louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06320860: FlexStone Enabled Kidney Stone Retrieval
Official title: FlexStone Enabled Kidney Stone Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Calculi
Lead sponsor: EndoTheia
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
First posted: 2024-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.

Detailed description: The clinical practice at Vanderbilt University Medical Center will perform standard flexible ureteroscopy (fURS) procedures using conventional stone retrieval baskets, the EndoTheia FlexStone basket, laser fibers for intracorporeal lithotripsy , and any other fURS accessory devices as determined by the surgeon. If renal calculi are present which the physician deems retrieval of would benefit from the added aimability of the EndoTheia FlexStone basket will be used.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 80 years of age
* Able to provide written informed consent
* Have renal stones present and are appropriate candidates for fURS

Exclusion Criteria:

* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
* Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
* Patients with active urinary tract infection or anatomy that complicates retrograde access to the ureter and kidney
* Patients who do not meet inclusion criteria
* Patients who are unable or unwilling to provide informed consent

Primary outcomes:
measure: Successful retrieval of kidney stones
timeFrame: Day 1 Post-Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT05858060: Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage
Official title: Practice of Osmotherapy in Severe SubArachnoid Hemorrhage Patients: Multicenter Observational Study (OSMO-SAH Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subarachnoid Hemorrhage, Traumatic
Keywords: Subarachnoid Hemorrhage, mannitol, hypertonic saline, outcome
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet inclusion and exclusion criterias will be consecutively included. Treatment will be given according to expert consensus of local center, including neurosurgical and intensive management.

Brief summary: The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question\[s\] it aims to answer are:

• whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients?

Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.


Eligibility criteria: Inclusion Criteria:

* ①age ≥18； ②aneurysmal subarachnoid hemorrhage; ③Hunt-Hess 3-5级

Exclusion Criteria:

* previous cranial decompression surgery, cerebrospinal fluid leakage or drainage,

  * bilateral pupils fixed or dilated,

    * hemodynamic instability,

      * hemoglobin \< 8g / L,

        * serum osmolality \> 320 mOsm / L,

          ⑥ combined with severe organ dysfunction (cardiac, pulmonary, hepatic, renal and so on);

          ⑦ serious electrolyte disorders (serum sodium concentration \<125 mmol / L or \>170 mmol / L), and difficult to correct within limited time;

          ⑧ serious acid-base balance disorders, and difficult to correct within limited time;

          ⑨ use of mannitol or HSS within previous six hours;

          ⑩ being pregnant.

Primary outcomes:
measure: modified Rankin score
timeFrame: 1 month after ictus
measure: modified Rankin score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02132260: Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Safety and Efficacy of a Naftifine Hydrochloride Cream 2%and the Naftin® Cream 2% in Patients With Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinea Pedis
Keywords: Naftifine
Naftin®
Tinea pedis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 890
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: The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years or older
* Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot
* The presence of interdigital tinea pedis infection
* The sum of the clinical signs and symptoms scores of the target lesion is at least 4, including a minimum score of at least 2 for erythema and a minimum score of 2 for either scaling or pruritus

Exclusion Criteria:

* Females who are pregnant, lactating or planning to become pregnant during the study period
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit
* Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks prior to baseline visit
* Use of systemic corticosteroids, antibiotics or antifungal therapies within one month prior to baseline visit
* Use of oral terbinafine or itraconazole within two months prior to baseline visit
* Use of immunosuppressive medication or radiation therapy within three months prior to baseline visit
* Any known hypersensitivity to Naftifine Hydrochloride, or any component of the formulation
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
* History of significant or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place undue risk by participation or could jeopardize the integrity of study evaluations
* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with tinea pedis evaluation
* Past history of dermatophyte infections with a lack of response ot antifungal therapy

Primary outcomes:
measure: Therapeutic Cure
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: http://catawbaresearch.com/contact/
name: Catawba Research
role: STUDY_CHAIR
affiliation: Taro Pharmaceuticals USA Inc.
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT02744560: Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C
Official title: Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.


Eligibility criteria: Inclusion Criteria:

* multitransfused beta thalassemic children with super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

Exclusion Criteria:

* liver decompensation child younger than 3 years patients with hepatitis B infection contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study

Primary outcomes:
measure: liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
References:
Clinical trial NCT06976060: High-Intensity Interval Training in a Community Gym
Official title: High-Intensity Interval Training in a Community Gym
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Age-related Strength Loss
Keywords: high-intensity interval training
older adults
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will deliver a 9 week high intensity interval training (HIIT) class using functional movements within a community based gym. The class will be twice a week. Outcomes are focused on cardiovascular endurance, balance, strength and muscle size and muscle quality changes. The outcomes will be assessed weekly.

Detailed description: We will measure cardiovascular endurance (2-minute Step Test; 2MST), balance (Functional Gait Assessment; FGA), muscular strength (Grip Strength and 5 times sit-to-stand; 5xSTS) and muscle size (thickness) and quality (echo intensity) on a weekly basis over the 9 week HIIT class.

Eligibility criteria: Inclusion Criteria:

* no contraindications to exercise (PAR-Q+)
* do not have severe mental impairment (\>14 on the SAGE)
* ability to walk 100 ft without the use of an assistive device

Primary outcomes:
measure: 2-minute Step Test Performance
timeFrame: Baseline and weekly over the 9 week intervention
Secondary outcomes:
measure: Functional Gait Asssessment
timeFrame: Baseline and weekly over the 9 week intervention
measure: 5 times sit to stand
timeFrame: Baseline and weekly over the 9 week intervention
measure: Grip Strength
timeFrame: Baseline and weekly over the 9 week intervention
measure: Muscle Thickness
timeFrame: Baseline and weekly over the 9 week intervention
measure: Muscle Echo Intensity
timeFrame: Baseline and weekly over the 9 week intervention
Other outcomes:
Locations:
city: Omaha
country: United States
facility: UNMC Engage Wellness Medical Fitness Center
state: Nebraska
Study officials:
References:
Clinical trial NCT00790660: A Study to Assess the Safety and Tolerability of ASP1941 in Adults With Type 2 Diabetes Mellitus.
Official title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Multiple Dose Study to Assess the Safety and Tolerability of ASP1941 in Adult Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: ASP1941
Type 2 Diabetes Mellitus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intended to assess safety and tolerability of ASP1941 compared to placebo in adult subjects with type 2 diabetes mellitus

Detailed description: Trial includes a two week washout period before entering the treatment period for subjects on oral anti-diabetic medication.

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus
* HbA1c value between 7.0 and 10.0%
* Body mass index between 20 and 45 kg/m2

Exclusion Criteria:

* Established diagnosis of type 1 diabetes mellitus
* Serum creatinine \> upper limit of normal range
* Proteinuria (microalbumin/creatinine ratio \> 300 mg/g)
* Urinary tract infection
* Severe uncontrolled Hypertension
* Significant renal, hepatic or cardiovascular disease
* HIV Positive
* History of drug or alcohol abuse/dependency

Primary outcomes:
measure: Evaluation of safety through clinical safety labs and adverse events
timeFrame: 6 Weeks
Secondary outcomes:
measure: Evaluation of routine PK and PD parameters
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT05314660: Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children
Official title: Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caries Arrest
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 135
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 equal groups receiving 3 different protocols
Primary purpose: PREVENTION

Brief summary: Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.

Detailed description: 135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.

The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.

Eligibility criteria: Inclusion Criteria:

* healthy children aged 3-5
* residents of mansoura city
* having at least one carious dentine lesion

Exclusion Criteria:

* large carious lesions approximating the pulp
* signs of pulpitis, fistula, abscess.

Primary outcomes:
measure: Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
timeFrame: 1 year
Secondary outcomes:
measure: Early childhood oral health impact scale (ECOHIS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Basma Hamza
state: Dakahlia
Study officials:
References:
Clinical trial NCT03108560: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
Official title: A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: sublobar resection
lobectomy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: RenJi Hospital
name: Fujian Medical University Union Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo No.2 Hospital
First posted: 2017-04-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.


Eligibility criteria: Inclusion Criteria:

* cT1N0M0 non-small-cell lung cancer
* ground-glass opacity, ≤2cm, GGO≥25%
* eligible for both lobectomy and sublobar resection
* intraoperative pathology is minimally-invasive adenocarcinoma or invasive adenocarcinoma
* intraoperative pathology of biopsied station 10 lymph node is negative

Exclusion Criteria:

* intraoperative pathology is benign nodule, atypical adenomatous hyperplasia, or adenocarcinoma in-situ
* intraoperative pathology of biopsied station 10 lymph node is positive
* multiple GGOs, lesions other than dominant lesion are malignant or \>5mm
* history of thoracic surgery
* history of malignancy in recent 5 years
* unstable systemic disease
* patients with psychiatric disorders

Primary outcomes:
measure: Overall Survival
timeFrame: five years after surgery
Secondary outcomes:
measure: Disease Free Survival
timeFrame: five years after surgery
measure: Local and distant recurrence rates
timeFrame: five years after surgery
measure: Pulmonary Function: forced expiratory volume in 1 second (FEV1) in liter
timeFrame: 3rd, 6th, 12th, and 24th month after surgery
measure: Pulmonary Function: forced vital capacity (FVC) in liter
timeFrame: 3rd, 6th, 12th, and 24th month after surgery
measure: Pulmonary Function: diffusing capacity of the lungs for carbon monoxide (DLCO) in mL/min/mmHg
timeFrame: 3rd, 6th, 12th, and 24th month after surgery
measure: Morbidity rate
timeFrame: up to 30 days after surgery
measure: Mortality rate
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Di Ge, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05971160: Creating Access to Resources and Economic Support
Official title: Creating Access to Resources and Economic Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-02
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are:

1. Do microgrants with or without peer mentoring improve mental health?
2. Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection?

Researchers will compare mental health outcomes among three groups of participants:

A. Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months.

C. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* gender identity different from sex assigned on original birth certificate
* access to a mobile phone or email
* score \> 0 on the material hardship index

Exclusion Criteria:

* inability to provide informed consent in English

Primary outcomes:
measure: Change in psychological distress, as measured by Kessler 6
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University (online recruitment)
state: North Carolina
Study officials:
affiliation: Duke University
name: Tonia C. Poteat, PhD
role: PRINCIPAL_INVESTIGATOR
References: