louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06138717: The Effect of Aerobic Exercises and Yoga Exercises in Axial Spondyloarthritis
Official title: The Effect of Aerobic Exercises and Yoga Exercises on Spinal Mobility, Functional Capacity and Disease Activity in Axial Spondyloarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Axial Spondyloarthritis and Ankylosing Spondylitis
Keywords: Axial spondyloarthritis, yoga, aerobic exercise
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 60
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: Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. This study aimed to determine the effect of yoga-based exercises combined with aerobic exercise on spinal mobility, disease activity and aerobic capacity in AxSpA.

Detailed description: The study included 60 AxSpA patients according to ASAS criteria. Patients will be divided into two groups randomised. Group 1 (n=30) received only aerobic exercise, group 2 (n=30) received aerobic exercise and yoga exercises will be applied. Aerobic exercise intensity will be measured by cardiopulmonary exercise test (CPET). determined.

Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 sessions.

Functional capacity before and after treatment, 6-min walk test (6MWT) and VO2 maximum and disease activity will be assessed by ASDAS-CRP. Clinical measurements Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQL) scale will be used. Fibromyalgia symptom severity scale and widespread pain index scores will be calculated.

Eligibility criteria: Inclusion Criteria:

Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints

Exclusion Criteria:

* Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients

Primary outcomes:
measure: VO2 max
timeFrame: six week
measure: Six minute walk test
timeFrame: six week
Secondary outcomes:
measure: BASMI
timeFrame: six week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT01538017: Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture
Official title: Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dupuytrens Contracture
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
* Clearly defined strings

Exclusion Criteria:

* Allergies to used medication
* International Normalised Ratio more than 2.0
* Pregnancy and breastfeeding
* Previous treatment for DC in affected finger
* Former inclusion in the study with another string
* Activity in disease at time of study
* PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit

Primary outcomes:
measure: Clinical improvement
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Center for Planned surgery - Regionalhospital Silkeborg
Study officials:
affiliation: Regionshospitalet Silkeborg
name: Jeppe Lange, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01623817: Effectiveness of Vancomycin Loading Therapy
Official title: Effectiveness of Vancomycin Loading Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of tish clinical research study is to identify that loading of vancomycin can facilitate rapid attainment of target trough serum vancomycin concentration.

Detailed description: The Study drug

* Vancomycin : a glycopeptide antibiotic, is the first line agent in the treatment of methicillin resistant staphylococcus aureus

Study design : Randomized controlled trials

Study Drug Administration

* If your doctor believes you are eligible, and you agree to take part in this study, you will be randomized to two treatment groups.

Eligibility criteria: Inclusion Criteria:

* Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division
* Patients with SIRS (systemic inflammatory response syndrome)
* Intravenous vancomycin therapy deemed necessary

Exclusion Criteria:

* Age less than 20 years
* Age more than 75 years
* Current renal insufficiency defined as estimated Glomerular filtration rate \< 50mg/min/1.73 m2 by MDRD equation
* History of adverse events to vancomycin 5. Pregnant woman

Primary outcomes:
measure: Time duration for concentration of vancomycin to reach target trough of 15-20 mg/L
timeFrame: Peak level drawn 1 hour after the completion of loading dose. Sequential trough level drawn 30 min before each standard dose for the next 4 doses.
Secondary outcomes:
measure: Adverse event rate in each arm, including nephrotoxicity and rash.
timeFrame: 7 days post-treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyong Ran Peck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02652117: Regional Anesthesia in Cardiac Pediatric Patients Less Than 5 Years Old
Official title: Retrospective Review of Regional Anesthesia in Cardiac Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2016-01-11
Enrollment: 545
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac Pediatric Patients less than 5 years old

Brief summary: This retrospective review presents a comparison of pediatric patients less than 5 years old undergoing cardiac surgery with general anesthesia with spinal, caudal epidural, or caudal epidural with catheter anesthesia from July 2007 to July 2013 observing differences in time to extubation, reintubation, and hypercarbia.

Detailed description: Intra-operative anesthesia medical records of pediatric patients undergoing cardiac surgery will be acquired from July 2007 to July 2013. Allocation of regional anesthesia, and the use of spinal versus epidural versus epidural with catheter administration will be determined by provider preference. Date of surgery, age in months, gender, type of surgery, type of anesthesia, regional drugs, PaCO2 upon arrival in the PICU, time to extubation, and reintubation if applicable will be recorded. Time to extubation will be categorized into within the OR, less than 24 hours, or greater than or equal to 24 hours. PaCO2 levels will be categorized into hypercarbia (PaCO2 ≥ 50mmHg) and normal (PaCO2 \< 50mmHg).

Eligibility criteria: Inclusion Criteria:

* Must be pediatric patients undergoing cardiac surgery under the age of 5 years old between the years 2007 and 2013

Exclusion Criteria:

* None

Primary outcomes:
measure: To expect difference in time to extubation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Sudhakar Subramani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fawcett WJ, Edwards RE, Quinn AC, MacDonald IA, Hall GM. Thoracic epidural analgesia started after cardiopulmonary bypass. Adrenergic, cardiovascular and respiratory sequelae. Anaesthesia. 1997 Apr;52(4):294-9. doi: 10.1111/j.1365-2044.1997.80-az0088.x.
citation: Liu S, Carpenter RL, Neal JM. Epidural anesthesia and analgesia. Their role in postoperative outcome. Anesthesiology. 1995 Jun;82(6):1474-506. doi: 10.1097/00000542-199506000-00019. No abstract available.
Clinical trial NCT02097017: Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Official title: Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Alleviation
Dilatation and Evacuation
Laminaria Placement
Keywords: lidocaine
laminaria
dilatation and evacuation
pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-26
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo.

a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation \& evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D\&E procedure.


Eligibility criteria: Inclusion Criteria:

* • Informed consent

  * Women with a gestational age of 12-24 weeks by last menstrual period.

Exclusion Criteria:

* • CRL assesed by ultrasound as \<10 weeks

  * Clinical Uterine size \>24 weeks
  * Fetus Bi Parietal Diameter \> 50 mm
  * Known amide allergy

Primary outcomes:
measure: Pain immediately after inserton of first laminaria
timeFrame: immediately after first laminaria insertion
Secondary outcomes:
measure: Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E
timeFrame: After speculum removal, 15 minutes after speculum insertion and before D&E
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT03537417: Heart Rate Variability in Pneumothorax
Official title: Changes in Heart Rate Variability in Ventilated Patients Undergoing Tension Pneumothorax for Thoracoscopic Cervical Sympathectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumothorax
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy for hyperhidrosis

Brief summary: Changes in heart rate variability in anesthetized, ventilated patients undergoing tension pneumothorax for thoracoscopic cervical sympathectomy


Eligibility criteria: Inclusion Criteria:

* age 15 - 50 years
* body mass index 25 - 45

Exclusion Criteria:

* heart rate other than sinus
* cardiac pacemaker status
* heart transplant

Primary outcomes:
measure: Changes in heart rate variability
timeFrame: From immediately after induction of general anesthesia and mechanical ventilation to 10 minutes after initiation of pneumothorax
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00975117: Spermotrend in the Treatment of Male Infertility
Official title: Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Infertility
Keywords: Dietary supplement
male infertility
spermatogenesis
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 86
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.


Eligibility criteria: Inclusion Criteria:

* Male infertility unrelated to major testicular conditions
* Must have at least one altered seminal parameter.
* Signed informed consent

Exclusion Criteria:

* Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy.
* Previously treated and cured testicular condition.
* Non-transmissible chronic diseases
* Use of antioxidant agents within 6 months.
* Use of vitamins within 6 months.
* Use of anti-inflammatory drugs within 6 months.
* Use of hormones prescribed by an andrologist within 6 months
* Positive serology/HIV
* Leukocytospermia

Primary outcomes:
measure: Parameters of seminal analysis at weeks 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Fertilization achievement
timeFrame: 24 weeks
measure: Presence of mild or severe adverse effects
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: "Ramón González Coro" Gynecologic and Obstetric Hospital
Study officials:
affiliation: "Ramón González Coro" Gynecologic and Obstetric Hospital
name: Miguel Aguilar Charara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
Clinical trial NCT01534117: Platelet Function Analysis in Head Trauma: ASA/Plavix
Official title: Platelet Function Analysis in Head Trauma: ASA/CLOPIDOGREL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Injury Trauma Blunt
Lead sponsor: Chang, Steve S., M.D.
Sponsor class: INDIV
Collaborators: name: Santa Barbara Cottage Hospital
name: Accumetrics, Inc.
First posted: 2012-02-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.

Detailed description: The platelet function analyzer VerifyNow® P2Y12 uses ADP as agonists to induce platelet activation and ascertain the level of platelet function impaired by these medications. VerifyNow® Aspirin Assay utilizes arachidonic acid as the agonist to measure platelet function specifically along this pathway. Our research question for this study is as follows:

Does the administration of desmopressin (DDAVP) and/or the transfusion of platelets in patients with head trauma reverse the platelet inhibition caused by Aspirin and/or Plavix? The investigators hypothesize that with the administration of platelets and/or DDAVP that there is a reversal of the inhibition.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18yrs
2. Must be a trauma patient with blunt head trauma.
3. Must be on Aspirin and/or Plavix
4. Subject or Legally Authorized Representative (LAR) (per Heath and Safety Code, Sections 24170 to 24179.5) must sign study consent within 4 hours from the first blood draw. (If this criterion is not met the initial blood draw must be destroyed and NOT run for study results).

Exclusion Criteria:

1. Hemoglobin ≤ 10 GM/DL
2. Platelet Count ≤ 150 K/MCL
3. Pregnant Females
4. Subjects on Warfarin, Heparin or Enoxaparin

Primary outcomes:
measure: Platelet inhibition
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
affiliation: Santa Barbara Cottage Hospital
name: Steve S Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03179241: Outcome After Selective Dorsal Rhizothomy Concerning Life Quality, Cerebral Imaging and Cognition
Official title: SDR-Auswertung, Unterteil Kognition, Bildgebung, Lebensqualität
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy, Spastic
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with SDR at the Charité University clinics and who are able to perform tasks according to study protocols are eligible to enroll.

Brief summary: Selektive dorsal rhizotomy (SDR) has been used as treatment option in children suffering from cerebral palsy (CP) for several decades and multiple studies demonstrated its benefits. Nevertheless, there are still no proven strategies for patient selection, optimal point of time for the operation or pre- and postoperative therapies. The evaluation of the impact of selective motor control, cognition and cerebral imaging findings on the motor outcome and life quality in children with CP who underwent SDR at the Charité University clinics will clarify these critical points in daily care for patients with CP.

Detailed description: SDR at the Charité University clinics. Two study visits before surgery and during the follow-up 3 months, 6 months, 12 months, 24 months and 5 years post-operatively.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cerebral palsy
* able to perform most tasks according to study protocols
* parents and physician decided to perform SDR

Exclusion Criteria:

* not able to perform any tasks according to study protocols
* no candidate for SDR

Primary outcomes:
measure: Motor function measured by GMFCS
timeFrame: 5 years
measure: Motor function measured by GMFM-88
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life measured by "Disabkids"-Questionaire (German version)
timeFrame: 5 years
measure: Quality of life measured by questionaire "kid screen"
timeFrame: 5 years
measure: Selective motor control
timeFrame: 5 years
measure: Spasticity by modified Ashworth scale
timeFrame: 5 years
measure: Spasticity by modified Tardieu scale
timeFrame: 5 years
measure: Contractures by range of motion (ROM)
timeFrame: 5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University clinics
Study officials:
affiliation: social pediatric center, departement of neuropediatrics
name: Anne K van Riesen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413841: Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief
Official title: Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Angina
Keywords: PCI
oxygen
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.


Eligibility criteria: Inclusion Criteria:

* Stable angina or NST-ACS undergoing PCI

Exclusion Criteria:

* Blood oxygen \<95%
* Cognitive dysfunction
* STEMI
* Intubation

Primary outcomes:
measure: Chest pain measured with VAS
timeFrame: 1 h
Secondary outcomes:
measure: Troponin-levels after PCI
timeFrame: 2 days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital, Lund
Study officials:
References:
citation: Zughaft D, Bhiladvala P, Van Dijkman A, Harnek J, Madsen Hardig B, Bjork J, Ekelund U, Erlinge D. The analgesic effect of oxygen during percutaneous coronary intervention (the OXYPAIN Trial). Acute Card Care. 2013 Sep;15(3):63-8. doi: 10.3109/17482941.2013.822083.