louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01602939: Cladribine Plus Pegylated Interpheron Alfa-2a in Systemic Mastocytosis
Official title: Subcutaneous Cladribine Plus Pegylated Interpheron Alfa-2a in Advanced Systemic Mastocytosis With D816V and Other Exon 17 KIT Mutations.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Systemic Mastocytosis
Keywords: Mast cell
Mastocytosis
Mast cell disease
Lead sponsor: Hospital Virgen de la Salud
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 10
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 aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Cladribine plus Pegylated Interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying D816V or other exon 17 KIT mutations.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years.
* Diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with D816V or other exon 17 KIT mutations.
* ECOG ≤ 3.
* Signed informed consent.

Exclusion Criteria:

* Impaired liver function (total bilirubin ≥ 2.0 mg/dl, AST or ALT \> 3 x upper limit of normal)not related to mastocytosis.
* Impaired renal function (≥ 2.0 mg/dL)not related to mastocytosis.
* Grade III-IV cytopenias not related to mastocytosis. Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction \< 50%).
* Pregnancy or breastfeeding.
* Female patients who do not use contraceptive methods.

Primary outcomes:
measure: To evaluate the effect of therapy on bone marrow mast cell infiltration.
timeFrame: 6 months
Secondary outcomes:
measure: To determine the effect of therapy on serum tryptase levels and other altered peripheral blood parameters due to mastocytosis.
timeFrame: 6 months
measure: To evaluate the effect of therapy on mast cell-mediator release symptoms: pruritus, flushing, gastrointestinal symptoms or anaphylaxis).
timeFrame: 6 months
measure: To determine de safety of combined therapy with low doses of cladribine plus pegylated interpheron alpha-2a.
timeFrame: 6 months
measure: To evaluate the effect of therapy on mastocytosis skin lesions.
timeFrame: 6 moths
measure: To evaluate the effect of therapy on mastocytosis-related organomegalies.
timeFrame: 6 months
measure: To evaluate the effect of therapy on mastocytosis-related bone alterations.
timeFrame: 6 months
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Instituto de Estudios de Mastocitosis de Castilla La Mancha; Hospital Virgen del Valle
Study officials:
affiliation: Instituto de Estudios de Mastocitosis de Castilla La Mancha
name: Luis Escribano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771039: Ocular Manifestations of Inflammatory Bowel Disease
Official title: Ocular Manifestations of Chronic Inflammatory Bowel Disease (IBD): Retrospective Study in the Hepato-gastroenterology Department of the Nancy CHRU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Ophthalmopathy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department

Brief summary: Ocular damage is found in the 3rd rank of extra intestinal manifestations (MEI) Potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management Rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with IBD at the Nancy CHRU and describe all the ocular manifestations that can be found.


Eligibility criteria: Inclusion Criteria:

* Adult patients followed at Nancy University Hospital for IBD and having consulted in the ophthalmology department

Exclusion Criteria:

* Minor patients
* patients without IBD
* patients for whom there is no ophthalmology consultation

Primary outcomes:
measure: frequency
timeFrame: baseline
Secondary outcomes:
measure: Number
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03746639: Therapeutic Ultrasound on Renal Function
Official title: Effects of Therapeutic Ultrasound Applied to The Lumbar Region on Renal Function: A Randomised Controlled Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Therapy; Complications
Low Back Pain
Keywords: Chronic Pain
physiotherapy
renal function
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2018-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates whether therapeutic ultrasound (TUS) treatment applied to lumbar region with chronic low back pain affect renal function.

Detailed description: Low back pain is a common problem and there are many treatments for chronic low back pain, including TUS. Investigators routinely observed increased blood creatinine and urea levels in some of patients who received TUS.

Half of patients will receive TUS treatment for low back pain while the other half will not receive. The patients will be evaluated at baseline and the end of the treatment . The serum creatinine, serum cystatin C, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and GFR will be measured at each evaluation.

Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 65 years
* with chronic mechanical low back pain for at least 3 months
* with glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2, as calculated using the Modification of Diet in Renal Disease formula .

Exclusion Criteria:

* history of lumbar surgery
* having inflammatory low back pain
* having pregnancy
* having active infection
* history of malignancy
* having coagulation disorder
* having a cardiac pacemaker
* having heart failure
* having uncontrolled hypertension or hypotension
* having active psychiatric disease
* presence of skin diseases on low back pain
* taking medicines for low back pain during the physical therapy treatment (except for paracetamol)
* taking a new drug for another disease or undergoing a dose change for a drug taken during the course of physiotherapy.

Primary outcomes:
measure: Concentration of serum creatinine
timeFrame: 1 day
measure: Value of 24-hour urine creatinine
timeFrame: 1 day
measure: Value of creatinine clearance
timeFrame: 1 day
measure: glomerular filtration rate
timeFrame: 1 day
measure: Concentration of serum cystatin C
timeFrame: 1 day
measure: Value of 24-hour urine microalbumin
timeFrame: 1 day
measure: Value of 24-hour urine microprotein
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03744039: Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers
Official title: Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Neuroarthropathy Charcot
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 1160
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: 290-1160 consecutive patients with type 1 or type 2 diabetes mellitus and acute or chronic osteo-neuroarthropathy in 29 diabetic-foot centers in France and Belgium (members of workgroup " diabetic foot " in French-speaking Society of Diabetology)

Brief summary: Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.


Eligibility criteria: Inclusion Criteria:

* The patient has received written information about the study and did not oppose to participate
* The patient is affiliated to a health insurance programme
* The patient is at least 18 years old
* The patient is admitted to hospitalization or consultation
* The patient is diagnosed with type 1 or type 2 diabetes mellitus
* The patient is diagnosed with acute or chronic osteo-neuroarthropathy

Exclusion Criteria:

* The patient participates in another interventional study
* The patient refuses to participate

Primary outcomes:
measure: Charcot foot's diagnostic criteria
timeFrame: inclusion visit
measure: Description Charcot foot's treatment
timeFrame: inclusion visit
Secondary outcomes:
measure: Number of Charcot foot
timeFrame: inclusion visit
measure: Surgery of Charcot foot
timeFrame: inclusion visit
measure: Register of Charcot foot
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Le Grau du Roi
country: France
facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi
city: Nîmes
country: France
facility: Nimes University Hospital
Study officials:
References:
Clinical trial NCT02776839: Mobile Sensing and Support for Depression
Official title: Monocentric Study for Development of a Smartphone Application for Patients With Depressive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Switzerland: ETH
name: Switzerland: Makora
First posted: 2016-05-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is two fold, first to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms, second to explore the detection of daily-life behavior based on smart phone sensor information to identify subjects with a clinically meaningful depression level.

Detailed description: To conduct a very first pilot trial, a monocentric, single-arm clinical study is conducted. The study is approved by the local ethics committee of the Canton of Zurich in Switzerland and the Swiss Agency for Therapeutic Products. It is conducted in full accordance with the Declaration of Helsinki, with all subjects providing their electronic informed consent prior to participation. As the main interest lies in a proof of concept of the proposed MOSS app, emphasis is put on real life conditions. A range of different recruitment channels is used to attract subjects from the general public; they include physical flyers, online posts on relevant online bulletin boards and the Google Play Store.

Eligibility criteria: Inclusion Criteria:

* self-declaration of depressive symptoms
* app runs on Android 4.0 and higher
* germen speaking

Exclusion Criteria:

* psychotic symptoms
* bipolar symptoms
* drug or alcohol dependency
* dementia

Primary outcomes:
measure: Patient Health Questionnaire - for depression (PHQ-9)
timeFrame: baseline
Secondary outcomes:
measure: Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app
timeFrame: at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months
Other outcomes:
measure: Patient Health Questionnaire - for depression (PHQ-9) change
timeFrame: baseline and every other week for at least 6 weeks up to 6 months
Locations:
Study officials:
affiliation: University of Zurich
name: S Weidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06024239: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)
Official title: A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects, Subjects With Generalized Anxiety Disorder (GAD) and Subjects With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Generalized Anxiety Disorder (GAD)
Bipolar Disorder (BPD)
Keywords: ABBV-932
Generalized Anxiety Disorder (GAD)
Bipolar Disorder (BPD)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD).


Eligibility criteria: Inclusion Criteria:

* For healthy volunteer cohort:

  -- Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal.
* For participants with generalized anxiety disorder (GAD) or bipolar disorder (BPD)

  * Participants with GAD or BPD (as confirmed by MINI) meet participant psychiatric history criteria described in the protocol.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 28
measure: Time to Cmax (Tmax)
timeFrame: Up to Day 28
measure: Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
timeFrame: Up to Day 28
measure: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
timeFrame: Up to Day 28
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 129
Secondary outcomes:
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research CNS /ID# 260270
state: California
city: Grayslake
country: United States
facility: Acpru /Id# 255945
state: Illinois
city: Marlton
country: United States
facility: Hassman Research Institute Marlton Site /ID# 260271
state: New Jersey
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01344239: Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair
Official title: Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: aortic aneurysm
ischemia/reperfusion
preconditioning
pulmonary injury
intestinal injury
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate whether limb remote ischemic preconditioning (LRIP) has protective effects against intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Detailed description: Remote ischaemic preconditioning may confer the cytoprotection in critical organs. We hypothesized that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.The primary outcomes included the biomarkers reflecting intestinal injury (serum intestinal fatty acid binding protein, endotoxin levels and diamine oxidase activity) and the variables reflecting pulmonary injury (arterial-alveolar oxygen tension ratio, alveolar-arterial oxygen tension difference and respiratory index). In addition, the severity of intestinal and pulmonary injury was assessed with different scoring methods, respectively. Markers of oxidative stress and systemic inflammation were measured as well.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of abdominal aortic aneurysm
* Must be received open abdominal aortic aneurysm repair

Exclusion Criteria:

* age \>80 years old
* Acute coronary syndrome or myocardial infraction within
* 3 months
* Chronic obstructive pulmonary emphysema
* angina pain within 48 hours of repair procedure
* ejection fraction less than 40%
* poor pulmonary function (PaO2 \<60mmHg)
* history of inflammatory bowel disease
* history of diarrhea (≥2 liquid stools per day for ≥2 days) within 1 week of surgery
* intestinal chronic inflammatory disease

Primary outcomes:
measure: Limb remote ischemic preconditioning has effective protection of lung injury in patients undergoing elective open abdominal aortic aneurysm repair
timeFrame: June,2011
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ke-Xuan Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03829839: Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity
Official title: Common and Dissociable Effects of Oxytocin and Lorazepam on the Neurocircuitry of Fear - an Ultra-high Field Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oxytocin, Lorazepam, Anti-Anxiety Agents, Physiological Effects of Drugs
Keywords: Amygdala, anxiety, benzodiazepines, fear, fMRI, lorazepam, oxytocin, 7 Tesla
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: High-potency benzodiazepines have strong anxiolytic effects accompanied by significant adverse effects including impaired cognitive function, drowsiness, dizziness and impaired motoric abilities. Importantly, the long-term use of benzodiazepines may produce dependence and withdrawal. Therefore, there is considerable scientific and public interest in identifying new anxiolytic agents.

The hypothalamic peptide oxytocin (OXT) has anxiolytic effects both in healthy participants and patients with anxiety disorders by decreasing fear-associated amygdala activity. However, so far no human study has directly compared the underlying anxiolytic mechanisms of OXT and established anxiolytic agents on amygdala activity. Importantly, the amygdala is not a homogenous structure but rather consists of several subdivisions with structural and functional differences.

Therefore, the rationale of the present project is to determine the effects of intranasal OXT and the high-potency benzodiazepine lorazepam on fear-associated responses in intra-amygdalar subregions.


Eligibility criteria: Inclusion Criteria:

* healthy male volunteers
* right-handed

Exclusion Criteria:

* Current or past psychiatric illness
* Current or past physical illness
* Psychoactive medication
* Sedative medication
* MRI contraindication (e.g. metal in body, claustrophobia)

Primary outcomes:
measure: Neural responses to emotional faces in the amygdala subregions
timeFrame: Neural activations with be measured with 7 Tesla fMRI in an emotional face matching task that lasts 20 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
References:
Clinical trial NCT01847339: A Study of Epidural Bupivacain-soaked Absorbable Gelatin Sponge on Post-operative Pain in Lumbar Laminectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lumbar Laminectomy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effective relief of pain is of paramount importance to anyone treating patients undergoing surgery. Post-operative pain increases the possibility of post-surgical complications, raises the cost of medical care, and most importantly, interferes with recovery and return to normal activities of daily living. Therefore pain control is essential in the management of patients undergoing spinal surgery.Parenteral administration of narcotics has been the mainstay for postoperative pain relief in patients undergoing laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of pain control in several major surgical interventions including spinal surgery. However, some of the side effects have limited their widespread use (eg, late-onset respiratory depression). Therefore, alternative measures of pain control including infiltration of paraspinal musculature with local anesthetics have been investigated with conflicting results. In situations such as laminectomies, where the epidural space is exposed as part of the surgical procedure, the application of absorbable gelatin sponge soaked in local anesthetics appears to be an alternative for providing postoperative analgesia. By investigating the probable analgesic effects of this method the investigators may relieve post laminectomy pain with minimal side effects and also costs.


Eligibility criteria: Inclusion Criteria:

* ASA grade I or III
* scheduled to undergo lumbar laminectomy

Exclusion Criteria:

* Patients who are younger than 18 years of age
* pregnant
* spinal or lateral stenosis
* previous intervertebral disc surgery at that level
* patients with history of chronicity (symptoms \>6 months duration) or coexisting medical conditions such as substance abuse or withdrawal, hyperthyroidism, anxiety disorder, affective disorder, hepatic or renal impairments

Primary outcomes:
measure: reported post operative pain
timeFrame: Day 1
measure: recorded opioid consumption
timeFrame: Day 1
Secondary outcomes:
measure: reported pain
timeFrame: Day 1
measure: reported side effects
timeFrame: Day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Farhad Firoozbakhsh, MD
role: PRINCIPAL_INVESTIGATOR
References: