louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01265212: Prevalence of Human Papillomavirus in Men Living in the Northern Plains
Official title: Prevalence of Human Papillomavirus in Men Living in the Northern Plains
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male residents of South Dakota.

Brief summary: HPV infection is associated with cervical and other anogenital cancers. HPV may also be associated with the development of prostate cancer. The purpose of the study is to determine the prevalence of HPV infection in men living in South Dakota.


Eligibility criteria: Inclusion Criteria:

* Male
* Ages 18-65
* Living in South Dakota (AKA Northern Plains)

Exclusion Criteria:

-

Primary outcomes:
measure: Determine the prevalence of HPV in men living on the Northern Plains
timeFrame: No time point
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Sanford Health
name: Diane Maher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01973712: Periprosthetic Distal Femur Fracture
Official title: Treatment of Periprosthetic Distal Femur Fractures: A Randomized Controlled Trial of Locking Plate Osteosynthesis Versus Retrograde Nailing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periprosthetic Fractures
Distal Femur Fractures
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 94
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: A periprosthetic distal femur fracture is a fracture close to a knee implant. This type of fracture is often difficult to fix because of the close proximity of the two surgical implants which can sometimes interfere with proper bone healing. Improper healing can cause significant impairment and sometimes requires additional surgeries to correct the problem. Despite considerable interest and research put into developing techniques to repair this fracture surgeons do not know which is the best way to treat this type of fracture.

Our multicentre orthopaedic study group is conducting this study to compare two standard, but different treatments for periprosthetic distal femur fractures. One treatment consists of open surgery and the placement of a plate and screws along the side of the femur. The other consists of implanting an intramedullary nail in the femur.

The goal of this study is to directly compare the two treatments to see if one treatment results in better patient outcomes than the other.


Eligibility criteria: INCLUSION CRITERIA:

Age 18 years and older Displaced periprosthetic fracture of the distal femur Fracture amenable to both treatment groups, in the opinion of the investigator Knee prosthesis is well-fixed and non-stemmed Open box femoral component Provision of written informed consent

EXCLUSION CRITERIA:

Presence of an active infection around the fracture (soft tissue or bone) Open fracture Injury Severity Score (ISS) \> 15 or any associated major injuries of the lower extremities Medical contraindication to surgery Pregnant women Likely problems, in the judgment of the investigators, with maintaining follow-up

Primary outcomes:
measure: Timed Up and Go (TUG) test
timeFrame: 3 months
Secondary outcomes:
measure: Rates of re-operation
timeFrame: 12 months
Other outcomes:
measure: Rates of malunion
timeFrame: 12 months
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital, Department of Orthopaedic Surgery
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Aaron Nauth, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Emil Schemitsch, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3.
Clinical trial NCT04074512: Copper Histidinate Treatment for Menkes Disease
Official title: Copper Histidinate Treatment for Menkes Disease
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Menkes Disease
Lead sponsor: Sentynl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD

Brief summary: This study investigates the clinical effects and safety of subcutaneous Copper Histidinate treatment for newly diagnosed Menkes disease patients under 6 years of age.


Eligibility criteria: Inclusion Criteria:

1. The subject must be a newly diagnosed Menkes disease patient in the United States.
2. Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study.
3. Male or female, aged 0 to \<6 years of age.
4. Confirmed diagnosis of Menkes disease based on the following clinical and/or biochemical and/or molecular characteristics:

   Clinical: Abnormal hair color and/or texture, and/or seizures, and/or hypotonia, and/or developmental delay; or Biochemical: Low serum copper levels (\< 75 mcg/dL) and/or ceruloplasmin and/or abnormal plasma catecholamine levels; or Molecular: Mutation(s) in the ATP7A gene (deletion/duplication, nonsense, missense, or canonical or non-canonical splice junction mutations).
5. For newly diagnosed Menkes disease patients, whose molecular ATP7A gene mutation confirmation is pending these patients should have serum copper levels \< 75 mcg/dL.
6. Ability to adhere to the prescribed subcutaneous Copper Histidinate injection regimen.
7. Willingness to comply with all study visits and procedures.

Exclusion Criteria:

1. Pre-existing liver (e.g., hepatitis, biliary atresia, cirrhosis) or kidney disease (e.g., serum creatinine \>1.0 mg/dL).
2. History of bleeding diatheses.
3. Diagnosis of Wilson disease.
4. Any disease or condition that, in the opinion of the Investigator, has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.
5. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02972112: Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
Official title: Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Specific Phobia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.


Eligibility criteria: Inclusion Criteria:

1. Hebrew speaking pregnant women week 32 + 0 to 37 + 0
2. fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).

Exclusion criteria:

1. Women who suffer from a psychotic disorder, PTSD or suicidal ideation
2. High risk pregnancies
3. Alcoholism or drug abuse and dependence.

Primary outcomes:
measure: Pregnancy-Related Anxiety Questionnaire
timeFrame: In the end of second session of intervention- up to 4 weeks from screening
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Tel Aviv Sourasky Medical Center
Study officials:
References:
citation: O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
Clinical trial NCT04909112: Olfactory and Taste Disturbances in Sjogren's Syndrome
Official title: Olfactory and Taste Disturbances in Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Sjogren's syndrome
olfactory disorder
taste disorder
(intra-nasal and oral) trigeminal impairments
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Sjögren syndrome is an autoimmune disease, responsible for xerostomia and xerophthalmia. Other organs and tissues can be affected: the skin, vaginal and nasal mucous membranes. As well, olfactory disorders have been also described in Sjögren syndrome.

Xerostomia often causes significant functional impairment of taste function. Impairment of taste function has been poorly evaluated in Sjögren syndrome like olfactory or (intra-nasal and oral) trigeminal disorders.

Detailed description: The aim of the study is to evaluate olfactory, taste (intra-nasal and oral) trigeminal functions in patients with Sjogren's syndrome compared to patients without sicca syndrome.

Eligibility criteria: Inclusion Criteria:

* group 1 : patients with Sjogren's syndrome
* group 2: patients without sicca syndrome
* older than 18 years old
* consenting to participate to the study

Exclusion Criteria:

* smoking patients
* patients with stomatitis
* patients with upper respiratory tract infection

Primary outcomes:
measure: Olfactory detection thresholds for Phenyl-ethyl alcohol
timeFrame: Day 0
measure: Olfactory detection thresholds for Butanol
timeFrame: Day 0
measure: Olfactory detection thresholds for Pyridine
timeFrame: Day 0
Secondary outcomes:
measure: Taste detection thresholds for salty taste
timeFrame: Day 0
measure: Taste detection thresholds for sweet taste
timeFrame: Day 0
measure: Taste detection thresholds for sour taste
timeFrame: Day 0
measure: Taste detection thresholds for bitter taste
timeFrame: Day 0
measure: Taste detection thresholds for trigeminal stimuli
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne-Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: Clovis FOGUEM, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02653612: Intraoperative Imaging of Pulmonary Adenocarcinoma
Official title: Intraoperative Imaging of Pulmonary Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Lung Cancer
Keywords: surgery
folate receptor
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Pennsylvania
First posted: 2016-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal is to improve surgery by preventing tumor cells from being left behind at the time of surgery. This includes finding residual tumor cells in the wound after surgery.

Detailed description: The goal is to improve the intraoperative identification of tumor cells at positive margins and regional metastases that may be missed by a surgeon during a pulmonary resection. Improved identification of tumor cells will result in superior disease clearance and more accurate clinical staging. The investigators hypothesize that targeted fluorescent imaging during surgery will improve identification of positive margins and metastases. Since folate receptor alpha (FR ) is expressed on 55% of resectable lung cancer, the investigators will utilize a fluorescent probe that targets these tumors. As real-time imaging provides more information to the surgeon, more personalized and directed operations can be conducted. This work will allow for more preservation of normal tissue, decreased morbidity, decreased surgical time, increased surgical confidence, improved cancer detection, decreased unnecessary surgery and ultimately improved tumor free survival. This technology should transform clinical surgery from an art that depends fully on the human factor to a procedure that has precision and fail safes.

Eligibility criteria: Inclusion Criteria:

* lung cancer
* surgical candidate
* operable
* resectable

Exclusion Criteria:

- no allergies to contrast dyes

Primary outcomes:
measure: Margin assessment
timeFrame: At the time of surgery
measure: Lymph node assessment
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Colleen Gaughan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05881512: Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Official title: Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
OSA
Lead sponsor: Somnial Inc
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 years or older
* In good general health, as evidenced by medical history and diagnosed with moderate or severe OSA
* In-lab PSG, within the last 6 months, with an AHI of 15-50/hour. In addition, \<25% of the respiratory events on the diagnostic PSG can be attributed to central apneas
* BMI less than or equal to 32

Exclusion Criteria:

* No or mild OSA (AHI \<15/h) or very severe OSA (AHI \>50/hour), exclusively postural sleep apnea, or isolated Rapid-Eye-Movement (REM) sleep associated OSA.
* Patients who are cachectic (BMI \<18.5 kg/m2) or obese (BMI \>32 kg/m2).
* Patients should not have enlarged tonsils (size 3-4) and/or adenoids, nasal polyps, neuromuscular disease, hypoglossal nerve palsy, abnormal pulmonary function tests, severe pulmonary hypertension, valvular heart disease, heart failure (New York Heart Association, NYHA III-IV), recent myocardial infarction, significant cardiac arrhythmias, atrial fibrillation, stroke, opioid usage, uncontrolled hypertension, known allergic reaction to adhesives or latex, active psychiatric disease, co-existing non-respiratory sleep disorder, pregnancy or significant metal implants or cardiac/other pacemakers.
* Patients with facial hair that affects the correct placement of the electrodes, if they are unwilling to shave.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: Overnight (day 1)
Secondary outcomes:
measure: Arterial Oxygen Saturation (SaO2)
timeFrame: Overnight (day 1)
Other outcomes:
measure: Sleep Quality
timeFrame: Overnight (day 1)
Locations:
city: Commack
country: United States
facility: United Diagnostics
state: New York
Study officials:
affiliation: ENT & Allergy Associates, LLP
name: Lee Shangold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981812: Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Official title: Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: PET
PEM
Positron Emission Mammography
Breast Biopsy
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

* female
* subject is 25-100 years of age
* subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
* subject is able to provide informed consent

Exclusion Criteria:

* subject is pregnant
* subject is actively lactating or discontinued breastfeeding less than 2 months ago
* subject has breast implants
* subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
* subject has contraindications for core biopsy and other invasive procedures
* subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus
* subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
* subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging

Primary outcomes:
measure: Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
timeFrame: At time of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnnati
country: United States
facility: UC Hospital, The Barrett Center
state: Ohio
Study officials:
affiliation: Univeristy of Cincinnati
name: Mary C Mahoney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Amy Argus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952912: Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates
Official title: Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostate Hyperplasia
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 160
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.

To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.


Eligibility criteria: Inclusion Criteria:

* •Qmax \< 12 mL/s, IPSS \>19

  * Age between 50 and 70 years
  * Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure.

Exclusion Criteria:

* •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery

Primary outcomes:
measure: Qmax at one year postoperatively
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Qmax at other time points after surgery
timeFrame: 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
measure: resected adenoma weight
timeFrame: right after the operation
measure: operation time
timeFrame: during the operation
measure: blood loss
timeFrame: perioperatively and on the first postoperative day
measure: postoperative International Prostate Symptom Score
timeFrame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
measure: duration of catheterization
timeFrame: after the operation
measure: length of postoperative hospital stay
timeFrame: after the operation
measure: QOL
timeFrame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
measure: PVR
timeFrame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital
state: Fujian
Study officials:
References:
citation: Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24.