louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05795543: Subtalar Arthrodesis by Single Versus Double Screws
Official title: Single Versus Double Screws Fixation of Subtalar Arthrodesis : A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subtalar Osteoarthritis Secondary to Inflammatory Arthritis
Keywords: subtalar arthrodesis
screws
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participant divide to 2 groups first group subtalar arthrodesis by single screw second group subtalar arthrodesis by double screws
Primary purpose: TREATMENT

Brief summary: Compare clinical and radiological outcome of use of single screw versus double screws fixation for subtalar arthrodesis

Detailed description: The subtalar joint consists of an anterior, posterior and medial joint facet, which allows for inversion - and eversion of the foot. Several pathologies may lead to pain originating from the subtalar joint, including primary arthritis, posttraumatic arthritis, congenital or acquired deformities, instability, tarsal coalition or inflammatory diseases Management of these pathologies variable including conservative and operative treatment once conservative treatment has failed subtalar fusion is a common surgical procedure which is a well-established and widely accepted There are many surgical techniques described for fusion , one of these techniques is fixation with screws The rate of non-union varies among authors between 0-46%, that's may due to lack of standardization of techniques should be used

Eligibility criteria: Inclusion Criteria:

* All patients who will be operated by subtalar fusion for any indication Age range 18 - 65

Exclusion Criteria:

* Age \< 18 years , \> 65 Acute calceneal fracture Infection Non union Bone defect that need bone graft Refusing to participate in the study

Primary outcomes:
measure: Fusion rate
timeFrame: 3 month
Secondary outcomes:
measure: Functional assessment -rate of complications(e.g. non-union, post-operative infections, Instability) -secondary surgery procedures
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
citation: Wirth SH, Viehofer A, Fritz Y, Zimmermann SM, Rigling D, Urbanschitz L. How many screws are necessary for subtalar fusion? A retrospective study. Foot Ankle Surg. 2020 Aug;26(6):699-702. doi: 10.1016/j.fas.2019.08.017. Epub 2019 Sep 6.
citation: Buch BD, Myerson MS, Miller SD. Primary subtaler arthrodesis for the treatment of comminuted calcaneal fractures. Foot Ankle Int. 1996 Feb;17(2):61-70. doi: 10.1177/107110079601700202.
Clinical trial NCT06167343: Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction
Official title: Examining Anterior Cruciate Ligament Reconstruction With Quadriceps- vs. Semitendinosus Tendon Graft for Young Federated Male Football Players.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL
ACL Injury
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Hospital Vithas
First posted: 2023-12-12
Enrollment: 54
Sex: MALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.

Detailed description: The anterior cruciate ligament is one of the most common traumatic injuries in football, and surgery is proposed to restore knee stability. However, following surgery, few studies have focused on functional recovery of the knee with a wide arsenal of physical tests. Therefore, this study aims to study the efficacy for young football players of two types of grafts based on the most common tendons, the quadricipital and the semitendinosus (without the semimembranosus). Follow-ups will be performed at three months, six months, one year and two years after reconstruction. The variables measured will be isokinetic strength of flexors and extensors, unipodal jump test, self-perceived function, pain and tendon architecture with ultrasound.

Eligibility criteria: Inclusion Criteria:

* Confirmed anterior cruciate ligament rupture by MRI.
* Prognosis of anterior cruciate ligament reconstruction surgery.
* Be a registered or recreational football player.

Exclusion Criteria:

* Previous knee surgery.
* Having articular cartilage lesions of Outerbridge grade greater than III-IV.

Primary outcomes:
measure: Lower limb strength
timeFrame: Participants will be followed over 24 months
measure: Horizontal hop test
timeFrame: Participants will be followed over 24 months
Secondary outcomes:
measure: Self-reported functionality
timeFrame: Participants will be followed over 24 months
measure: Knee pain
timeFrame: Participants will be followed over 24 months
measure: Pressure pain threshold
timeFrame: Participants will be followed over 24 months
measure: Tendon ultrasound
timeFrame: Participants will be followed over 24 months
measure: Perimeters
timeFrame: Participants will be followed over 24 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT02973243: The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
Official title: The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Renal Failure
Respiration Failure
Myocardial Infarction
Severe Sepsis
Keywords: early warning scoring
respiration rate
acute care teams
NEWS
CREWS
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 446
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: The investigators plan to observe a non-probability, convenience sample of patients which will consist primarily of acutely ill hospitalized adult patients (at least 18 years of age). Study participants will be recruited from all eligible patients during the enrollment period who are having vital signs monitoring performed as Standard of Care.

Brief summary: To evaluate the effect of automated recording on frequency of recorded scores, number of automated notifications and serious events.

Detailed description: The frequency of EWS scores, number of automated notifications and serious events performed on a general ward is contingent on the quality and frequency of vital signs measurement like respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and more frequent scoring.

We examine the influence of different respiration rate sensor concepts and measurements on scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the study units during the period of data collection

Exclusion Criteria:

* palliative patients

Primary outcomes:
measure: Number of NEWS Scores
timeFrame: 8-12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Ysbyty Gwynedd Hospital
Study officials:
affiliation: Ysbyty Gwynedd Hospital
name: Christian P Subbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00738543: Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
Official title: Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Antiseptics
Administration, cutaneous
Iodophors
Chlorine compounds
Anti-infecting agents, local
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: Concejo de Ciencia y Tecnología del Estado de Guanajuato
name: Pisa SA de CV
First posted: 2008-08-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.

Detailed description: Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit site of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers.

Exclusion Criteria:

* History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex

Primary outcomes:
measure: Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
timeFrame: 24 hours
measure: Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
timeFrame: 24 hours
measure: Bacterial Colony Forming Units for the Control Period
timeFrame: 24 hours
Secondary outcomes:
measure: Presence of Skin Reactions for the 10% Povidone-iodine Period
timeFrame: 24 hours
measure: Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: University of Guanajuato School of Medicine
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Alejandro E Macias, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01681043: Sleep Investigation in Respirator Treated ICU Patients: the Importance of Intensive Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Sleep
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Sleep investigation in respirator treated ICU patients: the importance of intensive environment.

Sleep disturbances in the ICU seem to lead to development of delirium, prolonged ICU stay and increased mortality.

The hypothesis of this study is: minimizing of disturbing factors in the ICU, such as noise, light, therapeutic and diagnostic procedures between 10 p.m. and 6 a.m. will improve sleep quality in respirator treated ICU patients.

Methods: randomized interventional study. 48-hour polysomnographic sleep measurement acc. AASM's standard in 46 awake respirator treated patients: 24 hours under ordinary circumstances and 24 hours under the protocol 'Quiet in the room' between 10 p.m. and 6 a.m. after randomization.


Eligibility criteria: Inclusion Criteria:

* awake and relevant respirator treated patients with expected 2 or more respirator dags

Exclusion Criteria:

* GCS \< 11
* cerebral hemorrhage or infarction during the current hospitalization
* delirium
* inotropes and/or vasopressors

Primary outcomes:
measure: the number of arousals
timeFrame: per hour of sleep
Secondary outcomes:
measure: total sleep time
timeFrame: 24 hours
measure: N1 sleep
timeFrame: 24 hours
measure: N2 sleep
timeFrame: 24 hours
measure: N3 sleep
timeFrame: 24 hours
measure: REM sleep
timeFrame: 24 hours
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Department of Anaesthesia and Intensive Care, Vejle Hospital
Study officials:
References:
Clinical trial NCT04213443: Fetal Growth Pattern in Short Stature Women
Official title: Fetal Growth Pattern in Short Stature Women as a Model for True Intrauterine Growth Restriction Prediction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Growth Restriction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of short stature under 1.6 meters.

Brief summary: Women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.

Detailed description: Based on a patient registry, women of short stature tend to be classified regarding fetal growth by the same criteria as women of normal and tall stature. The objective of the following study is to evaluate fetal growth patterns parallel to women's height and try to make conclusions regarding possible definitions of subjective Intra-uterine growth restriction.

Informed consent is not required due to the retrospective nature of the study. Patient information including medical, obstetric and general background will be collected.

Eligibility criteria: Inclusion Criteria:

* Women under 1.6 meters of height.
* Singleton pregnancy.
* Low risk pregnancy.
* Accurate dating.

Exclusion Criteria:

* Women over 1.6 meters of height.
* Multiple pregnancy.
* High risk pregnancy.

Primary outcomes:
measure: Estimated fetal weight changes.
timeFrame: Up to 1 year from admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01021943: Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
Official title: The Role of Spironolactone in Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Kidney Transplant
Keywords: calcineurin inhibitors
fibrosis
spironolactone
Focus of the study is to assess if aldosterone blockade has an effect on interstitial fibrosis amongst kidney transplant recipients
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the effect of spironolactone on interstitial fibrosis in kidney transplant recipients receiving calcineurin inhibitors


Eligibility criteria: Inclusion Criteria:

* Kidney Failure
* Age \> 18
* Kidney transplant recipients

Exclusion Criteria:

* Patients taking angiotensin receptor blockers or inhibitors of the angiotensin reconverting enzyme
* Kidney transplant performed more than one month from enrollment in the study
* Hyperkalemia (K\> 5.5 meqL)

Primary outcomes:
measure: Interstitial fibrosis in kidney transplant biopsies (time zero biopsy and at 6 months post intervention)
timeFrame: 2 years
Secondary outcomes:
measure: allograft function and proteinuria
timeFrame: 2 years
measure: Fibrosis markers in kidney biopsies such as TGF-B
timeFrame: 2 years
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional Nutricion Salvador Zubiran
Study officials:
References:
Clinical trial NCT01244243: Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Official title: Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: stroke
rehabilitation
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 41
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: The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old
2. Had stroke between 11-26 weeks ago
3. Have some weakness in one of your wrists or hands due to stroke
4. Did not have too much disability prior to stroke
5. Do not have major depression

Exclusion Criteria:

1. Non-English speaking
2. If you have trouble keeping good attention
3. Pregnant, advanced liver, kidney, heart, or lung disease
4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
5. Cannot undergo MRI scanning
6. Have history of brain surgery or seizures

Primary outcomes:
measure: Action Research Arm Test
timeFrame: change from baseline to 1 month post-end treatment, Intention To Treat
measure: Arm Motor Fugl-Meyer Test
timeFrame: change from baseline to 1 month post-end treatment, Intention To Treat
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of Californai Irvine
name: Steven C Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKenzie A, Dodakian L, See J, Le V, Quinlan EB, Bridgford C, Head D, Han VL, Cramer SC. Validity of Robot-Based Assessments of Upper Extremity Function. Arch Phys Med Rehabil. 2017 Oct;98(10):1969-1976.e2. doi: 10.1016/j.apmr.2017.02.033. Epub 2017 May 5.
Clinical trial NCT05100043: Interleukin 4 and Interferon Gamma Predictors of Human Papillomavirus Immunotherapy in Warts
Official title: IL-4 and IFN-γ As Immunologic Predictors of Response to HPV Immunotherapy in Warts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Warts Hand
Wart, Genital
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 36
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are attendants in Zagazig University Hospitals Dermatology outpatient clinic

Brief summary: In the present study the investigators assessed the invitro role of IL-4 and IFN-γ in predicting the response to bivalent HPV vaccine after whole blood stimulation

Detailed description: 40 Patients and 40 controls are enrolled in the study. Participants suffer from chronic recurrent cutaneous and genital warts. Blood samples were withdrawn then whole blood cultures are prepared. Cultures are stimulated with bivalent HPVvaccine. IL-4 and IFN-γ measurement in culture supernatants by ELISA. IL-4 and IFN-γ are investigated to predict the therapeutic response to bivalent HPV vaccine immunotherapy in warts.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent and recalcitrant cutaneous and anogenital warts.

Exclusion Criteria:

* History of allergy to the HPV vaccine
* Active viral, fungal, or bacterial infections
* Immunosuppressive diseases or drugs.
* Autoimmune diseases, or other systemic diseases, e.g., hepatic, or renal disorders, diabetes, meningitis or convulsions
* Skin allergies
* Pregnancy and lactation
* Earlier wart treatment at least one month before enrollment.

Primary outcomes:
measure: Change of IFN-γ and IL-4 levels
timeFrame: 48 hours
Secondary outcomes:
measure: Change in the size of warts
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Faculty of Medicine, Zagazig University , Zagazig, Egypt
name: Ayman Marei, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004643: Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Erythematosus, Systemic
Keywords: arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 2000-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus.

II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.

Detailed description: PROTOCOL OUTLINE:

Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Disease Characteristics

* Clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria
* Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), topical corticosteroids, and antimalarials
* Intolerable side effects from corticosteroids or other immunosuppressive drugs Failure on immunosuppressives not required
* No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive glomerulonephritis

Prior/Concurrent Therapy

* No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on study

Patient Characteristics

* Hematopoietic: WBC at least 2000; Platelets at least 100,000
* Renal: Creatinine clearance at least 20 mL/min
* Other: No major infection within 2 weeks prior to entry
* Negative pregnancy test required of fertile women
* Effective contraception required of fertile women. Advised for men during and for 75 days after therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Bruce Richardson
role: STUDY_CHAIR
References:
citation: Yung RL, Richardson BC. Cytarabine therapy for refractory cutaneous lupus. Arthritis Rheum. 1995 Sep;38(9):1341-3. doi: 10.1002/art.1780380926. No abstract available.