louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05267379: An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Official title: An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 700
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 aged 18 years or older with an indication to undergo an ERCP, without pancreatic cancer, chronic pancreatitis, altered anatomy of the upper digestive tract and an ongoing acute pancreatitis.

Brief summary: Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death. The pathophysiology of PEP and the underpinnings of the preventive effect of rectal NSAID (RN) is poorly understood. Guidelines advise to take preventive measures with a single dose of 100mg RN, peri-ERCP. While NSAID administration reduces the risk with 40%, PEP still occurs after ERCP. In addition, patients with a PEP history have a higher risk to develop recurrence after a subsequent ERCP. This might suggest that an underlying genetic risk may contribute to increasing the incidence of PEP in some patients.

Detailed description: This study is a hypothesis driven and hypothesis free analyses of PEP risk variants. Integrative analysis of NSAID pharmacokinetics and-genetics in PEP patients.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* written informed consent
* Indication to undergo an ERCP

Exclusion Criteria:

* Pancreatic cancer
* Chronic pancreatitis
* Ongoing acute pancreatitis
* Altered anatomy, defined as anatomical variations in which gall and/or pancreatic juices (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater.

Primary outcomes:
measure: Differences in SNP's in NSAID metabolization genes
timeFrame: 1 month
Secondary outcomes:
measure: Diclofenac levels
timeFrame: 2 hours
measure: Correlation diclofenac levels and NSAID metabolization gene polymorphisms
timeFrame: 1 month
measure: Genes involved in development of PEP
timeFrame: 1 month
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: RadboudUMC
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Erwin van Geenen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432379: BOTOX® Prophylaxis in Patients With Chronic Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 1168
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 Migraine

Brief summary: This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic migraine
* Willing to use BOTOX® as preventative treatment for migraine

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence Rate of Dysphagia
timeFrame: 64 weeks
Secondary outcomes:
measure: Incidence Rate of Intractable Migraine
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
city: Oviedo
country: Spain
city: Stockholm
country: Sweden
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Matharu M, Pascual J, Nilsson Remahl I, Straube A, Lum A, Davar G, Odom D, Bennett L, Proctor C, Gutierrez L, Andrews E, Johannes C. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017 Dec;37(14):1384-1397. doi: 10.1177/0333102417724150. Epub 2017 Jul 31.
Clinical trial NCT03414879: Ketamine Versus Lidocaine Nebulization for Awake Fiberoptic Intubation
Official title: Ketamine Versus Lidocaine Nebulization for Awake Nasal Fiberoptic Intubation: a Prospective, Randomized Double-blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Detailed description: Difficult airway is one of the major challenges facing anesthesiologists. This challenge is compounded when the patient is treated while awake. The additional burden is to complete this procedure comfortably thus ensuring patient cooperation which is a vital part of successful performance. Several methods have been tried in literature to facilitate awake intubation by fiberoptic bronchoscope (FOB)

This randomized double-blinded study is performed to compare ketamine versus lidocaine for nebulization for awake nasal fiberoptic intubation as regard efficacy and side effects.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II of both sexes with body weight from 60-90 kg, and planned for elective awake nasal fiberoptic intubation due to expected difficulty in airway management (e.g. limited mouth opening, trismus, mandibular/ maxillary swellings or tumors, ludwig's angina, or other indications).

Exclusion Criteria:

* body weight \< 60 kg or \> 90 kg
* uncooperative, with mental or psychological problems
* known allergy to any of the study drugs
* pregnancy
* hypertension
* cardiac disease
* liver or renal impairment
* epilepsy,
* asthmatic,
* previous bad experience of awake intubation,
* emergency operations or
* coagulation abnormalities

Primary outcomes:
measure: Dose of supplemental lidocaine
timeFrame: Intraoperative
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Intraoperative
measure: Patient satisfaction score
timeFrame: first 24 hours
measure: Patient tolerability score
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT02794779: Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
Official title: Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cesarean Section During Labor
Keywords: cesarean section
labor
oxytocin
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women.

Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.

Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).


Eligibility criteria: Inclusion Criteria:

* Cesarean delivery during labor.
* Spinal anesthesia

Exclusion Criteria:

* Change of anesthesia

Primary outcomes:
measure: Oxytocin dose
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital Universitário de Brasília
state: Distrito Federal
Study officials:
References:
Clinical trial NCT00804479: The Long Term Impact of Initiating Pramipexole Versus Levodopa in Early Parkinson's Disease (CALM-PD Cohort Study)
Official title: Unblinded, Multicenter, Prospective Follow-up of Long-term Consequences of Initiating Patients With Parkinson's Disease on Either Pramipexole or Levodopa.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson's Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Pharmacia Corp. (Peapack, NJ)
name: Boehringer Ingelheim
First posted: 2008-12-08
Enrollment: 222
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Available 301 subjects enrolled in CALM-PD

Brief summary: To determine the long-term consequences (8 years) of initiating patients with Parkinson's disease on either pramipexole or levodopa. We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England (S/E) scale 8 years after randomization.


Eligibility criteria: Inclusion Criteria:

* Available 301 subjects enrolled in the CALM-PD study.

Exclusion Criteria:

* Those not enrolled in the CALM-PD study.

Primary outcomes:
measure: We hypothesize that patients initiating therapy with pramipexole compared with levodopa will demonstrate less self-reported disability as measured by the Modified Schwab and England.
timeFrame: 8 years from date randomized in CALM study
Secondary outcomes:
measure: Our secondary specific aim is to develop and estimate a structural model that will allow us to uncover the causal pathways through which treatments effect outcomes.
timeFrame: 8 years from randomization of CALM-PD study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
citation: Parkinson Study Group CALM Cohort Investigators. Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. Arch Neurol. 2009 May;66(5):563-70. doi: 10.1001/archneur.66.1.nct90001.
Clinical trial NCT04267679: Cannabidiol for Anxiety
Official title: Prospective Evaluation of Cannabidiol (CBD) on Anxiety: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anxiety
Lead sponsor: CB2 Insights
Sponsor class: OTHER
Collaborators: name: Green Lotus Hemp
First posted: 2020-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot trial seeks to investigate the effect of 25 mg full-spectrum CBD soft gel capsules (up to a total dosage of 100mg per day) on individuals with diagnosed anxiety. All participants will take CBD soft gel capsules for 12 weeks, and will be assessed at 6 weeks and 12 weeks post-enrollment using measures of anxiety, sleep and perception of change.


Eligibility criteria: 1. Male or female patients 18 years of age or older with a GAD-7 score of 10 or greater
2. Presenting to a participating clinic for initial evaluation for a medical cannabis card
3. Willingness to abstain from the use of all other cannabis products for the trial period (3 months)
4. Not pregnant or planning to become pregnant during the trial period (3 months)
5. Not breastfeeding or planning to breastfeed during the trial period (3 months)
6. No history of cannabis use within 4 weeks of enrollment
7. No history of lifetime cannabis use disorder or other substance use disorders (except: tobacco use disorder)
8. No history of lifetime daily cannabis use
9. No family history of psychosis (e.g., bipolar disorder or schizophrenia)
10. No history of adverse reactions to cannabis
11. No recent changes to prescribed anxiety medications (within the last 1 month)
12. Provision of informed consent

Primary outcomes:
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Perception of change
timeFrame: 12 weeks
measure: Protocol Compliance
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04357379: IQOS (Non-Cigarette Tobacco Product) Pilot Study
Official title: Impact Of IQOS Non-Cigarette Tobacco Product On Reinforcement Value and Use In Current Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Tobacco Use
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A novel type of non-cigarette tobacco product was recently approved for sale in the US, the heated tobacco product (HTP) IQOS. IQOS may be less harmful than cigarettes, and there are some reports that it may produce more rewarding subjective effects compared to e-cigarettes. The approval of IQOS provides a unique opportunity to gather preliminary data surrounding IQOS. The goal of this pilot study is to assess the subjective effects and relative reinforcement value of IQOS, including its downstream effects on cigarette smoking. Current smokers will complete a one-week baseline period where they smoke as normal before attending an in-person lab visit. During the in-person lab visit, participants (n=10) will sample a traditional cigarette and a novel IQOS tobacco product. Participants will answer questionnaires about each product they sample and then complete a preference assessment in which they choose between the IQOS and their own cigarette. Finally, participants will take home a tobacco product they sampled to use ad libitum (1-week sampling). During the at-home baseline and sampling weeks, participants will complete electronic daily diaries cataloging their tobacco use. Biomarkers (i.e., expired carbon monoxide, cotinine) will corroborate self-reported indices of use.


Eligibility criteria: Inclusion Criteria:

* daily cigarette smoker
* interested in using non-cigarette tobacco product
* have a smartphone that can receive text messages and has access to the internet or have an e-mail account they check daily (necessary for daily diary completion).

Exclusion Criteria:

* additional tobacco use criteria
* additional medical criteria

Primary outcomes:
measure: Number of Participants Who Prefer IQOS
timeFrame: Lab Visit 2, occurring approximately one week after the initial screening/baseline visit
Secondary outcomes:
measure: Cigarettes Per Day
timeFrame: Week 2 of study
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT01905579: Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Official title: Correlation Between Aqueous Protein Level and Clinical Grading of Flare and Flaremetry.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Keywords: flaremetry
aqueous proteins
clinical grading
Compare flaremetry readings with the protein content of the aqueous
Compare flaremetry readings with clinical grading of flare
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare flaremetry readings with the protein content of the aqueous humor and the clinical grading of flare.

Detailed description: A total of 20 patients will be included. 10 patients with uveitis and 10 control patients scheduled for phacoemulsification. Each patient will undego complete ophthalmic examination and clinical biomicroscopic grading of the anterior chamber flare applying the SUN working group grading system. Aqueous specimens will be obtained by anterior chamber paracentesis for protein analysis. Each Patient will undego paracentesis and 0.2 ml of aqueous will be obtained. The aqueous sample will be stored at -70°C until the time of analysis for protein content. Objective assessment of flare will be done.

Eligibility criteria: Inclusion Criteria:

* 10 patients with uveitis with cataract
* 10 patients without uveitis with cataract
* Inactive inflammation for at least 3 months

Exclusion Criteria:

* Infectious uveitis
* endophthalmitis
* cases with corneal scar

Primary outcomes:
measure: compare flaremetry readings with the protein content of the aqueous humor
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: The Eye Center
Study officials:
affiliation: THE EYE CENTER
name: Samir S Shoughy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoughy SS, Elkum N, Tabbara KF. Aqueous protein level and flare grading. Acta Ophthalmol. 2015 Mar;93(2):e173-4. doi: 10.1111/aos.12522. Epub 2014 Aug 31. No abstract available.
Clinical trial NCT00158379: Taxol Carboplatin and Erythropoetin
Official title: Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 105
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: Time to progression (physical examination and radiologic imaging


Eligibility criteria: Inclusion Criteria:

* patients with primary ovarian cancer
* ECOG- 0-2
* Age \>= 18
* no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer
* adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin \<= 2,0 mg%, creatinine \<= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range
* written informed consent

Exclusion Criteria:

* before-existing heart illness, Cardiac infarct within last 6 months
* Radiotherapy within 4 weeks for study entry
* Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)

Primary outcomes:
measure: Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%
timeFrame: every 3 months for up to 3 years
Secondary outcomes:
measure: Toxicity
timeFrame: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jalid Sehouli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00675779: Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
Official title: Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Pain
Keywords: endometriosis
atorvastatin
oral
contraception
pain
relief
pelvic pain in women with endometriosis
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Biomet Polska Sp. z.o.o.
First posted: 2008-05-12
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.


Eligibility criteria: Inclusion Criteria:

* informed written consent
* premenopausal women aged 18-45
* clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
* pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain \> 6 points on Biberoglu \& Behrman scale \[1981\])
* no clinical signs of sexually transmitted disease

Exclusion Criteria:

* cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
* pregnancy or lactation
* unexplained uterine/cervical bleeding
* hormonal therapy within last 3 months (for GnRH analogs 6 months)
* irregular menses (\> 35 days) or secondary amenorrhoea (\>3 months)
* other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
* sexually transmitted disease (gonorrhoea, Chlamydia)
* uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
* chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)

Primary outcomes:
measure: pain relief
timeFrame: 3,6,12 months
Secondary outcomes:
measure: inflammatory status
timeFrame: 6 months
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences, Department of Gynecology and Obstetrics
Study officials:
affiliation: University of California, Davies, USA
name: Antoni J Duleba, MD
role: STUDY_CHAIR
affiliation: Poznan University of Medical Sciences, Poland
name: Leszek Pawelczyk, MD PhD
role: STUDY_DIRECTOR
References: