louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05200117: Pregnolia System Intra-observer Variability
Official title: Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix; Pregnancy
Cervical Stiffness
Keywords: Cervical Stiffness
Intra-Observer Variability
Pregnolia System
Cervical Stiffness Index
CSI
Stiffness measurement
Lead sponsor: Pregnolia AG
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at gestational ages between 14+0 and 36+6 weeks.

Brief summary: The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Pregnant woman
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman

Exclusion Criteria:

* Lack of informed consent
* Placenta praevia totalis with haemorrhage (irrespective of severity)
* Severe vaginal bleeding
* Rupture of membranes before 34 weeks (to be excluded with pH test)
* Visible tissue scarring at 12 o'clock position on cervix
* Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
* Cervical dilation ≥ 3 cm
* Cerclage or pessary in place

Primary outcomes:
measure: Cervical Stiffness Index
timeFrame: Measurements between 14+0 and 41+6 weeks gestational weeks
Secondary outcomes:
measure: Cervical Stiffness Index (CSI, in mbar)
timeFrame: Measurements between 14+0 and 41+6 weeks gestational weeks
measure: Elapsed time between
timeFrame: Measurements between 14+0 and 41+6 weeks gestational weeks
measure: Device-related adverse events
timeFrame: Measurements between 14+0 and 41+6 weeks gestational weeks
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Kantonsspital Frauenfeld
Study officials:
References:
Clinical trial NCT01920217: Identification Sepsis Related Single Nucleotide Polymorphism (SNP) by Whole Exome Sequencing
Official title: Identification Sepsis Related SNP by Whole Exome Sequencing: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
SNP
mortality
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: within 24 hours after admited in ICU

Brief summary: Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. Single nucleotide polymorphism (SNP) was promising genetic biomarker for sepsis patients. The present study was designed to screen several SNP by whole exome sequencing which evaluate the sepsis related snp site in order to be a new target for the treatment of sepsis.

Detailed description: The study is a non-intervention, prospective observational study. Purpose of this sudy is to screening several SNPs by whole exome sequencing which can be used as genetic marker for sepsis patients. We will collect whole blood samples from patients with sepsis inRespiratory Intensive Care Unit (RICU), the Emergency Intensive Care Unit (EICU), or the Department of Surgery's ICU 301 Hospital since January 2013, and then whole exome sequencing was used to Screen SNPs which were related to sepsis. Then another 500 sepsis patients and 500 normal controls were used to validated the sequencing results.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sepsis
* Patients who agree with the study

Exclusion Criteria:

* Aged \<18 years;
* Into the group who died within 24 hours;
* Agranulocytosis (\<0.5 × 109 / L);
* Combined HIV infection.

Primary outcomes:
measure: sepsis related SNP site
timeFrame: 28 days after admitted to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Huijuan Wang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02090517: Laser Therapy Versus Electrosurgery For Nasal Telangiectasias
Official title: Evaluation of Laser Therapy Vs Electrosurgery For Nasal Telangiectasias Using A Novel Vascular Imaging Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Telangiectasis
Keywords: Nasal telangiectasis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to compare the efficacy of various treatment options for eliminating nasal telangiectasias. The study will compare the outcome of treating nasal telangiectasias with the following; no treatment (control site), alexandrite laser, pulsed dye laser, combination pulsed dye laser and Nd:YAG 1064nm multiplex laser system and electrosurgery.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Willing to return for follow up visit
* 0.5 - 3 millimeter Vessel size
* 5 Non-contiguous nasal vascular lesions

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Unwilling to return for follow up
* Pregnant Women
* Vessels less than 0.5 millimeter caliber
* Less than 5 non-contiguous vessels

Primary outcomes:
measure: Reduction of Area of Nasal Telangiectasias by Laser Therapy Vs Electrosurgery
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of Cosmetic Improvement
timeFrame: 3 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California-Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140317: 5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial
Official title: 5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Syndrome
Hemodynamic Instability
Keywords: patients included in the directavi trial
TAVR Hemodynamic performances long term follow up
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients included in the DIRECTAVI trial

Brief summary: A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.

Detailed description: All patients (n=236) included in the DIRECTAVI randomized trial conducted between May 2016 to May 2018 will be prospectively assessed for up to 5 years follow-up . The DIRECTAVI prospective, randomized, single-center, open-label trial, demonstrated the non-inferiority of a "direct TAVR" strategy using the third-generation balloon-expandable Edwards SAPIEN 3 device (Edwards Lifesciences, Irvine, CA, USA)

A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.

Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.

Eligibility criteria: Inclusion criteria:

* Older than 18 years old.
* patients included in the DIRECTAVI trial

Exclusion criteria:

- Patients not living in France

Primary outcomes:
measure: the incidence of patients without THV dysfunction
timeFrame: up to 5 years
measure: the incidence of patients without correct hemodynamic performance
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, PU PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06656117: Comparitive Effects of Elliptical Training vs Resistance Training on Cardiopulmonary Parameters in Post CABG Patients
Official title: Comparitive Effects of Elliptical Training vs Resistance Training on Cardiopulmonary Parameters in Post CABG Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Artery Bypass Graft CABG
Keywords: CABG
Elliptical training
Resistance training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this parallel-group randmoized control trial (RCT),post Cabag patients will br assigned to either elliptical training group or to resistance training group .This study aims to evualate the comparative effects of eliptical training vs resistance training on cardiopulmonary parameters
Primary purpose: TREATMENT

Brief summary: COMPARATIVE EFFECTS OF ELLIPTICAL TRAINING VS RESISTANCE TRAINING ON CARDIOPULMONARY PARAMETERS IN POST CABG PATIENTS

Detailed description: Coronary artery bypass grafting (CABG) has been widely and increasingly used since the 1960s as a common surgical procedure to restore blood flow into the stenotic coronary arteries

. It is one of the effective ways to treat coronary artery disease, which can significantly relieve patients' myocardial ischemia and hypoxia symptoms and improve their quality of life.

Data were collected from Itefaq hospital, sehat medical complex Lahore. Borg dyspnea and quality of life (SF12) questioner were used before and after the intervention.

Assessment was done through the tool before and after the treatment.

Eligibility criteria: Inclusion Criteria:

* Both male and female age 45-55 years.
* Post Coronary Artery Bypass Grafting (CABG) patients at phase III cardiac rehabilitation were included .
* Patients who had physically active lower limbs were included .

Exclusion Criteria:

* Participants who had psychological conditions that may influence understanding or answering of questionnaire.
* Patients with other cardiac lesions combined with simultaneous surgical management, such as valvular lesions, macro vascular lesions, and ventricular wall tumors.
* Patients diagnosed with emergency CABG, minimally invasive CABG, or recurrent cardiac surgery.
* Patients with severe dysfunction of important organs such as the lung, liver, and kidney.
* Patients with recent major surgery or trauma of other parts of body.
* Pregnant or lactating women.

Primary outcomes:
measure: modified borg dyspnea scale
timeFrame: 4 weeks
measure: Health related quality of life(SF12)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sialkot
country: Pakistan
facility: Sehat medical complex
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumera Hameed, M.PHIL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03705117: Open-label V565 Target Engagement Study
Official title: An Open-label Exploratory Study in Patient Volunteers With Ulcerative Colitis (UC), to Investigate Lamina Propria Presence and Evidence of Biological Effect of the Oral Domain Antibody V565
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: VHsquared Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 5
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: BASIC_SCIENCE

Brief summary: The purpose of the study is to confirm that V565 enters inflamed tissue, binds to TNF and reduces inflammation after oral dosing to patients with IBD.

Detailed description: Single-site, open-label study in up to 6 patients treated for up to 7 days with sigmoidoscopy and biopsies before and after treatment period to determine biological activity.

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of UC for 12 months or more
* Distal disease, accessible by flexible sigmoidoscopy
* Mild to moderate UC as defined as Mayo score between 3 - 10 with Mayo endoscopic sub score ≥1

Exclusion Criteria:

* A known hypersensitivity to any of the inactive ingredients of the study treatment
* A diagnosis of any IBD except UC
* Isolated proctitis
* Stool culture positive for C. difficile or other enteric infection
* Untreated tuberculosis (TB); positive QuantiFERON-TB Gold Test result (performed by Central Laboratory)
* Evidence of previous or present hepatitis B or C infection
* Known severe viral infection within six weeks prior to Visit 1
* Current use of topical mesalazine or anti-infectives for serious infection (or within 1 week)
* Anti-TNFα therapy other than the study drug
* Parenteral or enteral nutrition therapy
* Current use of any biologic agent
* Primary failure or secondary loss of response (LOR) to use of a TNFα inhibitor
* Contraindication to TNFα inhibitor
* Clinically significant abnormal laboratory test result at screening
* Taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.

Primary outcomes:
measure: Reduction of phosphorylation in mucosal biopsies
timeFrame: After 7 days oral treatment
measure: Presence of drug in mucosal biopsies
timeFrame: After 7 days oral treatment
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal London Hospital
Study officials:
affiliation: VHsquared Ltd.
name: Suhail Nurbhai, MBChB
role: STUDY_DIRECTOR
References:
Clinical trial NCT04213417: Effectiveness of Matrix Rhythm Therapy on Increased Muscle Tone, Balance and Gait Parameters in Stroke Survivors
Official title: Effectiveness of Combining Matrix Rhythm Therapy and Bobath Toncept on Increased Muscle Tone, Balance and Gait Parameters in Stroke Individuals With Spastic Hemiparesis: A Single-Blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke survivor
spasticity
Matrix Rhythm Therapy
balance
gait
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Matrix-Rhythm-Therapy(MRT) has been included in neuro-rehabilitation program for stroke patients to regulate increased muscle tone.

There are no controlled studies with large sample size on the efficacy of MRT on spasticity. In this context,to the best of our knowledge, our study is the first study on this subject. The results of the study will develop a new perspective for management of spasticity and will ensure more common use of MRT.Further studies are needed on superiority of MRI over other treatment methods used in gait and balance rehabilitation of hemiparetic individuals. The aim of this study was to investigate the effectiveness of combining Bobath therapy (BT) and MRT on muscle tone,balance and gait parameters in stroke individuals with spastic hemiparesis.


Eligibility criteria: Inclusion Criteria:

* aged between
* to discharge from the hospital,
* to have single-sided hemiparesis for the first time,
* to have hemiparesis at least four weeks earlier.
* to have Modified Rankin Score of ≤3, Modified Ashworth Scale score between 1-5 for the lower extremity.

Exclusion Criteria:

* to use a cardiac pacemaker,
* to have aphasia, open wound in the area to be treated,
* to have circulatory problem, skin lesions, other neurological, psychiatric and/or orthopedic problems other than hemiparesis affecting gait.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: 1 year
measure: The Single Leg Stance Test
timeFrame: 1 year
measure: Timed "Get Up & Go" Test
timeFrame: 1 year
measure: Evaluation of Spatio-Temporal Parameters of Gait
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of Joint Range of Motion
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: FİLİZ ALTUG, Prof.
role: STUDY_CHAIR
affiliation: Pamukkale University
name: GÜLSÜM TIKAÇ, PT, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Avrasya University
name: UĞUR CAVLAK, Prof.
role: STUDY_DIRECTOR
References:
citation: Unal A, Altug F, Tikac G, Cavlak U. Effectiveness of matrix-rhythm therapy on increased muscle tone, balance and gait parameters in stroke survivors: a single-blinded, randomized, controlled clinical trial. Acta Neurol Belg. 2021 Jun;121(3):689-699. doi: 10.1007/s13760-020-01391-6. Epub 2020 Jun 14.
Clinical trial NCT02077517: Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
Official title: Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Morbid Obesity
Keywords: Roux en Y Gastric Bypass
Postoperative complications
Hand sewn anastomosis
Stapled anastomosis
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 400
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: The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years
* absence of previous bariatric surgery

Exclusion Criteria:

* less than 18 years old
* coagulation disorders or liver cirrhosis

Primary outcomes:
measure: postoperative complications
timeFrame: within the first month after surgery
Secondary outcomes:
measure: hospital stay
timeFrame: within the first month after surgery
measure: % of excess weight lost
timeFrame: five years after surgery
Other outcomes:
measure: operative time
timeFrame: during surgical procedure
Locations:
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
state: Murcia
Study officials:
References:
Clinical trial NCT06821217: The Effect of an App-based Intervention on Quality of Life in Patients With Endometriosis.
Official title: A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Pain
Quality of Life
Life Style
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 308
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:

* Does the App-based intervention improve the quality of life?
* Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.

Participants will:

* Use an App-based intervention or be in the control group (no App-use) for 6 months
* Visit or have a telephone consultation after 3 and 6 months
* Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months


Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 or older
* Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
* Endometriosis, confirmed by surgery or clinically suspected
* Possession of a smartphone

Exclusion Criteria:

* Planned endometriosis surgery or planned hormonal therapy in the study period
* Surgery and/or new hormonal therapy in the last three months
* Malignant diseases
* Pregnancy
* Breastfeeding
* Active desire for pregnancy in the study period
* Fertility treatment
* Simultaneous participation in other intervention studies

Primary outcomes:
measure: Life quality
timeFrame: 6 months
Secondary outcomes:
measure: Pain relief
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Gynecology and Obstetrics, Women's University Hospital, Inselspital Bern, University of Bern
Study officials:
affiliation: University Hospital Bern, Insel Gruppe AG
name: Marietta Gulz, MD
role: PRINCIPAL_INVESTIGATOR
References: