louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01349998: Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
Official title: An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Tinea Cruris
Tinea Corporis
Lead sponsor: Tinea Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 604
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.


Eligibility criteria: Inclusion Criteria:

* Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol

Exclusion Criteria:

* Pregnancy and allergies. Additional criteria listed in protocol

Primary outcomes:
measure: Number of Subjects with Adverse Events
timeFrame: One Year
Secondary outcomes:
measure: Clinical Cure and Mycological Cure
timeFrame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Other outcomes:
Locations:
city: Fremont
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Miramar
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Warren
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Paramus
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Cincinatti
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Goodletsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Lynchburg
country: United States
state: Virginia
city: Belize City
country: Belize
city: San Salvador
country: El Salvador
city: San Pedro
country: Honduras
state: Sula
city: Cidra
country: Puerto Rico
Study officials:
References:
Clinical trial NCT05148598: ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
Official title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Scleroderma, Diffuse
Keywords: Hand Dysfunction
Scleroderma
Scleroderma, Diffuse
Lead sponsor: Paracrine, INC.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Prospective
* Randomized Parallel Group
* Placebo-Controlled
* Safety and Efficacy Trial
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Detailed description: The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Eligibility criteria: Key Inclusion Criteria:

* Diffuse cutaneous scleroderma (duration \> 5 years)
* Cochin Hand Function Scale ≥ 20 units
* Symptoms consistent with Raynaud's Phenomenon
* Ability to safely undergo liposuction

Key Exclusion Criteria:

* Active infection
* Contracture(s) of any finger
* Sympathectomy within 6 months of Screening Visit
* Rheumatoid Arthritis

Primary outcomes:
measure: Cochin Hand Function Score
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06045598: Postural Control, Ankle and Trunk Proprioception in Type 2 Diabetes
Official title: Investigation of the Influence of Postural Control, Ankle and Trunk Proprioception in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type2diabetes
Keywords: type 2 diabetes
postural control
proprioception
sensation
cognition
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 31 patients between the ages of 18-65 who were diagnosed with Type 2 diabetes and 31 healthy participants who were not diagnosed with Type 2 diabetes, who applied to Hasan Kalyoncu University Application and Research Center, will participate in the study. All participants will be given detailed information about the study and signed a written informed consent form stating that they have voluntarily accepted the study.

Brief summary: The investigators aim to assess the postural control, ankle, and trunk proprioception, plantar sensation, and general cognitive status in patients with Type 2 diabetes.

Detailed description: The investigators aim to assess the postural control on different floors with eyes open, eyes closed, and cognitive dual-task, ankle, and trunk proprioception, plantar sensation, and general cognitive status of patients diagnosed with Type 2 diabetes between the ages of 18-65, and to compare them with healthy controls.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18-65
* Volunteering to participate in researc
* Being diagnosed with Type 2 diabetes according to the criteria of the American Diabetes Association (ADA)

Exclusion Criteria:

* Insufficient cognitive level
* Traumatic nerve injury
* Presence of congenital anomaly in the upper extremity
* Presence of systematic disease (eg: rheumatological)
* Having a problem involving the neurological system
* Surgery involving the upper extremity in the last 6 months

Primary outcomes:
measure: Postural Control
timeFrame: 20 minutes
measure: Ankle proprioception
timeFrame: 10 minutes
measure: Lumbal proprioception
timeFrame: 5 minutes
Secondary outcomes:
measure: Plantar sensation
timeFrame: 5 minutes
measure: Cognitive status
timeFrame: 10 minutes
measure: Dynamic Balance
timeFrame: 1 minute
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
citation: Gorniak SL, Lu FY, Lee BC, Massman PJ, Wang J. Cognitive impairment and postural control deficit in adults with Type 2 diabetes. Diabetes Metab Res Rev. 2019 Feb;35(2):e3089. doi: 10.1002/dmrr.3089. Epub 2018 Nov 8.
Clinical trial NCT04245098: Carpal Tunnel Syndrome and Amyloidosis
Official title: Carpal Tunnel Syndrome and Amyloidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyloidosis
Carpal Tunnel Syndrome
Keywords: carpal tunnel syndrome
amyloidosis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

Detailed description: Carpal tunnel syndrome (CTS) can be caused by the deposition and accumulation of misfolded proteins called amyloid and is often an early manifestation of systemic amyloidosis.

Patients with cardiac amyloidosis often have carpal tunnel syndrome that precedes cardiac manifestations by several years, and many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

The investigators sought to identify the prevalence and type of amyloid deposits in patients undergoing carpal tunnel surgery and evaluate for cardiac involvement

Eligibility criteria: Inclusion Criteria:

* Patients undergoing carpal tunnel syndrome surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with cardiac involvement in echocardiogram
timeFrame: 2 years
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Maria Del Carmen Navarro-Saez
state: Barcelona
Study officials:
References:
Clinical trial NCT04499898: Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding
Official title: Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Esophageal Varices
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Detailed description: A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Eligibility criteria: Inclusion Criteria:

* • Aged \>18 years

  * Cirrhotic patients with arterial hypertension
  * Endoscopic evidence of medium/large-sized esophageal varices

Exclusion Criteria:

* • History of variceal bleeding or previous primary prevention of varices.

  * Portal vein thrombosis or previous porto-systemic shunts as TIPS.
  * Patients on drugs affecting portal pressure (beta blockers, nitrates).
  * Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
  * Patients with severe respiratory diseases (COPD, bronchial asthma).
  * Uncontrolled diabetes mellitus
  * Renal impairment
  * Hepatocellular carcinoma
  * Allergy to carvedilol
  * Pregnancy or lactation

Primary outcomes:
measure: Number of patients with the first variceal bleeding within 1 year
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: Asem Elfert, Prof
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of medicine
name: Nabila Abd El-Nasser Abd El-Wahed El-Gazzar, ass. lect
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05273645: PrOgnosis Following Esophageal FisTula FormaTion in Pts Undergoing CathetER Ablation for AF Study
Official title: World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrio-Oesophageal Fistula
PVI
Catheter Ablation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PVI and developing an AOF

Brief summary: Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.

Detailed description: Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation.

The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.

Eligibility criteria: Inclusion Criteria:

* Atrio-oesophageal fistula after Ablation
* Indication for AF ablation as per current guidelines
* Performing the ablation at an ablation centre

Exclusion Criteria:

* No Atrio-oesophageal fistula after Ablation

Primary outcomes:
measure: Incidence of AOF following percutaneous catheter ablation
timeFrame: 5 year
Secondary outcomes:
measure: Diagnosis and management of AOF
timeFrame: 5 year
measure: Mortality rate
timeFrame: 5 year
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: Klinik für Rhythmologie
state: Schleswig-Holstein
Study officials:
affiliation: Universitaet Luebeck
name: Roland R Tilz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03010345: The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
Official title: The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cleft of Alveolar Ridge
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.

Detailed description: to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.

Eligibility criteria: Inclusion Criteria:

* Medically free patients.
* Patients suffering from alveolar cleft with anterior fistulas.
* Age Between 7 and 13 Years
* Both sexes.
* Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
* Highly motivated patients.

Exclusion Criteria:

* non motivated patients

Primary outcomes:
measure: Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
timeFrame: 21 days
Secondary outcomes:
measure: Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Galal El Behiry, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04435145: Warning Labels and College Students' Sugar-Sweetened Beverage Intake
Official title: The Impact of Warning Labels on Reducing College Students' Sugar-Sweetened Beverage Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 1067
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sugar-sweetened beverages (SSBs) are one of the few dietary items causally linked to the development of obesity and chronic disease. SSB consumption among young adults are particularly concerning, because of the high levels of consumption and the influence of disease risk in later life. College students, particularly freshmen, are a captive audience when it comes to dietary consumption because many of them consume their meals in residential dining halls. We are currently working with Michigan Dining to implement warning labels on SSB fountain dispensers to examine whether carefully tailored signage could alter beverage choices of college students. The current study aims to assess changes in dietary intake before and after the labels are posted, in a representative sample of University of Michigan students who eat at residential dining halls.


Eligibility criteria: Inclusion Criteria:

* Currently enrolled student at the University
* Visited one of three large dining halls at least 100 times in the first 1.5 months of the academic year

Exclusion Criteria:

-

Primary outcomes:
measure: Beverage Intake Questionnaire-15
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
citation: Leung CW, Wolfson JA, Hsu R, Soster K, Mangan S, Falbe J. Warning Labels Reduce Sugar-Sweetened Beverage Intake among College Students. J Nutr. 2021 Jan 4;151(1):179-185. doi: 10.1093/jn/nxaa305.
Clinical trial NCT00225745: Ghrelin Levels in Pancreatic Cancer Patients
Official title: Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Ghrelin
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients who have not received treatment. Healthy age-matched controls.

Brief summary: The primary outcome measure for this study is plasma ghrelin level.

Detailed description: The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are:

* Patients with cachexia versus patients without cachexia
* Patients with cachexia versus healthy controls

Eligibility criteria: Inclusion Criteria:

* Histological or cytological proof of pancreatic adenocarcinoma
* The control are will include healthy age-matched patients without cancer
* The test arm will include patients with pancreatic cancer and they will divided into two groups: those with and without weight loss
* Patients must have recovered from any major infections and/or surgical procedures

Exclusion Criteria:

* Patients with other serious medical illness like congestive heart failure, thyroid disease,liver disease or renal failure - conditions that will alter their nutritional state
* Patients on appetite stimulant and those receiving total parenteral nutrition
* Patients who have undergone gastrectomy or those who have gastric ulcers
* Patients receiving active chemotherapy
* No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or for which patient has been disease free for at least five years.

Primary outcomes:
measure: To evaluate plasma ghrelin levels in patients with pancreatic cancer and compare with age matched controls
timeFrame: prior to treatment
Secondary outcomes:
measure: To investigate the role of ghrelin in pathophysiology of cancer cachexia
timeFrame: prior to treatment
measure: To generate hypotheses for future studies and treatment based on the findings
timeFrame: prior to treatment
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: J Marc Pipas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06236945: HUTT to Assess Cardiac Autonomic Nervous Function
Official title: Composite Autonomic Scoring Scale and HUTT to Assess Cardiac Autonomic Nervous Function: A Preliminary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autonomic Nervous System Diseases
Lead sponsor: The First Hospital of Hebei Medical University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 1122
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 1122 (546 males, 576 females) samples were collected according to the inclusion and exclusion criteria.

Brief summary: Autonomic nervous system diseases can cause abnormalities in the circulatory system, leading to malignant arrhythmia and sudden cardiac death. Standardized, operable, and simplified diagnostic indicators are urgently needed to evaluate autonomic nervous function, particularly cardiac autonomic nervous function. The investigators use HUTT in order to provide data support for cardiac autonomic nervous system evaluation.

Detailed description: In this study, 169 samples with vertical tilt test and 24-h Holter ECG data from February 13, 2023 to October 31, 2023 were selected. The AC, DC, and 24-h HRV were compared with the CASS to identify the indicators with the strongest correlation with the CASS sympathetic and vagus nerve scores. The best index was selected, and the score intervals were delimited. The sensitivity and specificity of the defined vagal and sympathetic intervals were analyzed.

Eligibility criteria: Inclusion Criteria:

* Vertical tilt test and 24-hour holter electrocardiogram were performed at the same time

  * Receive treatment in our hospital.

Exclusion Criteria:

* Taking benzodiazepines or hypotensive drugs within 24 hours

  * Combined with mental illness, severe dementia, serious organ disease

    * Severe arrhythmia, deep breathing and poor coordination of Valsaval movements affected the interpretation of results.

Primary outcomes:
measure: To find the indicators which are most correlated to the sympathetic and vagus nerves.
timeFrame: February 13, 2023 to December 31, 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital Of Hebei Medical University
state: Hebei
Study officials:
affiliation: Department of Neurology，Xuanwu Hospital，Capital Medical University，Beijing，China.
name: Yan Ding, M.D.
role: PRINCIPAL_INVESTIGATOR
References: