louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01189357: Revision Meniscal Transplants; Lateral and Medial
Official title: Revision Meniscal Transplants; Lateral and Medial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Revision of Meniscal Transplant
Keywords: meniscal transplant
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: failed meniscal transplantation

Brief summary: During the period 1989-1999, a number of patients underwent a meniscal transplantation. A few transplants were not successful. These patients form the population of this study. They all underwent a Total Knee Prosthesis (TKP) or unicompartmental knee prosthesis (UKP) after the failure of the transplants The goal of this study is to evaluate their current medical condition, to perform a survival analysis, and to determine the clinical outcome.

The clinical result will be stipulated by means of standardized questionnaires (KOOS, HSS and SF-36)and clinical examination.


Eligibility criteria: Inclusion Criteria:

* failed Meniscal transplantation between 1989 and 1999

Primary outcomes:
measure: Perform a survival analysis of meniscal transplants. Failure of transplant was defined as replacement of the allograft by a knee prothesis.
timeFrame: 20 years after surgery
Secondary outcomes:
measure: Clinical evaluation of the knee after TKP/UKP following a failed meniscal transplant.
timeFrame: 20 years after surgery
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: René Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891657: Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy
Official title: A Randomised, Prospective, Multi-Centre Clinical Study of SprayShield™ Adhesion Barrier System as a Barrier for the Prevention of Adhesion Formation After Laparoscopic Myomectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibroid
Myoma
Leiomyoma
Keywords: Adhesion
Fibroid
Myoma
Leiomyoma
Myomectomy
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is planned as a prospective, randomised, parallel, controlled, multi-centre, open label, comparative evaluation of SprayShield™ Adhesion Barrier plus good surgical technique, versus good surgical technique alone, with a blinded, third party video evaluation of adhesion formation at second look laparoscopy (SLL) following laparoscopic myomectomy.


Eligibility criteria: Inclusion Criteria:

* Females, 18 years of age or older, of child-bearing potential.
* Subject has at least one myoma \>= 3 cm.

Exclusion Criteria:

* Pregnant or lactating females.
* Females undergoing prior open or closed myomectomy for treatment of myomas.
* Evidence of current active endometriosis or infection
* History of or active inflammatory bowel disease or pelvic inflammatory disease.
* Presence of a frozen pelvis, or hydrosalpinges.

Primary outcomes:
measure: Number of Sites Adherent to the Uterus
timeFrame: 8-12 weeks post myomectomy
measure: Mean Severity Score of Sites Adherent to the Uterus
timeFrame: 8-12 weeks post myomectomy
measure: Mean Extent Score of Sites Adherent to the Uterus
timeFrame: 8-12 weeks post myomectomy
measure: Area of Sites Adherent to the Uterus (cm^2)
timeFrame: 8-12 weeks post myomectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Pius Clinic
Study officials:
affiliation: Pius Clinic
name: Rudy Leon De Wilde, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05435157: Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.
Official title: Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Gastric ultrasound
Full stomach
Surgery
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fasted diabetic and non-diabetic patients scheduled for surgery.

Brief summary: Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

Detailed description: The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Eligibility criteria: Inclusion Criteria:

* BMI\<40 kg.m-2;
* Age over 18 years;
* American Society of Anesthesiologists' physical status status I-III
* who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent

Exclusion Criteria:

* Pregnancy
* Recent upper gastrointestinal bleed (\< 1 month)
* Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)
* Previous surgical procedures on the esophagus, stomach, or upper abdomen
* Gastroesophageal reflux disease
* Previous use of prokinetics or high doses of opiates.

Primary outcomes:
measure: Residual gastric volume
timeFrame: Preoperative
Secondary outcomes:
measure: Antral cross-sectional area
timeFrame: Preoperative
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: IBSAL
Study officials:
affiliation: Anesthesiology Service. Salamanca University Hospital
name: José A. Sastre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8.
Clinical trial NCT02813057: Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions
Official title: Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.

Detailed description: The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.

Eligibility criteria: Inclusion Criteria:

* Unilateral inguinal hernia

Exclusion Criteria:

* Contralateral hernia repair history
* Recurrent inguinal hernia
* Incarceration or strangulation
* Bilateral inguinal hernia
* Severe congestive heart failure
* Severe hypertension
* Rheumatoid arthritis
* Systemic or neurologic diseases altering lower extremity functions

Primary outcomes:
measure: Functional loss in lower extremity muscles
timeFrame: postoperative day 3
Secondary outcomes:
measure: Duration of hospital stay
timeFrame: From time of admission to time of discharge an approximate length of three days
measure: Postoperative pain score
timeFrame: Postoperative 12 hour
measure: Recurrence rate
timeFrame: Postoperative 4 months
measure: Complications
timeFrame: Postoperative 1 month
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Ayhan Mesci, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: Akgul N, Yaprak M, Dogru V, Balci N, Arici C, Mesci A. Quantitative assessment of the impacts of stoppa repair and total extraperitoneal repair on the lower extremity muscular functions in cases of unilateral inguinal hernia: a randomized controlled study. Hernia. 2017 Jun;21(3):377-382. doi: 10.1007/s10029-016-1559-6. Epub 2016 Dec 10.
Clinical trial NCT02004457: Engaging HIV Patients in Primary Care by Promoting Acceptance
Official title: Engaging HIV Patients in Primary Care by Promoting Acceptance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Primary care
Engagement
Acceptance
Disclosure
Stigma
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2013-12-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Engagement in primary care for People Living with HIV/AIDS (PLWHA) is a significant public health concern because reduced commitment to care puts PLWHA at risk for illness progression, death, and transmission of HIV to others. This project will develop a novel treatment, brief acceptance-based behavior therapy (ABBT), to promote self-acceptance of HIV status as a pathway to reducing engagement barriers. The clinical and public health impact of this project will be the development of a simple, low-cost, disseminable intervention that enhances longitudinal commitment to care so PLWHA can obtain effective medical treatments that will prolong survival and improve quality of life. We hypothesize that individuals randomized to brief ABBT will showed increased longitudinal attendance of primary care appointments.


Eligibility criteria: Inclusion Criteria:

* new to the primary care clinic
* HIV+
* between 18 and 60 years old
* entering HIV care for the first time
* able to speak and read English sufficiently to be able to complete the study procedures
* have access to a telephone

Exclusion Criteria:

* psychiatrically or cognitively impaired

Primary outcomes:
measure: Frequency of attended primary care medical appointments
timeFrame: 9 months
measure: Acceptance and Action Questionnaire-2
timeFrame: 9 months
measure: HIV Disclosure Scale
timeFrame: 9 months
Secondary outcomes:
measure: Berger HIV Stigma Scale
timeFrame: 9 months
measure: Disclosure to others
timeFrame: 9 months
measure: Social Support Questionnaire
timeFrame: 9 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
citation: Moitra E, LaPlante A, Armstrong ML, Chan PA, Stein MD. Pilot Randomized Controlled Trial of Acceptance-Based Behavior Therapy to Promote HIV Acceptance, HIV Disclosure, and Retention in Medical Care. AIDS Behav. 2017 Sep;21(9):2641-2649. doi: 10.1007/s10461-017-1780-z.
Clinical trial NCT04909957: Prediction of Lymph Node Invasion for Prostate Adenocarcinoma
Official title: Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma of the Prostate
Keywords: MRI
Lymph node
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population consists of patients operated on for an adenocarcinoma of the prostate by radical prostatectomy with extensive lymph node dissection and for whom pre-operative MRI is available and analyzable.

Brief summary: Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.


Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate treated by prostatectomy with extensive lymph node dissection
* Available pre-operative +/- PET choline

Exclusion Criteria:

* Unanalyzable pre-operative MRI

Primary outcomes:
measure: Predicted risk of lymph-node involvement vs Briganti 2017
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Predicted risk of lymph-node involvement vs Briganti 2012, Briganti 2018, Briganti 2019 and MSKCC
timeFrame: immediately after the intervention/procedure/surgery
measure: Biochemical recurrence free survival
timeFrame: immediately after the intervention/procedure/surgery
measure: Extra-prostatic disease
timeFrame: immediately after the intervention/procedure/surgery
measure: Seminal vesicle invasion
timeFrame: immediately after the intervention/procedure/surgery
measure: Automatic segmentation of the index lesion
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
Clinical trial NCT01739257: Use of Theater to Invoke Empathy and Reduce Bias in Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Student Bias
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: The Arnold P. Gold Foundation
First posted: 2012-12-03
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The effect of medical humanities on medical student bias and clinical management is unclear. This study characterized medical student attitudes toward obese individuals and whether reading a play employing empathic characters can modulate negative reactions.


Eligibility criteria: Inclusion Criteria:

* medical student at UC Davis, UC Irvine, or Mayo Medical School

Exclusion Criteria:

* none

Primary outcomes:
measure: Explicit fat bias
timeFrame: four months
measure: implicit fat bias
timeFrame: four months
measure: empathy scale
timeFrame: four months
Secondary outcomes:
measure: Patient-Centered Care
timeFrame: four months
measure: Appraisal of obesity
timeFrame: four months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis School of Medicine
state: California
Study officials:
affiliation: UC Davis School of Medicine
name: Richard L Kravitz, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Medical School
name: Rachel Hammer, BA
role: STUDY_DIRECTOR
affiliation: UC Irvine School of Medicine
name: Johanna Shapiro, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06905457: Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among HS
Official title: Comparative Effect of Vojta Therapy and Bobath Therapy on Lower Limb Spasticity and Motorcity Among Hemiparetic Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Stroke is clinical defined as a neurological syndrome characterized by acute disruption of blood flow to an area of brain and corresponding onset of neurological defects related to the concerned area of brain. Hemiplegic patient primarily affects the upper limb and lower limb of one side and typically results in flaccidity and difficulties with motor control and function.

Detailed description: The aim of this study will compare the Effect of Vojta therapy and Bobath therapy on lower limb spasticity and motorcity among hemiparetic stroke patients. Methodology: Randomize clinical trials will be carried out on lower limb spasticity and motorcity among hemiparetic stroke patients. This study will include adult's stroke (1-4 months post- onset). Inclusion criteria in which diagnosed with hemiplegic patients, aged 25-75 years and willingness to participants.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hemiparetic stroke.
* adult's stroke (1-4 months post- onset)
* Ability to follow instructions and participate in testing
* Aged 25-75 years.

Exclusion Criteria:

* Previous history of brain surgery.
* Pregnant women.
* Limitation in cognitive skills like Aphasia, deteriorated consciousness or dementia.
* Severe cardiovascular disease (unstable hypertension)"

Primary outcomes:
measure: Fugl-Meyer Assessment scale(FMA)
timeFrame: 12 Months
measure: Modified ashworth scale( MAS)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Aqsa physiotherapy clinic, Main Sheikhupura road near Sitara Velly
state: Punjab
Study officials:
References:
Clinical trial NCT02764957: Green Coffee Extract and Metabolic Syndrome
Official title: Effects of Green Coffee Extract Supplementation on Anthropometric Measurements, Glycemic Control, Blood Pressure, Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metabolic syndrome (Mets) is an assemblage of risk factors which can increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Green coffee extract (GCE) is derived from unroasted coffee beans and has substantial amounts of polyphenols primarily chlorogenic acids (CGA). It has been shown that GCE and CGA can exert a positive influence over Mets components including blood pressure, blood glucose, inflammation, oxidative stress, insulin resistance and blood lipids. Up to our knowledge no study has been conducted on humans in the field of GCA influences on Mets patients. Therefore, this study is planned to evaluate GCA supplementation effects on anthropometric measurements, glycemic control, blood pressure, lipid profile in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Waist circumference\>102 cm in men and \>88 cm in women
* Fasting blood glucose\>100 mg/dL (5.6 mmol /L)
* Systolic blood pressure\>130 mmHg or diastolic blood pressure\>85mmHg
* Triglycerides\> 150 mg/dL (1.7 mmol/L)

Exclusion Criteria:

* Insulin administration
* Pregnancy and breastfeeding
* regular consumption of coffee and green tea

Primary outcomes:
measure: fasting blood glucose
timeFrame: 8 weeks
Secondary outcomes:
measure: HOMA-IR
timeFrame: 8 weeks
measure: blood pressure
timeFrame: 8 weeks
measure: insulin
timeFrame: 8 weeks
measure: hemoglubin A1c
timeFrame: 8 weeks
measure: triglyceride
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT04835857: Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Official title: Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Healthy
Keywords: Blood Pressure, Cuff less, Wearable, BP
Lead sponsor: Dynocardia, Inc
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults

Brief summary: (1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.

Detailed description: (1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.

Eligibility criteria: Inclusion Criteria:

* Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
* Agree to commit to participate in the current protocol.
* Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
* A difference of \>10 mm Hg in left versus right arm oscillometric systolic BP.
* Upper extremity arteriovenous hemodialysis shunt.
* Wrist distortion or pain from arthritis.
* Prior trauma or surgery at the radial artery monitoring site.

Primary outcomes:
measure: Comparison of Diastolic Blood Pressure
timeFrame: up to 30 minutes
measure: Comparison of Systolic Blood Pressure
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Skin Irritation
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Newton
country: United States
facility: Dynocardia Inc
state: Massachusetts
Study officials:
affiliation: Dynocardia, Inc
name: Mohan Thanikachalam, MD
role: PRINCIPAL_INVESTIGATOR
References: