louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01234389: Immediate Detection of Helicobacter Infection With a New Electrochemical System.
Official title: Immediate Detection of Helicobacter Infection With a New Electrochemical System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: H. Pylori Infection
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Helicobacter pylori-infection (H. pylori) affects about fifty percent of the general population and is associated with peptic ulcer disease, non-cardia gastric adenocarcinoma and gastric lymphoma. Currently, diagnostic methods include breath tests, serology, stool antigen tests, histology or the Helicobacter urease test (HUT).

The aim of our study is to access the clinical reliability of a new, electrochemical device for rapid H. pylori detection.

Detailed description: The newly developed electrochemical device for H. pylori detection consists of a working and reference electrode between which a biopsy sample is administered. Afterwards, acquired voltage-values could be analysed for characteristics typical for H. pylori infection (ammonia). According to Sydney classification, biopsies are taken from gastric antrum and corpus for electrochemical H. pylori detection, HUT and immunohistochemistry (IHC). HUT results are evaluated after 24 hours. Furthermore, every patient will receive 13C-urea breath test. IHC is designated as the gold standard of H. pylori diagnosis.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing EGD

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Residing in institutions (e.g. prison)
* PPI intake
* antibiotic use, actual or within the last 4 weeks

Primary outcomes:
measure: Effectiveness of the newly developed device in comparison to IHC, HUT and C13-urea breath test.
timeFrame: Oktober 2009 - February 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg
state: Bayern
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Markus F. Neurath, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg
name: Helmut Neumann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441929: Pregnancy Ultrasound Satisfaction Scoring System
Official title: How Difficult a Fetal Ultrasound Can be: Time for a Dedicated Classification System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Satisfaction in Pregnant Women
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation

Brief summary: Sonographic imaging stands as the mainstay of fetal anatomical investigation and the primary screening tool for structural abnormalities early in pregnancy. This study aimed to evaluate the occurrence and effect of a cluster of maternal features on sonographic image quality and operator satisfaction.

Detailed description: This was a cross-sectional, single-center observational study of ultrasound scans performed on singleton pregnant women who underwent ultrasound imaging at 11-14 weeks and 19-21 weeks gestation. From March 2023 to March 2024, a convenience cohort of pregnant women who presented for prenatal care at the Fetal Medicine and Prenatal Diagnosis Unit of "Di Venere" Hospital in Bari (Apulia, Southern Italy) and the Obstetrics and Gynecology Unit of Vito Fazzi Hospital in Lecce (Apulia, Southern Italy) to receive routine gestational ultrasound was recruited for the present study.

The inclusion criteria were singleton pregnancy and the presence of one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, a previous abdominal surgery, and a limited echo absorption. No exclusion criteria related to women's gestational age or ethnicity were applied.

Eligibility criteria: Inclusion Criteria:

Pregnant women presenting one or more of the risk factors widely described in the literature as limiting features, i.e., excess weight (BMI\>24.9 Kg/m2), retroverted uterus, the presence of myomas, previous abdominal surgery, and limited echo absorption.

Exclusion Criteria:

* No limiting factors described above
* No pregnant women

Primary outcomes:
measure: Operator ultrasound satisfaction
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari Aldo Moro
Study officials:
References:
Clinical trial NCT04992429: Do Prostheses of SphinkeeperTM Migrate After Operation?
Official title: Do Prostheses of SphinkeeperTM Migrate After Operation? - a Prospective Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 32
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: Candidates for sphinkeeper operation due to fecal incontinence will be enrolled in this study.

Brief summary: 32 patients who underwent sphinkeeper operation got enrolled in this study. The primary endoint is to explore the movement of the prostheses examined by manometry and ultrasound. The secondary endpoint is to find out about the functional outcome when migration of prostheses occurs and to examine differences in morphology of the sphincters after operation.

Detailed description: The SphinkeeperTM is a new surgical procedure in order to treat refractory fecal incontinence, which includes up to ten self-expandable prostheses. These get implanted into the intersphincteric space and due to constriction of the anal canal and better contractibility continence should be improved. Because this is a new technique, there is only limited data about its clinical efficacy.

In this study, patients, aged 18-90 years, who met the inclusion criteria and have received a SphinkeeperTM operation, were enrolled. Functional outcomes and quality of life got measured by standard questionnaires before surgery and 1, 2, 3 and 6 months after surgery. Furthermore, in routine check ups patients received endoanal anorectal manometry for pressure measurement and endoanal ultrasound to determine the position of the prostheses.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna
* Ability and willingness to understand and comply with study interventions and restrictions.
* Voluntarily signed informed consent after full explanation of the study to the participant

Exclusion Criteria:

* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives
* Inability to communicate well with the investigator due to language problems or reduced mental development
* Inability or unwillingness to give written informed consent

Primary outcomes:
measure: Migration of prostheses
timeFrame: 6 months
Secondary outcomes:
measure: Influence of migration of the prostheses in functionality
timeFrame: 6 months
measure: Psychological and physical well-being
timeFrame: 6 months
measure: Morphology of the anal sphincter after operation
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Head of Pelvic Floor Surgery
name: Stefan Riss, Prof.MD
role: STUDY_CHAIR
References:
Clinical trial NCT02374229: Ablation of the Pulmonary Artery With High Pulmonary Hypertension During Mitral Valve Surgery
Official title: Surgical Ablation of Ganglion Plexuses of the Pulmonary Artery in Patients With Valvular Heart Disease, Complicated by High Pulmonary Hypertension May Reduce Its Degree.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
pulmonary artery denervation
mitral valve disease
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective randomized study was to evaluate the effectiveness and safety of the original ablation procedures ganglion plexus pulmonary artery with simultaneous correction of valvular heart disease, complicated by high pulmonary hypertension.

Detailed description: Pulmonary hypertension is a serious condition, the severity of which is often underestimated. About 10% of significant mitral heart disease complicated by high pulmonary hypertension (more than 60 mm Hg). Up to 70% of patients retain this level of pulmonary hypertension after successful treatment of heart valve disease.The quality of life of patients with persistent high pulmonary hypertension is significantly lower than in patients with mild to moderate degree. Risks of recurrent tricuspid insufficiency and right ventricular dysfunction is much higher. Despite the use of modern drug therapy of pulmonary hypertension in patients with valvular heart disease satisfactory clinical effect is achieved only in a small number of patients. Our team proposed a new original method of ablation of the pulmonary artery with simultaneous open cardiac surgery correction of mitral heart disease in patients with high baseline pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* Patients with mitral stenosis or insufficiency complicated by high pulmonary hypertension (mean pulmonary artery pressure in invasive monitoring more than 35 mm Hg), which are subject to surgical treatment.

Exclusion Criteria:

* pulmonary stenosis;
* pulmonary embolism in history;
* congenital heart disease.

Primary outcomes:
measure: Death of the patient
timeFrame: 3 weeks
Secondary outcomes:
measure: Mean pulmonary artery pressure in invasive monitoring
timeFrame: 3weeks; 6 and 12 months after the procedure.
measure: Exercise tolerance (the 6 minute walk test (6MWD)
timeFrame: 3weeks; 6 and 12 months after the procedure.
measure: quality of life
timeFrame: 3weeks; 6 and 12 months after the procedure.
measure: adverse events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Aleksandr V Bogachev-Prokophiev, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925129: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
Official title: A Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Lead sponsor: Planned Parenthood of Greater New York
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a double-blinded, randomized, placebo-controlled trial evaluating the use of High-frequency Transcutaneous Electrical Nerve Stimulation (HfTENS) compared to sham TENS for pain control during medication abortion with mifepristone and misoprostol through 70 days' gestation.


Eligibility criteria: Inclusion Criteria:

* Patients seeking medication abortion with a definite, singleton, intrauterine pregnancy (IUP) \< 70 days' gestation on ultrasound
* Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)22 score \> 4
* Age equal to or greater than 18 years
* Provide informed consent to participate
* Willing to adhere to study procedures, including access to a smart phone, ability to receive text messages and answer online surveys on smart phone

Exclusion Criteria:

* Contraindication to medication abortion
* Allergy to mifepristone or misoprostol
* Contraindication or allergy to ibuprofen
* History of cardiac arrhythmia
* Presence of an implantable device with electrical discharge, i.e. cardiac pacemaker
* History of chronic pain disorder
* Any opioid use during previous 30 days
* Current or prior use of TENS
* BMI \> 30

Primary outcomes:
measure: Pain on numeric rating scale
timeFrame: 8 hours following misoprostol
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Planned Parenthood of New York City - Margaret Sanger Center
state: New York
Study officials:
affiliation: Planned Parenthood of Greater New York
name: Ariella Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldman AR, Porsch L, Hintermeister A, Dragoman M. Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):100-107. doi: 10.1097/AOG.0000000000004208.
Clinical trial NCT05018429: Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Official title: Nerve Sparing Versus Non Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bladder Cancer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Shantou Central Hospital
First posted: 2021-08-24
Enrollment: 100
Sex: MALE
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: Enroll patients who received RARC.

Brief summary: To compare the perioperative, functional, and oncologic outcomes between non nerve sparing and nerve sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

Detailed description: This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: non nerve sparing group and nerve sparing group. Patient demographic and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility criteria: Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
4. Patients those who are able to cooperate and complete the follow-up.
5. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.

Primary outcomes:
measure: day-time continence rate
timeFrame: 6 months
measure: night-time continence rate
timeFrame: 6 months
measure: postoperative sexual function
timeFrame: 6 months
Secondary outcomes:
measure: perioperative complication rate
timeFrame: 3 months
measure: operative time
timeFrame: 24 hours
measure: estimated blood loss
timeFrame: 24 hours
measure: overall survival
timeFrame: 1 year
measure: recurrence-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315729: Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
Official title: Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 380
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with adolescent idiopathic scoliosis

Brief summary: The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention.

The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.


Eligibility criteria: Inclusion Criteria:

* Females aged 10-13 years
* Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees)

Exclusion Criteria:

* Patients with scoliosis other than idiopathic
* Trauma
* Inflammatory disease
* Malignancies
* Diabetes
* History of previous spine surgery

Primary outcomes:
measure: Scoliosis Curve Progression
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children'S Hospital of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Evalina L Burger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05716529: Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes
Official title: Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athletes: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
Rehabilitation After ACL Reconstruction
Accelerated Protocol
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of a rehabilitation program after an ACL reconstruction is to regain mobility and muscle function and ultimately to return to sports participation. Purpose of the study: to investigate the effect of the accelerated rehabilitation program on knee pain, and function in patients post ACLR surgery. Fifty adult amateur males athletes who underwent ACLR surgery participated in this study, their age ranged from 18 to 35years.They were randomly assigned into two equal groups. Group (A) received accelerated rehabilitation protocol and group (B) received conventional physical therapy program. Treatment sessions were conducted 5 times per week for 22 weeks for both groups. All patients assessed pre and post treatment for pain intensity using visual analogue scale (VAS), and knee function using knee injury and osteoarthritis outcome score (KOOS), knee effusion, and LSI of Hop test.


Eligibility criteria: Inclusion Criteria:

* Patients were participated in this study if they fulfilled the following criteria:

  * Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps.
  * Have an ACLR with an autolongous hamstring (HT) graft.
  * Age range from 18-40 years old.
  * Football players or who perform physically demanding work.
  * Have no other ligamentous injury.
  * Have nomeniscectomy previous to or simultaneouswith ACLR.
  * Have no cartilage damage.

Exclusion Criteria:

* • Patients younger than 18 or older than 35 years old

  * Have ACLR with any graft other than hamstring (HT) graft
  * Have ACL revision surgery
  * Have other ligamentous injury
  * Have a meniscectomy previous to or simultaneous with ACLR.
  * Had meniscal repair simultaneously with ACLR
  * Have cartilage damage.

Primary outcomes:
measure: visual analogue scale
timeFrame: 22 weeks
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 22 weeks
measure: limb symmetry index of Hop test battery
timeFrame: 22 weeks
measure: knee effusion grading scale
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta university
state: Eldakahlyia
Study officials:
References: