louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00415727: Prevention Of Morbidity In Sickle Cell Disease Pilot Phase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sickle Cell Anaemia
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure and/or oxygen supplementation.

Detailed description: Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not \>94% after 2 weeks of autoCPAP

Eligibility criteria: Inclusion Criteria:

1. Age \>4 years.
2. Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
3. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.

Primary outcomes:
measure: Change in processing speed index
Secondary outcomes:
measure: Frequency of pain measured via SMS and pain diary
measure: Adverse events e.g. headache, anorexia, weight loss, nausea, vomiting, reduction in steady state red or white cell count
measure: Change in Blood pressure
measure: Number of omissions on Conners Continuous Performance Test
measure: Change in Chervin sleep Questionnaire
measure: Change in Behaviour Rating Inventory of Executive Function (BRIEF)
measure: Change in number of abnormalities (Adams' criteria) on TCD
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Neuroscience Unit, Institute of Child Health
city: London
country: United Kingdom
facility: Kings College hospital
Study officials:
affiliation: Institute Of Child Health and Great Ormond Street Hospital
name: Fenella Kirkham, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021627: Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
Official title: A Multicenter Randomized Controlled Study of Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sinus Bradycardia
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shandong University of Traditional Chinese Medicine
name: The Second People's Hospital of Yuhuan City
First posted: 2021-08-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years old;
2. Symptomatic sinus bradycardia;
3. Not meet the class I indications for pacemaker implantation.

Exclusion Criteria:

1. Structural heart disease, heart surgery history;
2. Drug-induced SB, sinus pause \>2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) \>525 ms;
3. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
4. With Significant congenital heart disease, ejection fraction was \<40% measured by echocardiography;
5. Allergic to contrast media;
6. Contraindication to anticoagulation medications;
7. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Poor general health; 10.Life expectancy less than 6 months.

Primary outcomes:
measure: Symptom score after operation
timeFrame: 48 months
Secondary outcomes:
measure: Quality of life score
timeFrame: 48 months
measure: Psychological quality score
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06296927: Effect of Emotional Freedom Technique on Perceived Pain, Situational Anxiety and Satisfaction Levels During Mammography Screening.
Official title: The Effect of the Emotional Freedom Technique Applied During Mammography Screening on Perceived Pain, Situational Anxiety and Satisfaction Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammography Screening
Pain
Anxiety
Keywords: mammography
pain
Emotional Freedom Technique
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 94
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled two-group study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine the effect of Emotional Freedom Technique on perceived pain level, situational anxietyl and satisfaction level during mammography screening.

Detailed description: The randomized controlled and experimental study will be conducted with 94 women who applied to the Cancer Early Diagnosis, Screening and Education Center for mammography screening. The women in the experimental group (n=47) will be applied the Emotional Freedom Technique before mammography screening and the women in the control group (n=47) will be given routine mammography screening. The Sociodemographic Information Form, Visual Analog, Situational Anxiety Inventory, blood pressure monitor, thermometer and saturation device will be used to collect the data.

Eligibility criteria: Inclusion Criteria:

* Having a first mammography screening
* Knowing how to read and write,
* Having entered menopause (at least 1 year has passed since the last menstruation)

Exclusion Criteria:

* Having any cognitive or hearing problems,
* Having used painkillers before the procedure,
* Having no chronic diseases (cardiovascular, respiratory tract),
* Having a diagnosed mental illness (schizophrenia, bipolar disorder),
* Having epilepsy (as it is a contraindication for EFT applications),

Primary outcomes:
measure: Anxiety
timeFrame: 20 minute
measure: Pain Level
timeFrame: 10 minute
Secondary outcomes:
measure: Satisfaction Level
timeFrame: 10 minutes
measure: Blood Pressure
timeFrame: 5 minutes
measure: Thermometer
timeFrame: 5 minutes
measure: Saturation
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pendik District Health Directorate Maternal Child Health and Family Planning Center
Study officials:
References:
Clinical trial NCT05981027: Static Stretching Exercises and Ultrasound Elastography Evaluation
Official title: Acute Effects of Static Stretching Exercises and the Mulligan Bent Leg Raise Technique on Hamstring Muscle Stiffness: an Ultrasound Elastography Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Muscle
Muscle Stretching Exercise
Elastography
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of thid study was to compare two methods applied to increase the flexibility of the hamstring muscles and objectively evaluate changes in muscle stiffness using the two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young individuals with hamstring shortness were divided into two groups by simple randomization. The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive static stretching exercises to the second group. Hamstring flexibility was evaluated with the sit-and-reach test, and muscle stiffness with the 2D SWE method.


Eligibility criteria: Inclusion Criteria:

* Having a limitation of more than 25° in the active knee extension test
* Only engaged in recreational sports during the study period

Inclusion Criteria:

* Having a history of lower extremity injury within the last two years
* Not volunteering to participate in the study.

Primary outcomes:
measure: Back-saver sit-and-reach test
timeFrame: Up to 2 months
Secondary outcomes:
measure: Two-dimensional Shear Wave Elastography
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Süleyman Demirel Üniversitesi
state: Merkez
Study officials:
References:
Clinical trial NCT05692427: Evaluation of Cryotherapy in Granuloma Pyogenicum
Official title: Evaluation of Cryotherapy in Granuloma Pyogenicum by Means of Cryopen Compared to Surgical Removal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Granuloma, Pyogenic
Cryotherapy Effect
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical excision needs general anesthesia and might have complications due to anesthesia. Cryotherapy can be used in an outpatient setting and doesn't need general anesthesia.

This study will evaluate if cryotherapy works in granuloma pyogenicum with the advancement of no general anesthesia.


Eligibility criteria: Inclusion Criteria:

diagnosis of granuloma pyogenicum

Exclusion Criteria:

no approvement of cryotherapy

Primary outcomes:
measure: Recurrence of Granuloma pyogenicum
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT04357327: Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)
Official title: Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
SARS-CoV 2
Corona Virus Infection
Keywords: SARS-CoV-2
COVID-19
Saliva
nCoV-2019
Coronavirus
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Consecutive recruitment of both patients with COVID-19 like symptoms (i.e., cough, fever, dyspnea) and patients with low risk phenotype
Primary purpose: DIAGNOSTIC

Brief summary: The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program.

The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.

The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.

Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.

The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).


Eligibility criteria: Inclusion Criteria:

People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection

Exclusion Criteria:

none

Primary outcomes:
measure: Sensibility
timeFrame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.
measure: Specificity
timeFrame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: ASST dei Sette Laghi
state: VA
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Lorenzo Azzi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302327: GLP Analogs for Diabetes in Wolfram Syndrome Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus Associated With Genetic Syndrome
Wolfram Syndrome
Keywords: Wolfram syndrome
Diabetes mellitus
Exenatide
GLP-1 analog
beta cell function
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Wolfram syndrome, also referred to as DIDMOAD (diabetes insipidus, diabetes mellitus, optic atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and apoptosis leading to diabetes, neurodegeneration and psychiatric illness. Accumulating evidence indicates that beta-cell failure and neuronal cell dysfunction in Wolfram's syndrome results from a high level of ER stress in affected cells. The current treatment of Wolfram syndrome is insulin, which fails to prevent the progression of beta-cell failure.

Several studies showed that GLP-1 analogs are very effective in protecting beta-cells from ER stress. Herein, the investigators suggest studying the impact of GLP-1 analogs in the treatment of patients with Wolfram syndrome.

The investigators will Study the effects of GLP-1 analog (Exanatide) on beta-cell function and glycemic control of patients with Wolfram syndrome. Evaluation of beta cell function will be done by performing meal test and IVGTT test before starting GLP-1 therapy, and after 3 month of treatment.


Eligibility criteria: Inclusion Criteria:

1. Genetic or definitive clinical diagnosis of Wolfram's syndrome including: diabetes mellitus, optic atrophy and at least one additional neurological dysfunction (diabetes insipidus, sensorineural deafness, neurogenic bladder or other type of autonomic or peripheral neuropathy)
2. Age \>18 years
3. Duration of diabetes of \<10 years.

Exclusion Criteria:

1. pregnant women
2. patients who are unable to give inform consent.

Primary outcomes:
measure: beta cell function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Gil Leibowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danielpur L, Sohn YS, Karmi O, Fogel C, Zinger A, Abu-Libdeh A, Israeli T, Riahi Y, Pappo O, Birk R, Zangen DH, Mittler R, Cabantchik ZI, Cerasi E, Nechushtai R, Leibowitz G. GLP-1-RA Corrects Mitochondrial Labile Iron Accumulation and Improves beta-Cell Function in Type 2 Wolfram Syndrome. J Clin Endocrinol Metab. 2016 Oct;101(10):3592-3599. doi: 10.1210/jc.2016-2240. Epub 2016 Jul 26.
Clinical trial NCT04406727: UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial With UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: HIV-1 Infection
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this phase III study is to evaluate the efficacy between treatments (UB-421 Arm vs. Placebo Arm) by measuring the proportion of subjects with reduction in HIV-1 RNA viral load.


Eligibility criteria: Inclusion Criteria:

1. HIV-1 seropositive
2. Have a history of at least 6 months on antiretroviral treatment
3. Receiving a stable combination antiretroviral therapy (ART) for at least 8 weeks before Screening

Exclusion Criteria:

1. Subjects with HBsAg positive or HCV antibody positive, along with ALT or AST \> 4 x upper limit of normal (ULN)
2. Females who are pregnant
3. Any vaccination within 2 weeks prior to the Screening
4. Any prior exposure to UB-421

Primary outcomes:
measure: Change in HIV-1 RNA viral load between 2 arms
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03365427: Post-operative Rehabilitation of Total Knee Arthroplasty With Applications on Smart Phone
Official title: Effect of Applications on Smart Phone on Post-operative Rehabilitation of Total Knee Arthroplasty: A Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Arthropathy of Knee
Keywords: rehabilitation
application on smart phones
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.

Detailed description: Apart from surgical technique, the outcome of total knee arthroplasty (TKA) also largely depend on adequate rehabilitation and subsequent functional recovery after surgery.Rehabilitation affects or even determines various performance of post-operative knee, including knee range-of-motion (ROM), muscle strength, functional independence, all of which subsequently affect patients' quality of life. Conventional way of rehabilitation is exercise therapy, which rely on guidance of therapists and the self-efficacy of patients.

An application (APP) on smart phone was designed for people received TKA to play the role of guider and help improving patients' self-efficacy. This is a single-centre randomized clinical trial, with an anticipation of 200 patients with knee osteoarthritis enrolled, who will be randomly assigned into experiment group or control group. The patients in the experiment group will be introduced to this APP and requested to use it regularly, while the patients in the control group will receive pure conventional rehabilitation. Primary outcome includes Visual analogue scale (VAS) of pain, knee society score (KSS), ROM, ability of daily living (ADL) before operation and at 2 weeks and 6 weeks after surgery. All potential covariates of those two groups, such as age, sex, and pre-operative kellgren-lawrence scores would be matched by completely randomize.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as knee osteoarthritis with bearing X-ray
* Education level of middle school and above
* Prepared to take single-knee primary TKA

Exclusion Criteria:

* Severe varus/valgus (over 10 degree) of affected knee before surgery
* Stiffness of affected knee before surgery

Primary outcomes:
measure: The change of knee pain
timeFrame: before operation, 2 and 6 weeks after operation
Secondary outcomes:
measure: The change of the range of motion of affected knee
timeFrame: before operation, 2 and 6 weeks after operation
measure: The change of the symptoms of the affected knee
timeFrame: before operation, 2 and 6 weeks after operation
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05263427: Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
Official title: Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstetrical Complications
Monitoring Injury of Scalp of Newborn
Keywords: Fetal Heart Rate
Monitoring
Uterine contraction
Electrocardiogram
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: BioSerenity
name: National Research Agency, France
First posted: 2022-03-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions.

The goal here is to assess the performance of the device in real situation during labour.

This study will be carried out in the maternity labor ward in CHU Lille, France.

The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.

For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman in labor
* Singleton
* Cephalic presentation

Exclusion Criteria:

* Hospitalisation for a medical termination of pregnancy
* Death in utero
* Multiple pregnancy

Primary outcomes:
measure: Fetal heart rate with the TOCONAUTE
timeFrame: 1 year
Secondary outcomes:
measure: Uterine contractions with the TOCONAUTE according to the different phase of labor.
timeFrame: 1 year
measure: Maternal heart rate with the TOCONAUTE
timeFrame: 1 year
measure: Fetal heart rate with the TOCONAUTE according to the different phase of labor.
timeFrame: 1 year
measure: Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)
timeFrame: 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Charles Garabedian, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: