louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00747812: Study of Occipital Nerve Stimulation for Drug Refractory Migraine
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Occipital Nerve Stimulation for Drug Refractory Migraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Migraine
Keywords: Headache
Migraine
Refractory
Chronic
Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 11
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 safety and effectiveness of an implantable device to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.


Eligibility criteria: Inclusion Criteria:

* Be diagnosed with multiple migraines per month of moderate to severe intensity;
* Be refractory to medication;
* Be an appropriate candidate for the surgical procedures required fo this study;
* Be willing and able to comply with all study related procedures;
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have onset of headache after age 50;
* Are current substance abusers (including alcohol and illicit drugs);
* Have a significant psychiatric disorder;
* Have previously been treated with occipital nerve stimulation (either temporary trial or permanent implant);
* Have had nerve stimulation for pain relief.
* Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
* Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radiofrequency procedure currently in effect.
* Have a condition currently requiring or likely to require the use of MRI or diathermy;
* Have an active implantable device;
* Are pregnant or lactating or planning to become pregnant in the next 14 months;
* Have participated in any drug or device trial in the last 4 weeks or plant to participate in any other study during the next 14 months.

Primary outcomes:
measure: Number of Hours of Headache
timeFrame: 12 weeks
measure: Number of Days With 4 or More Hours of Headache
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital - Dept of Clinical Neurosciences
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Peter J. Goadsby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317912: Perioperative Lignocaine and Sleep Disturbance
Official title: Effect of Peroperative Intravenous Infusion of Lignocaine on the Quality of Postoperative Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Disturbance
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to study the effect of an intravenous infusion of lidocaïne in a multimodal analgesic protocol on the architecture sleep during the first postoperative night.

Detailed description: To study the effect of lidocaïne, we plan to include 40 patients, randomized in 2 groups, undergoing open prostate surgery in this randomized placebo-controlled trial.

Before anesthesia induction, these patients receive an intravenous lidocaine infusion (bolus 1,5 mg.kg-1 followed by a continuous infusion of 2mg.kg-1.h during 24 hours) or an equal volume of placebo. Then the anesthesia is induced with propofol, sufentanil et rocuronium. The postoperative analgesia is provided by paracetamol, tramadol and patient-controlled analgesia (PCA) with morphine or oral oxycodone. A polysomnography is registred on the preoperative night and on the first postoperative night.

Eligibility criteria: Inclusion Criteria:

* Radical prostatectomy

Exclusion Criteria:

* BMI \> 30
* Neurologic/psychiatric diseases or therapeutics, seizyres
* Cardiac disease, second or third degree atrioventricular block
* Obstructive sleep apnea syndrome
* History of liver or renal insufficiency
* and any contraindication to the anesthetic protocol of the study.

Primary outcomes:
measure: Time ratio between rapid eye movement sleep(REM) + Stage 3 sleep / Stage 1 + Stage 2 sleep
timeFrame: Postoperaty day 1
Secondary outcomes:
measure: Sleep latence
timeFrame: Postoperaty day 1
measure: Sleep time
timeFrame: Postoperaty day 1
measure: Cumulative Opioid use
timeFrame: Postoperaty day 1
measure: Quality of analgesia (Visual Analogic Scale)
timeFrame: Postoperaty day 1
Other outcomes:
Locations:
Study officials:
affiliation: CHU Liege - Department of Anesthesia and Intensive Care Medicine
name: Isabelle Maquoi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
citation: Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
Clinical trial NCT03624712: Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
Official title: Prospective, Tricentric Open Trial on the Analysis and Optimization of Predictive and Therapeutic Models in Uterine Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Neoplasms
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg
name: University of Homburg
name: University Hospital Freiburg
First posted: 2018-08-10
Enrollment: 580
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with operable or inoperable uterine malignancy (cervical cancer, endometrial cancer, sarcoma)

Brief summary: Evaluation of clinical, therapeutic and prognostic relevance of new experimental results as well as optimization of therapeutic models and development of a new algorithm for therapeutic plan and therapy in patients with uterine neoplasm


Eligibility criteria: Inclusion Criteria:

* Confirmed uterine malignancy ( cervical cancer, endometrial cancer, sarcoma)
* If operable: surgical primary therapy: laparoscopic/robot-assisted or open radical gyneco-oncological surgery
* Written consent
* Willingness and ability to participate in all study-specific procedures
* Age ≥ 18 years

Exclusion Criteria:

* Severe and acute general disease in the last 4 weeks
* Acute or chronic psychiatric disorders
* Other factors questioning study participation (e.g. acute psychosocial stress, insufficient understanding of nature and consequences of the study, inadequate skills of the German language)

Primary outcomes:
measure: CTC and DTC analysis
timeFrame: 12 months
measure: HPV
timeFrame: 12 months
measure: DNA
timeFrame: 12 months
measure: Douglas cytology
timeFrame: 12 months
measure: Proteomic analysis
timeFrame: 12 months
measure: Sentinel lymph nodes
timeFrame: 12 months
measure: Peripheral nerve conduction velocity
timeFrame: 12 months
measure: Urodynamic- cystomanometry between pre an post radical gynecological surgeryuroflowmetry
timeFrame: 12 months
measure: CTC and DTC analysis
timeFrame: 12 months
measure: Urodynamic- urethral pressure profile between pre an post radical gynecological surgeryuroflowmetry
timeFrame: 12 months
measure: Urodynamic- uroflowmetry between pre an post radical gynecological surgeryuroflowmetry
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Women's Health
Study officials:
References:
Clinical trial NCT05319912: A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
Official title: A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN1840
WTX101
Omeprazole
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.


Eligibility criteria: Inclusion Criteria:

* Non-smoker
* Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
* Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
* Willing and able to adhere to contraception requirements.

Exclusion Criteria:

* Participant was mentally or legally incapacitated
* History or presence of clinically significant medical or psychiatric condition or disease.
* History of any illness that might have interfered with drug absorption.
* History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
* History or presence of alcoholism or drug abuse.
* Female participants who were pregnant or lactating.
* Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
* Serum ceruloplasmin and copper values outside of the normal range at screening.
* On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
* Participation in a previous clinical trial with ALXN1840.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
timeFrame: Predose (0 hour) up to 192 hours postdose
measure: Maximum Measured Plasma Concentration (Cmax) of Total Mo
timeFrame: Predose (0 hour) up to 192 hours postdose
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 through 14 days following final dose (up to Day 43)
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Trial Site
state: Nebraska
Study officials:
References:
Clinical trial NCT00186212: Alternative Support for Rural and Isolated Women in an HMO
Official title: Alternative Support for Rural and Isolated Women in an HMO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Disorders, Post-traumatic
Depression
Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
First posted: 2005-09-16
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effects of a workbook/journal for helping isolated women to cope with breast cancer.


Eligibility criteria: Inclusion Criteria:

* 1) is a woman; and 2) has been diagnosed with primary breast cancer

Exclusion Criteria:

* 1) is under 18; or 2) can not speak and read in English

Primary outcomes:
measure: depression
measure: posttraumatic stress disorder
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Cheryl Koopman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696612: Dermoscopy in Nails
Official title: Dermoscopic Nail Changes in Vitiligo
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vitiligo
Healthy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Vitiligo patients attending dermatology outpatient clinic of Assiut University Hospital

Brief summary: Study types and frequency of nail changes in patients with vitiligocompared to healthy subjects

Detailed description: Dermoscopy is a noninvasive diagnostic tool that is currently being used for different skin lesions, several inflammatory \& infectious diseases, and skin appendages disorders. ") In daily practice, dermoscopy may confirm clinical diagnosis and guides in the management of nail diseases, permitting a better visualization of symptoms. (2) Nail dermoscopy (Onychoscopy) was initially used only in the assessment of nail pigmentation, but now it is widely utilized for the evaluation of many nail disorders. (3) It enhances visible nail features; however, it can also help identify additional unique and fascinating features not visible to the naked eye. 2) Vitiligo is an acquired dyschromia of the skin in which there is loss of epidermal melanocytes The prevalence of vitiligo is approximately 0.1 - 2% worldwide. (5) Vitiligo is classified as segmental, acrofacial, generalized, and universal and less commonly mucosal and trichome.

Vitiligo has been described as a systemic disease. It has been associated with other autoimmune disorders as Diabetes (DM), Lupus, Psoriasis, Alopecia areata (AA), Hashimoto thyroiditis, and Gravesdisease.

Nails can show changes in association with many disorders such as renal, hepatic, pulmonary, autoimmune and collagen diseases. (67) Dermoscopic nail changes has been reported in several autoimmune disorders such as, in DM; longitudinal striations, pitting, onycholysis, \& splinter hemorrhage, (® in AA; scaly cuticle, punctate leukonychia, oncholysis, \&oncychoschizia®and in Collagen Vascular disorders; dilated capillaries, capillary dropout, and avascular areas. (10) To the best of our knowledge, dermoscopic nail changes in vitiligo haven't been reported yet. However, few studies had discussed clinical nail changes in vitiligo such as: (11) longitudinal ridging, absent lunula, leukonychia, pitting, in addition to less common nail changes such as flag sign and Terry's nails

Eligibility criteria: Inclusion Criteria:

* Age Adults patients 12-50 years old All types of vitiligo: Focal, generalized, acrofacial, segmental

Exclusion Criteria:

* patients older than 50 (because of aging's nail changes Patients with autoimmune disorders Patients using systemic medication for any reason including oral contraceptive pill

Primary outcomes:
measure: Nail changes in Vitiligo
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06284512: Uveal Melanoma - Comparative Study
Official title: Uveal Melanoma In Sonography and Color Fundus Photos - A Comparative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveal Melanoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
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: Patients with uveal melanoma will be included in this study.

Brief summary: The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of uveal melanoma

Exclusion Criteria:

* Inadequate or missing information on the clinical course in patient charts
* Imaging not feasible due to any reason.

Primary outcomes:
measure: Largest Basal Diameter
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology and Optometry
Study officials:
affiliation: Deparment of Ophthalmology and Optometry
name: Reinhard Told, MD, PhD, Priv.-Doz.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05039112: Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Official title: Clinical Comparison of 2 Daily Disposable Toric Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Astigmatism
Keywords: Contact lenses
Daily disposable
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study to evaluate the overall performance of PRECISION1™ for Astigmatism contact lenses with MyDay® Toric contact lenses.

Detailed description: Subjects will be expected to attend 4 visits and wear study lenses daily for approximately 10 hours per day. On the day prior to the Week 1 Follow-up visit of each crossover period, subjects will be asked to wear the respective study lens for at least 16 hours. The expected duration of subject participation in the study is approximately 3 weeks.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear study contact lenses for at least 16 hours on the day prior to the Week 1 Follow up visit of each lens type.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current/previous wear of PRECISION1 for Astigmatism or MyDay Toric contact lenses.
* Current wear of spherical contact lenses.
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week).
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent of lenses with axis orientation within ±30 degrees inclusive from the intended axis, 10 minutes after lens insertion
timeFrame: Day 1, 10 minutes after lens insertion, each product
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Pittsburg
country: United States
facility: Alcon Investigator 6567
state: Kansas
city: Sterling Heights
country: United States
facility: Alcon Investigator 8097
state: Michigan
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Warwick
country: United States
facility: Alcon Investigator 6401
state: Rhode Island
city: Memphis
country: United States
facility: Alcon Investigator 6353
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04606212: The Effects of Losartan on Emotion Processing
Official title: Losartan Effects on the Emotion Processing in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Losartan
emotion processing
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the effect of losartan (50mg, single dose) on salience processing

Detailed description: In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on salience processing in healthy participants will be examined. The study will adopt a previously validated visual Oddball fMRI paradigm, starting 90 minutes after subjects receive 50mg losartan or placebo. The task requires participants to respond to emotional and novelty oddballs. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* hypertension

Primary outcomes:
measure: Neural activity as measured by BOLD fMRI during processing of emotional and novel stimuli
timeFrame: 105 to 145 minutes after treatment administration
Secondary outcomes:
measure: Neural activity as measured by BOLD fMRI during processing of different categories of emotional and novel stimuli
timeFrame: 105 to 145 minutes after treatment administration
measure: Accuracy for target oddballs
timeFrame: 105 to 145 minutes after treatment administration
measure: Reaction times for target oddballs
timeFrame: 105 to 145 minutes after treatment administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References: