louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01178775: Development and Validation of Perceived Fatigue Meaning Scale on Walking Program
Official title: Development and Validation of Perceived Fatigue Meaning Scale and Its Effect on Individualized Patient Education and Walking Program for Managing Fatigue in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: fatigue
meaning
education
walking program
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2010-08-10
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this three-year study are to:

1. develop and validate a perceived meaning of fatigue scale
2. examine the effect of individualized patient education and walking programs on alleviating fatigue in patients with gastric or colorectal cancer,and further explore the relationship between the perceived meaning of fatigue and intervention outcome.

Detailed description: In the first year, patients will be recruited from oncology inpatient wards and outpatient clinics in two medical center hospitals in Taipei. Purposive sampling will be used to recruit outpatients or inpatients receiving chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, one-way analysis of variance, and exploratory factor analysis.

In the second and third years, an experimental design consisting of three groups including a control group, an education only group, and an education and walking program group will be used. Data will be collected at treatment weeks 1, 4,8,12,16 including three cycles of chemotherapy. Data will be analyzed by descriptive analysis, independent t-test, Pearson correlation, and generalized estimating equations. At least 230 subjects will be interviewed in the first year.

At least 105 of patients with gastric cancer or colorectal will be classified into the three groups in the second and third year. We expect the results of this study to explore the meaning of fatigue and to help develop a common strategy to manage fatigue in Taiwan. The results can help clinicians and researchers to tailor interventions for cancer patients with severe fatigue.

Eligibility criteria: Inclusion Criteria:

* The patients with gastric cancer during receiving chemotherapy
* Those who are willing to participate in the research
* Aged above 18

Primary outcomes:
measure: Fatigue Symptom Inventory
timeFrame: Time point(s) at which outcome measure is assessed at 16 Weeks after recruting in this study .
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shiow-Ching Shun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01144975: Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
Official title: A Randomized Study of the Safety and Biologic Activity of XOMA 052 in Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Type 2
Mellitus
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 76
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: The study hypothesis is that XOMA 052 is likely to improve glycemic control in subjects with Type 2 Diabetes Mellitus.

The purpose of this study is to determine whether XOMA 052 improves glycemic control in subjects on Metformin monotherapy whose diabetes is still not adequately controlled.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with T2D (disease duration \>= 6 months)
* HbA1c measurements \>= 7.0% and \<= 10.0%
* On a stable regimen of metformin monotherapy
* Age \>= 18 and \<= 75
* Stable diet and exercise regimen
* BMI \<= 40 kg/m2

Exclusion Criteria:

* Significant signs and symptoms of uncontrolled hyperglycemia (i.e., polyuria, polydipsia, or polyphagia)
* Uncontrolled hypertension (systolic \> 170 mmHg and/or diastolic \> 110 mmHg)
* Known to be positive for Hep B surface antigen (HBsAg), Hep C virus (HCV), or HIV
* History of allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* Advanced stage heart failure (New York Heart Association \[NYHA\] class 3 or 4)
* Pulmonary disease requiring medication other than inhaled corticosteroid s
* History of tuberculosis or positive PPD test.
* Active leg, foot, or decubitus ulcer
* Any significant inflammatory, rheumatologic, or systemic autoimmune disease
* History or any symptoms of a demyelinating disease
* History of severe non-proliferative or proliferative retinopathy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, daily fasting blood glucose measured by the subject using a glucose monitor, and treatment-emergent adverse events.
timeFrame: Day 0 pre-dose through Day 420
Secondary outcomes:
measure: Pharmacokinetic assessments of XOMA 052 from serum samples collected at time points specified in the protocol.
timeFrame: Day 0 pre-dose through Day 420
measure: Anti-inflammatory activity measured by hs-CRP and cytokines collected at time points specified in the protocol.
timeFrame: Day 0 pre-dose through Day 420
measure: Anti-diabetic activity measured by HbA1c, FPG, OGTT, C-peptide, and insulin collected at time points specified in the protocol.
timeFrame: Day 0 pre-dose through Day 420
Other outcomes:
Locations:
city: Mexico City
country: Mexico
Study officials:
References:
Clinical trial NCT03001375: Laparoscopic Splenic Flexure Mobilization
Official title: Is it Necessary to do Splenic Flexure Mobilization in Laparoscopic Resection of Upper Rectal Tumors?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Splenic Flexure Mobilization
Keywords: Laparoscopic colectomy.
Splenic flexure mobilization.
Anastomotic leakage.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 140
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: This retrospective cohort study conducted on 140 patients who underwent laparoscopic anterior resection for upper rectal cancer in the period from May 2011 to November 2015, comparison will be done on splenic flexure mobilization excluding .

Detailed description: Presently, it is acknowledged that laparoscopic colectomy for left sided colorectal cancer is the most common surgery operated in laparoscopic colorectal surgeries, However the most debatable question in such type of operations that is it mandatory to do splenic flexure mobilization or not? In the literatures colorectal surgeons divided into 2 teams, those with splenic flexure mobilization in laparoscopic left colorectal resection to have tension free, well vascularized anastomosis On the other hand those against splenic flexure mobilization reported that omitting this step does not significantly affect the leakage rate, morbidity or the oncological outcomes In this study, we evaluate the necessity of splenic flexure mobilization in laparoscopic anterior resection for upper rectal tumors and its impact on the operative time, total morbidity, leakage rate, oncological safety and continence level

Eligibility criteria: Inclusion Criteria:

* Patients with upper rectal tumors.

Exclusion Criteria:

* Low and mid rectal cancer
* Splenic flexure tumors, descending colon cancer,
* patients with associated lesions in the right or transverse colon
* Emergency cases.

Primary outcomes:
measure: the incidence of leakage rate in laparoscopic anterior resection with splenic flexure mobilization versus non mobilization of splenic flexure
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01677975: The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melanoma
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-09-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.


Eligibility criteria: Inclusion Criteria:

Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2.

Exclusion Criteria:

Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Blegdamsvej 9
country: Denmark
facility: Ultrasounddepartment 4123, Rigshospitalet
state: København Ø
Study officials:
References:
Clinical trial NCT04349475: Therapeutic Omegas for Triglyceride Suppression
Official title: Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: triglycerides
glucose
adiposity
Air displacement plethysmography
Continuous glucose monitoring
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Oklahoma
First posted: 2020-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are \~30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 21-39 yrs
* Pre-pregnancy BMI 28-39
* Fasting Triglyceride ≥120 mg/dL measured by 15 wks

Exclusion Criteria:

* Pre-gestational diabetes or prediabetes
* History of gestational diabetes,
* History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks
* Tobacco or illicit substance use
* Chronic steroid use

Primary outcomes:
measure: Maternal Fasting and Postprandial Triglycerides
timeFrame: 34 weeks gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado/Anschutz Medical Campus
state: Colorado
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Colorado, Denver
name: Teri L Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
Clinical trial NCT01875575: Oral Glucose Stimulation in Normal-weight and Obese Volunteers
Official title: Oral Glucose in Normal-weight and Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocrine System Diseases
Keywords: glucagon-like peptide-1
peptide tyrosine tyrosine
ghrelin
stomach
small intestine
gastric emptying
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients.


Eligibility criteria: Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.5 or healthy obese subjects with a body-mass index of \> 30
* Normal eating habits
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* Any abnormality detected during the screening procedure
* history of gastrointestinal disorders
* food allergies

Primary outcomes:
measure: Effect of different oral glucose loads on secretion of satiation hormones
timeFrame: 240min.
Secondary outcomes:
measure: Effect of different oral glucose loads on gastric emptying
timeFrame: 240min.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer-Gerspach AC, Cajacob L, Riva D, Herzog R, Drewe J, Beglinger C, Wolnerhanssen BK. Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Mar 4;11(3):e0150803. doi: 10.1371/journal.pone.0150803. eCollection 2016.
Clinical trial NCT01168375: The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy
Official title: The Role of Umbilical Cord Serum Therapy on Improvement of Corneal Epithelial Defect Following Diabetic Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Corneal Epithelial Defect
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ophthalmic Research Center
First posted: 2010-07-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 80 diabetic patients underwent vitrectomy and had no history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency will be randomized into two groups (double blind)to evaluate the role of umbilical cord serum therapy on improvement of corneal epithelial defect following diabetic vitrectomy. Both groups will take the conventional medication including Chloramphenicol, Betamethasone, Cycloplegic eye drops besides the case group will take umbilical cord serum eye drop in the eye operated. After surgery the corneal epithelial defect will be measured by slit lamp.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with corneal epithelial defect following diabetic vitrectomy at labbafinejad Hospital

Exclusion Criteria:

* Any history of Eye herpes infection, Refractive surgery, Autoimmune disease, Immune deficiency
* Patients with one eye
* Use of any eye drops except Chloramphenicol, Betamethasone, Cycloplegic and contact lens for corneal epithelial defect

Primary outcomes:
measure: measurement of corneal epithelial defect
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT02166775: Correlation Between Sagittal Balance of the Spine and Psychopathological Profile
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kyphosis in Depressed or Anxious Patients
Lordosis in Patients With Manic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kyphosis in Depressed or Anxious Patients - Lordosis in Patients With Manic

Brief summary: In this trial, the correlation between the psychopathological profile and sagittal balance unexplored to date spine will be studied. Indeed, a number of patients who benefited from well-conducted surgical treatment, targeted and tailored to their pathology, respond poorly to it. The investigators wonder if there are biomechanical factors or factors of psychopathological order which might influence the effectiveness of treatment. This seems logical for the entire medical community, but it has never been demonstrated in a clinical trial.

Detailed description: The purpose of this study is to find a global diagnostic and standardized tool , easy to use, on psychopathological factors influencing the posture of the patients lombalgia so that in this will be used to use identify upstream surgery, the patients undergoing psychiatric treatment of mood rather than surgical treatment. And thus may economise a surgical operation and its complications and the related expenses.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 70 years ·
* Spine surgery outpatients with or without low back pain with radicular ·- Affiliated to a social security scheme,
* Having signed an informed consent and were informed of the results of the consultation prior to inclusion

Exclusion Criteria:

* Patients having the major diseases of the spine: deformities (scoliosis, kyphosis), tumors, fractures, inflammatory and metabolic ·
* Patients having a spinal surgery history ·
* Patients difficult to inform ( emergency ward patients, patients with difficulties in oral comprehension)

Primary outcomes:
measure: sagittal balance of the spine : - kyphosis in depressed or anxious patients- lordosis in patients with manic
timeFrame: 2 hours
Secondary outcomes:
measure: link between the psychopathological profile and questionnaires
timeFrame: 2 hours
Other outcomes:
Locations:
city: Service de Chirurgie du Rachis, HUS
country: France
facility: Dr SCHULLER Sébastien
state: Strasbourg
Study officials:
affiliation: Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
name: Sébastien SCHULLER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Chirurgie du Rachis, Hôpital Civil, Hôpitaux universitares de Strasbourg
name: Yann Philippe CHARLES, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01973075: Genetic Etiology in Premature Ovarian Insufficiency
Official title: Genetic Etiology in Premature Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Ovarian Insufficiency
Genetic Predisposition to Disease
Keywords: Premature Ovarian Insufficiency (POI)
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2013-10-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are admitted to obstetrics and gynecology department

Brief summary: Premature Ovarian Insufficiency (POI), first described by Albright in 1942, is defined as an increase in Follicle Stimulating Hormone (FSH), an insufficiency of the ovarian function leading to an early menopause (\<40 years of age).Today, only 35% of POI's etiology can be explained. Causes enlightening POI may be enumerated as follows, according to their frequency: genetic mutations, autoimmune defects and abnormalities detected on the X chromosome.The purpose of the study is to determine the frequency of the genetic abnormalities and polymorphisms described above in the POI Turkish population


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosed premature ovarian failure patients
* 20-40 years old female patients

Exclusion Criteria:

* Surgical surgical menopause
* Female patients who can't meet the age range criteria

Primary outcomes:
measure: Genetic etiology in Premature ovarian Insufficiency
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical school Obstetrics department
Study officials:
affiliation: Istanbul University
name: Engin Oral, Prof,OBGYN
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337775: The Turkish Version of the Smartphone Impact Scale
Official title: The Reliability and Validity of the Turkish Version of the Smartphone Impact Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Addiction Psychological
Healthy
Addiction
Keywords: smartphone
technological addiction
smartphone psychosocial impact
smartphone use
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample will consist of volunteer, healthy participants.

Brief summary: Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive, affective, social, and behavioral impacts of smartphones in everyday life. The purpose of this study was to translate and cross-culturally adapt the SIS instrument into Turkish and investigate its psychometric properties.

Detailed description: Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive, affective, social, and behavioral impacts of smartphones in everyday life. The purpose of this study was to translate and cross-culturally adapt the SIS instrument into Turkish and investigate its psychometric properties. Two hundred healthy young adults will include. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of SIS (SIS-T) to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the Smartphone Addiction Scale (SAS-T) and Turkish version of the Nottingham Health Profile (NHP-T) will determine to check the validity.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 35 years
* Having a smartphone that was connected to the Internet for at least 6 months
* Being a volunteer to participate

Exclusion Criteria:

* Having cognitive impairment
* Having disabilities in understanding, speaking and reading Turkish

Primary outcomes:
measure: Smartphone Impact Scale
timeFrame: Baseline (First assessment)
Secondary outcomes:
measure: Smartphone Impact Scale
timeFrame: Within a 5-to-7-day period after the first assessment (Second assessment)
measure: Smartphone Addiction Scale
timeFrame: Baseline (First assessment)
measure: Nottingham Health Profile
timeFrame: Baseline (First assessment)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ebru Kaya Mutlu, PhD
role: PRINCIPAL_INVESTIGATOR
References: