louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01318720: Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
Official title: Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Thrust Manipulation
Non-Thrust Manipulation
Lead sponsor: Masefield and Cavallaro Physical Therapy
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.


Eligibility criteria: Inclusion Criteria:

* Neck pain of less than 3 months
* No symptoms below the shoulder
* Baseline Neck Disability Index score of 10 or greater

Exclusion Criteria:

* Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
* History of whiplash injury within the past two months
* Diagnosis of cervical spinal stenosis
* Uni-lateral or bi-lateral upper extremity radicular symptoms
* Evidence of central nervous system involvement
* Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes
* Prior surgery to the neck or thoracic spine
* Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims
* Insufficient English language skills to complete the questionnaires
* Inability to comply with treatment and follow-up schedule
* Women who may be pregnant

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: Short-term outcome 1 week
Secondary outcomes:
measure: Global Rating of Change (GROC)
timeFrame: Short-term outcome 1 week
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Long Island University
state: New York
city: Brooklyn
country: United States
facility: Masefield Cavallaro Physical Therapy
state: New York
Study officials:
affiliation: Masefield Cavallaro Therapy
name: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996420: Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty
Official title: Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study."
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Anesthesia, Spinal
Hemodynamic Monitoring
Crystalloid Solutions
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.

The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.

The primary endpoint is to evaluate total duration of hypotension, defined as a MAP \< 65 mmHg, calculated during all the perioperatory time.

Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.


Eligibility criteria: Inclusion Criteria:

* Age 50-80 years
* ASA I, II or III
* primary elective hip arthroplasty

Exclusion Criteria:

* spinal anesthesia contraindications
* periferical vasculopaty
* other diseases which indicates better an invasive monitoring by radial artery cannulation
* atrial fibrillation
* denial or inability to provide informed consent

Primary outcomes:
measure: total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours)
timeFrame: from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IORizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Bonarelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05564520: International Multicenter Study on Lipin-1 Deficiency
Official title: Etude Multicentrique Internationale Sur le déficit en Lipin-1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lipin-1 Deficiency
Keywords: Inherited Metabolic Diseases
enzymatic deficiency
rhabdomyolysis
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with lipin1 deficit with two mutations on the LIPIN1 gene and having undergone acute rhabdomyolysis, 50 to 150 patients

Brief summary: LIPIN1 is an international registry that allows the collection of data on the follow-up, management and treatment of patients with Lipin-1 deficiency.

Detailed description: This study evaluates survival, cardiac function, quality of life, fatigability, treatment tolerance and comparison of the efficacy of different current treatments in patients with Lipin-1 deficiency.

Eligibility criteria: Inclusion Criteria:

Patient at least 12 months with Lipin1 deficiency confirmed by molecular biology (two causal mutations in the LPIN1 gene)

Exclusion Criteria:

Opposition of the patient or his parents to participate to the study

Primary outcomes:
measure: Evaluation of survival in patients with Lipin-1 deficiency
timeFrame: According to routine care
Secondary outcomes:
measure: Evaluation of cardiac function in patients with Lipin-1 deficiency
timeFrame: According to routine care
measure: Comparison of the effectiveness of different current treatments in patients with Lipin-1 deficiency
timeFrame: According to routine care
measure: Evaluation of the quality of life of patients with Lipin-1 deficiency
timeFrame: According to routine care
measure: Evaluation of the tolerance of treatments in patients with Lipin-1 deficiency.
timeFrame: According to routine care
measure: Evaluation the fatigability of patients with Lipin-1 deficiency
timeFrame: According to routine care
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
Study officials:
affiliation: Necker Hospital
name: Pascale De Lonlay, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Imagine
name: Hortense De Calbiac, Ph.D.
role: STUDY_CHAIR
affiliation: Institut Imagine
name: Caroline Tuchmann-Durand, Pharm D
role: STUDY_CHAIR
References:
Clinical trial NCT00764920: Skin Imaging With Technologies in Development
Official title: Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pigmented Skin Lesion of Uncertain Nature
Keywords: human skin
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 750
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine Medical Clinic

Brief summary: The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.

Detailed description: Normal and lesional skin will be assessed by the following imaging modalities:

1. Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.
2. Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.
3. Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.
4. Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.
5. Multiphoton Microscopy can provide images of structures of the skin.

Eligibility criteria: Inclusion Criteria:

* adult male or female 7 and older; able to carry out study instructions

Exclusion Criteria:

* Younger than 7 years old
* pregnant woman
* breast feeding

Primary outcomes:
measure: Collect information on normal and lesional skin
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Kristen M Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06235320: Paracetamol Effect on Prostaglandins and Blood Pressure
Official title: Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 72
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 first cohort consists of patients of the headache consultation at Charité Campus Mitte, where data is collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.

The second cohort consists of patients attending oral surgery consultations at the Institute of Dentistry, Oral and Maxillofacial Surgery, for whom data is also collected both within and outside of clinical routine, whereby the medical care of the respective patients takes place in the usual routine.

Brief summary: This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.


Eligibility criteria: Inclusion Criteria:

* Headache and orosurgical patients treated at the respective charite outpatient clinic.
* Age 18 years or older
* Able to consent
* Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
* Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction

Exclusion Criteria:

* Pregnancy
* Arterial hypertension
* Use of beta blockers
* Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
* Stable prophylactic therapy of migraine for less than 3 weeks
* Use of tryptans in the last two days (Frovatriptane in the last 6 days)
* Oral surgery patients using paracetamol or ibuprofen in the last 24 hours
* Known allergy to paracetamol or ibuprofen

Primary outcomes:
measure: Prostanoid levels
timeFrame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Secondary outcomes:
measure: Blood pressure
timeFrame: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01365520: A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A
Official title: Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 4
Sex: MALE
Minimum age (years): 12
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).


Eligibility criteria: Inclusion Criteria:

* Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
* Body weight between 10 to 120 kg
* Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Previous participation in this trial defined as withdrawal
* Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
* Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

Primary outcomes:
measure: Area under the curve
timeFrame: Infusion, 48 hours
measure: Incremental recovery
timeFrame: Infusion, 30 minutes
measure: In vivo t1/2
timeFrame: Infusion, 48 hours
measure: Total clearance (CL)
timeFrame: Infusion, 48 hours
Secondary outcomes:
measure: Maximal concentration (Cmax)
timeFrame: 15 minutes after trial drug administration
measure: Number of adverse events
timeFrame: up to 48 hours after trial drug administration
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.
Clinical trial NCT02451020: Acclimatization of Healthy Subjects During a Stay at 3200 m
Official title: Acclimatization of Healthy Subjects During a Stay at 3200 m
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of High Altitude
Keywords: healthy volunteers
acclimatization
sleep
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2015-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.

Detailed description: This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.

Eligibility criteria: Inclusion Criteria:

* Perfect health
* Born, raised and currently living at low altitude (\<800m)
* Informed consent.

Exclusion Criteria:

* Any acute or chronic disease
* heavy smoking (\>20 cigarettes per day).

Primary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 7 at 3200 m
Secondary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 1 at 3200 m
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 21 at 3200 m
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 1 at 700 m (low altitude baseline)
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01139320: Biomarkers in DNA Samples From Younger Patients With Newly Diagnosed Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin
Official title: Pharmacogenetics of Mylotarg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-08
Enrollment: 300
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.

Brief summary: RATIONALE: Studying samples of DNA from patients receiving gemtuzumab ozogamicin may help doctors learn more about the effects of gemtuzumab ozogamicin on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in DNA samples from younger patients with newly diagnosed with acute myeloid leukemia receiving gemtuzumab ozogamicin.

Detailed description: OBJECTIVES:

* To analyze candidate-coding polymorphisms in CD33 of DNA samples from children with newly diagnosed acute myeloid leukemia treated with gemtuzumab ozogamicin on COG-AAML03P1.
* To determine the association between these polymorphisms and clinical response of patients treated with this regimen.

OUTLINE: Archived DNA samples are analyzed for candidate polymorphisms in CD33 by PCR-based sequencing.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Newly diagnosed acute myeloid leukemia
* Treated with gemtuzumab ozogamicin on COG-AAML03P1
* Genomic DNA samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Association between coding polymorphisms in CD33 with clinical response to gemtuzumab ozogamicin
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Jatinder Lamba, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646720: Teleassessment in Neck Pain
Official title: Teleassessment in Neck Pain Patients: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Pain
Assessment, Self
Kinesiophobia
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic neck pain

Brief summary: New technologies have improved the aproach of patients with different pathologies. Neck pain is a prevalent pathology in physical therapy clinics. Evaluating patients with an electronical device could decrease the services saturation and the proffesionals overload.


Eligibility criteria: Inclusion Criteria:

* Presence of neck pain
* Between 18 and 65 years
* Accepted to sign the informed consent

Exclusion Criteria:

* Cognitive impairment.
* Traumatic accidents.
* Other orthopedic or neurologic pathology.

Primary outcomes:
measure: Changes in range of movement
timeFrame: Baseline
measure: Changes in trigger points
timeFrame: Baseline
measure: Changes in neck endurance (anterior)
timeFrame: Baseline
measure: Changes in neck endurance (posterior)
timeFrame: Baseline
measure: Changes in quality of life
timeFrame: Baseline
measure: Changes in quality of life (Visual Analogue Scale)
timeFrame: Baseline
Secondary outcomes:
measure: Changes in kinesiophobia
timeFrame: Baseline
measure: Changes in functionality
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: