louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02283112: Validation of Drug Assays in Various Biological Matrices
Official title: Validation of Drug Assays in Various Biological Matrices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infection
Lead sponsor: University of Liverpool
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers receiving specific medication or healthy volunteers taking no medication.

Brief summary: This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* Unable to give informed consent

Primary outcomes:
measure: To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations)
timeFrame: Follow up up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen Univeristy Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT03827512: Arterial Doppler Waveforms Analysis in PAD
Official title: Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: French Vascular Physicians
Keywords: Vascular physicians
Peripheral artery disease
classification
doppler waveforms
Saint-Bonnet
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: French Society of Vascular Medicine
First posted: 2019-02-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Vascular physicians enrolled in the mailing list of French society of vascular medicine

Brief summary: The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.

To assess the impact of an educational process

Detailed description: Peripheral artery disease (PAD) is a common pathology that affects more than 200 million people worldwide. The prevalence of this pathology is estimated in France at 11% in patients over 40 years old. The Doppler arterial waveforms analysis is an important element to assess the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A number of classifications have been proposed but their use varies from one university to another. We hypothesize that there is a great heterogeneity in the description of the arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently been proposed and we will evaluate the effect of the use of this one. The main objective is to evaluate the differences of terminology used when describing arterial Doppler waveforms.

The secondary objectives are: to understand the variations observed and expected (initial, continuous training, place of exercise ...) and to study the effect of a new classification on the heterogeneity of responses.

Eligibility criteria: Inclusion Criteria:

* Vascular physicians enrolled in the mailing list of French society of vascular medicine

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Differences of terminology
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Effect of a new classification on the heterogeneity of terminology used
timeFrame: through study completion, an average of 1 year
measure: Variations of description of the arterial Doppler waveforms
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Guillaume MAHE, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053012: Investigating Reaction Time Among Children Who Snore
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Snoring
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 93
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who snore and are coming to Nationwide Children's for a sleep study or adenotonsillectomy.

Brief summary: The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.


Eligibility criteria: Inclusion Criteria:

* Ability to understand how to perform reaction time test and complete without assistance.

Exclusion Criteria:

* Children who are unable to understand or perform test or parents refusal.

Primary outcomes:
measure: Reaction time
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06150612: Unwinding Anxiety for Migraine: Pilot
Official title: Unwinding Anxiety for Migraine: Pilot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Anxiousness
Lead sponsor: Yeshiva University
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 24
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 is a pilot study that aims to understand the feasibility and acceptability of a mobile health educational app plus group-based mindfulness therapy on anxiety and migraine-related disability among people with migraine.


Eligibility criteria: Inclusion Criteria:

* 18 or older
* Meets diagnostic criteria for migraine
* Reports anxiety symptoms of 5 or more on GAD-7
* Has a smartphone

Exclusion Criteria:

* Under the age of 18
* Presence of suicidal ideation
* Reports severe depression on PHQ-9
* Lack of group readiness

Primary outcomes:
measure: Feasibility
timeFrame: 6 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: Assessed at 6 weeks, immediately post-intervention
Other outcomes:
measure: Change in Anxiety
timeFrame: Change from Week 0 to Week 10
measure: Change in Headache-Related Disability
timeFrame: Change from Week 0 to Week 10
Locations:
city: Bronx
country: United States
facility: Rousso Building
state: New York
Study officials:
References:
Clinical trial NCT00470912: Sunscreen RV 2457C in Photoinduced CLE
Official title: Photoprotective Effects of the RV 2457C Sunscreen Milk in Photoinduced Cutaneous Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Lupus Erythematosus
Skin Lesion
Experimental Photoinduction
Protective Sunscreen
Keywords: cutaneous lupus erythemaosus
photoprotection
photoprovocation
Sunscreen RV 2547C
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2007-05-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lupus erythematosus (LE) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. In all subsets of LE, skin lesions occur preferentially in sun-exposed areas.

Previous studies have demonstrated that the lesions in LE patients reproduced in controlled experimental conditions. The initial reports suggested that the action spectrum for the LE was in the UVB range (290 to 320 nm), but more recent studies have demonstrated that UVA (320 to 400 nm) can contribute to the induction of LE skin lesions.

Antimalarial agents and topical steroids are the main treatments of chronic LE. The second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. Moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen.

The aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against UV-B and UV-A, used exclusively, in the photoinduced LE.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects
* Patient aged of 18 years or more
* Documented medical history of chronic cutaneous lupus erythematosus (lupus erythematosus tumidus, discoid lupus erythematosus, subacute lupus erythematosus) without any sign of systematic involvement
* patients who have a history of positive provocative phototestimg using a standardized protocol during a previous photobiologic exploration
* informed consent

Exclusion Criteria:

* Pregnant women, nursing mothers
* subjects with lupus erythematosus with systematic involvement
* subjects with a medical history of another photodermatosis
* subjects with sun erythema, residual pigmentation, dermatological lesion, abnormal skin pigmentation which might interfere with a study evaluation on test sides
* subjects who had sun solar simulator exposure on their backs within 12 weeks prior to enter to the study
* subjects with a known intolarance to one of the formula compounds

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich Heine University of Duesseldorf, Depatment of Dermatoly
state: NRW
Study officials:
affiliation: Heinrich-Heine University of Duesseldorf, Department of Dermatolgy
name: Annegret Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06502912: Association Between Iron Reserves and Perioperative Neurocognitive Disorders
Official title: Association Between Iron Reserves and Perioperative Neurocognitive Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Neurocognitive Disorders
Keywords: iron reserves
Perioperative neurocognitive disorders
elderly
iron overload
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 12984
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital based group

Brief summary: Iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. However, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. This retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.


Eligibility criteria: Inclusion Criteria:

* Geriatric surgical patients ≥65 years old

Exclusion Criteria:

* preoperative use of antipsychotics
* diagnosis or history description of preoperative cognitive disorders including dementia and Parkinson's

Primary outcomes:
measure: Number of participants with postoperative delirium
timeFrame: Within the first seven days following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05485012: Reinforcing Effects of Marijuana and Opioids
Official title: Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Marijuana Use
Opioid Use
Keywords: marijuana
opioid
healthy participants
laboratory study
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-08-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.


Eligibility criteria: Inclusion Criteria:

* Ages 18-50
* Experience with marijuana and opioids
* General good health
* Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,

Exclusion Criteria:

* Significant medical complications/conditions

Primary outcomes:
measure: Self-Administration
timeFrame: Collected once during each self-administration session
Secondary outcomes:
measure: Subjective measures
timeFrame: Baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely)
measure: Heart rate
timeFrame: Baseline, post-dose during each session (change from baseline is assessed)
measure: Blood pressure
timeFrame: Baseline, post-dose during each session (change from baseline is assessed)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shanna Babalonis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611312: Effects of Delivery Mode of Cognition Intervention in Early Alzheimer's Disease
Official title: Effects of Intense Cognitive Training on Standardized Measures of Cognition in Those With Very Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Cognitive training
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2008-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild Alzheimer Disease. We anticipate that scores on clinical cognitive tests will be better after the training.

Detailed description: Twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fMRI). Scanning will be done while subjects perform a verbal learning task. Ten subjects will be scanned before and after the two week training. Another ten will be scanned twice at a two week interval before beginning the cognitive training.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of very mild Alzheimer's Disease (CDC of 0.5) and mild Alzheimer's Disease (CDC of 1.0)

Exclusion Criteria:

* Neurologic disorder other than Alzheimer's disease

Primary outcomes:
measure: Composite score of 5 cognitive tests including 1)WAIS digit span, 2) word fluency, 3) trail making test-A 4) Rey Osterrieth complex figure and 5) MMSE
timeFrame: 2 weeks with FU at 2 and 4 months
Secondary outcomes:
measure: Brain activity during functional brain imaging
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Yvonne Colgrove, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01044212: Bowel Function After Minimally Invasive Urogynecologic Surgery
Official title: Bowel Function After Minimally Invasive Urogynecologic Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Disorder of Intestine
Keywords: Urogynecology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at Strong Memorial Hospital.

Procedures may include:

* robot-assisted laparoscopic sacrocolpopexy
* sacrospinous ligament suspension
* uterosacral ligament suspension/paravaginal defect repair
* colpocleisis
* cystocele repair

Additional procedures may include:

* hysterectomy
* adnexectomy
* culdoplasty
* minimally invasive sling procedure (TVT or TOT)
* periurethral collagen injections
* enterocele repair

Exclusion Criteria:

* Planning to undergo laparotomy.
* Undergoing rectocele or perineocele repair as part of surgery.
* Taking Miralax, laxatives, enemas, or suppositories daily, at the time of enrollment.
* Presence of a colostomy.
* Chronic kidney disease
* Insulin-dependent diabetes mellitus
* Known cardiac disease
* Gastric ulcers
* Difficulty swallowing or esophageal stricture
* Persistent nausea and vomiting
* Signs and symptoms consistent with bowel obstruction

Primary outcomes:
measure: Time to First Post-op Bowel Movement
timeFrame: Within 1 week of surgery
Secondary outcomes:
measure: Pain Level Associated With First Postoperative Bowel Movement
timeFrame: Within 1 week of surgery
measure: Consistency of First Postoperative Bowel Movement
timeFrame: Within 1 week of surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03272412: Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.
Official title: Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ongoing Pregnancy Rate
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 1205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are undergoing IVF treatments with artificial endometrial preparation with hormonal replacement therapy.

Brief summary: This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.


Eligibility criteria: Inclusion Criteria

1. Age \<50 years old
2. Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:

   1. Embryos in fresh cycle with donated oocytes.
   2. Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
   3. Frozen embryo transfers in cycles with autologous oocytes.
3. Endometrial line: \>6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
4. Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
5. Embryo transfer of blastocyst (day 5-6).
6. Signed Informed Consent

Exclusion Criteria

1. Uterine pathology (submucous o intramural fibroids (\>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
2. Simultaneous participation in another clinical study.
3. Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.

Primary outcomes:
measure: Concentration of serum Progesterone levels
timeFrame: The day of embryo transfer
measure: Ongoing Pregnancies depending on Progesterone levels ranges.
timeFrame: Week 5-12 after Embryo Transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
Study officials:
References:
citation: Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.
Clinical trial NCT03187912: Accelerated Corneal Cross-linking With Different Riboflavin Solutions
Official title: Effect-evaluation of an Accelerated Corneal Cross-linking Protocol With Different Riboflavin Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconus
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. In addition, new riboflavin solutions with HPMC (hydroxylpropyl methylcellulose) instead of dextran found its way into CXL-treatment. The aim of this trial is to evaluate clinical outcomes in an accelerated corneal collagen cross-linking protocol with different riboflavin solutions.


Eligibility criteria: Inclusion Criteria:

* Progressive Keratoconus
* Indication for treatment
* Preoperative Pachymetry \> 400

Exclusion Criteria:

* Pregnancy
* Re-CXL
* Keratitis
* Other visual acuity limiting eye diseases than corneal ectatic diseases

Primary outcomes:
measure: Kmax
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative central stromal depth of the Demarcation Line
timeFrame: 1 month
measure: LogMAR
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology
Study officials:
References: