in Patients With Necrotic Pulp (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Pain, Chronic
Necrotic Pulp
Keywords: calcium hydroxide
propolis
post-operative pain
necrotic pulp
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Propolis is a resinous product of honeybees. Propolis is said to be effective against resistant microorganisms inside the root canal compared to the gold standard medication known as calcium hydroxide. The clinical trial tests the effect of propolis versus calcium hydroxide on pain in patients with necrotic teeth.

Detailed description: Propolis is an immunomodulatory, antioxidant, flavonoid-rich resinous product of honeybees. Propolis was reported as less cytotoxic and more effective against resistant microorganisms than calcium hydroxide as well as biocompatible to the periradicular tissues than existing intracanal medicaments. The aim of this single-blinded randomized clinical trial was to evaluate the effect of propolis versus calcium hydroxide, intracanal medicaments, on post-operative pain in patients with necrotic single canal teeth. Methods: Forty-six participants with an age range of 20-40 years old, diagnosed as having necrotic pulp in their single-rooted, single canal teeth were included in this study, with 23 participants in each group. Treatment was done in two visits and intracanal medicament was applied for one week in between. Participants were instructed to rate their pain score by a numerical rating scale after 24, 48, 72 hours and at 7 days.

Eligibility criteria: Inclusion Criteria:

* • Asymptomatic patients with age range 20 - 40 years

  * Necrotic, single canal maxillary and mandibular teeth with periapical infection presented as radiolucency or widening in the periodontal membrane space.
  * Medically - free of any systemic disease
  * Teeth with complete root formation

Exclusion Criteria:

* • Pregnant or lactating females

  * Teeth with vital pulps, internal or external resorption or anatomic abnormalities
  * Teeth with cracks, curvatures, root caries and calcified canals
  * Double or triple-rooted teeth
  * Patients with facial swelling, acute pulpal or periapical lesion
  * Teeth that are not indicated for endodontic treatment: Bad oral hygiene, mobile or recessed
  * Previously endodontically-treated teeth

Primary outcomes:
measure: post-operative pain
timeFrame: one week. line of 10 points
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03164824: Thai Version of Functional Rating Index
Official title: Thai Version of the Functional Rating Index for Patients With Back and Neck Pain: Cross-cultural Adaptation and Psychometric Properties Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Questionnaire
Keywords: Questionnaire
Functional Rating Index
Cross-cultural adaptation
Psychometric properties testing
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From physical therapy department in 9 settings in Thailand

Brief summary: The purposes of this study were to conduct cross-cultural adaptation of the Functional Rating Index (FRI), to test psychometric properties of the translated questionnaire and to examine head-to-head comparisons with other questionnaires.

Detailed description: This study comprised 2 major stages: 1) Cross-cultural adaptation and 2) psychometric properties testing.

Cross-cultural adaptation stage:

The FRI was cross-culturally adapted to Thai following the well-accepted guideline for the process of cross-cultural adaptation of self-report measure.

Psychometric properties testing stage:

The patients with back or neck pain completed the questionnaires at the first visit, the second visit and at 2-week (or at discharge or when reporting 80% improvement from the first visit).

Eligibility criteria: Inclusion Criteria

The participants were eligible if they were:

1. aged 18 years or older
2. seeking physical therapy treatment for a complaint of back and/or neck pain
3. able to understand, read, speak and write Thai

Exclusion Criteria:

The participants who were not willing to take part in the study, unable to understand, read, speak and write Thai were excluded from this study.

Primary outcomes:
measure: questionnaire scores at the first visit
timeFrame: 20-25 minutes each time
Secondary outcomes:
measure: questionnaire scores at the second visit
timeFrame: 5 minutes each time
measure: Global Perceived Effect Scale (GPES) at the second visit
timeFrame: 3 minutes each time
measure: questionnaire scores at 2 weeks
timeFrame: 20-25 minutes each time
measure: Global Perceived Effect Scale (GPES) at 2 weeks
timeFrame: 3 minutes each time
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Wunpen Chansirinukor, PhD
role: PRINCIPAL_INVESTIGATOR
References: