louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02179385: Empowerment and Support for the Diabetic Patient
Official title: Coaching for Health to Achieve New Goals in Empowerment for Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Type II diabetes
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.

Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.

Detailed description: Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* At least one oral anti diabetic drug
* HbA1c above 7.5% ot above 0.5% of personal target
* Preparedness for change
* Fluent Hebrew or Arabic

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Incompetency to sign consent
* Participation in another clinical trial
* Unstable psychotic disease
* Complex health condition

Primary outcomes:
measure: Clinical composite
timeFrame: 0, 6, 12, 18 months from randomization
Secondary outcomes:
measure: Change in Self Treatment Score
timeFrame: 0, 6, 12, 18 months from randomization
measure: Change in Self Efficacy Score
timeFrame: 0, 6, 12, 18 months from randomization
Other outcomes:
measure: Change in Quality of life score
timeFrame: 0, 12 months from randomization
Locations:
Study officials:
References:
Clinical trial NCT01156285: Acute Anterior Uveitis: Psychic Burden and Pain
Official title: Acute Anterior Uveitis: Psychic Burden and Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Uveitis
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2010-07-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute attack of anterior uveitis

Brief summary: Acute anterior uveitis (AU) is a common reason for attendance at ophthalmic outpatient clinics. The painfulness and the fear of a transient or even persistent loss of vision may markedly reduce the individual's subjective well-being and pose a psychological burden.

This study will test the hypothesis that during an attack of AU the patient experiences a marked reduction in psychological and physical well-being.

Prospective, hospital-based epidemiologic study using a patient questionnaire with standardized psychological tests and a pain scale.


Eligibility criteria: Inclusion Criteria:

* Acute attack of anterior uveitis

Exclusion Criteria:

* Other forms of uveitis
* Chronic anterior uveitis
* Therapy started

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Ophthalmology, Medical University Graz
state: Styria
city: Vienna
country: Austria
facility: Department of Ophthalmology, Hietzing Hospital
Study officials:
affiliation: Hospital Hietzing
name: Saskia M Maca, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03969485: Hybrid Fractional Laser for Treatment of Off Face Body Skin Quality
Official title: Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Lead sponsor: Sciton
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs


Eligibility criteria: Inclusion Criteria:

1. Healthy male/female subjects between 40 to 65 years of age inclusive
2. Fitzpatrick skin type I-III
3. Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
4. Has poor skin texture
5. Has mild thin skin
6. Has some level of dyschromia on the treatment area as assessed by the Investigator
7. Can read, understand and sign informed consent form (English only)
8. Has indicated willingness to participate in the study by signing an informed consent form
9. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion Criteria:

1. Fitzpatrick skin type IV-VI
2. Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
3. Has tattoos, dysplastic nevi on the treatment area
4. Is pregnant and/or lactating
5. History or current photosensitivity
6. History or current use of medication with photosensitizing properties within past 6 months
7. History or current of chronic reoccurring skin disease or disorder affecting treatment area
8. History or current cancer of any type
9. Has signs of actinic bronzing
10. Has open lacerations, and abrasions on the treatment area
11. History of keloid formation, or hypertrophic scar formation, or poor wound healing
12. History of bleeding disorder, or is currently taking anticoagulation medications
13. Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
14. Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
15. The investigator feels that for any reason the subject is not eligible to participate in the study

Primary outcomes:
measure: Photography
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montclair
country: United States
facility: New Jersey Clinical Research Center
state: New Jersey
Study officials:
References:
Clinical trial NCT04416685: A New Anatomical Classification of Portal Vein Location of Pancreas Tumors
Official title: A New Anatomical Classification of Portal Venous Involvement in Locally Advanced Pancreatic Cancer to Predict the Surgical Difficulty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm Malignant Head Primary
Keywords: pancreas tumors
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location . Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.
Primary purpose: TREATMENT

Brief summary: In this retrospective study, we recorded the location of pancreatic tumors and relation/proximity to the portal vein. The surgical difficulty and requirement of additional interventions were also evaluated.

Detailed description: Between May 2014 and October 2018, all patients who underwent PD procedure were retrospectively reviewed. This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection. Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded. The local ethical committee was approved this study.

Data collection included demographical features, tumor characteristics including the PV level of the tumor considering computed tomography results, neoadjuvant therapy, surgical data, hospital stay, morbidity and mortality.

Anatomical classification was established based on the relationship between portal confluence (PC) and tumor location (Figure I). Those tumors located superior to the PC were classified as Level I, whereas tumors on the confluence inferiorly located to PC were classified as Level II and Level III.

Eligibility criteria: Inclusion Criteria:

* This retrospective cohort study identified all consecutive patients with T3 (stage IIA to III) adenocarcinoma of the head of the pancreas, who underwent concomitant venous (PV/SMV) resection.

Exclusion Criteria:

* Those patients with locally advanced tumors that were not responded to neoadjuvant therapy were excluded.

Primary outcomes:
measure: peri-operative or postoperative complication
timeFrame: up to one month
Secondary outcomes:
measure: hospital stay
timeFrame: up to one month
Other outcomes:
measure: in hospital mortality
timeFrame: up to two months
Locations:
Study officials:
References:
Clinical trial NCT00130585: Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method
Official title: The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Folate Bioavailability
Healthy
Keywords: Folate
Bioavailability
Stable isotopes
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Wageningen University
First posted: 2005-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objectives of this project are:

1. to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
2. to determine the bioavailability with a higher precision than previous methods.

The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.

Detailed description: Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.

Eligibility criteria: Inclusion Criteria:

* Serum B12 \>118pmol/L;
* Serum creatinine \<125micromol/L;
* Plasma total homocysteine \<26micromol/L.

Exclusion Criteria:

* Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
* Use of drugs interfering with folate metabolism;
* Use of B vitamins within the period three months prior to the study.
* Body Mass Index (BMI) \> 30

Primary outcomes:
measure: Bioavailability based on change in labelled folate concentration in plasma;
measure: Bioavailability based on change in folate concentration in plasma
Secondary outcomes:
measure: Bioavailability based on change in concentration in plasma homocysteine
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen Centre for Food Sciences
name: Petra Verhoef, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Martijn Katan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01018485: The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
Official title: Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Tremor
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: Eastern Health
First posted: 2009-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.

Aims:

1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.


Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria
* Age 18-80 years of age
* Competent to understand and sign informed consent
* Presence of symptomatic head and/or limb tremor

Exclusion Criteria:

* Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
* A known contraindication to Botox injection
* Pregnancy

Primary outcomes:
measure: A decrease in tremor
timeFrame: 6 months
Secondary outcomes:
measure: The safety profile of Botulinum Toxin in MS patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Health
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Andrew Evans, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05119985: Ultrasound Guided Peripheral Venous Cannulation in Patient Undergoing Elective Surgery Under General Anesthesia.
Official title: Ultrasound Guided Peripheral Venous Cannulation in Patient Undergoing Elective Surgery Under General Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vein Cannulation Guided by Ultrasound
Keywords: ultrasound
vein
cannulation
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
Collaborators: name: Masaryk Hospital Usti nad Labem
First posted: 2021-11-15
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are divided by block randomization into two arms. Arm A peripheral vein cannulation with ultrasound guidance and Arm B conventional cannulation.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates two different techniques for peripheral venous cannulation in operating theatre. Ultrasound guided insertion of peripheral cannula in comparison with conventional approach without any ultrasound guidance.

Detailed description: Peripheral venous catheter placement is one of the key tasks of an anesthesiologist, which needs to be completed before surgery in general anesthesia. The reported success rate of peripheral venous cannulation, when performed in a conventional manner, without any special technical tools which facilitate finding the peripheral vein, is only 51% during the first trial. However, up to 7% of patients require more than three cannulation trials. Ultrasound guidance of peripheral venous catheter insertion may increase success rate and shorten time to securing peripheral cannula. However, this approach has not been verified in the setting of operating theatre so far. This project aims to set the role of ultrasound guided venous cannulation in operating theatre.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years

Exclusion Criteria:

* Age \<18 years
* Patient disagreement with the insertion of peripheral venous catheter
* Disagreement of the patient with inclusion in a clinical trial
* Contraindication of ultrasound examination of the venous system
* Contraindication of the introduction of peripheral venous cannula on both upper limbs
* Necessity of securing other vein access than peripheral
* Contraindications of cannulation of peripheral vein

Primary outcomes:
measure: Number of Participants with Successful Securing of Peripheral Vein on First Attempt
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of Needed Attempts to Successful Securing of Peripheral
timeFrame: 60 minutes
measure: Number of Complication After and During Securing Peripheral Vein
timeFrame: 24 hours
measure: Time Needed to Secure Peripheral Vein
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
state: Ústí nad Labem Region
Study officials:
References:
Clinical trial NCT00547885: Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain
Official title: Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: dihydrocodeine
opioids, long acting
opioids, short acting
Chronic pain
non-malignant pain
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 60
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: We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the two treatment arms.

Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality of sleep, breakthrough pain and quality of life will also be improved with long acting dihydrocodeine.


Eligibility criteria: Inclusion Criteria:

* Chronic pain
* Use 5-10 P.Forte every day for the last two weeks
* 18-75 years.

Exclusion Criteria:

* Cancer
* Hepatic failure
* Severe mental disorders
* History of known substance abuse.

Primary outcomes:
measure: Pain
timeFrame: 9 weeks
Secondary outcomes:
measure: sleep quality and duration
timeFrame: 9 weeks
measure: quality of life
timeFrame: 9 weeks
measure: Depression and moods
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: National Competency Centre for Complex Disorders
state: Sør-Trøndelag
Study officials:
affiliation: Norwegian University of Science and Technology
name: Petter C Borchgrevink, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen L, Borchgrevink PC, Breivik HP, Fredheim OMS. A randomized, double-blind, double-dummy comparison of short- and long-acting dihydrocodeine in chronic non-malignant pain. Pain. 2014 May;155(5):881-888. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 15.
Clinical trial NCT04788485: Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Official title: Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates Using Combined Esophageal Multichannel Intraluminal Impedance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux in Neonates
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: study of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment

Detailed description: This is a prospective clinical trial conducted on 20 preterm neonates \< 37 weeks of gestation, admitted in NICU, maternity hospital, Ain Shams University. They were assessed for gastroesophageal reflux disease and investigated using ph-MII for detection of reflux episodes and they were given Smecta 3gm/day for 7 days at least as a food thickener and then ph-MII repeated to assess the response

Eligibility criteria: Inclusion Criteria:

* • Newborns free of any congenital anomalies or inborn errors of metabolism

  * Infants had signs of reflux like:

    1. Typical or atypical crying and/or irritability
    2. Apparent life-threatening event
    3. Poor appetite; weight loss or poor growth (failure to thrive)
    4. Vomiting
    5. Bronchopulmonary dysplasia
    6. Wheezing, stridor
    7. Recurrent pneumonitis
    8. Sandifer syndrome (ie, posturing with opisthotonus or torticollis)

Exclusion Criteria:

* • Newborns with GIT anomalies as trans-esophageal fistula, hiatus hernia and other GIT anomalies causing reflux.

  * Patients with Hirshsprung disease or delayed passage of meconium.
  * History of NEC in the baby.

Primary outcomes:
measure: Effect of smectite as food thickener for treatment of gastroesophgeal reflux in neonates
timeFrame: within 7 days
Secondary outcomes:
measure: Reliability of signs for diagnosis of gastroesophageal reflux in neonates using MII-pH
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University-Faculty of Medicine
Study officials:
References: