louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01386268: Kogenate FS Regulatory Post-Marketing Surveillance
Official title: KOGENATE® FS , Local Post Authorization Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Kogenate FS
Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia A in Korea

Brief summary: To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of hemophilia A
* Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
* Signed the informed consent form to participate in this study.
* For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available
* For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available
* For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
* Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

* Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.

Primary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: Up to 6 months
Secondary outcomes:
measure: Type of the treatment (prophylaxis, on demand, surgery)
timeFrame: Initial visit and 6 month f/u or at the end of the observation visit
measure: Total consumption of FVIII
timeFrame: Initial visit and 6 month f/u or at the end of the observation visit
measure: Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)
timeFrame: Initial visit, 6 month follow-up visit and 12 month follow-up visit
measure: General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient
timeFrame: 6 month f/u or at the end of observation visit
Other outcomes:
Locations:
city: Many locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02582268: A Novel IUD Insertion Technique
Official title: Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).


Eligibility criteria: Inclusion Criteria:

* Females desiring contraception with the use of IUD
* Females with history of previous vaginal delivery

Exclusion Criteria:

* Are pregnant or think they may be pregnant
* Septic pregnancy or abortion
* Have unexplained abnormal vaginal bleeding
* Have untreated cervical cancer
* Have malignant gestational trophoblastic disease
* Have uterine cancer
* Have uterine abnormalities
* Have or may have had a pelvic infection within the past three months
* Have or may have any sexually transmitted disease
* Have pelvic tuberculosis
* Are postpartum between 48 hours and 4 weeks
* Have benign gestational trophoblastic disease

Primary outcomes:
measure: degree of pain during IUD insertion
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina M Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dakhly DMR, Bassiouny YA. Ultrasound-guided intrauterine device insertion: a step closer to painless insertion: a randomized control trial. Eur J Contracept Reprod Health Care. 2017 Oct;22(5):349-353. doi: 10.1080/13625187.2017.1381234. Epub 2017 Oct 5.
Clinical trial NCT01304368: Effects of Thermotherapy on Chronic Neck Pain
Official title: Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Hyperthermia, Induced
Randomized Controlled Trial
Neck Pain
Sensory Thresholds
Pain Measurements
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 50
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: Chronic neck pain is a common worldwide problem. In the majority of cases, patients are treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the therapeutic application of topical heat - provides an easy to apply self-help strategy in patients with chronic neck pain. However, despite the frequent use in clinical practice, there is no research regarding this topic yet.

The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck pain induces changes in perceived pain intensity and in sensory processing.


Eligibility criteria: Inclusion Criteria:

* non-specific neck pain the last 3 months
* mean pain intensity of at least 4 on a 10-level numerical rating scale with "0" meaning "no pain" and "10" meaning "worst pain imaginable"

Exclusion Criteria:

* radicular symptoms
* congenital spine deformity
* skin diseases in the painful area to be treated
* pregnancy
* insulin-dependent diabetes mellitus
* rheumatic diseases
* oncologic diseases
* steroid medication
* anticoagulation medication
* recent invasive or surgical treatment of the spine

Primary outcomes:
measure: Neck pain intensity (100mm visual analog scale)
timeFrame: Day 14
Secondary outcomes:
measure: Pain related to motion
timeFrame: Day 14
measure: Neck disability index (NDI)
timeFrame: Day 14
measure: SF-36
timeFrame: Day 14
measure: Pain diary
timeFrame: From day 1 to day 14
measure: Pressure pain threshold
timeFrame: Day 14
measure: Vibration detection threshold
timeFrame: Day 14
measure: Mechanical detection threshold
timeFrame: Day 14
measure: Side effects
timeFrame: Day 14
measure: Medication and additional treat ment use
timeFrame: Day 14
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
state: Northrhine-Westphalia
Study officials:
References:
Clinical trial NCT03432468: Effect of Fully Blocking Type 1 Angiotensin Receptor on Target Organ Damage of Postmenopausal Hypertensive Women
Official title: Effect of Fully Blocking Type 1 Angiotensin Receptor on Blood Pressure, Cardiac Structure, Cardiac Function and Cognitive Function in Postmenopausal Hypertensive Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Left Ventricular Hypertrophy
Women
Lead sponsor: LanZhou University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the improvements of blood pressure levels, left ventricular hypertrophy, left ventricular diastolic function, vascular function and cognitive function between postmenopausal hypertensive women and age-matched hypertensive male patients through the evaluation of the effects of fully blocked AT1 receptor by valsartan. Additionally, the differences of the above indexes between the patients who were fully blocked AT1 receptor by valsartan and the patients who were treated with a single dose of valsartan treatment were assessed, so as to provide theory basis for clinical treatment of postmenopausal hypertensive women.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypertension
* Women are all postmenopausal
* Must provide written informed consent

Exclusion Criteria:

* Secondary hypertension
* Coronary disease
* Heart failure
* Arterial fibrillation
* Previous myocardial infarction
* Previous stroke
* Malignant disease
* Kidney failure
* Liver failure
* Neoplastic disease
* Severe neurological diseases
* Severe metabolic or organic decompensation
* Refuse to sign the informed consent form

Primary outcomes:
measure: Relative indexes of myocardial remodeling
timeFrame: Change from Baseline left ventricular mass index at 6 months.
measure: Relative indexes of myocardial remodeling
timeFrame: Change from Baseline left ventricular mass index at 12 months.
measure: Ambulatory blood pressure monitoring
timeFrame: Change from Baseline ABPM at 6 months.
measure: Ambulatory blood pressure monitoring
timeFrame: Change from Baseline ABPM at 12 months.
measure: Sexual hormones
timeFrame: Baseline sexual hormones.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01929668: Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients
Official title: Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
bowel preparation
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* age \>18 years old
* ulcerative colitis patients without symptoms for at least 1 year
* ulcerative colitis patients who undergo colonoscopy for surveillance

Exclusion Criteria:

* subjects who had abdominal surgery
* pregnant or breast feeding

Primary outcomes:
measure: Number of patients who are willing to use the same preparation method for the next colonoscopy.
timeFrame: day 1
Secondary outcomes:
measure: Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).
timeFrame: within 30 days after bowel preparation for colonoscopy
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University School of Medicine
name: Eun Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00681668: Quetiapine in Postpartum Depression
Official title: The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postpartum Depressive Disorder
Keywords: Postpartum Depression
Quetiapine
Psychotic Symptoms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent.
* Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Exclusion Criteria:

* Woman with pre-existing psychotic disorder
* Patients with alcohol or substance abuse or dependence
* Patients who pose an imminent risk of suicide or danger to self or others

Primary outcomes:
measure: The Change in the Hamilton Rating Scale for Depression (HAM-D)
timeFrame: Baseline Day 1 to final visit 28 weeks
Secondary outcomes:
measure: Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline Day 1 to final visit 28 weeks
measure: Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)
timeFrame: Baseline Day 1 to final visit 28 weeks
measure: Electrocardiogram (ECG), Vital Signs, Laboratory
timeFrame: Baseline Day 1 to final visit 28 weeks
Other outcomes:
Locations:
city: Herten
country: Germany
facility: Research Site
state: Westfalen-Lippe
Study officials:
affiliation: Westfälisches Zentrum Herten, Psychiatrie und Psychotherapie Im Schlosspark 20 45699 Herten
name: Luc Turmes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567268: Drug Use Investigation Of Gabapentin
Official title: Drug Use Investigation Of Gabapen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsies, Partial
Keywords: Post-Marketing surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 1273
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A9451163 prescribes the Gabapentin

Brief summary: The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

Patients need to be taking Gabapentin in order to be enrolled in the surveillance

Exclusion Criteria:

Patients not taking Gabapentin

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 12 weeks
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 12 weeks
measure: Clinical Efficacy Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Response Ratio (R Ratio)
timeFrame: 12 weeks
measure: Responder Rate
timeFrame: 12 weeks
measure: Percent Reduction From Baseline in Epileptic Seizure Frequency
timeFrame: 12 weeks
Other outcomes:
measure: Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories
timeFrame: 12 weeks
measure: Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance
timeFrame: 12 weeks
measure: Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06616168: Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens
Official title: Ministry of Health of Ukraine No. 2264 from 15.12.2022, Ministry of Health of Ukraine No. 310 from 08.05.2014, Ministry of Health of Ukraine No. 928 from 18.05.2023
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Bacterial Vaginosis
Lead sponsor: Danylo Halytsky Lviv National Medical University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Research concerning women pathogenic microflora during different conditions

Detailed description: Study of microflora of different groups of women of reproductive age, determination of pathogens and their further study, samples of a newly synthesized compound on isolated pathogens

Eligibility criteria: Inclusion Criteria:

* urogenital infections, pregnancy

Exclusion Criteria:

* healthy microflora

Primary outcomes:
measure: Estimation of the immune activity
timeFrame: 1 month
measure: Quantities of vaginal microflore bacteria
timeFrame: 2 months
Secondary outcomes:
measure: Quantities of bacteria in urine
timeFrame: 2 months
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: Danylo Halytsky Lviv National Medical University
Study officials:
affiliation: Danylo Halytsky Lviv National Medical University
name: Yulian Konechnyi
role: STUDY_DIRECTOR
References:
Clinical trial NCT00500968: Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Official title: Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Fistula
Keywords: Pancreas
Leakage
Fistula
tail
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2007-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed description: Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.

Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.

B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.

Exclusion Criteria:

* The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Primary outcomes:
measure: Drain fluid content analyses
timeFrame: At least 5 postoperative days
Secondary outcomes:
measure: Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent
timeFrame: At least 5 postoperative days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinksa university hospital
Study officials:
affiliation: Karolinksa university hospital
name: Urban Arnelo
role: STUDY_DIRECTOR
affiliation: Karolinksa university hospital
name: Farshad Frozanpor
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Lars Lundell, Professor
role: STUDY_CHAIR
References:
citation: Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.