louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01432249: Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Official title: Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pediatric Psoriasis
Keywords: pediatric psoriasis
enbrel
safety
efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients (ages of 8\~17)

Brief summary: Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.

Detailed description: All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.

Eligibility criteria: Inclusion Criteria:

1. Children and adolescents aged 8 years to 17 years at time of consent
2. Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

Exclusion Criteria:

1. Patients with known hypersensitivity to Enbrel or any component of the product
2. Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)

Primary outcomes:
measure: Safety measured by discontinuation due to adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks
timeFrame: 6 month
measure: Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02143349: The Effect of Coleus Forskohlii Extract on the Risk Factors of Metabolic Syndrome
Official title: Investigation of Appetite Suppressant Properties Associated With Coleus Forskohlii in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metabolic Syndrome
Obesity
Keywords: obesity
herbal remedies
metabolic disorders
Lead sponsor: Olive Lifesciences Pvt Ltd
Sponsor class: INDUSTRY
Collaborators: name: College of Health and Biomedicine, Victoria University
First posted: 2014-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Coleus forskohlii extract contains the bioactive compound, forskolin. Preliminary studies have shown that forskolin can increase fat metabolism thus reduce fat accumulation in both animals and humans. It has been suggested that forskolin may also suppress appetite thus reduce energy intake and results in weight loss. This study will evaluate the appetite suppressant properties of Coleus forskohlii extract. In addition the effect on central obesity and risk factors of metabolic syndrome will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Both Australian males and females, age 20-60 years, Overweight or obese (BMI \>25), waist circumference of \> 94 cm (male), waist circumference of \>80 cm (female)

Exclusion Criteria:

* Cigarette smoker, hypertension, all types of heart, liver and kidney disease, pregnancy, lactating, Type 1 diabetes and weight loss medication.

Primary outcomes:
measure: changes in appetite will be assessed using visual analogue scale; blood hormone levels will also be measured using commercial kits.
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: reduction in central obesity - waist circumference will be measured on fortnight basis
timeFrame: 12 weeks
Other outcomes:
measure: alterations in blood lipids. This will be measured using commercial kits
timeFrame: 12 weeks
Locations:
city: St. Albans
country: Australia
facility: College of Health and Biomedicine Victoria University
state: Victoria
Study officials:
References:
citation: obesity
citation: Shivaprasad HN, Gopalakrishna S, Mariyanna B, Thekkoot M, Reddy R, Tippeswamy BS. Effect of Coleus forskohlii extract on cafeteria diet-induced obesity in rats. Pharmacognosy Res. 2014 Jan;6(1):42-5. doi: 10.4103/0974-8490.122916.
Clinical trial NCT01043549: Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Official title: Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gilles de la Tourette Syndrome
Tics
Keywords: Gilles de la Tourette syndrome
Tics
Transcranial magnetic stimulation
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-01-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing premonitory sensations believed to induce tics. Patients will be randomized to an active or placebo (sham) group in a crossover design.


Eligibility criteria: Inclusion Criteria:

* Gilles de la Tourette syndrome as defined by DSM IV-R
* Yale Global Tics Severity Scale (YGTSS) score between 30 et 60
* Premonitory sensations (" urge to move ")
* Affiliated to the French social security regime
* Ability to give informed consent

Exclusion Criteria:

* rTMS : epilepsy, craniotomy scar, pacemaker or neural stimulator, metal implants or foreign bodies, claustrophobia, pregnancy
* Cognitive impairment (MMS ≤ 24/30)
* Axis I disorders according to DSM IV-R : psychosis or history of psychosis, bipolar illness, major depressive disorder, addictions (except to nicotine)
* Impulse control disorders
* Other chronic debilitating illnesses
* Unability to give informed consent
* Participation in another clinical trial

Primary outcomes:
measure: Yale global tic severity scale (YTGSS)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Inserm U975
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Andreas Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04950049: The Effect of Dilution and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
Official title: The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Effect
Keywords: Dexamethasone 21-phosphate
Pain
Pruritus
Glucose
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).

Detailed description: Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. In clinical practice, dexamethasone is always diluted with glucose in many cases, but diluted dexamethasone in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dilution with glucose on dexamethasone induced perineal irritation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* ASA physical status I-II

Exclusion Criteria:

* On regular use of analgesic
* Contraindication or allergy to steroid or glucose
* Drug or alcohol abuse
* Diagnosed with paresthesia or mental diseases
* Communication disorders
* Pregnancy or nursing

Primary outcomes:
measure: The incidence of dexamethasone-induced perineal irritation
timeFrame: During the first 3 min period after the injection of dexamethasone
Secondary outcomes:
measure: Duration of perineal irritation
timeFrame: After the injection of dexamethasone, up to 5 minutes
measure: The severity of perineal irritation
timeFrame: After the injection of dexamethasone, up to 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Yonghai Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02226549: Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Official title: A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: hepatitis C
Gilead
GS-9451
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 47
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: This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years, with chronic HCV genotype 1 infection
* Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
* Presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male
* Not pregnant or a nursing female

Exclusion Criteria:

* Co-infection with HIV or hepatitis B virus (HBV)
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Robert Hyland, DPhil
role: STUDY_DIRECTOR
References:
Clinical trial NCT01963949: Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events
Official title: Prospective, Observational Study of Biomarkers in Liver Cancer - Identification of Actionable Events
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients with a liver mass suspicious for HCC

Brief summary: To collect tumor tissue from patients with liver masses suspicious for primary liver cancer. The research biopsy will be used to identify biomarkers in future studies.

Detailed description: In this study patients are referred to the Department of Radiology for an image-guided (either CT or ultrasound) core needle biopsy of a liver mass suspicious for primary liver cancer as a part their clinical care. A written informed consent will be obtained for the clinical biopsy per standard protocol. Additional core biopsy of the liver mass will be performed for research purposes at the time of the clinical care biopsy. The additional research biopsy is not mandatory and is subject to a separate written informed consent, which will be obtained prior to the clinical biopsy.

Eligibility criteria: Inclusion Criteria:

1. Liver mass suspicious for primary liver cancer with a diagnostic liver biopsy planned as a part of clinical care
2. Age ≥ 18 years.
3. ECOG performance status 0-2
4. Adequate organ and marrow function as defined below:

   INR ≤ 1.5 platelets ≥ 70,000/mcl
5. Ability to understand and the willingness to sign a written informed consent
6. Target liver mass not subcapsular in nature as determined by the participating biopsy team
7. Child Pugh Turcotte score A or B

Exclusion Criteria:

1. Previous treatment for HCC
2. Any contraindication for clinical-care liver biopsy, including anti-coagulation therapy that cannot be discontinued prior to biopsy or large volume ascites

Primary outcomes:
measure: Biopsy of Liver Masses
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center
name: Adam Yopp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06554249: Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance
Official title: Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance Versus the Standard Technique for IUD Insertion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contraceptive Device
Keywords: IUD
Ultrasound
Full bladder
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Bedaya Hospital
First posted: 2024-08-15
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .

Detailed description: The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.

Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..

In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.

Eligibility criteria: Inclusion Criteria:

* Women requesting IUD insertion

Exclusion Criteria:

* Active pelvic infection
* Viable intrauterine pregnancy
* Uterine anomalies
* Uterine fibroid
* Wilson disease

Primary outcomes:
measure: Intensity of pain
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Success of IUD insertion
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baradwan S, Alshahrani MS, Alnoury A, Khadawardi K, Khan MA, Abdelkader RAA, Saleh OI, Galal HM, Mohamed SMA, Abdelhakim AM, Elgedawy AM, Elbahie AM, Gaber MA, Magdy AA, Shaheen K. Does Ultrasound Guidance Provide Pain Relief During Intrauterine Contraceptive Device Insertion? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Ultrasound Med. 2023 Jul;42(7):1401-1411. doi: 10.1002/jum.16166. Epub 2022 Dec 30.
Clinical trial NCT02359149: Intravitreal Injections by Nurses and Physicians Compared
Official title: Intravitreal Injections by Nurses or Physicians: a Randomized Controlled Trial Comparing Efficacy, Patient Satisfaction and Health Economy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Diseases
Keywords: Intravitreal injections
Nurses
Physicians
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-02-09
Enrollment: 328
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last years indications for their use and consequently the number of patients needing treatment, have been increasing. Most patients require multiple injections. This has resulted in many eye departments administering thousands of injections per year, also at St Olavs University Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections would be given not only by the physicians but also by the nurses. This study's objective is to compare efficiency, patient satisfaction and cost per patient of injections given by nurses and physicians.


Eligibility criteria: Inclusion Criteria:

* referred to the eye clinic for treatment of age related macular degeneration, diabetes retinopathy or retinal vein occlusion with anti-vascular endothelium growth factor
* Ability to provide written informed consent
* ability to comply with study assessments for the full duration of the study

Exclusion Criteria:

-

Primary outcomes:
measure: change in visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: incidence of ocular adverse events
timeFrame: from baseline to 12 months
measure: patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Department of Ophthalmology
Study officials:
affiliation: St Olavs University Hospital
name: Marit Fagerli, md
role: STUDY_DIRECTOR
References:
citation: Austeng D, Morken TS, Bolme S, Follestad T, Halsteinli V. Nurse-administered intravitreal injections of anti-VEGF: study protocol for noninferiority randomized controlled trial of safety, cost and patient satisfaction. BMC Ophthalmol. 2016 Oct 1;16(1):169. doi: 10.1186/s12886-016-0348-4.
citation: Bolme S, Morken TS, Follestad T, Sorensen TL, Austeng D. Task shifting of intraocular injections from physicians to nurses: a randomized single-masked noninferiority study. Acta Ophthalmol. 2020 Mar;98(2):139-144. doi: 10.1111/aos.14184. Epub 2019 Jul 3.
Clinical trial NCT02896049: Celsius TCS Hyperthermia System PMCF Trial
Official title: Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Solid Neoplasms
Keywords: neoplasms
hyperthermia
Lead sponsor: Celsius42 GmbH
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
First posted: 2016-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include all treatments performed with the Celsius TCS Hyperthermia System at the participating centers throughout the study period. (Normally these are neoplasm patients treated additionally with radiation and/or chemotherapy.)

Brief summary: Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.

Detailed description: During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters.

Eligibility criteria: Inclusion Criteria:

* treatment performed with the Celsius TCS Hyperthermia System

Exclusion Criteria:

* not applicable -

Primary outcomes:
measure: failures of the device as well as failure of persons using the device during treatment
timeFrame: one month after treatment
measure: any injury, harm or medically relevant discomfort occurring for the patients or the staff
timeFrame: one month after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Praxis-Klinik Hyperthermie
name: Hüseyin Şahinbaş, MD
role: PRINCIPAL_INVESTIGATOR
References: