louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01930071: PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Official title: PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2013-08-28
Enrollment: 4
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: To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.

Detailed description: Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide informed consent
* Age 18 or older
* Rutherford Classification of 3-5
* Lesions ≥10cm in length considered to be:

  * Chronic total occlusion (100% stenosis)
  * Diffuse stenosis (\>50% stenosis) with moderate to heavy calcification
  * In-stent restenosis (\>50% stenosis)
* Proximal and distal target vessels are 4.8 - 7.5 mm in diameter
* Orifice and proximal 1cm of SFA is patent
* Patent popliteal artery 3cm proximal to tibial plateau
* At least 1 patent tibial artery to the foot
* Patent femoral vein

Exclusion Criteria:

* History of deep vein thrombosis
* Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated
* Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications
* Documented in-sensitivity to anti-platelet medication
* Has a known or previous coagulopathy
* Pregnant or lactating
* Untreated flow-limiting aortoiliac occlusive disease
* Has renal failure (GFR \< 30mL/min)
* Major distal amputation (above the transmetatarsal) in the study or non-study limb
* Patient has had a procedure on the target limb within 30 days
* Previous bypass surgery on the target limb
* Bypass length required is greater than 35cm

Primary outcomes:
measure: Primary Patency
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01563471: Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
Official title: Single-centre, Randomised, Placebo-controlled, Double-blind, Dose Escalation Trial Investigating Pharmacokinetics, Pharmacodynamics and Tolerability of Three Different Single Intravenous Doses of Activated Recombinant Factor VIIa (rFVIIa/NovoSeven®) in Healthy Caucasian and Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Caucasian or Japanese
* Healthy as defined by medical history, physical and biological examinations

Exclusion Criteria:

* History of allergy or hypersensitivity reaction to any medication
* History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
* Alcohol or substance abuse disorder
* Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health

Primary outcomes:
measure: Area under the Curve (AUC) of FVII:C (Factor VII clotting activity) from 0-24 hours
Secondary outcomes:
measure: Mean residence time (MRT)
measure: Maximum plasma concentration (Cmax)
measure: Time to reach maximum plasma concentration (tmax)
measure: Area under the Curve (AUC) from 0-24 hours of the PT (Prothrombin Time)
measure: Adverse events
Other outcomes:
Locations:
city: Paris
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66. doi: 10.1097/01.mbc.0000169218.15926.34.
citation: Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Clinical trial NCT04255771: A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Official title: A Prospective Randomized Controlled Trial for Postoperative Adjuvant Chemotherapy for pTanyN0M0 Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy Effect
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study.

Detailed description: This project is to explore the effect of adjuvant chemotherapy on total tumor survival time, progression-free survival time, and recurrence-free survival time in patients with pTanyN0M0 upper urinary urothelial carcinoma with lymphatic vascular invasion (LVI) through a prospective case-control study. Therapeutic value of adjuvant chemotherapy for LVI(+) patients with pT1N0M0, pT2N0M0, and pT3-4N0M0 upper urinary urothelial carcinoma, respectively.

Eligibility criteria: Inclusion Criteria:

1. Aged 20-85 years;
2. ECOG score 0-1 points;
3. Patients with UTUC, undergoing radical nephrectomy, pathological staging For pTanyN0M0;
4. Patients voluntarily signed informed consent.

Exclusion Criteria:

1. Obvious cardiopulmonary dysfunction, serious diabetes and other chronic diseases;
2. Obvious chemotherapy contraindications;
3. Patients have a history of other organ malignancies;
4. Combined with tumors of other sites.

Primary outcomes:
measure: Total tumor survival time
timeFrame: 3 years
Secondary outcomes:
measure: progression-free survival time
timeFrame: 3 years
Other outcomes:
measure: relapse-free survival time
timeFrame: 3 years
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Qinghua Xia, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05788471: Effect of Neurodynamic Mobilization on Median Nerve Conduction Velocity in Carpal Tunnel Syndrome
Official title: Effect of Neurodynamic Mobilization on Median Nerve Conduction Velocity in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Median Nerve Entrapment
Carpal Tunnel Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine:

1. The effect of neurodynamic mobilization on the sensory and motor median nerve conduction velocity in carpal tunnel syndrome.
2. The effect of neurodynamic mobilization on the wrist pain in carpal tunnel syndrome.
3. The effect of neurodynamic mobilization on the hand function in carpal tunnel syndrome.

Detailed description: The findings of this study will provide physiotherapists with information to know if neurodynamic mobilization techniques is effective on median nerve conduction velocity in carpal tunnel syndrome also this will improve our body of knowledge about the best modalities for treating carpal tunnel syndrome. The finding of this study may help carpal tunnel syndrome patients to avoid the exposing to complications as a result of compression of median nerve in carpal tunnel syndrome.

Eligibility criteria: Inclusion Criteria:

* Forty carpal tunnel syndrome patients.
* All participants referred from a physician.
* Their ages range from 20-50 years old.
* Both genders will participate in the study.
* Their BMI ranges between 18.5-24.9kg/m2.
* All participants have carpal tunnel syndrome at least in one hand.
* All participants suffering from mild to moderate carpal tunnel syndrome.

Exclusion Criteria:

* Previous or current disease or trauma that might affect one or both upper limbs.
* Metabolic diseases that might associated with entrapment neuropathy such as diabetes mellitus, thyroid diseases, and autoimmune diseases.
* Pregnant women.
* Participants with congenital hand deformities.
* History of hand surgery.
* Sever cases of carpal tunnel syndrome that suffering from weakness of hand grip and atrophy of thenar muscle.

Primary outcomes:
measure: Assessing the change in nerve conduction velocity of the median nerve.
timeFrame: at baseline and after 4 weeks of intervention
measure: Assessing the change in wrist joint pain
timeFrame: at baseline and after 4 weeks of intervention
measure: Assessing the change in functional activity of the hand
timeFrame: at baseline and after 4 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physica therapy cairo university
Study officials:
affiliation: Cairo University
name: Raghda Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00206271: Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
Official title: A Randomized Early Intervention Study Comparing the Effect of Stiff Neck Collar, "Act-as-Usual" and Active Mobilisation on the One Year Outcome Following Whiplash Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Whiplash Injury
Keywords: whiplash injuries
neck pain
exercise movement techniques
immobilisation
Lead sponsor: The Back Research Center, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Pain Research Center
First posted: 2005-09-21
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms behind WAD are virtually unknown, as are the possible effects of early intervention. This trial was undertaken to compare the effect of three early intervention strategies for the prevention of developing chronic WAD following acute whiplash injury.

Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year and treatment effects were compared in terms of lasting neck pain, headache, disability and sick-leave.


Eligibility criteria: Inclusion Criteria:

* Been exposed to rear-end or frontal car collision
* Experienced symptoms within 72 hours
* 18 - 70 years

Exclusion Criteria:

* Could not be enrolled within 10 days of the collision
* Fractures or dislocations of the cervical spine
* Amnesia for the accident
* Unconsciousness in relation to the accident
* Injuries other than the whiplash injury
* Average neck pain during the preceding 6 months exceeding 2 on a box scale 0-10, where 0= no pain and 10= worst possible pain
* Significant pre-existing somatic or psychiatric disease
* Alcohol or drug abuse
* Does not read or understand Danish.

Primary outcomes:
measure: Neck pain intensity
measure: Headache intensity
measure: Neck disability
measure: Sick leave during the 12 month after inclusion
Secondary outcomes:
measure: Medication
measure: Number of non-painful complaints
measure: General health
Other outcomes:
Locations:
city: 5750 Ringe
country: Denmark
facility: The Back Research Center
city: 8000 Aarhus
country: Denmark
facility: Danish Pain Research Center
Study officials:
affiliation: The Back Research Center
name: Tom Bendix
role: STUDY_CHAIR
affiliation: Danish Pain Research Center
name: Troels S Jensen
role: STUDY_CHAIR
References:
Clinical trial NCT00279071: Use of Acupuncture for Stimulation of Labour
Official title: Use of Acupuncture for Stimulation of Labour
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dystocia
Keywords: dystocia
stimulation
acupuncture
oxytocin
Lead sponsor: Herning Hospital
Sponsor class: OTHER
Collaborators: name: Ringkjøbing County Research Fond
name: Union of Midwives Research Fond
First posted: 2006-01-19
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis:Acupuncture can be used as stimulation of labour in case of primary og secondary inertia.

A randomized controlled trial including 150 pregnant women Acupuncture has become a natural part of the range of obstetric treatments offered in danish delivery wards, but there is only little evidence to the effect of the acupuncture.

The women are randomized into to groups.

1. Acupuncture, Acu.points: KI3, Ki6, SP6, BL60, LI4, BL67(acupressure)
2. No treatment

The women will be asked in case beginning signs of inertia, if they want to parcipitate in the trial.

Inclusion criteria:

1. Normal pregnancy
2. In labour (orificium \< 8 cm), 37th week or thereafter
3. Ruptured membranes
4. Primary or secondary inertia

The women will just before randomization be vaginally explored and fetal heart monitored. The meassure of effect happens two hours after randomization.

The midwife who measures the effect, is blinded to the treatment or lack of, and also on the including exploration.

Secondary effect meassures: length of labour, use of oxytocin and number of contracions pr/min meassured twice:

1. before the randomization and again 1 hour after randomization.


Eligibility criteria: Inclusion Criteria:

1. Normal pregnancy
2. In labour (orificium \< 8 cm), 37th week or thereafter
3. Ruptured membranes
4. Primary or secondary inertia -

Exclusion Criteria:

1. Pathological pregnancy
2. Pathological labour
3. Medical diseases
4. Women who do not speak and undrestand danish

Primary outcomes:
Secondary outcomes:
measure: use of oxytocin
timeFrame: additional need for oxytocin infusion in 1. stage and 2. stage
measure: number of contractions/30 minutes
timeFrame: number og contractions in 1st. stage and 2nd. stage
Other outcomes:
Locations:
Study officials:
affiliation: Obstetric ward Herning and Holstebro hospitals
name: Kjeld Rasmussen, obst. dr.med
role: STUDY_CHAIR
References:
Clinical trial NCT04158271: Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients
Official title: Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Morbidity
Keywords: Airway Management
Tube Exchange
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator

Detailed description: Exchanging a tracheal tube (ETT) in the high-risk difficult airway patient carries the risk of hypoxemia and the potential of a lost airway. Maintaining continuous airway access during the exchange by incorporating an airway exchange catheter (AEC) or similar device may reliably lessen exchange risk, especially in the known or suspected difficult airway patient, by providing a conduit to facilitate ETT passage into the trachea. We evaluated some approven / etablished techniques in a Simulator based study design.

Eligibility criteria: Inclusion Criteria:

* residents and consultans of the Department of Anesthesiology

Exclusion Criteria:

* no

Primary outcomes:
measure: Evaluation of Strategies for Securing the Airway
timeFrame: through study completion, an average of 10 minutes
Secondary outcomes:
measure: Time for intervention
timeFrame: through study completion, an average of 10 minutes
measure: Anaesthesia Experience
timeFrame: through study completion, an average of 10 minutes
measure: IDS
timeFrame: through study completion, an average of 10 minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center of Johannes Gutenberg-University
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05688371: Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .
Official title: Comparison of Addition of Dexmedetomidine to Low Dose Morphine Versus Standard Dose of Morphine in Patiant Controlled Analgesia in Children Undergoing Pelvi Abdominal Exploration. a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PCA
Children
Dexmedetomidine
Morphine
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults

Detailed description: Patient-controlled analgesia (PCA) permits patients to self-administer small doses of opioid analgesics intravenously or subcutaneously at frequent intervals. PCA is used in the management of moderate-to-severe pain. Patient-controlled analgesia (PCA) is now used in children as young as 5 yr for the treatment of postoperative pain.

Eligibility criteria: Inclusion Criteria:

1. ASA I \& II of both sex.
2. Age between 8 and 12 years.
3. Patients scheduled for exploration surgery under general anesthesia.

Exclusion Criteria:

1. Parents refused to give consent.
2. Patients with history of allergy to morphine or dexmedetomidine.
3. Mental disorders.
4. Unsuitability for extubation.
5. Comorbidities as cardiac, pulmonary and obstructive sleep apnea.
6. children with chronic opioid use for \> 3 monthes

Primary outcomes:
measure: Post-operative pain intensity evaluation at (0,1, 2,6,12, 24h).
timeFrame: 24 hour
Secondary outcomes:
measure: Total morphine consumption in 24h postoperative.
timeFrame: 24 hour
measure: sedation
timeFrame: 24 hour
measure: respiratory depression
timeFrame: 24 hour
measure: nausea vomiting
timeFrame: 24 hour
Other outcomes:
Locations:
city: Egypt
country: Egypt
facility: Benisuef University Hospital
Study officials:
affiliation: Benisuef university hospital
name: Mariana abdelsayed Mansour, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06552078: Activation of Biobank Registry for Bilio-pancreatic Diseases
Official title: Activation of Biobank for Association Study Between Environmental and Genetic Factors in Inflammatory, Functional and Neoplastic Bilio-pancreatic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatitis
Pancreatic Disease
Non-Neoplastic Pancreatic Disorder
Pancreatic Adenocarcinoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 2000
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: Patients with biliopancreatic disorders

Brief summary: The purpose of establishing the biobank is to create a collection of biological material and clinical data, with a prospective and retrospective mold, in order to investigate the role of genetic predisposition in multifactorial bilio-pancreatic diseases, so that an evaluation of the possible association in the pathogenesis of exogenous factors with endogenous factors can be allowed.

Multifactorial diseases are in fact an expression of genetic predisposition upon which one or more environmental stimuli act. Usually the aforementioned factors are not capable individually of triggering disease but, when simultaneously present, can cause the pathological phenotype. Therefore, it becomes important in the description of disease pathogenesis to identify as many risk factors for disease prevention and early diagnosis.

Detailed description: Samples collected depending on the disease:

* Peripheral blood;
* Portal blood;
* Saliva;
* Urine;
* Stool;
* Cystic fluid;
* Pancreatic juice;
* Biopsy tissue specimens;

Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* signed informed consent

Exclusion Criteria:

* age \< 18 years
* unwilling to sign informed consent

Primary outcomes:
measure: The rate of patients with each pancreatic disorder presenting with certain exposures or certain biomarkers
timeFrame: Tthrough study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS OSpedale San Raffaele
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Paolo Giorgio Arcidiacono, MD
role: PRINCIPAL_INVESTIGATOR
References: