louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04724603: Phage Safety Retrospective Cohort Study
Official title: Phage Safety Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone and Joint Infection
Prosthetic Joint Infection
Keywords: bone and joint infection
phagotherapy
adverse event
Prosthetic Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a bone or joint or implant infection treated by phagotherapy at the CRIOAc Lyon and having had an adverse event

Brief summary: The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.


Eligibility criteria: Inclusion Criteria:

* patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event

Exclusion Criteria:

-

Primary outcomes:
measure: rate of patients having had an adverse event
timeFrame: 1 year
measure: rate of adverse event attributable to the surgery
timeFrame: 1 year
measure: type of adverse event attributable to the surgery
timeFrame: 1 year
measure: rate of adverse event attributable to the antibiotic treatment
timeFrame: 1 year
measure: rate of adverse event attributable to the phagotherapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05937503: Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain
Official title: Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Sensitization
Manual Therapy
Keywords: central sensitization
manual therapy
non-specific low back pain
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled study
Primary purpose: TREATMENT

Brief summary: Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP).

The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.

Detailed description: A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.

Eligibility criteria: Inclusion Criteria:

* non-spesific low back pain patients with pain longer than 12 weeks
* aged between 20-64 years male and female participants

Exclusion Criteria:

* concomitant disease that would interfere with treatment
* pregnancy
* have had any spinal surgery or fracture

Primary outcomes:
measure: Pain intensity
timeFrame: Up to one month
measure: Central Sensitization
timeFrame: Up to one month
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Up to one month
measure: Health Survey
timeFrame: Up to one month
measure: Hospital Anxeity and depresssion
timeFrame: Up to one month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Naime Ulug
state: Select State
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
References:
Clinical trial NCT01249703: The Early Diagnosis and Warning Role of Erectile Dysfunction
Official title: The Early Diagnosis and Warning Role of Erectile Dysfunction:a Multi-institutional Clinical Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Endothelial Dysfunction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2010-11-30
Enrollment: 150000
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: men with erectile dysfunction healthy men general male population

Brief summary: 1. Find the early diagnostic markers of erectile dysfunction;
2. Study the warning role of ED in some diseases.


Eligibility criteria: Inclusion Criteria:

1. Male and at least 18 years of age.
2. Provide signed informed consent.
3. Have a history of erectile dysfunction (ED: defined as a consistent change in the quality of erection that adversely affects the subject's satisfaction with sexual intercourse) .
4. Have a stable monogamous relationship with a female partner. To some subjects with poor sexual experience, re-evaluation would be conducted after a 4-weeks sex education.
5. Make at least four sexual intercourse attempts with the female sexual study partner during the 4-week therapeutic period without medication.
6. Agree not to use any other ED treatment for at least 4 weeks.

Exclusion Criteria:

1. severe diseases (such as congestive heart failure, arrhythmia, significant renal or hepatic dysfunction and anemia);
2. Had clinically noteworthy penile deformities, pelvic surgery or trauma of perineal region;
3. Had received long-term pharmacotherapy (including antioxidant agents, vitamins and traditional Chinese drugs).
4. An addiction problem (with a history of injection or administration of opium, poppy, heroin, hemp, morphine, cocaine, caffeine, ketamine and meperidine etc.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guang Dong
Study officials:
affiliation: Department of Urology
name: Chunhua Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05086003: Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
Official title: Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction Between Matched Sibling Donor-recipient Pairs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Renal Transplantation
Keywords: Renal transplantation
Bone marrow transplantation
Immune tolerance
Immunosuppression
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Combined kidney and bone marrow transplantation
Primary purpose: PREVENTION

Brief summary: Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* Matched siblings
* No contra-indication to thymoglobuline or total lymphoid irradiation

Exclusion Criteria:

* Pregnant women or breast feeding
* Infection with HIV, HBV or HCV
* Previous or presnt malignancy

Primary outcomes:
measure: Proportion of transplanted patients who were able to discontinue immunosuppression 12 months after transplantation.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Institution of Hematology, Rabin Medical Center
name: Moshe Yeshurun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05807503: Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury
Official title: Evaluation of the Effect of Early Administered Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury - PILOT Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TBI (Traumatic Brain Injury)
Keywords: TBI
neuroprotective treatment
Cerebrolysin
neuromonitoring
NIRS
ICP
ONDS
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 56
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: 56 patients in age from 28 to 91 years old, 33% female, 66% male, bleeding during the TBI:

* epidural: 16/56 (27%)
* subdural : 26/56 (45%)
* into deep structures: 14/56 (23%)

Brief summary: Traumatic Brain Injury TBI is one of the most common causes of death and recovery failure worldwide. Each element of treatment, starting from possible surgical treatment, patient monitoring and neuroprotective treatment, can be important in the overall outcome of patients' treatment. More and more elements of treatment are discussed in the literature in the multimodal approach to the patient with a trauma to the central nervous system. Cerebrolysin is a drug with a proven beneficial effect on the prognosis of patients with TBI. In our trial we stated the hypothesis that Cerebrolysin in combination with multimodal monitoring and surgical craniotomy is beneficial for the patients. In retrospective analysis we divided the patients into two groups : with and without cerebrolysin. We also analyzed how cerebrolysin influences the treatment results with the combination with additional neuromonitoring of both invasive intracranial pressure (ICP) measurement and non-invasive saturation in the jugular vein, nirs, ultrasound of the optic nerve diameter. We also analyzed if there is any change in the results of treatment after combining Cerebrolysin with another neuroprotective drug : amantadine. We also analyzed the influence of craniotomy combined with cerebrolysin treatment. In an observational study, we collected information on 56 patients.


Eligibility criteria: Inclusion Criteria:

* TBI diagnosis
* admission to ICU
* age \>18 y

Exclusion Criteria:

* initially lethal injury
* age \<18 y

Primary outcomes:
measure: Glasgow Outcome Scale GOS
timeFrame: 2 months
measure: Length Of Stay LOS
timeFrame: 2 months
measure: Mortality
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Pomeranian Medical University
state: Zachodniopomorskie
Study officials:
affiliation: The Department Of Specialist Nursing, Pomeranian Medical University
name: Konrad Jarosz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02718703: Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Official title: Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.


Eligibility criteria: Summary of Inclusion Criteria:

* Able to voluntarily provide written informed consent to participate in the study.
* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
* User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Primary outcomes:
measure: User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.
timeFrame: Up to 1 hour
measure: System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.
timeFrame: Up to 1 hour
measure: System Use Evaluation - HCP ( HealthCare Professional) questionnaire
timeFrame: Up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: BioKinetic Europe Ltd
state: Antrim
Study officials:
affiliation: LifeScan
name: Lorna Stewart
role: STUDY_DIRECTOR
References:
Clinical trial NCT01113203: Chronic and Acute Effects of Resistance Exercise on Older Subjects' Blood Pressure
Official title: Chronic and Acute Effects of Resistance Exercise on Older Subjects' Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: resistance training
blood pressure
hemodynamics
autonomic
Elderly Subjects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Associacao Fundo de Incentivo a Psicofarmcologia
name: Federal University of São Paulo
name: Delboni Auriemo
First posted: 2010-04-29
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aimed to evaluate the chronic and acute effects of high-intensity resistance training on blood pressure and its hemodynamic and neural determinators in healthy normotensive older subjects.

Detailed description: To investigate the chronic and acute effects of resistance training on blood pressure and its hemodynamic and neural determinators in elderly, 24 healthy normotensive older subjects were randomly divided into 2 groups: trained and control. The trained group was submitted a progressive high-intensity resistance training. Before and after 16 weeks, as well as, before and after the one training session, blood pressure (clinic and ambulatory), cardiac output (CO2 rebreathing), and autonomic modulation (spectral analysis of heart rate and blood pressure variabilities) were measured

Eligibility criteria: Inclusion Criteria:

* Age 60 to 80 years
* Normotensives
* Nonactive

Exclusion Criteria:

* Cardiovascular disease
* Cardiovascular medication
* Orthopedic problems

Primary outcomes:
measure: blood pressure
timeFrame: 16 weeks
Secondary outcomes:
measure: cardiovascular hemodynamics
timeFrame: 16 weeks
measure: cardiovascular autonomic modulation
timeFrame: 16 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Physical Education and Sport, University of São Paulo
state: SP
Study officials:
affiliation: School of Physical Education and Sport, University of São Paulo
name: Claudia LM Forjaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Queiroz AC, Kanegusuku H, Chehuen MR, Costa LA, Wallerstein LF, Dias da Silva VJ, Mello MT, Ugrinowitsch C, Forjaz CL. Cardiac work remains high after strength exercise in elderly. Int J Sports Med. 2013 May;34(5):391-7. doi: 10.1055/s-0032-1323779. Epub 2012 Nov 22.
Clinical trial NCT02120703: Pregabalin Compared to Gabapentin for Pain Control in Lumbar Disc Surgery
Official title: Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intervertebral Disc Prolapse
Keywords: Pregabalin
gabapentin
microdiscectomy
pain
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregabalin is claimed to have superior analgesic effect at lower doses and better pharmacological profile as compared to gabapentin esp. in perioperative pain control after major surgeries like intervertebral disc surgery.

The investigators found that pregabalin is equivalent to gabapentin for relief of post-operative pain at a lower dose in patients undergoing intervertebral disc surgery.


Eligibility criteria: Inclusion Criteria:

* 30-60 years age
* Any gender
* elective micro discectomy for intervertebral disc prolapse

Exclusion Criteria:

1. micro discectomy at two or more vertebral levels,
2. Instrumentation i.e. pedicle screw fixation, hooks etc.,
3. history of steroids or alcohol use,
4. Multiple co-morbids i.e. renal failure, chronic liver disease,
5. use of anticonvulsant drugs,
6. Spinal deformity,
7. Obesity (BMI \>30), 8) inability to understand and respond VAS and

9) patients with known allergy to GABA analogues.

Primary outcomes:
measure: Pain
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
state: Sind
Study officials:
affiliation: The Aga Khan University Hospital, Karachi, Pakistan
name: Mohsin Qadeer, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00480103: Intrauterine Embryo Development With ANECOVA Device
Official title: Multi-Center Evaluation Program NCVD1H Intrauterine Embryo'S Development Assisted by ANECOVA ACVd1 Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Healthy
Keywords: Embryo morphological and chromosomal features
Implantation and pregnancy rate
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
Collaborators: name: Anecova SA
First posted: 2007-05-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: We aim to compare the morphological and chromosomal features of human embryos cultured In Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as well as implantation and pregnancy rate.


Eligibility criteria: Inclusion Criteria:

* Women age below 37
* Hormonal serum levels within normal ranges (FSH, LH, E2, PRL, P4, T4, TSH)
* Negative serologic screening for HIV, Hep B and C
* No uterine or ovarian alterations found by ultrasound
* Normal BMI (19 - 29 kg/m2).

Exclusion Criteria:

* At least 8 stage MII oocytes are not retrieved
* Endometriosis or PCO
* Severe male factor in the partner

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
Study officials:
affiliation: Affiliated
name: Martin Velasco
role: STUDY_DIRECTOR
References:
citation: Blockeel C, Mock P, Verheyen G, Bouche N, Le Goff P, Heyman Y, Wrenzycki C, Hoffmann K, Niemann H, Haentjens P, de Los Santos MJ, Fernandez-Sanchez M, Velasco M, Aebischer P, Devroey P, Simon C. An in vivo culture system for human embryos using an encapsulation technology: a pilot study. Hum Reprod. 2009 Apr;24(4):790-6. doi: 10.1093/humrep/dep005. Epub 2009 Mar 9.
Clinical trial NCT03817203: Effects of Kinesio Taping Application in Women With Overactive Bladder
Official title: Assistant Professor, Physioterapist, PhD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of kinesio tape application on bladder symptoms and quality of life in women with overactive bladder (OAB).


Eligibility criteria: Inclusion Criteria:

* 20 to 65 years of age,
* having overactive bladder
* being volunteer

Exclusion Criteria:

* pregnancy,
* only stress incontinence,
* the presence of a malignant condition with a history of acute infection,
* having a mental problem to prevent co-morbidity, evaluation and cooperative

Primary outcomes:
measure: The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8
timeFrame: Change from baseline bladder symptoms at 6 weeks
Secondary outcomes:
measure: Urgency complaint assessed with the Perception of Intensity of Urgency Scale
timeFrame: Change from baseline urgency complaints at 6 weeks
measure: Daily urinary frequency measured with voiding diary
timeFrame: Change from baseline the average daily urinary frequency at 6 weeks
measure: The number of nocturia measured with voiding diary
timeFrame: Change from baseline the average number of nocturia at 6 weeks
measure: The number of urinary incontinence measured with voiding diary
timeFrame: Change from baseline the average number of urinary incontinence at 6 weeks
measure: pelvic floor muscle strength measured with Modified Oxford Grading scale
timeFrame: Change from baseline pelvic floor muscle strength at 6 weeks
measure: quality of life assessed with King's Health Questionnaire (KHQ)
timeFrame: Change from baseline quality of life at 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Gazi Mustafa Kemal Hospital
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda TOPRAK CELENAY
role: PRINCIPAL_INVESTIGATOR
affiliation: KTO Karatay University
name: Zehra Korkut
role: STUDY_CHAIR
affiliation: Ankara Gazi Mustafa Kemal Hospital
name: Kemal Oskay
role: STUDY_CHAIR
References: