louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04535895: Simultaneous Integrated Boost Technique in Breast Cancer Radiotherapy
Official title: Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Radiotherapy Side Effect
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.

Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.

The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.


Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer or ductal carcinoma in situ
* Breast conserving surgery
* Complete tumor resection
* Treatment with adjuvant radiotherapy of the breast
* Indication for boost Irradiation
* Given informed consent

Exclusion Criteria:

* Incomplete tumor resection
* Mastectomy
* Distant metastases at diagnosis
* Unable to give informed consent

Primary outcomes:
measure: Acute Radiation induced toxicity (grade 2 or higher)
timeFrame: Measurement at the last 1 day of radiotherapy
measure: Acute Radiation induced toxicity (grade 2 or higher)
timeFrame: Measurement 3 months after completion of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Dept. of Therapeutic Radiology and Oncology
name: Tanja Langsenlehner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurkmans CW, Dijckmans I, Reijnen M, van der Leer J, van Vliet-Vroegindeweij C, van der Sangen M. Adaptive radiation therapy for breast IMRT-simultaneously integrated boost: three-year clinical experience. Radiother Oncol. 2012 May;103(2):183-7. doi: 10.1016/j.radonc.2011.12.014. Epub 2012 Jan 24.
Clinical trial NCT00520195: Stair Instead of Elevator Use at Work: Cardiovascular Primary Preventive Effects on Hospital Employees.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2007-08-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an intervention study which evaluates the cardiovascular primary preventive effects of using stairs instead of elevators at the worksite during a 12-weeks period. We hypothesize that stair-climbing during working hours can meet the daily amount of physical activity recommended by current public health guidelines.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* No or little stair-use at work (\< 5 stories/day)
* Sedentary lifestyle

Exclusion Criteria:

* Positive answers to the health screening physical activity readiness questionnaire (PAR-Q)
* Part-time employment \< 80%
* Absence of more than 2 weeks during the intervention period
* Intention to begin a weight control program
* Medication changes which may influence blood pressure, lipid or glucose metabolism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Philippe Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739295: G-CSF in the Treatment of Toxic Epidermal Necrolysis
Official title: Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stevens - Johnson Syndrome
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 10
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: NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial.

Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.


Eligibility criteria: Inclusion Criteria:

* Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission

Exclusion Criteria:

* Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission
* Hypercoagulable state
* Cardiac or peripheral arterial disease
* Active malignancy
* Myelodysplastic syndrome or hematological malignancy
* Fructose intolerance
* Pregnancy
* Patient refusal

Primary outcomes:
measure: Time for healing
timeFrame: From date of randomization until the date of complete healing, assessed up to 30 days.
measure: Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa)
timeFrame: At admission and at day 5
measure: Biological data: Neutrophilic count
timeFrame: Every day during the 14th first days
Secondary outcomes:
measure: Biological data: WBC count
timeFrame: 3 months after discharge
measure: Biological data: WBC formula
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Burn Centre of the University Hospital of Liège
city: Loverval
country: Belgium
facility: IMTR Burn Centre
Study officials:
References:
Clinical trial NCT00214695: A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Official title: A Subjective Evaluation of Inflow Pain Associated With the Use of an Experimental Solution for Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2005-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the inflow pain using an experimental peritoneal dialysis solution compared to a current solution for the management of end stage renal disease (ESRD) in peritoneal dialysis (PD) patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have given written informed consent after the nature of the study has been explained.
* Patients who are at least 18 years of age.
* Patients who have been treated with PD using specific solutions for at least 30 days before the screening visit.
* Patients who experience pain on infusion based on medical judgement.

Exclusion Criteria:

* Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before to screening visit.
* Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit.
* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
* Patients who have received an investigational product within 30 days preceding the screening visit.
* Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study).
* Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Huddinge Sjukhus, Njurmed kliniken K 56
Study officials:
References:
Clinical trial NCT02007395: Prospective Study on Polypectomy Complications: SPoC.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Polypectomy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 5170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population undergoing endoscopic polypectomy

Brief summary: Colonoscopy has been shown to reduce both the colo-rectal cancer incidence and mortality, due to its capability to detect and remove precancerous lesions. However, polypectomy is associated with complications, such as bleeding and perforation, with an estimated overall incidence of about 10%, with polyp size and right-sided location considered as major risk factors. Aim of present study was to prospectively evaluate the early and delayed (30-days follow-up) complications of polypectomy in a multicenter regional Italian real practice setting


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing endoscopic polypectomy

Exclusion Criteria:

* pregnancy
* incapacity to give informed consent

Primary outcomes:
measure: complications of endoscopic polypectomy
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00152295: A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Official title: A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postmenopause
Keywords: Postmenopausal
Amenorrhea
Hormone replacement therapy
HRT
asoprisnil
Estrogen Replacement Therapy, postmenopause
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 18
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Detailed description: The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

Eligibility criteria: Inclusion Criteria:

* Successful completion of study M00-198
* Continued good general health
* Negative urine pregnancy test

Exclusion Criteria:

* History of known or suspected cancer other than basal cell carcinoma in last 5 years
* History of reproductive endocrine disorder
* Submucous or other symptomatic fibroid which would confound efficacy
* Ovarian mass
* Ongoing treatment with an excluded medication
* Stenosis of the cervix
* Any abnormal lab result the study-doctor considers significant.

Primary outcomes:
measure: The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
timeFrame: Throughout Study
measure: The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
timeFrame: Months 3,6
measure: Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
timeFrame: Months 3,6
Secondary outcomes:
measure: Frequency and amount of vaginal bleeding assessed via daily diary.
timeFrame: Throughout study
measure: Frequency and severity of hot flushes assessed via daily diary.
timeFrame: Throughout study
measure: Mean change from baseline in endocrine determinations.
timeFrame: Months 2,4,and 6
measure: Global efficacy question
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Medical Director
role: STUDY_CHAIR
References:
Clinical trial NCT03492814: Comparing Different Suturing Techniques on the Post-operative Morbidity After Removal of Impacted Mandibular Third Molar
Official title: Comparing the Effect of Different Suture Techniques on the Post Operative Morbidity After Surgical Removal of Impacted Mandibular Third Molar- A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swelling
Trismus
Keywords: impacted third molar
suturing
post-operative morbidity
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.

Detailed description: Third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. Wound closure technique is an operative factor which is associated with reduced post-operative morbidity. In the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. This study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing surgical removal of mesioangular impacted mandibular third molar.
* Healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II).
* patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol.

Exclusion Criteria:

* Patients having systemic conditions that might have an effect on the bone growth or periodontal healing.
* patients who are on antibiotics premedication or any drugs that might affect wound healing.

Primary outcomes:
measure: change in the Measurement of mouth opening
timeFrame: baseline( preoperative) and 3rd and 7th day postoperatively.
measure: postoperative swelling
timeFrame: baseline ( preoperative) and 3rd and 7th day postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka Manipal Medical College
Study officials:
affiliation: Melaka Manipal Medical College
name: Abdul Kalam Azad, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00834314: Randomized Pilot Study Comparing Two Vacuum-wound-dressings for Open Abdomen Treatment
Official title: Vacuum-Therapy in Open Abdomen Treatment - Randomized Pilot-trial Comparing Fascial Closure and Survival With "Vacuum-Pack"-Technique vs. "Abdominal Dressing"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open Abdomen
Temporary Abdominal Closure
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2009-02-03
Enrollment: 3
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 primary purpose of the study is to determine whether two vacuum-wound-dressing techniques (the so called "abdominal dressing" versus "vacuum-pack-technique") are equally effective in the treatment of open abdomen.

Secondary purpose is the comparison of feasibility and economic aspects.


Eligibility criteria: Inclusion Criteria:

* Patients indicated for open-abdomen-treatment by responsible consultant surgeon where vacuum-technique is judged technically possible

Exclusion Criteria:

* Technical reasons
* unjustified risk-benefit-ratio of manipulations necessary for application of vacuum-pack-technique or abdominal-dressing-technique

Primary outcomes:
measure: Failure of delayed abdominal fascial closure (non-prevented ventral hernia) and/or in-hospital-death of any cause (combined primary outcome)
timeFrame: until end of vacuum-therapy or death
Secondary outcomes:
measure: vacuum-therapy-related morbidity/complications
timeFrame: until hospital dismissal or death
measure: length of vacuum-therapy
timeFrame: until end of vacuum-therapy or death
measure: costs of vacuum-therapy
timeFrame: until end of vacuum-therapy or death
measure: total length of ICU-stay
timeFrame: until end of ICU-therapy or death
measure: post-dismissal health-related quality of life (SF36 and EQ-5D questionnaire)
timeFrame: 12 weeks after hospital dismissal
measure: recurrent hernia/abdominal wall dehiscence after initial facial closure during hospital stay
timeFrame: 12 weeks post hospital dismissal
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre - Surgical Department
state: Baden-Wuerttemberg
Study officials:
affiliation: University Medical Center Mannheim, Germany, Surgical Department
name: Stefan Post, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brock WB, Barker DE, Burns RP. Temporary closure of open abdominal wounds: the vacuum pack. Am Surg. 1995 Jan;61(1):30-5.
citation: Barker DE, Green JM, Maxwell RA, Smith PW, Mejia VA, Dart BW, Cofer JB, Roe SM, Burns RP. Experience with vacuum-pack temporary abdominal wound closure in 258 trauma and general and vascular surgical patients. J Am Coll Surg. 2007 May;204(5):784-92; discussion 792-3. doi: 10.1016/j.jamcollsurg.2006.12.039. Epub 2007 Mar 26.
Clinical trial NCT00916214: Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program
Official title: Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polypharmacy
Lead sponsor: Ringkobing Love Apotek
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Prevention
First posted: 2009-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care plan in improving compliance among elderly polypharmacy users at community pharmacy settings. The specific objective of the project is to determine effects of pharmaceutical care program on medication adherence and persistence among elderly polypharmacy users.


Eligibility criteria: Inclusion Criteria:

* Both men and woman aged more than 65 years and taking more than 2 drugs

Exclusion Criteria:

* Inhabitants of nursing homes
* People receiving unit dose dispensing of medicine

Primary outcomes:
measure: change in medication adherence from run-in to the end of phase 1
timeFrame: 6 months
measure: persistence of mean medication adherence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ringkøbing
country: Denmark
facility: Ringkøbing Løve Apotek
Study officials:
affiliation: Ringkøbing apotek
name: Muhammad Saeed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06238895: Optimizing Dosing Strategies in Oral Iron Supplementation
Official title: Optimizing Dosing Strategies in Oral Iron Supplementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Iron Deficiencies
Iron Deficiency Anemia
Iron Deficiency Anemia Treatment
Keywords: iron deficiency anemia
oral iron supplementation
iron supplementation
gender differences
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 100
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 clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency.

The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.

Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* ≥18 years of age
* Iron deficiency: Ferritin \<30 µg/l
* hemoglobin ≥ 80 g/l
* CRP \< 5 mg/l

Exclusion Criteria:

* Refusal of study participation,
* Regular administration of Erythropoietin
* Oral or intravenous iron supplementation \<12 weeks prior to investigation
* Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate
* Blood transfusion or donation \<12 weeks prior to investigation
* Active chemotherapy
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.

Note

Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):

Anemia (as defined by the WHO): Hemoglobin \<130 g/L for men, Hemoglobin \<120 g/l for women, Hemoglobin \<110 g/l for pregnant women

Primary outcomes:
measure: Change of Hemoglobin after 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Proportion of participants achieving treatment goal
timeFrame: 12 weeks
measure: Change of iron parameters from baseline
timeFrame: 12 weeks
measure: Side effects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
References: