louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02884557: NKT Role in the Regulation of the Inflammatory Bowel Disease
Official title: Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Primary Sclerosing Cholangitis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.

Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.


Eligibility criteria: Inclusion Criteria:

* Patients with PSC alone, IBD alone or PSC + IBD
* Obtention of oral and written consent
* Patients affiliated with the social security system

Exclusion Criteria:

* Minor patient
* Suspicion of malignant lesion of the colon
* Inability for information
* person unable to consent, and not benefiting from a legal protection regimen
* Person deprived of liberty

Primary outcomes:
measure: The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: The number of NKT infiltrating colonic biopsies, using immunohistochemical staining
timeFrame: Through study completion, an average of 1 year
measure: The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry
timeFrame: At the time of the inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU, Hôpital Claude Huriez
Study officials:
affiliation: University Hospital, Lille
name: Pierre Desreumeaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03880357: To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis
Official title: Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study Comparing Taro Product to RLD and Both Active Treatments to a Placebo Control in the Treatment of Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scalp Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

Detailed description: Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥18 years
* All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
* Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
* A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
* Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis

Primary outcomes:
measure: treatment success on the Physician's Global Assessment (PGA) of disease severity
timeFrame: Study Week 4 (Day 28 ± 4 days)
measure: clinical success on the Physician's Global Assessment (PASI) of disease severity
timeFrame: Study Week 4 (Day 28 ± 4 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Taro Pharmaceuticals
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT02299557: The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Official title: A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fecal Incontinence
Spinal Cord Injury
Lead sponsor: RDD Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out period.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent.
* Male or female subjects 18 to 55 years of age;
* Spinal Cord Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
* At least 4 unwanted/unexpected incontinent events/week

Exclusion Criteria:

* Known allergy to Oxymetazoline or silicone.
* Pregnancy or lactation.
* Active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
* Type 1 diabetes mellitus;
* Insulin treated type 2 diabetes mellitus;
* Renal insufficiency.
* Liver insufficiency.
* Malignant disease within 5 years of screening;
* History of rectal surgery.
* History of HIV, hepatitis B, hepatitis C.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
* Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
* Hypertension (blood pressure over 150/105 mm Hg in screening visit)
* Unable to understand the use instruction, as judged by the investigator.

Primary outcomes:
measure: To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
timeFrame: 4 weeks
Secondary outcomes:
measure: Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;
timeFrame: 4 weeks
measure: Number of participants with adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. sz. Belgyógyászati Klinika
Study officials:
References:
Clinical trial NCT00362557: Imaging Techniques in Body Magnetic Resonance Imaging "MRI"
Official title: Body Magnetic Resonance (MR) Imaging Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinically Indicated MR Imaging
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-08-10
Enrollment: 36
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who may require a body MRI examination

Brief summary: Any patient already receiving a scheduled MR scan of the body for any clinical indication will be eligible for this program.

Detailed description: If patients agree to participate in this program, it would require only a slightly longer examination time. This time would vary according to the body area/organ being visualized but would not exceed 30 minutes over the length of the clinical examination. Volunteers are eligible if they are willing to undergo an MR examination.

Patients would not be required to make any additional visits beyond their clinically-indicated visits. The study duration would vary according to the body area/organ visualized but would not exceed 30 minutes over the length of the clinical examination. Volunteers would be required to keep one study appointment to include one MR imaging examination.

There will be no interruption to the standard care given to patients who participate in this trial since the clinical portion of their examination will be completed prior to the study portion of the exam.

Eligibility criteria: Inclusion Criteria:

* Male or Female clinically scheduled to undergo MR Imaging at Johns Hopkins Medical Institutions

Exclusion Criteria:

* Contraindications to MR Imaging

Primary outcomes:
measure: Magnetic resonance signal
timeFrame: One Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: David A Bluemke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pontiff M, Moreau NG. Safety and Feasibility of 1-Repetition Maximum (1-RM) Testing in Children and Adolescents With Bilateral Spastic Cerebral Palsy. Pediatr Phys Ther. 2022 Oct 1;34(4):472-478. doi: 10.1097/PEP.0000000000000941. Epub 2022 Aug 12.
Clinical trial NCT05185557: BRIANSTORM - Early Identification of Patients With Brain Metastases
Official title: BRIANSTORM - Early Identification of Patients With Brain Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Rectal Adenocarcinoma
Brain Metastases
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients with metastatic rectal cancer and presence of lung metastasis.

Brief summary: A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

Detailed description: In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times

Eligibility criteria: Inclusion Criteria:

* Primary rectal tumor location

  * Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
  * Able to understand written information
  * Consent to samples for translational research

Exclusion Criteria:

* Contraindications for MRI Priorly treated or known brain metastases

Primary outcomes:
measure: Incidence of brain metastasis
timeFrame: 2 years
Secondary outcomes:
measure: Number of brain metastases eligible for local treatment options
timeFrame: 2 years
measure: Median two year overall survival
timeFrame: 2 years last patient
measure: Prognostic value of circulating DNA levels at baseline
timeFrame: 2 years last patient
measure: Descriptive biological analysis of tumor tissue and circulating tumor DNA
timeFrame: 2 years last patient
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
Study officials:
affiliation: Department of Oncology, Aarhus University Hospital
name: Anders K Boysen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03758157: Clinical Accuracy of the welloStationX
Official title: welloStationX Determination of Clinical Accuracy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: Wello Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be selected from amongst non-profit clinical sites and through social media posts for subjects to come to a test site or to be evaluated in his or her own home in the widespread Dallas/Fort Worth area.

Brief summary: This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.

Detailed description: Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people.

This study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer.

Eligibility criteria: Inclusion Criteria:

* Male or female.
* 5 years and up.
* Signed informed consent form.

Exclusion Criteria:

* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.
* immunization within seven days of the test

Primary outcomes:
measure: Clinical Agreement Through Clinical Bias Evaluation
timeFrame: one day
Secondary outcomes:
measure: Clinical Repeatability
timeFrame: one day
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Agape Clinic
state: Texas
Study officials:
affiliation: Wello Inc.
name: Alan C Heller
role: STUDY_CHAIR
References:
Clinical trial NCT00002557: Combination Chemotherapy in Patients With Advanced or Recurrent Mycosis Fungoides
Official title: PROTOCOL FOR THE MANAGEMENT OF MYCOSIS FUNGOIDES AND THE SEZARY SYNDROME
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-07-19
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of etoposide with or without doxorubicin and methotrexate in treating patients who have mycosis fungoides.

Detailed description: OBJECTIVES: I. Assess the response rate in patients with Stage III/IV or recurrent mycosis fungoides or Sezary syndrome treated with oral etoposide, with the addition of doxorubicin, then methotrexate for poor responders. II. Assess changes in the hematologic and immunologic status of the tumor in these patients.

OUTLINE: Patients are treated sequentially on Regimens A, B, and C depending on response. The following acronyms are used: CF Leucovorin calcium, NSC-3590 DOX Doxorubicin, NSC-123127 MTX Methotrexate, NSC-740 VP-16 Etoposide, NSC-141540 Regimen A: Single-Agent Chemotherapy. VP-16. Regimen B: 2-Drug Combination Chemotherapy. VP-16/DOX. Regimen C: 3-Drug Combination Chemotherapy. VP-16/DOX/MTX.

PROJECTED ACCRUAL: Study duration will be at least 3 years with an anticipated accrual of 3 patients/year.

Eligibility criteria: DISEASE CHARACTERISTICS: Stage III/IV mycosis fungoides or Sezary syndrome Stage I/II cutaneous T-cell lymphoma in relapse following interferon therapy also eligible

PATIENT CHARACTERISTICS: Age: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alpha for Stage I/II disease allowed Chemotherapy: Prior isotretinoin for Stage I/II disease allowed Endocrine therapy: Prior topical steroids for Stage I/II disease allowed Radiotherapy: Prior ultraviolet therapy for Stage I/II disease allowed Prior x-ray therapy for Stage I/II disease allowed Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town School of Medicine
Study officials:
affiliation: University of Cape Town
name: Nicolas Novitzky, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05039957: Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital
Official title: Management of Fracture Ankle in Patients With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation: Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes is a well-known risk factor for complications following ankle fracture fixation.Current recommendations for operative treatment of ankle fractures in patients with diabetes consist of increased rigid fixation and prolonged periods of non-weight bearing with minimally invasive techniques.

Yee et al described a treatment algorithm for ankle fractures in diabetes patients based on the extent of their diabetic complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and suggest that primary ankle arthrodesis may be an option in severe situations.

Ebaugh et.al. described the technique of fixing the ankle joint in diabetic patients without joint preparation .

Primary hindfoot arthrodesis with Calcaneotibial nail with formal joint preparation was described by many authors as treatment for ankle fractures in diabetic patient .

To our knowledge, there is no comparative study in management of ankle fractures in diabetic patients using these two different techniques.

Our hypothesis is to try to prove that management of diabetic fracture ankle by hindfoot nail without joint preparation is better than other techniques regarding overall lower complication rate, higher functional outcome and better option for treatment of these patients using minimal invasive approaches in those high risk patients.


Eligibility criteria: Inclusion Criteria:

* • All subjects aged 50y or more with recent fracture ankle (less than two weeks) with uncontrolled diabetes in form of high level of hemoglobinA1C ( \>6.4% ) and/ or high random blood sugar level on admission (\>200mg/dl). Patients with one or more complications due to diabetic e,g. neuropathy, nephropathy , and/or peripheral vascular disease.

Exclusion Criteria:

* • Previous ankle fracture fixation in the same side.

  * Charcot arthropathy
  * Polytrauma, multiple skeletal injury.

Primary outcomes:
measure: Complication rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References: