louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03754946: The Critical Threshold of Pulse Oximetry Plethysmographic Waveform Parameters in High Quality CPR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiopulmonary Resuscitation
Keywords: cardiopulmonary resuscitation
pulse oximetry plethysmographic waveform
quality monitor
partial pressure of end-tidal carbon dioxide
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were admitted to the participant hospitals and met the inclusion criteria were included in the study.

Brief summary: The purpose of this study is to analyze the relationship of the area under the curve (AUC) and/or the amplitude (Amp) of pulse oximetry plethysmographic waveform (POP) with partial pressure of end-tidal carbon dioxide (PETCO2) which could be used to reflect its quality in cardiopulmonary resuscitation (CPR), and then to determine the critical threshold of POP parameters in high quality CPR.


Eligibility criteria: Inclusion Criteria:

* Cardiac arrested
* The time from cardiac arrest to receiving basic life support is less than 10 minutes
* Get advanced life support (endotracheal intubation and PETCO2 monitoring)

Exclusion Criteria:

* Defuse CPR
* chronic obstructive pulmonary disease (COPD) with type II respiratory failure
* Terminal malignant tumors or terminal stage of other diseases
* Rib fracture
* Cardiac arrest caused by hemorrhagic shock pulmonary embolism and cardiac tamponade
* Sever anemia(HGB\<7g/dl)
* Untreated tension pneumothorax
* Tinea unguium, dyeing Fingernails and other factors affect the monitor of Pulse Oximetry Plethysmographic Waveform such vasculitis and Raynaud's phenomenon

Primary outcomes:
measure: the cut-off value of POP parameters in High Quality CPR
timeFrame: one year
measure: Compare different predictors
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT06640946: Pain Control for Laser Epilation in Pilonidal Disease
Official title: Pain Control for Laser Epilation in Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pilonidal Disease
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Placebo versus agent crossover per patient
Primary purpose: TREATMENT

Brief summary: It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.

Detailed description: Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10.

Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit.

Twenty patients will be recruited and each patient will act as their own control.

Eligibility criteria: Inclusion Criteria: undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -

Exclusion Criteria: Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser

-

Primary outcomes:
measure: Pain related to laser follicle ablation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital at Waltham
state: Massachusetts
Study officials:
affiliation: Boston Children's
name: Ashley P Stoeckel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03267446: Doppler Imaging and Morbidly Adherent Placenta
Official title: The Role of Grey Scale Ultrasound, 2D, and 3D Power Doppler in Diagnosing and Predicting the Surgical Risks in Patients With Morbidly Adherent Placenta.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antepartum Hemorrhage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to assess the value of adding 3D power Doppler (as a diagnostic technique) to gray scale technique in the antenatal diagnosis of morbidly adherent placenta as well as predict the surgical outcome regarding the type of surgery and the intra operative morbidities.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 45.
* Pregnant 32 weeks or more.
* Placenta previa (Major and Minor).
* History of previous cesarean section.

Exclusion Criteria:

* Medical disorders such as bleeding disorders.
* Lethal fetal anomalies.
* Delivery before 34 weeks.

Primary outcomes:
measure: Sensitivity of 3D power Doppler in detecting morbidly adherent placenta.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo Univeristy
name: Ahmed M Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490346: Tissue Drug Levels of HIV Medications
Official title: A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: HIV 1
Pharmacokinetics
Drug levels
Treatment naive
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-12-13
Enrollment: 22
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: HIV-positive individuals beginning anti-retroviral treatment.

Brief summary: The aim of this study is to find out why HIV continues to make copies in people taking HIV drugs. The investigators want to know if the medications most people use to treat HIV get into the lymphatic tissue where HIV persists.


Eligibility criteria: Inclusion Criteria:

* HIV+
* Treatment naive or \>30 days off ARV therapy
* Documented sensitivity to prescribed antiretrovirals
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential
* Ready to start ARV therapy

Exclusion Criteria:

* Contraindications to surgical \& endoscopy procedures (as judged by PI)
* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
* Pregnancy

Primary outcomes:
measure: Intracellular antiretroviral drug concentrations
timeFrame: Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months & 6 months
Secondary outcomes:
measure: Evidence of HIV replication in blood and lymphoid tissue
timeFrame: Measured at baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, & 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Timothy Schacker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01576146: Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
Official title: A Multicenter Open-label Extension Study to Assess the Long-term Safety and Efficacy of KAI-4169 (Also Known as AMG 416) in the Treatment of Chronic Kidney Disease-Mineral and Bone Disorder in Patients With Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Keywords: Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Chronic kidney disease-mineral and bone disorder
Parathyroid hormone
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 30
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 evaluate the long term safety and efficacy of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis who had completed 12 weeks of treatment with etelcalcetide in parent study 20120331 (KAI-4169-005; NCT01414114).


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent.
* Subject completed the 12 week treatment phase in the parent study study 20120331 ( KAI-4169-005; NCT01414114).

Exclusion Criteria:

* Subject pregnant or nursing

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.
Secondary outcomes:
measure: Percent Change From Baseline in Parathyroid Hormone
timeFrame: Baseline (of the parent study 20120331) and Weeks 13, 26 and 52
measure: Percent Change From Baseline in Serum Corrected Calcium
timeFrame: Baseline and Weeks 13, 26 and 52
measure: Percent Change From Baseline in Serum Phosphorus
timeFrame: Baseline and Weeks 13, 26 and 52
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: M D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02027246: Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury
Official title: Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
autologous bone marrow mononuclear cells
stem cell therapy
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 63
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Detailed description: Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of any type of chronic Spinal cord injury
* Age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/ Hepatitis B Virus/ Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* other acute medical conditions such as respiratory infection
* pregnancy and lactation

Primary outcomes:
measure: Change in clinical symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: 6 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
affiliation: Neurogen Brain and Spine Institute
name: Alok K Sharma, M.S., M.Ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar AA, Kumar SR, Narayanan R, Arul K, Baskaran M. Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. Exp Clin Transplant. 2009 Dec;7(4):241-8.
citation: Yoshihara T, Ohta M, Itokazu Y, Matsumoto N, Dezawa M, Suzuki Y, Taguchi A, Watanabe Y, Adachi Y, Ikehara S, Sugimoto H, Ide C. Neuroprotective effect of bone marrow-derived mononuclear cells promoting functional recovery from spinal cord injury. J Neurotrauma. 2007 Jun;24(6):1026-36. doi: 10.1089/neu.2007.132R.
citation: Sharma A, Gokulchandran N, Chopra G, Kulkarni P, Lohia M, Badhe P, Jacob VC. Administration of autologous bone marrow-derived mononuclear cells in children with incurable neurological disorders and injury is safe and improves their quality of life. Cell Transplant. 2012;21 Suppl 1:S79-90. doi: 10.3727/096368912X633798.
Clinical trial NCT02690246: Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia
Official title: A Questionnaire Based Study on Symptoms and Treatment Results in Hereditary Hemorrhagic Telangiectasia (HHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HHT; Indirectly we accept healthy volunteers only as control cohort in questionnaires of affected persons.

Brief summary: Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. The purpose of this study is to provide data about multiple clinical aspects of HHT and responses to treatment. For comparison of some aspects also data of non-affected relatives is collected (second cohort). the questionnaire has been designed primarily for web based entry, but can also be circulated in paper format on request.

Detailed description: Specific aspects include potential consequences from iron deficiency, efficacy and safety of self-packing, effect of female sex hormones, mortality, effects on the immune system.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of Hereditary Haemorrhagic Telangiectasia

Exclusion Criteria:

* unable to provide informed consent

Primary outcomes:
measure: Effect of nasal self-packing to treat epistaxis on the quality of life in patients with HHT measured mainly by Glasgow Benefit Inventory (GBI)
timeFrame: 34 months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 34 months
Other outcomes:
measure: Number of patients with restless legs syndrome according to a questionnaire including the criteria by Allen et al., Sleep Medicine 4(2003) 101-119
timeFrame: 34 months
measure: Number of infectious diseases and complications in comparison to healthy spouses
timeFrame: 34 months
measure: Hormonal changes: Change of number of visible telangiectases during menstrual cycle and pregnancy
timeFrame: 34 months
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: University Hospital, Essen
name: Urban Geisthoff, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01981746: Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
Official title: Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Strength
Healthy Volunteers
Keywords: adductor canal block
healthy volunteers
US-guided peripheral nerve block
lower limb
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.


Eligibility criteria: Inclusion Criteria:

* 18-30 years
* Men
* ASA 1
* Body Mass Index 18-25

Exclusion Criteria:

* Allergy to study medication
* Earlier trauma or surgery to the lower limb
* Diabetes Mellitus

Primary outcomes:
measure: Number of subjects with reduced quadriceps strength
timeFrame: 0.5 to 6 hours post block
Secondary outcomes:
measure: Quadriceps strength in percentage of baseline
timeFrame: 2, 3 and 4 hours post block
measure: Quadriceps strength calculated as AUC
timeFrame: 30 minutes to 6 hours post block
measure: Modified 30-second Chair Stand test
timeFrame: 2 and 4 hours post block
measure: VAS pain scores during warmth stimulation
timeFrame: Mean value for the periode 30 minutes - 6 hours post block
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jaeger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaeger P, Grevstad U, Koscielniak-Nielsen ZJ, Sauter AR, Sorensen JK, Dahl JB. Does dexamethasone have a perineural mechanism of action? A paired, blinded, randomized, controlled study in healthy volunteers. Br J Anaesth. 2016 Nov;117(5):635-641. doi: 10.1093/bja/aew318.
citation: Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):553-8. doi: 10.1097/AAP.0000000000000298.
Clinical trial NCT02786446: Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones
Official title: Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Keywords: Lidocaine gel
Extracorporeal shockwave lithotripsy
Naproxen sodium
Pain score
Lead sponsor: Shifa International Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We want to compare the effect of lignocaine 2 % gel, Naproxen sodium and their combination on the pain control during extracorporial shock wave lithotripsy for renal stones.

Detailed description: Introduction of ESWL (extracorporeal shock wave lithotripsy) has revolutionized the treatment of urolithiasis due to its noninvasive in nature, cost effectiveness, reduced hospitalization time and less morbidity1, 2.Impact of shock waves cause pain in most of the patient requiring analgesia or sedation. It is important to make patient pain free to get the maximum possible stone free rates3, 4. Opioids are used most commonly for pain relief in ESWL but with side effects requiring patient monitoring and delayed hospital stay3, 4. NSAIDS also showed promising results regarding pain control in ESWL without side effects of opoids1, 5. Local analgesia gels have controversial role in relieving pain in ESWL 1, 6. There are yet no guidelines for pain relief during ESWL1, 4. We intend to compare the effect of local analgesia gel, oral NSAIDS and their combination on pain during lithotripsy.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years Having renal stone Meet the criteria for ESWL

Exclusion Criteria:

* H/o chronic use of analgesia, 2) Allergy to any of the used medications, 3) those having ureteric stones, 4) Serum creatinine\>1.4, 5) Pregnant patients, 6) having gastric ulcer disease, 7) not willing to participate, 8) Have coagulopathy and 9) active urinary-tract infection.

Primary outcomes:
measure: Mean pain score
timeFrame: During or immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03580746: Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
Official title: Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Clubfoot
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective study of children with club foots treated by two different options.

Brief summary: There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the investigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release.

Detailed description: There are many different treatments of congenital talipes equinovarus. At our institution, the investigators use the Ponseti method with manipulation and immobilization of the foot. In this study the invistigators should like to demonstrate the better outcome in clinical results and in gait analysis of patients treated with the Ponseti method, compared to the 'older' methods of taping and posteromedial release. Trial objectives With this study the investigators would like to investigate whether clinical results and gait analysis in patients treated with Ponseti has better results compared to patients treated with the older methods.

Eligibility criteria: Inclusion Criteria:

* All patients with talipes equinovarus who have been treated at our institution

Exclusion Criteria:

* Patients with other disorders which may influence the clinical or gait analysis outcome

Primary outcomes:
measure: Clinical results
timeFrame: 1 year
Secondary outcomes:
measure: Gait analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: University Hospitals of Leuven
state: Vlaams-Brabant
Study officials:
References: