louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05609253: Itraconazole to Prevent Recurrent Barrett's Esophagus
Official title: Itraconazole Repurposing to Reduce Residual Cancer Risk in Patients With High-risk Barrett's Esophagus After Ablation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Barrett Oesophagitis With Dysplasia
Keywords: Barrett's esophagus
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas, Southwestern Medical Center at Dallas
First posted: 2022-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The primary purpose is to determine the ideal formulation (capsule versus solution) of itraconazole in this short-term pilot study.
Primary purpose: PREVENTION

Brief summary: Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure


Eligibility criteria: Inclusion Criteria:

* Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* Inability to provide informed consent, New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)\>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (\>450 ms for men and QTc\>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.

Primary outcomes:
measure: Itraconazole drug and blood levels
timeFrame: 8-12 months after study initiation
Secondary outcomes:
measure: Safety and tolerability of itraconazole
timeFrame: 8-12 months after study initiation
measure: Effects of itraconazole on Gli1 expression
timeFrame: 8-12 months after study initiation
measure: Effects of itraconazole on (Patched) PTCH expression
timeFrame: 8-12 months after study initiation
measure: Effects of itraconazole on AKT pathway
timeFrame: 8-12 months after study initiation
measure: Effects of itraconazole on angiogenesis
timeFrame: 8-12 months after study initiation
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT02153853: Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?
Official title: Does Obesity Increase the Risk of Conversion and Short Term Complications in Laparoscopic Rectal Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Obesity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rectal cancer treated with laparoscopic surgery at the Department of Gastrointestinal Surgery, Hvidovre Hospital, Denmark.

Brief summary: Obesity is on the rise in the Western population and BMI has been shown to be associated with an increased risk of per- and postoperative complications.

The investigators intend to study a population of more than 300 patients undergoing laparoscopic surgery for rectal cancer.

The investigators main outcome measure will be the conversion rate, and the investigators also intend to study other indications of short term complications, such as peroperative bleeding, infection, re-operation and mortality.

The investigators hypothesise that increased BMI does not increase the risk of conversion.


Eligibility criteria: Inclusion Criteria:

* Patients with rectal cancer undergoing laparoscopic surgery, Hvidovre Hospital, Denmark.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Conversion rate
timeFrame: Day 1
Secondary outcomes:
measure: Peroperative Bleeding
timeFrame: Day 1
measure: Length of Hospital Stay
timeFrame: Time of Discharge (3-80 days after surgery, mean: 11 days)
measure: Short term complications
timeFrame: Time of Discharge (3-80 days after surgery, mean: 11 days)
measure: Readmission within 30 days after surgery
timeFrame: 30 days after discharge
measure: 30-day mortality
timeFrame: 30 days after surgery
measure: Duration of surgery
timeFrame: Day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
Study officials:
References:
Clinical trial NCT06361953: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder
Official title: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder: Sensory Motor Rhythm and Alpha-Theta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.

In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR.


Eligibility criteria: Inclusion Criteria:

* Normal hearing and vision,
* had never undergone neurofeedback sessions,
* diagnosed as GAD by a psychiatrist,
* no history of neurological disorders
* undergoing other therapies

Exclusion Criteria:

* started other treatments during the study
* missed more than one session

Primary outcomes:
measure: The Beck Anxiety Inventory
timeFrame: Pre-test, after 5 weeks and two month follow up
measure: The Perceived Stress Questionnaire
timeFrame: Pre-test, after 5 weeks and two month follow up
measure: Spielberger's state-trait anxiety test
timeFrame: Pre-test, after 5 weeks and two month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Science
Study officials:
References:
Clinical trial NCT01444053: Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject selection is based on a history of wearing one of two types of contact lenses for at least five years. Age-matching subjects into 4 age-brackets will be attempted with a target of five subjects in each age bracket among the two types of lenses.

Brief summary: The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.


Eligibility criteria: Inclusion Criteria:

* The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
* The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
* The subject must have best corrected visual acuity of 6/7.5 or better in each eye.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the statement of informed consent
* The subject must be between 18 and 43 years of age

Exclusion Criteria:

* On medication known to affect accommodation
* Active ocular surface pathology
* Had eye surgery
* Significant ocular tissue anomaly
* Any medical condition that may be prejudicial to the study
* Diabetes

Primary outcomes:
measure: Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear
timeFrame: Approximately 40 minutes
measure: Amplitude of Accommodation after 5 years of contact lens wear
timeFrame: Approximately 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
Study officials:
References:
Clinical trial NCT06680453: Accidentology and Traumatology Associated With Foiling in Brittany
Official title: Accidentology and Traumatology Associated With Foiling in Brittany
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sport Injuries
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier des Pays de Morlaix
name: Hospital, Quimper
name: Centre Hospitalier de Bretagne Sud
name: Hospital, Douarnenez
First posted: 2024-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person of legal age, meeting the inclusion and non-inclusion criteria, presenting to an emergency department following a boating accident.

Brief summary: In the 2010s, the practice of water sports was turned upside down by the arrival of a new discipline: foiling. The number of sailors, particularly amateurs, is increasing every every year. The foil offers greater speed and height, and has therefore the accidents and injuries that result. injuries. But there are very few studies on the subject. The TRAUMAF study proposes to compare the distribution of the number of patients injured during water sports with and without the use of foils. The study also looks at patient management and the type of injury. The aim is to anticipate the management of these patients during periods of practice of these sports.

Translated with DeepL.com (free version)


Eligibility criteria: Inclusion Criteria:

* Patient of legal age
* Patient not expressing refusal to participate in the study
* Patient consulting an emergency room following a boating accident that occurred no more than 7 days previously
* Patient able to complete a questionnaire

Exclusion Criteria:

* Minor patient
* Patients who are illiterate and/or do not understand French
* Patient under legal protection

Primary outcomes:
measure: Evaluate the importance of foil-equipped craft in the occurrence of water-related injuries.
timeFrame: 12 months
Secondary outcomes:
measure: Provide the doctor in charge of the patient with objective data on the most likely lesions and their potential severity.
timeFrame: 12 months
measure: Analysis of the type and location of lesions observed between the foil and no-foil groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
state: Finistère
city: Douarnenez
country: France
facility: Centre Hospitalier Michel Mazéas
state: Finistère
city: Morlaix
country: France
facility: Centre Hospitalier de Morlaix
state: Finistère
city: Quimper
country: France
facility: Centre Hospitalier Intercommunal de Cornouaille
state: Finistère
city: Lorient
country: France
facility: GHBS Hôpital du Scorff
state: Morbihan
Study officials:
References:
Clinical trial NCT04814953: HRQoL Keratinocyte Carcinomas
Official title: HRQoL and Development of Health Utilities in Patients With Keratinocyte Carcinomas
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Actinic Keratoses
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2021-03-24
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the Department of Dermatology of the University Hospital of Ghent and the Erasmus MC Rotterdam. In addition, patients in other hospitals and dermatology clinics will be asked to participate. Two general practitioners will also include patients with a KC or actinic keratoses.

Brief summary: Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available.

Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools.

Study design: Longitudinal observational study (at time 0 and time 0 +12 months).

Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).

Detailed description: See protocol

Eligibility criteria: Inclusion criteria

1. Patients with one or more premalignant lesion or KC diagnosed by a dermatologist or by histopathology untill 10 years previous to inclusion.

Exclusion criteria

1. Patient is younger than 18 years old or unable to provide consent.
2. Patient is unable to remember the diagnosis or symptoms of their KC or premalignant lesion upon request by the doctor.
3. Patient was diagnosed with a melanoma or another NMSC.
4. Patient is unable to understand the task and questionnaires.

Primary outcomes:
measure: Health utility (by using a time trade off questionnaire)
timeFrame: 1 year
measure: Health utility (by using the 15D questionnaire)
timeFrame: 1 year
measure: Health utility (by using the EQ-5D-5L questionnaire)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Dermatology, Ghent University Hospital
city: Rotterdam
country: Netherlands
facility: MC Rotterdam Department of Dermatology
Study officials:
affiliation: Ghent University Hospital, Department of Dermatology
name: Lieve Hoorens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741153: Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus
Official title: The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lens Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will be diagnosed with pseudo-exfolian syndrome

Brief summary: Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.


Eligibility criteria: Inclusion Criteria:

* Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital.

Exclusion Criteria:

* Patients with previous intraocular surgery.

Primary outcomes:
measure: the percentage of diabetic patients with pseudo-exfoliation syndrome
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00670553: A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer
Official title: A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Head & Neck Cancer
Esophageal Cancer
Keywords: Prostate,
Head & Neck,
Esophageal
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-05-02
Enrollment: 7
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: The purpose of this study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.


Eligibility criteria: Inclusion criteria:

* Patients with age ≥18 years
* Confirmed diagnosis of prostate cancer, SCC esophageal cancer or head \& neck cancer
* No evidence of distant spread of the disease

Exclusion criteria:

* Patients who have severe and/or uncontrolled medical conditions
* Female patients who are pregnant or breast feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
timeFrame: 1 to 28 days
Secondary outcomes:
measure: Safety profile of oral LBH589 when given in combination with standard Radiotherapy
timeFrame: min 1 month
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02718053: Reliability of Spasticity Measurement With Lokomat
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Spasticity, Lokomat
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects are selected from patients hospitalized in our neurorehabilitation unit

Brief summary: The purpose of the study is to evaluate the reliability of spasticity measurement with Lokomat


Eligibility criteria: Inclusion Criteria:

* patients affected by lower limbs spasticity

Exclusion Criteria:

* medical contraindications to mobilization with Lokomat

Primary outcomes:
measure: correlation of spasticity measurement obtained with L-Stiff (Lokomat) and Ashworth scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: CO
Study officials:
References:
Clinical trial NCT01713153: Comparing Misoprostol and Oxytocin in Uniject for Postpartum Hemorrhage (PPH) Prevention in Senegal
Official title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
prevention
misoprostol
Uniject
oxytocin
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: ChildFund International
First posted: 2012-10-24
Enrollment: 1365
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor

Detailed description: This study will assess the programmatic implications (including feasibility, acceptability, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Eligibility criteria: Inclusion Criteria:

* women delivering in community health centers (case de sante) with a trained study provider (matrone) who are able to provide informed consent

Exclusion Criteria:

* women with known contraindications to prostaglandins

Primary outcomes:
measure: Mean change in hemoglobin
timeFrame: during 3rd trimester and 1-3 days postpartum
Secondary outcomes:
measure: Occurrence and management of side effects
timeFrame: 1 hour postpartum
measure: correct timing of drug administration
timeFrame: collected immediately following birth, verified 1-3 days postpartum
measure: change in hemoglobin ≥ 2 g/dL
timeFrame: during third trimester and 1-3 days postpartum
measure: additional interventions
timeFrame: during birth
measure: referrals
timeFrame: 0-3 days postpartum
measure: acceptability
timeFrame: 1-3 days postpartum
Other outcomes:
Locations:
city: Thiadiay and Kolda
country: Senegal
facility: Health huts in the district of Thiadiaye and Kolda
state: Thiadiaye and Kolda
Study officials:
References:
citation: Diop A, Daff B, Sow M, Blum J, Diagne M, Sloan NL, Winikoff B. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial. Lancet Glob Health. 2016 Jan;4(1):e37-44. doi: 10.1016/S2214-109X(15)00219-3.