louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02909270: Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Official title: A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Patients With Thyroidecomy (Scheduled)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male or female at least 20 years of age
* Patients without clinically significant lab
* Patients scheduled for thyroidectomy

Exclusion Criteria:

* Another clinical trials within 1 month
* History of previous surgery on same position
* Anticoagulant, general steroids within a week from surgery
* Immunosuppression or autoimmune disease
* General or local infection
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertentsion, diabetes mellitus, coagulation deficiencies)
* Incompatible medications
* History of drug or alcohol abuse, mental disorder
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* History of esophagus diseases
* Keloid symptoms

Primary outcomes:
measure: adhesion incidence rate following 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Su won
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02733770: Chances in Portal System Flow After Two Bariatric Procedures
Official title: Comparison in Portal Flow After Sleeve Gastrectomy and Mini Gastric Bypass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Portal Vein Thrombosis
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Obesity if a health endemic problem over the entire world. Bariatric surgery is the best chance for those patients with morbid obesity to loss weight and to maintain the loosed weight.

Metabolic surgery is the new name for bariatric surgery like sleeve gastrectomy and gastric by pass due to the recognized changes in the homeostasis of the hormonal secretion responsive to the hunger status. After sleeve gastrectomy we observe many patients with thrombus of the portal vein system. This phenomena may be attributed to changes in the portal flow due to devascularization of the great curvature of the stomach.

The aim of the study is to compare the portal flow by intra-operative Doppler ultrasound before and after surgery of the two procedures as sleeve gastrectomy and gastric bypass, were the vascularization is not changed by the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients accepted for bariatric surgery for the bariatric surgery committee.
* Primary procedure
* No hypercoagulability status know

Exclusion Criteria:

* Hypercoagulability status
* patients after any abdominal surgery of the forgut

Primary outcomes:
measure: Measurement of Portal flow
timeFrame: three month
Secondary outcomes:
measure: Determine the relation between the operation and thrombosis
timeFrame: three month
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta MC
Study officials:
References:
Clinical trial NCT04677270: Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
Official title: Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Solving
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2020-12-21
Enrollment: 397
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A digital problem solving tool was tailored to people in the general public with practical or emotional problems during COVID-19. Content analysis were used to account for the types of problems participants used the tool to solve. Participants were randomized to one of two versions of the problem solving tool, a simple and a more advanced graphical interface. These versions were compared on participant-rated usability, credibility and the level of actual interaction with the tool.


Eligibility criteria: Inclusion Criteria:

* can use the Swedish language
* access to, and knowledge how to use, a digital internet-capable device

Exclusion Criteria:

* under 16 years
* no practical or emotional problems during pandemic

Primary outcomes:
measure: System Usability Scale
timeFrame: immediately after the intervention
measure: Treatment Credibility Scale
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Use of intervention
timeFrame: immediately after the intervention
Other outcomes:
measure: Problem categories
timeFrame: immediately after the intervention
Locations:
city: Stockholm
country: Sweden
facility: Centrum för Psykiatriforskning
Study officials:
affiliation: Karolinska Institutet
name: Martin Kraepelien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hentati A, Forsell E, Ljotsson B, Kraepelien M. Practical and Emotional Problems Reported by Users of a Self-guided Digital Problem-solving Intervention During the COVID-19 Pandemic: Content Analysis. JMIR Form Res. 2021 Oct 4;5(10):e31722. doi: 10.2196/31722.
Clinical trial NCT06212570: KeyScope Study in Uganda
Official title: KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Neoplasm
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Uganda Cancer Institute
First posted: 2024-01-19
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.

The investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.


Eligibility criteria: Inclusion Criteria:

* diagnosis of intra-abdominal mass suspicious for cancer
* body mass index (BMI) of 18-30
* weight 20-100kg
* biopsy necessary to determine cancer diagnosis and classify pathology
* surgeon determine that laproscopic biopsy it technically appropriate

Exclusion Criteria:

* significant comorbidities
* previous major abdominal surgery
* current pregnancy

Primary outcomes:
measure: Establish the clinical safety KeySuite
timeFrame: Day of surgery
Secondary outcomes:
measure: Time to complete surgery
timeFrame: Day of surgery
measure: Estimated blood loss
timeFrame: Day of surgery
measure: Surgical injuries and adverse events
timeFrame: Day of surgery
Other outcomes:
measure: Surgical site infection
timeFrame: 30 days
measure: Post-operative complications
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Locations:
city: Kampala
country: Uganda
facility: Uganda Cancer Institute
Study officials:
affiliation: Duke Health
name: Tamara Fitzgerald, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174470: Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Official title: Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Lead sponsor: Virility Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Ability to follow study instructions and complete study assessment tools

Exclusion Criteria:

* History of cardiovascular disorders
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/lesions
* Any neurological disorder
* Any psychiatric disease and/or psychiatric medications

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Baseline
Secondary outcomes:
measure: Incidence of post-treatment Adverse Events
timeFrame: 72 hours
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Ilan Gruenwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05791552: Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
Official title: Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Secretion
Alzheimer Disease
Brain Nose Interface
Lead sponsor: Noselab GmbH
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a first in man study investigating the feasibility of the collection, storage, processing and analysis of 4 key biomarkers for the diagnosis of Alzheimer's disease \[AD\] in nasal secretion. Nasal secretion \[NS\] constitutes a minimally invasive access to cerebrospinal fluid \[CSF\]. Therefore, it could be highly suitable for detection and monitoring of the AD relevant biomarkers pTau181, total Tau, Amyloid-ß1-40 and Amyloid-ß1-42. This study evaluates correlations of biomarker patterns in NS and CSF. Furthermore, the correlations of the 4 AD specific biomarkers in nasal secretion and CSF is investigated. For this study, patients with cognitive impairment (AD and NonAD group) and healthy controls were included.


Eligibility criteria: Inclusion Criteria:

* Group A Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available
* Group B Patient WITHOUT cognitive disorder and without pathologies in the nasal area

Exclusion Criteria:

* Presence of an obstructing nasal cavity disease
* Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
* Inability to give consent

Primary outcomes:
measure: Detection of brain specific biomarkers in nasal secretion
timeFrame: 1-2 years
measure: Distinction of pathologic and physiologic biomarker patterns in nasal secretion
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Noselab GmbH
state: Bayern
Study officials:
References:
Clinical trial NCT06445452: The Impact of SNAP-Ed Among Bhutanese Adults Residing in New Hampshire
Official title: The Impact of SNAP-Ed on Dietary Quality, Food Safety Handling Behaviors, and Insulin Resistance Among Bhutanese Adults Residing in New Hampshire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supplemental Nutrition Assistance Program Education
Bhutanese Refugee Adults
Lead sponsor: University of New Hampshire
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 54
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 pilot randomized controlled trial is to test the potential efficacy of Supplemental Nutrition Assistance Program Education (SNAP-Ed) among Bhutanese refugee adults residing in New Hampshire. The main questions are whether direct SNAP-Ed delivered through 6 lessons affects dietary quality and biomarkers of metabolic risk. Participants in the SNAP-Ed arm will be asked to participate in weekly lessons delivered in their homes by a bicultural and bilingual nutrition educator. Individuals in the control group did not receive SNAP-ED. All participants will be asked to complete surveys and provide blood and fecal samples prior at baseline and at the end of the study period (7 to 8 weeks).


Eligibility criteria: Inclusion criteria are (1) identifies as a Bhutanese refugee (2) 18 years and older (3) does most of the cooking and shopping for his/her household. Exclusion Criteria are (1) has been told by her/his doctor that she/he has diabetes (2) history of use of glucose lowering medications (3) pregnant or trying to become pregnant (4) currently diets for weight loss or dietary restrictions.

Primary outcomes:
measure: Healthy Eating Index Score
timeFrame: 0 and 7-8 weeks
measure: Glucose Homeostasis Biomarkers
timeFrame: 0 and 7-8 weeks
measure: Lipid Panel
timeFrame: 0 and 7-8 weeks
measure: Inflammatory Biomarkers
timeFrame: 0 and 7-8 weeks
measure: Gut Microbiome Composition
timeFrame: 0 and 7-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Building Community in New Hampshire
state: New Hampshire
Study officials:
References:
Clinical trial NCT03365752: Chloroprocaine Spinal for Outpatient Knee Surgery
Official title: A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Knee Arthroscopy
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 39
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: TREATMENT

Brief summary: Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while avoiding the side effects of a general anesthetic, thus promoting earlier discharge.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a knee arthroscopy that is anticipated to be less than one hour
* Age 18 to 80 years
* Ability to follow study protocol
* English speaking

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 18 years old and older than 80
* Allergy or intolerance to one of the study medications
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients unable to undergo a spinal anesthetic or Laryngeal Mask Airway (LMA)/GA or patient refusal to spinal anesthesia or LMA/GA

Primary outcomes:
measure: Readiness for Discharge
timeFrame: Determine within 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: David Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143052: Bone Status and Insulin Resistance in Hirsutism
Official title: Body Composition, Insulin Concentration, Androgens and Bone Status in Women Referred With Hirsutism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirsutism
Keywords: Hirsutism
Bone status
Androgens
insulin
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Study population: hirsute patients vs. controls

Brief summary: The purpose of this study is to investigate how the bones of hirsute women are different from bones of healthy women. The change in hormone content in the blood will also be investigated. The study can be used to evaluate whether it will be relevant to bone scan all newly referred hirsute women.

Hirsute women are often over-weight and often have an increased amount of the male sex hormone in their blood. Their blood tests often show changes reminding of the ones seen in diabetic patients.

All hirsute women referred to the department will undergo an investigation revealing the reason for the increased hair growth. The investigation includes clinical investigation (height, weight and degree of hair growth), blood tests (for hormone status and bone status analysis) and bone scanning of the abdomen (body composition).

The trial includes a group of 50 strongly hairy women and a control group of 50 healthy women with normal hair growth. They are matched by body weight, since weight has great importance for the bone mineral content and thereby for osteoporosis in the long run.


Eligibility criteria: Inclusion Criteria:

Hirsute subjects:

* Belonging to group 1 or 2.
* Age: 20-46
* Hirsute score: \>7
* Written informed consent

Control group:

* Age: 20-46
* Hirsute score: 0 (without razing)
* Regular menses
* Written informed consent

Exclusion Criteria:

* Previous cosmetic treatment for hirsutism.
* Use of contraceptive pill (within the past 6 months)
* Systemic steroid treatment \> 6 weeks (ever)
* Age above 46 years/post menopause (increased FSH)
* Recognized diabetes mellitus or other endocrine disease
* Eating disorder
* Serious, treatment demanding disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Diabetes Research Center
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Dorte Glintborg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01404052: Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Ultrasound on Osteoarthritis Pain of the Knee
Official title: Effects of Transcranial Direct Current Stimulation and Transcranial Ultrasound on the Perception of Pain Due to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Osteoarthritis
Keywords: transcranial direct current stimulation
transcranial ultrasound
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Highland Instruments, Inc.
First posted: 2011-07-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain associated with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation. Before, during and after stimulation, the investigators will measure and assess changes intracranial blood flow with transcranial ultrasound.


Eligibility criteria: STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. Having chronic osteoarthritis knee pain in either knee (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
5. Must have the ability to feel pain as self reported

Exclusion Criteria:

1. Subject is pregnant.
2. Contraindications to tDCS:

   * metal in the head
   * implanted brain medical devices
3. Contraindications to TUS:

   * metal in the head
   * implanted brain medical devices
4. History of alcohol or drug abuse within the past 6 months as self reported
5. Use of carbamazepine within the past 6 months as self reported.
6. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
7. History of neurological disorders as self reported.
8. History of unexplained fainting spells as self reported,
9. History of head injury resulting in more than a momentary loss of consciousness as self reported
10. History of neurosurgery as self reported

Primary outcomes:
measure: Changes in pain scale
timeFrame: Measured for approximately 2 months
Secondary outcomes:
measure: Changes in cutaneous allodynia/hyperalgesia
timeFrame: Measured for approximately 2 months
measure: Assessment of hemodynamic changes with transcranial ultrasound
timeFrame: Measured for approximately 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital (SRH)
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: