louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05204823: Evaluation of the Glycemic Index in 4 Dairy Beverages.
Official title: Evaluation of the Glycemic Index in 4 Dairy Beverages.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Index
Cognitive Performance
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the glycemic index and glycemic load of 4 chocolate milk drinks.

Detailed description: Subjects will make a total of 5 visits. Four visits where they will drink a chocolate milkshake at each visit. In the other visit they will take glucose, as a comparator product.

Due to the low amount of sugars in the shakes, subjects will drink the equivalent of 25g of glucose.

At each visit subjects will have to come fasting, and samples will be collected at 9 different times.

Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes (10 men and 10 women).
* Subjects aged between 20 and 35 years.
* Subjects with a body mass index between 20 and 25 kg/m2.

Exclusion Criteria:

* Subjects suffering from diabetes mellitus or any chronic disease.
* Subjects with medical problems or a diagnosed psychiatric disorder.
* Subjects with alcohol abuse or excessive alcohol consumption (\>3 glasses of wine or beer/day).
* Subjects consuming any pharmacological medication that may affect memory.
* Participation in another clinical trial in the three months prior to the study.
* Unwillingness or inability to comply with clinical trial procedures.
* Subjects whose condition does not make them eligible for the study according to the investigator's criteria.
* Pregnant or lactating women.

Primary outcomes:
measure: Glucose
timeFrame: The glucose evolution will be measured for 210 minutes after product consumption.
Secondary outcomes:
measure: Glucose
timeFrame: Each product will be measured at 15, 30, 45, 60, 90, 120 and 150 minutes after consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Fco Javier López Román
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01779323: Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
Official title: Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Male Stress Urinary Incontinence
Keywords: SUI
stress urinary incontinence
male
transobturator sling
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 34
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the urology clinic.

Brief summary: The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. The investigators theorize that the sling helps with primary hypermobility of this pathophysiologic cause of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* The control group:
* normal male subjects
* The Intervention group:
* male
* with stress urinary incontinence
* 45 years or older
* history of prior radical prostatectomy
* complains of stress urinary incontinence
* scheduled for a transobturator sling surgery
* ability and willingness to provide written consent

Exclusion Criteria:

* absolute or relative contraindications to MRI
* claustrophobia
* inability to undergo the male sling surgery
* PI judgement

Absolute contraindications to MRI:

* electronically, magnetically, and mechanically activated implants
* ferromagnetic or electronically operated active devices
* metallic splinters in the eye
* ferromagnetic hemostatic clips in the central nervous system

Relative contraindications to MRI:

* cochlear implants
* other pacemakers
* nerve stimulators
* lead wires or similar wires
* prosthetic heart valves
* hemostatic clips
* non-ferromagnetic stapedial implants

Primary outcomes:
measure: Change in urethral mobility
timeFrame: Within 2-5 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01489423: Tissue and Blood Biomarkers From Patients With Stage III or Stage IV Melanoma Treated With Ipilimumab With or Without Sargramostim
Official title: Correlative Analyses of Specimens From Eastern Cooperative Group Study E1608
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma (Skin)
Keywords: stage IIIC melanoma
stage IV melanoma
recurrent melanoma
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-09
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients who participated in E1608 and provided samples for research.

Brief summary: RATIONALE: Studying samples of tissue and blood in the laboratory from patients treated with ipilimumab with or without sargramostim may help doctors learn more about the effects of ipilimumab and sargramostim on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research trial studies tissue and blood biomarkers in patients with stage III melanoma or stage IV melanoma treated with ipilimumab with or without sargramostim.

Detailed description: OBJECTIVES:

* To compare the pathology of primary melanomas, melanoma metastases, and post-treatment melanoma metastases in relation to clinical outcomes for patients receiving ipilimumab plus sargramostim (GM-CSF) and patients receiving ipilimumab alone.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on effector immune function in patients with metastatic melanoma.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on regulatory immune function in patients with metastatic melanoma.
* To determine the effects of the addition of systemic GM-CSF to ipilimumab on anti-tumor humoral immunity in patients with metastatic melanoma.

OUTLINE: Serum, peripheral blood mononuclear cells, and tumor tissue (from primary tumor and post-treatment biopsies) samples are analyzed for biomarkers predictive of clinical outcomes, immune function, and anti-tumor humoral immunity by IHC, RT-PCR, flow cytometry, ELISPOT assays, and ELISA.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of measurable unresectable stage III or stage IV melanoma
* Treated with ipilimumab with or without sargramostim on clinical trial ECOG-E1608
* Primary tumor tissue and optional post-treatment biopsies of tumors from easily accessible tissues

PATIENT CHARACTERISTICS:

* ECOG performance status 0 or 1

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Primary brisk lymphocytic infiltrates associated with better outcomes (overall survival, progression-free survival, and clinical response)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farber Cancer Institute
name: F. Stephen Hodi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03895723: Minimally Invasive Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Official title: Minimally Invasive(Laparoscopic and Robotic) Versus Open Liver Resection for Patients With Colorectal Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Liver Metastasis
Keywords: Colorectal liver metastasis
Minimally invasive surgery
Robotic surgery
Laparoscopic surgery
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A: minimally invasive surgery Arm B: open
Primary purpose: TREATMENT

Brief summary: To examine survival of patients who underwent minimally invasive versus open liver resection for colorectal cancer with liver metastases.

Detailed description: the minimally invasive procedure contain laparoscopic or robotic surgery

Eligibility criteria: Inclusion Criteria:

* patients were diagnosed with colorectal cancer liver metastases
* without extra-hepatic liver metastases
* age were within 18-75 yeas
* the numbers of metastases more than 3
* the maximal tumor size of liver metastases more than 10 cm

Exclusion Criteria:

* liver metastases were unresectable.

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: 3 years disease-free survival
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years overall survival
measure: Sugical complications
timeFrame: 1 months after sugery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Wenju Chang
state: Shanghai
Study officials:
References:
Clinical trial NCT04515823: Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy
Official title: The Flat OGTT During Pregnancy -Prevalence and Risk for Adverse Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-08-17
Enrollment: 2085
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.

Brief summary: The aim of the study is to examine the relationship between "flat" sugar curve on OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal outcomes.

Detailed description: A retrospective cohort analysis of all women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.

Eligibility criteria: Inclusion Criteria:

* Performing the OGTT test during the pregnancy

Exclusion Criteria:

* lack of documentation or Non-performance of OGTT test during the pregnancy.

Primary outcomes:
measure: To evaluate the characteristics and perinatal outcomes of parturients with a flat glucose curve on 100 grams oral glucose tolerance test (OGTT).
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rinat Gabbay-Benziv, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116123: Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients
Official title: Comparison of the Pressure Ulcer Prevention Effects of Two Mattresses With Different Support Surfaces Used in Bedridden Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Nursing Caries
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: This study was conducted to investigate the effectiveness of two types of mattresses with different support surfaces used in bedridden patients.

Method: The sample of this quasi-experimental study consisted of 60 patients according to the inclusion criteria. A group I and group II of 30 patients each were formed from the sampled patients. For the patients in group I, a bed with a cube/block system and vibration (massage) feature was used. For the patients in group II, a viscoelastic mattress was used. The data of the study were collected with the ''Patient Identification Form'', ''Braden Scale'', ''Pressure Wound Observation Form'' and ''Wound Measurement Chart''. Number-percentage distributions, Chi-square, Fisher's Exact Probability Test and Mann-Whitney-U tests were used to evaluate the data.

Implications for Clinical Practice: It was determined that the support surface used affected the pressure sore size and the mattress with cube/block system and vibration (massage) feature created smaller sized wounds in the sacrum, trochanter, malleolus and heel regions. In the sacrum, scapula, and heel regions, although not statistically significant in terms of wound stage and the number of patients who developed pressure sores, it was seen that the mattress with cube/block system and vibration (massage) feature was more effective.


Eligibility criteria: Inclusion Criteria:

* A "low risk" rating on the Braden Scale.
* Voluntary informed consent from conscious patients and consent from the legal guardian for unconscious or confused patients.
* Absence of pressure sores upon admission to the clinics.
* A BMI (Body Mass Index) not exceeding 30.00 (as classified by the World Health Organization).

Exclusion Criteria:

* The patient's bed was changed in less than ten days after inclusion in the study,
* Patient referral,
* Discharge
* Exhitus was the exclusion criteria.

Primary outcomes:
measure: Number of patients without pressure ulcers
timeFrame: Patients were followed up for four weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Agri
country: Turkey
facility: Agri İbrahim Cecen University
Study officials:
References:
Clinical trial NCT03417323: Effects of Compression Wear on Muscle Soreness
Official title: Effects of Compression Wear on Whole-body Electromyostimulation and Exercise-induced Muscle Soreness. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Regeneration
Repeated Bout Effect of WB-EMS
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
First posted: 2018-01-31
Enrollment: 23
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study address two main topics:

1. The effect of compression garment on whole-body electromyostimulation (WB-EMS) induced muscle soreness in young adults
2. The repeated bout effect of one intense session of WB-EMS as determined by various regeneration parameters

Detailed description: Using a cross-over design we applied 2 intense WB-EMS training sessions either with or without subsequent wearing of compression garments (long tights) for 5 days at baseline and after a washout period of 4 weeks. Healthy young to middle aged athletes used compression garments immediately postexercise for 24 hours and further 12 h during the day. Blood samples, questionnaires, resting metabolic rate and performance test were applied prior and 24, 48,72 and 96 h post-exercise consistently without wearing compression garments.

Eligibility criteria: Inclusion Criteria:

* healthy athletes with \>5 years of experience in competition balls sports and corresponding discipline specific resistance exercise

Exclusion Criteria:

* diseases and medication affecting muscle metabolism
* contraindication for WB-EMS

Primary outcomes:
measure: Maximum isokinetic leg extensor strength
timeFrame: 5 days
Secondary outcomes:
measure: Perceived physical state
timeFrame: 5 days
measure: Resting metabolic rate
timeFrame: 5 days
measure: Myoglobin
timeFrame: 5 days
measure: Heart rate variability
timeFrame: 5 days
measure: creatine-kinase (CK) concentration
timeFrame: 5 days
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of Medical Physics University of Erlangen-Nurnberg
city: Erlangen
country: Germany
facility: Institute of Medical Physics, University of Erlangen-Nurnberg
Study officials:
affiliation: German Sport University, Cologne
name: Helmut Lötzerich, PhD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang Kemmler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemmler W, Teschler M, Bebenek M, von Stengel S. [(Very) high Creatinkinase concentration after exertional whole-body electromyostimulation application: health risks and longitudinal adaptations]. Wien Med Wochenschr. 2015 Nov;165(21-22):427-35. doi: 10.1007/s10354-015-0394-1. Epub 2015 Oct 26. German.
Clinical trial NCT03920150: Vitamin D 24'000 IU for Oral Intermittent Supplementation
Official title: Vitamin D 24'000 IU for Oral Intermittent Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Keywords: optimal vitamin D value
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient will be recruited by their general practitioner. Patients will be randomly assigned to be supplemented with monthly solution (control group), monthly capsules (IMP group) or weekly capsules after calculation of a individual loading dose (IMP + loading dose group).
Primary purpose: TREATMENT

Brief summary: Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values \>75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.

Detailed description: Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.

All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.

Eligibility criteria: Inclusion Criteria:

* vitamin D deficiency by serum level \<50 nmol/l

Exclusion Criteria:

* hypercalcaemia

Primary outcomes:
measure: Serum level of vitamin D
timeFrame: 3 months of treatment
Secondary outcomes:
measure: Serum level of vitamin D after loading dose
timeFrame: up to 4 months of treatment
measure: Adverse Drug Reactions
timeFrame: 3 months of treatment
measure: Adherence to medication
timeFrame: 3 months of treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Pharmaceutical Care Research Group
Study officials:
affiliation: Pharmaceutical Care Research Group
name: Kurt E Hersberger, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01418950: Improving Parental Knowledge: Supplementation of Prematurity Counseling With Written Information
Official title: Improving Parental Knowledge: Randomized Trial of Supplementation of Prematurity Counseling With Written Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Prematurity Counseling for pregnant women and their family
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnant women who receive study counseling which includes gestational age specific written information in addition to the verbal counseling will have better knowledge of problems and outcomes of prematurity than women who receive standard counseling which consists of only verbal counseling.


Eligibility criteria: Inclusion Criteria:

* English speaking pregnant women who are between 23-34 weeks of gestation
* Who are 18 years and older
* Open to all ethnic groups.
* Admitted in preterm labor to Froedtert and Waukesha Hospitals labor and delivery unit.

Exclusion Criteria:

* Pregnant women who are known to have infants with congenital anomalies or other associated conditions apart from prematurity that could be a significant factor to the outcome of the baby.
* Pregnant women who have been included in this study and discharged at some point and again admitted for preterm labor will be excluded from the study.
* If a participant delivers before completing the Parent Knowledge Questionnaire, she will be excluded.

Primary outcomes:
measure: Maternal knowledge of problems of prematurity as measured by number of correct answers on the knowledge questionnaire will be assessed in the study and control groups.
timeFrame: Within 24 hours of counseling the primary outcome will be assessed
Secondary outcomes:
measure: The change in maternal anxiety score before and after counseling as measured by the State-Trait-Anxiety-Inventory will be compared between the study and control groups
timeFrame: The pre-counseling anxiety score will be obtained immediately after consent is obtained for the study. The post-counseling anxiety score will be obtained within 24 hours of counseling
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Mir Basir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.