louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02744651: EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract
Official title: EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Neoplasms
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

- Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

Detailed description: Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Eligibility criteria: Inclusion Criteria:

* All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

Exclusion Criteria:

* Mental illness
* Extreme co-morbidity

Primary outcomes:
measure: Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: University Hospital of Lund
state: Skane
Study officials:
affiliation: Region Skåne
name: Jan Johansson, SrConsultant
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04877951: PC in Stance and During Functional Mobility Following BIG for PD
Official title: Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: postural control
gait
Lead sponsor: University of South Dakota
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.

Detailed description: LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. Postural instability and gait disturbance is another debilitating feature of Parkinson's disease. While LSVT BIG targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. This study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. Alternative amplitude programs have also been designed to meet the needs of patients with PD. These programs adjust frequencies for patients and individualize sessions more than LSVT BIG. We are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as LSVT BIG in our outcome measures.

Eligibility criteria: Inclusion Criteria:

* Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking.

Exclusion Criteria:

* Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration

Primary outcomes:
measure: Mini Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: Pre-Intervention (baseline) and Post-Intervention (week 5)
measure: Fullerton Advanced Balance Scale (FAB)
timeFrame: Pre-Intervention (baseline) and Post-Intervention (week 5)
measure: Functional and Multidirectional Reach Tests
timeFrame: Pre-Intervention (baseline) and Post-Intervention (week 5)
measure: Center of Pressure measures (digitized walkway)
timeFrame: Pre-Intervention (baseline) and Post-Intervention (week 5)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of South Dakota
name: Patti J Berg-Poppe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05174351: Beta-blocker Discontinuation in Heart Failure With Preserved Ejection Fraction
Official title: Effect of Beta-blocker Discontinuation on Functional Capacity and Cardiac Hemodynamics in Patients With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Keywords: HFpEF
Beta-blocker
echocardiogram
6MWT
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 HFpEF patients.

Detailed description: This is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 HFpEF patients. The study involves 2 visits that are 4 weeks apart. The first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. No long term follow up beyond the 2nd visit.

Eligibility criteria: Inclusion Criteria:

* Stable HFpEF patients with NYHA Class II-III or elevated BNP ≥100
* N=30 (Target: 30).
* Age: 50 \~ 80 years.
* ECHO evidence of EF ≥50% and Grade 2 or 3 diastolic dysfunction.
* Chronic loop diuretic use
* Currently on beta-blocker

Exclusion Criteria:

* Beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease.
* Heart rate \> 100 bpm
* Recent hospitalization due to HF within 3 months
* Non-English speaker

Primary outcomes:
measure: Changes in KCCQ-23 score
timeFrame: Baseline and after 4 weeks of beta blocker discontinuation
Secondary outcomes:
measure: Changes in cardiac mechanics by echocardiography
timeFrame: Baseline and after 4 weeks of beta blocker discontinuation
measure: Changes in biomarker
timeFrame: Baseline and after 4 weeks of beta blocker discontinuation
measure: 6 minute walk test
timeFrame: Baseline and after 4 weeks of beta blocker discontinuation
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health / John Dempsey Hospital
state: Connecticut
Study officials:
affiliation: UConn Health
name: Kai Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01652651: Risk and Resilience Factors in Learning Disabilities Population
Official title: The Contribution of Risk and Resilience Factors in Learning Disabilities Population to Academic and Emotional Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Disorders
Keywords: Learning Disorders
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 70
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to report preliminary outcomes of executive function and psychopathology symptoms of a manual-based psychological intervention for adolescents diagnosed with learning disorders- I can succeed (ICS).


Eligibility criteria: Inclusion Criteria:

* Learning Disorder diagnosis
* Normal range IQ
* Regular class attendance

Exclusion Criteria:

* Suicidal ideation and psychosis

Primary outcomes:
measure: Change in Child Behavior Checklist (CBCL) (Achenbach, 1991).
timeFrame: base line (time 0) and end of treatment (3 month)
Secondary outcomes:
measure: Change in The standardized Brain Resource cognition assessment, ''IntegNeuro,'' (Clark et al., 2006).
timeFrame: base line (time 0) and end of treatment (3 month)
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children Medical Center of Israel
Study officials:
affiliation: Schneider's Children Medical Center of Israel
name: Daphne Kopelman-Rubin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996151: Testosterone MD-Lotion Residual Washing Study
Official title: A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypergonadism
Keywords: Hypergonadism
Testosterone Transfer
Lead sponsor: Acrux DDS Pty Ltd
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects ≥18 and ≤ 70 years

Exclusion Criteria:

* Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion

Primary outcomes:
measure: The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.
timeFrame: March 2010
Secondary outcomes:
measure: The safety and tolerability of Testosterone MD-Lotion 2% following a single dose application. This will be performed by review of adverse events, EKG and assessment of laboratory parameters (haematology, biochemistry, urinalysis and hormone levels).
timeFrame: March 2010
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: QPharm Pty Ltd
state: Queensland
Study officials:
affiliation: Acrux Pharma Pty Ltd
name: Tina Soulis, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02426151: Bioequivalence of a Single Subcutaneous Dose of BEPO and REPO in Healthy Male Subjects
Official title: A Randomized, Open Label, Single-dose 2x2 Crossover Study to Compare Pharmacokinetic, Pharmacodynamic Profiles, and Tolerability of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 46
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To Compare Pharmacokinetic and Pharmacodynamic Profiles of BEPO-A and REPO-A in Healthy Male Subjects

Detailed description: To Compare Pharmacokinetic and Pharmacodynamic Profiles of EPO (BEPO-A (4000 IU)) and EPO (REPO-A (4000 IU)) in Healthy Male Subjects

Eligibility criteria: Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 19 and 40 years, clinically healthy;
* BMI between 19 and 28;
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \< 85 mmHg

Exclusion Criteria:

* Hemoglobin \<13 g / dL
* Ferritin \<20 ng/mL or TIBC \> 360 ug/ dL
* Vitamin B12 \< 200 pg/mL or floate \< 4 ng/mL
* %reticulpcyte \> 3%
* platelet \< 100,000/ul or \> 400,000/ul
* GFR \< 60mL/min/1.73m2
* Going to or during treatment of the tumor
* Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation
* Clinical history of autoimmune or hereditary anemia
* A Positive reaction in the nicotine tests
* Principal Investigator of the study criteria.

Primary outcomes:
measure: Cmax and AUClast
timeFrame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
Secondary outcomes:
measure: AUCinf, Tmax, t1/2β, CL/F, MRTinf (mean residence time) of Erythropoietin
timeFrame: 1D before dosing, 1h, 2, 4h, 7h, 10h,12h, 14h, 2D 0h, 2D 8h, 3D 0h, 4D 0h, 5D 0h, 6D 0h,
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01501851: Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness
Official title: Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrauterine Growth Restriction
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 265
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiarty care clinic

Brief summary: Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness

Detailed description: The aim of the present study is to assess the value of using ultrasound measurement of placental diameter and thickness as a predictor of low birthweight.

Eligibility criteria: Inclusion Criteria:

1. Singleton viable pregnancy.
2. Gestational age at least 36 complete weeks as calculated by LMP.
3. Non scared uterus.

Exclusion Criteria:

1. Multiple fetal pregnancy.
2. Intrauterine fetal death.
3. Known congenital fetal anomalies.
4. Presence of uterine or adnexal gross pathology.
5. Presence of any medical disorder e.g. Diabetes mellitus \& hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: outpatient clinic at Ain Shams University Maternity Hospital.
Study officials:
References:
Clinical trial NCT01673451: 2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CNS
Keywords: insomnia
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).


Eligibility criteria: Included:

* Healthy males or females, ages 18 to 55 years (Part A) or 65 to 80 years (Part B)
* Who report typical time in bed 7.5 to 9 hours
* Who report typical bedtime 22:00 - 24:00 and typical wake time 06:00 - 08:00
* Who report typical sleep latency of \<= 30 minutes
* All females must be of non-childbearing potential, or subjects who have been sterilized surgically or who are otherwise proven sterile. Females must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) test result at Screening and a negative urine pregnancy test at Baseline.
* Body mass index BMI \> 18 and 32 kg/m2 at Screening

Excluded:

* Performed shift work within 2 weeks prior to Screening
* Had taken a flight across three or more time zones in the 7 days prior to Screening
* Female subjects who are nursing
* With a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profile of E2006
* With a known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
* Hypersensitivity to the study drug or any of the excipients

Primary outcomes:
measure: Incidence of Adverse events (AEs)
timeFrame: 28 days
Secondary outcomes:
measure: Plasma concentrations of E2006
timeFrame: Part A up to 288 hours postdose; Part B: up to 324 hours postdose
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Parexel, California Clinical Trials
state: California
city: Glendale
country: United States
state: California
Study officials:
affiliation: Parexel
name: Dohwa Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01676051: Surgical Prep in Hand Surgery
Official title: Efficacy of Surgical Preparation Solutions in Hand Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Scrubbing
Disinfection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing clean, elective hand surgery without implants

Brief summary: The purposes of this study are to identify the common bacterial flora on the hand and evaluate the efficacy of readily available skin-preparation solutions in the elimination of bacterial pathogens from the surgical site following skin preparation. The null hypothesis is that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in pre-operative skin preparation in clean, elective hand surgery cases.


Eligibility criteria: Inclusion Criteria:

* the following procedures (carpal tunnel release, trigger finger release, cyst excision, 1st dorsal compartment release)

Exclusion Criteria:

* prisoners
* pregnant women

Primary outcomes:
measure: Number of positive cultures
timeFrame: after skin prep solution has dried
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Montefiore Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savage JW, Weatherford BM, Sugrue PA, Nolden MT, Liu JC, Song JK, Haak MH. Efficacy of surgical preparation solutions in lumbar spine surgery. J Bone Joint Surg Am. 2012 Mar 21;94(6):490-4. doi: 10.2106/JBJS.K.00471.
citation: Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
citation: Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
Clinical trial NCT06863051: Effect of Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant
Official title: Clinical and Radiographic Evaluation of Xenograft With Albumin Platelet-Rich Fibrin or Leucocyte- Platelet-Rich Fibrin on Immediate Implant Placement in Mandibular Molar Extraction Sites: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immediate Implant Placement
Keywords: Implant
PRF
Albumin
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to compare between Immediate Implant grafted with xenograft and Alb-PRF gel versus xenograft with L-PRF.

Detailed description: The objective of this study will be to compare between xenograft with Alb-PRF gel and xenograft with L-PRF ( L-PRF Block ) in the aspects of :

* Peri-implant vertical defect depth.
* Crestal bone level.
* Bucco-lingual bone width.
* Keratinized tissue width

Eligibility criteria: 1. Inclusion criteria

   * The presence of non-restorable mandibular molar.
   * Patient 18-45 years old
   * Intact buccal and lingual walls
   * Good oral hygiene.
   * Prescence of sufficient restorative space.
   * Jumping gap more than 2 mm.
2. Exclusion criteria

   * Proximity of anatomical structures
   * Acute localized infection (suppuration at the surgical field)
   * Patients on chemotherapy or radiotherapy.
   * Patients who have systemic disorders (diseases) {diabetes mellitus, autoimmune disease, ...etc},
   * Pregnant patients.
   * Smoking and Alcohols.
   * Presence of periapical pathology affecting the neighboring teeth.

Primary outcomes:
measure: Vertical peri-implant bone level
timeFrame: Immediate Post-Operative and 6 months after surgery
measure: Keratinized tissue Width
timeFrame: Immediate Post-Operative and 6 months after surgery
measure: Crestal bone level
timeFrame: Immediate Post-Operative and 6 months after surgery
Secondary outcomes:
measure: Implant Stability
timeFrame: Immediate Post-Operative and 6 months after surgery
measure: Bucco-lingual bone width
timeFrame: Immediate Post-Operative and 6 months after surgery
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Kafrelsheikh University, Faculty of Dentistry
Study officials:
References: