louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00575835: Oral Vitamin D Supplementation in Elderly Women
Official title: Oral Vitamin D Supplementation in Elderly Women: Twice a Day or Three Times a Year? A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optimal Vitamin D Administration
Keywords: vitamin D
seasonal variation
PTH
bone markers
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Päivikki and Sakari Sohlberg Foundation, Finland
name: Lilly Foundation
First posted: 2007-12-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare oral vitamin D supplementation administered in two different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of 25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in vitamin D concentrations in these treatments. 3) Find out safety of these treatments


Eligibility criteria: Inclusion Criteria:

* Females
* 70-80 years
* Living in the community

Exclusion Criteria:

* Renal disease
* Diseases that contraindicate vitamin D supplementation
* Medications affecting bone
* Malignancy

Primary outcomes:
measure: Blood 25 OH D vitamin concentrations
timeFrame: 8 times during the year
Secondary outcomes:
measure: serum calcium, 24-hour calcium excretion in urine, creatinine clearance
timeFrame: 8 times during the year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, department of medicine, division of endocrinology
Study officials:
References:
Clinical trial NCT02373735: Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes
Official title: Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: stroke volume variation
radical cystectomy
blood loss
postoperative complications
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of stroke volume variation (SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.

Detailed description: The purpose of this study is to investigate the effect of stroke volume variation(SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. Patients were randomized to fluid management to maintain \<10% SVV (group A), or to undergo fluid management during radical cystectomy to maintain SVV 10-20% (group B). Intraoperative blood loss and hemodynamic parameters, perioperative laboratory data, and postoperative complications were compared between two groups.

Eligibility criteria: Inclusion Criteria:

* Bladder cancer patients who received radical cystectomy
* Patients with American Society of Anesthesiologists physical status scale classification 1, 2
* Patients who agree with written informed consent

Exclusion Criteria:

* Patients with history of arrhythmia, heart failure patients
* Patients with history of renal failure patients
* Patients with history of abdominal surgery
* Patients who received emergency operation
* Patients who do not agree with study

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: During operation
Secondary outcomes:
measure: Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)
timeFrame: During 30 days after operation
measure: Length of hospital stay/ICU stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06083935: Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
Official title: Effect of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Poly Cystic Ovary Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 120
Sex: FEMALE
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: Polycystic ovary syndrome (PCOS) is one of the most prevalent disorders worldwide. Insulin resistance, inflammation and disturbance in sex hormone levels are the main contributing factors of this disease.The majority of studies addressing the status of chronic low-grade inflammation in PCOS have focused on the measurement of C-reactive protein (CRP) followed by stimulation of interleukin 6 (IL-6) and tumor necrosis factor (TNF-alpha).

Daflon 500 mg tablets (containing 90% of diosmin and 10% of hesperidin) is used in patients to treat varicose veins, venous ulcers, hemorrhoids and lymphatic insufficiency. It has anti-diabetic, anti-inflammatory, microcirculatory, and antioxidant effects. So the aim of the work is to investigate the effect of Diosmin/Hesperidin in the management of PCOS through evaluation of Oxidative stress and inflammation, improvement of signs and symptoms through patients' follow-up, improvement of PCOS status by sonography and hormonal levels, measuring of anti-diabetic effect by measuring, fasting insulin, HOMA-IR and measuring the improvement of patient's quality of life by using the women health questionnaire (WHQ).


Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of PCOS aged in the range from18-40 (premenopausal adults) diagnosed with PCOS according to Rotterdam criteria by an expert gynecologist; (1) oligo-ovulation and/or anovulation (2) Clinical and biochemical hyperandrogenism and (3) polycystic ovaries on ultrasonography

Exclusion Criteria:

* 1-Pregnant and nursing women 2-Menopause women 3-Diabetic patients 4-Adrenal hyperplasia 5-Adrenal Tumor 6-Thyroid dysfunction 7-Women on confounding medications which affect ovarian function

Primary outcomes:
measure: Improvement of the inflammation
timeFrame: 4 months
measure: Improvement of glycemic index
timeFrame: 4 months
Secondary outcomes:
measure: Improvement of PCOS status levels
timeFrame: 4 months
measure: Improvement of patient's quality of life
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05045235: Optimization of Drug Prescriptions in the Care Pathway for the Elderly, With the Final Objective of Reducing the Iatrogenic Risk
Official title: Optimization of Drug Prescriptions in the Care Pathway for the Elderly, With the Final Objective of Reducing the Iatrogenic Risk.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Iatrogenic Effect
Prescription
Follow-up
Consultation
Keywords: iatrogenic
prescription
follow-up
consultation
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient hospitalized in the geriatric medicine department with olymedicated drugs

Brief summary: The IATROPREV project is an organizational innovation experimentation project, carried out in Hauts-de-France by the University hospitals of Amiens and Lille, the ARS and the URPS Doctors and Pharmacists of Hauts-de-France and following to the social security financing law of 2018, allowing experimentation with new organizations in the health sector, according to article 51. The objectives of this course are to improve the relevance of prescription in elderly people with multiple drugs as well as, the coordination of care between the city and the hospital through the sharing of information and the establishment of multi-professional consultations between the various care actors.


Eligibility criteria: Inclusion Criteria:

* patient hospitalized in the geriatric medicine department
* Potential involvement of a drug in hospitalization or potential or proven iatrogenic event during hospitalization;
* Numerous therapeutic modifications (3 or more);
* Drug interaction or introction of a new drug with one or more drug interactions;
* Medicinal product with a narrow therapeutic marge drug requiring close monitoring.

Exclusion Criteria:

* patient non hospitalized in the geriatric medicine department

Primary outcomes:
measure: Change of side effect number in ederly with polymedicated drugs
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
Study officials:
References:
Clinical trial NCT02675335: Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
Official title: Accelerated Wound Healing in Diabetic Ulcers by Sitagliptin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetic Foot
Keywords: Diabetic foot ulcer, Sitagliptin
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the effect of Sitagliptin on the healing of stable, nonhealing diabetic foot ulcers. This is a randomized placebo-controlled Trial.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* at least 1 diabetic foot ulcer with a size between 1 and 20 sqcm
* stable size of the foot ulcer for at least 2 weeks
* HbA1c \<= 8% under Treatment with Insulin, metformin, sulfonylureas, SGLT2 Inhibitors, glinides or glitazones

Exclusion Criteria:

* local purulent signs of Inflammation at ulcer site
* planned interventional or surgical therapy of a macro vessel disease of the lower limb
* glomerular filtration rate \<30ml/min
* liver cirrhosis CHILD B or C
* pregnancy, lactation
* allergy against Sitagliptin
* ongoing treatment with dipeptidyl peptidase 4 (DPP4) Inhibitors

Primary outcomes:
measure: mean ulcer size after a treatment period of 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Innsbruck
name: Wolfgang-M Franz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06337435: Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding
Official title: The Ability of the Multi-Looped Lingual Retainer Activated by A New Method to Align Lower Incisor Crowding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crowding of Anterior Mandibular Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with mild to moderate crowding

Brief summary: this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding

Detailed description: 1. patients preparation( photo- impression- x-ray- scan the lower cast to calculate the crowding )
2. The multi-looped lingual retainer was fabricated on the patient's lower cast
3. The lingual surfaces of teeth were etched with 35% phosphoric acid for 20 seconds The multi-looped lingual retainer was activated in the new way (Kattan method ) by tightening a steel ligature wire 0.010 inches, to the reinforcement 0.020-inch stainless steel arch-wire.
4. the bonding agent was applied on such surfaces after a good isolation and was light-cured for 20 seconds.
5. A flowable composite resin was applied. After checking its fit on the surface of the teeth, The lingual wire was bonded with a drop of flowable composite resin and was light-cured for 20 seconds.
6. follow-up the patients \* Outcomes: The improvement of lower incisors irregularity using Little Irregularity Index.

Eligibility criteria: Inclusion Criteria:

* Adult male and female patients, the ages of 16 to 25, the patients having class I canine with mild to moderate lower incisors crowding
* good oral hygiene.

Exclusion Criteria:

* Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.

Primary outcomes:
measure: The improvement of lower incisors irregularity using Little Irregularity Index.
timeFrame: follow-up three to six months
Secondary outcomes:
measure: The stability of lower incisor positioning after ending treatment
timeFrame: after 1-3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry Cairo university
Study officials:
affiliation: bassel.alhawash@dentistry.cu.edu.eg
name: bassel mouafak alhawash, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05662735: Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
Official title: Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hernia, Hiatal
Laparoscopic
Surgery
Recurrence
Mesh
Primary
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: Rijnstate Vriendenfonds
First posted: 2022-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.


Eligibility criteria: Inclusion Criteria:

* Participant of the initial PRIME study
* Alive

Exclusion Criteria:

* No informed consent
* Additional hiatal hernia repair surgery during the follow-up period
* Pregnancy
* Patients that have stated they do not want to be approached for follow-up research

Primary outcomes:
measure: Percentage of objective recurrence of a hiatal hernia
timeFrame: 5-10 years
Secondary outcomes:
measure: Percentage of clinical recurrence of a hiatal hernia
timeFrame: 5-10 years
measure: Symptoms of gastroesophageal reflux disease
timeFrame: 5-10 years
measure: Patient satisfaction
timeFrame: 5-10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03672435: Strabismus Recovery With Proparacaine and Oculocardiac Reflex
Official title: Does Proparacaine Enhance Strabismus Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Bradycardia
Nausea
Pain
Keywords: post operative recovery
oculocardiac reflex
extra ocular muscle
conjunctiva
numbing drop
heart rate
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: strabismus surgery patients

Brief summary: Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.

Detailed description: In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.

Eligibility criteria: Inclusion Criteria:

* Strabismus surgery

Exclusion Criteria:

* none

Primary outcomes:
measure: pain (post op pain Likert scale)
timeFrame: hours (1-4) in recovery room
Secondary outcomes:
measure: nausea
timeFrame: hours (1-4) in recovery room
measure: heart rate
timeFrame: hours (1-4) while in recovery room
measure: time to recovery
timeFrame: minutes (30-240) from entry recovery room to discharge
Other outcomes:
Locations:
Study officials:
affiliation: Alaska Blind Child Discovery
name: Robert W Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019.
citation: Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.
Clinical trial NCT02207335: Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
Official title: A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Detailed description: A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility criteria: Inclusion Criteria:

* Female
* 18-70 years old
* ECOG 0-1
* Expected lifetime more than 12 weeks

Exclusion Criteria:

* Pregnancy
* Brain Metastasis,
* Severe Infection

Primary outcomes:
measure: RECIST 1.1
timeFrame: -7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Zhongsheng Tong, Master
role: STUDY_DIRECTOR
References:
citation: Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Clinical trial NCT04838535: Follicular Fluid Raman Shifts and IVF Outcomes
Official title: The Correlation Between Follicular Fluid Raman Spectrum and Embryo Development in Infertile Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
IVF
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study intends to collect about 150 cases of follicular fluid samples from PCOS and non-PCOS infertility patients undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles (in clinical routines).We tend to detect Raman metabolic profile of the follicular fluid of the PCOS and non-PCOS groups, and find the correlation between the metabolic profile of the follicular fluid of PCOS patients and the oocyte quality, IVF outcome and subsequent embryo development are also under investigation. Metabolomics analysis was applied to look for markers of follicular fluid in PCOS patients, and further exploring data and strategies to improve the embryonic development potential and IVF outcome of PCOS patients.


Eligibility criteria: Inclusion Criteria:

* Patients fit the Rotterdam criteria for PCOS
* Patients under IVF cycles

Exclusion Criteria:

* Patients with male factors infertility
* Patients with fallopian tube factors infertility

Primary outcomes:
measure: Difference between polycystic ovary syndrome and normal follicular fluids
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai JiAi Genetics and IVF Institute
state: Shanghai
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: Xiaoxi Sun, Prof.
role: STUDY_CHAIR
affiliation: Shanghai JiAi Genetics & IVF Institute
name: Jing Fu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: