louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00705263: Satisfaction in Patients Receiving the PegIntron Pen Plus Rebetol for Hepatitis C (Study P04244)(COMPLETED)
Official title: Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Slovenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepacivirus
Lead sponsor: Schering-Plough
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 113
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: Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol at sites in Slovenia.

Brief summary: The current gold standard for treatment of chronic hepatitis C is pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness. This is the idea behind the development and usage of the PegIntron pen (PegPen). Therefore, it is worthwhile to evaluate patients' satisfaction with this novel device. The results of the study will be used to improve PegPen training techniques for patients and health care providers.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C treated with the PegIntron pen plus Rebetol

Exclusion Criteria:

* Not willing to participate in the study

Primary outcomes:
measure: Number of Participants Satisfied With the PegIntron Pen, Including the Assessment of the Device Accuracy and Ease of Use.
timeFrame: After 4 weeks of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05409963: Tobacco Impact on Quality of Life on Snus-use, Dual Use, Smoke Use and Non-using.
Official title: Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use
Keywords: Cigarette smoking
Health
Population characteristics
Quality of life
Tobacco smokeless.
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-06-08
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Three thousand women and men were randomly selected by the Swedish population data-base (SPAR) in rural areas of southwest Sweden.

Brief summary: The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers.

Detailed description: Tobacco use is a major public health issue. The number of smokers decrease simultaneously as oral moist snuff (called "snus"), is promoted as a healthier alternative in spite its' negative health effects. Studies of health-related quality of life (HRQOL) of those who use snuff are lacking. Recruitment of 674 women and 605 men aged 18 to 65 years through a Swedish population data-base was performed for this cross-sectional study in southwestern Sweden. Subjects completed a questionnaire about tobacco use and the 36-item Short Form Health Survey (SF-36). The non-parametric Mann-Whitney test was used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

Age 18 to 65 years

Exclusion Criteria:

not understand the Swedish language

Primary outcomes:
measure: Health-related quality of life was measured using SF-36.
timeFrame: The time when the data entry is made, about 8 weeks
measure: Tobacco habits.
timeFrame: The time when the data entry is made, about 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
name: Solbrith Wachsmann, DMPhil
role: STUDY_DIRECTOR
affiliation: Region Västra Götaland, Research, Education, Development & Innovation, Primary Care Research, Sweden
name: Gun Rembeck, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109263: Prevention of the Procedural Pain in the Newborn
Official title: Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of the Procedural Pain in the Newborn
Keywords: Breast-feeding
Saccharose
Breast-feeding newborn
cortical pain responses
near infrared spectroscopy (NIRS)
Salivary rate cortisol
heel lance
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 114
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

Detailed description: Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Eligibility criteria: Inclusion Criteria:

* Gestationnel age included between 37 and 42 weeks
* Born in the CHRU of Brest
* Breast-Fed
* Score of Apgar upper to 7
* No pathology malformative
* Absence of known chromosomal abnormality
* Consent of parents

Exclusion Criteria:

* Maternal drug use
* Morphinic treatment
* Barbiturate treatment
* Benzodiazépine treatment

Primary outcomes:
measure: Increase of the total concentration of haemoglobin
timeFrame: Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes
Secondary outcomes:
measure: Dosage of rate salivary cortisol
timeFrame: before and after painful gesture
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre hospitalier universitaire
Study officials:
affiliation: Pole de la femme, de la Mère et de l'Enfant, CHRU de Brest
name: Jean-Michel ROUE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02219763: The Effects of a Weight Management Program on Body Weight and Quality of Life
Official title: A Longitudinal Study to Investigate the Effects of a 14-visit Comprehensive Lifestyle Weight Management Program on Body Weight and Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 50
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: Adults (over age 18) with a BMI ≥ 25 enrolled in the 12-week Healthy Habits for Life (HHL) group program from the MGH Weight Center will be recruited. Subjects will be recruited over a 5-month period.

Brief summary: Evaluate the impact of a 12-week behavioral weight management program on body weight and quality of life. We hypothesize that participants will lose body weight and see improved quality of life after program completion.

Detailed description: This study will evaluate weight change and quality of life among individuals after completion of a 12-week comprehensive group weight management program. Findings from this study will also help with program development and improvement within our center. The already established weight management program is called Healthy Habits for Life (HHL) and includes a total of 14 visits (one individual visit both before and after the 12 group sessions).

All patients who are enrolled in the Healthy Habits for Life group program at the Weight Center have an individual visit with a registered dietitian prior to beginning the group as part of standard care. At this visit the dietitian will obtain informed consent for participation in the research study and provide subjects consenting to participate in the study with the IWQOL-lite quality of life questionnaire.

After completion of the 12 HHL group sessions, all patients at the Weight Center have another individual visit with the dietitian to review weight and behavior changes since the initial evaluation. At this visit, subjects participating in the research study will again be provided with the IWQOL-lite questionnaire to fill out.

Eligibility criteria: Inclusion Criteria:

* English speaking adults aged 18 or older
* BMI ≥ 25
* Enrolled in HHL program at the MGH Weight Center

Exclusion Criteria:

* Non-English speaking patients

Primary outcomes:
measure: Weight Change
timeFrame: Approximately 4 months after enrollment
Secondary outcomes:
measure: Quality of Life
timeFrame: Approximately 4 months after enrollment
Other outcomes:
measure: Blood laboratory values
timeFrame: Approximately 4 months after enrollment
Locations:
city: Boston
country: United States
facility: MGH Weight Center, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Sonja S Goedkoop, MSPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04895163: Acute Appendicitis in Foreign Workers of Northern Israel
Official title: Acute Appendicitis in Foreign Workers of Northern Israel: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: Acute appendicitis
Foreign workers
Complicated appendicitis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 117
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis

Brief summary: To Compare the outcome to acute appendicitis in foreign workers to the native patients.

Detailed description: This is a retrospective case-control study. The investigators identified all patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis. The study group included all foreign workers and the control group was age, sex, and co-morbidities matched group from the local population. The investigators compared time to presentation, admission parameters and disease outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-50 who were admitted to our institution between January 1st, 2013 and October 31st, 2018, with the diagnosis of acute appendicitis

Exclusion Criteria:

* Pregnant women
* Patient whose pathology report of the appendix was normal

Primary outcomes:
measure: Percent of complicated disease
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
Study officials:
References:
Clinical trial NCT00241163: TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)
Official title: An Open, Randomised, Prospective, Multicentre, Parallel-group Trial to Compare Efficacy and Safety of TachoComb S Versus Standard Surgical Treatment in Patients Undergoing Surgical Resection of Superficial Renal Tumour.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Resection of Superficial Renal Tumour
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective is to compare efficacy and safety of TachoComb S and standard surgical treatment for the control of local bleeding in patients undergoing surgical resection of renal tumours. Specific objectives include the comparison between test treatments of intra-operative haemostatic efficacy as well as post-operative blood loss, haematoma formation, and surgeon's rating of usefulness of test treatment.


Eligibility criteria: Inclusion Criteria:

Patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. After the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained.

Exclusion criteria:

Patients undergoing an emergency operation, or with more than one tumour will be excluded. Patients with a clinically abnormal value of prothrombin time or activated partial thromboplastin time, anamnetic evidence of coagulation disorders and a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen will be excluded. In case the tumour was resected by use of a laser scalpel, infrared coagulator or argon beamer and if any fibrin glue haemostatic was used before randomisation the patient will be excluded from the trial. Furthermore, patients will be excluded if extensive resection/extirpation of the kidney become necessary or in case of serious surgical complication occurring during the operation.

Primary outcomes:
measure: Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.
Secondary outcomes:
measure: Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
measure: Adverse events will be recorded from screening until follow-up.
Other outcomes:
Locations:
city: Roskilde
country: Denmark
Study officials:
affiliation: Takeda
name: Please refer to this study by ClinicalTrials.gov identifier NCT00241163, Nycomed
role: STUDY_CHAIR
References:
Clinical trial NCT03541863: Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients
Official title: What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Fulvestrant
Progression
Endocrine sensitivity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

Brief summary: What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China.

Detailed description: There is no evidence of treatment after progression of Ful. We retrospectively evaluated HR+, HER2- MBC patients failed on Ful 500mg as first line or second line therapy from 2014 to 2017 in 6 institutions. Treatment pattern, PFS, OS and safety were analyzed to figure out the situation and efficacy of treatment after Fulvestrant.

Eligibility criteria: Inclusion Criteria:

* Patients who were treated with Fulvestrant between June 2014 to June 2017 as first line or second line therapy
* Patients received subsequent treatment after progressing on Fulvestrant for at least one cycle (\>1 month)
* Complete medical history was available

Exclusion Criteria:

* Subsequent treatment was not standard therapy (cannot be classified into endocrine therapy/ chemotherapy)
* Medical history was incomplete

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: OS
timeFrame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
measure: Fulvestrant sensitivity
timeFrame: 6 weeks
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04181463: Nasal Inhalation of Isopropyl Alcohol for the Treatment of Nausea in Patients With Cancer
Official title: Inhalation Approaches to Nausea: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-29
Enrollment: 112
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: The goal of this research study is to understand the effect of inhalation approaches in reducing nausea in cancer patients.

Detailed description: In this study, inhalation of a study solution will be compared to inhalation of placebo, both in the form of preparation pads (a small square of material that contains the solution). Isopropyl alcohol may be a part of the preparation pads. A placebo is not a drug. It looks like the study solution but is not designed to treat any disease or illness. It is designed to be compared with the study solution to learn if the study solution has any real effect.

Inhalation of the study solution may help to control your nausea. Future patients may benefit from what is learned. There may be no benefits for you in this study.

Your participation is completely voluntary. Before choosing to take part in this study, you should discuss with the study team any concerns you may have, including side effects, potential expenses, and time commitment.

Eligibility criteria: Inclusion Criteria:

* Rate current severity of acute/chronic nausea \>= 4 on NRS (Numeric Rating Scale)
* Diagnosis of cancer
* Able to read/write in English
* Referred to supportive care service as an inpatient or outpatient
* Rate anxiety as =\< 4 on ESAS-FS (Edmonton Symptom Assessment Scale-Financial Distress and Spiritual Pain)
* Participants must agree to inhale isopropyl alcohol

Exclusion Criteria:

* Received anti-emetics in the last 30 minutes
* Received medical procedures (e.g. blood draws) which required exposure of isopropyl alcohol in the last 30 minutes
* Inability to inhale through nares (including recent upper respiratory infection)
* Known allergy to isopropyl alcohol
* Delirium (i.e., score \>= 7 on the Memorial Delirium Assessment Scale \[MDAS\])
* Have never been on anti-emetics during the course of the treatment here (anti-emetic naive)

Primary outcomes:
measure: Change in nausea
timeFrame: Baseline up to 5 minutes post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Yvonne J Heung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03675763: Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
Official title: Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Conditions
Colic, Infantile
Gastro-Intestinal Disorder
Keywords: Skull
Osteopathic Manipulation
Infantile Colic
Clinical Trial
Massage
Infant
Osteopathic Medicine
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 58
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.


Eligibility criteria: Inclusion criteria:

* infants diagnosed with colic,
* with 0-90 days of age,
* who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study.

Exclusion criteria:

* infants diagnosed with any sort of pathological illness, allergies or food intolerance
* who have suffered any intracranial hemorrhages or skull fractures.

Primary outcomes:
measure: Crying
timeFrame: Change from baseline crying at 24 days, also evaluated at days 7 and 14
Secondary outcomes:
measure: Sleep
timeFrame: Change from baseline sleep at 24 days, also evaluated at days 7 and 14
measure: Severity-ICSQ
timeFrame: Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03957863: Study of Erythropoietin in Newborns and Children
Official title: Study of Erythropoietin in Newborns and Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborn Infant
Child Under One Year of Age
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborn or child under 1 year of age

Brief summary: Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney.

Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml.

In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities.

The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.


Eligibility criteria: Inclusion Criteria:

* infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study

Exclusion Criteria:

* child treated with recombinant erythropoietin

Primary outcomes:
measure: EPO concentration UI/L
timeFrame: Baseline
measure: Electrophoretic profile of EPO
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References: