louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03364920: Serum Maresin-1 Predicts the Severity of Severe Acute Pancreatitis
Official title: Serum Maresin-1 Level Predicts the Disease Severity and Clinical Outcomes of Severe Acute Pancreatitis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis, Acute
Keywords: Maresin-1
SAP
IPN
MODS
Mortality
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes severe acute pancreatitis between 18ys and 75ys.Patients with disorder of glucolipide metabolism will be excluded. Alcoholic pancreatitis and HTG-AP patients will be also excluded. Patients will be divided into 2 groups according to their level of serum maresin-1.

Brief summary: This is a retrospective study about serum Maresin-1 level in different severe acute pancreatitis patients. The investigators want to study the correlation between the level of serum Maresin-1 and the severity of SAP, of course the clinical outcomes. The investigators want to find some biomarkers and strategy target drugs of severe acute pancreatitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Severe Acute Pancreatitis
* Biliary pancreatitis
* 7 days of the onset

Exclusion Criteria:

* Surgical patients
* Serious diseases and infection
* Alcoholic pancreatitis
* Hypertriglyceridemia pancreatitis
* Disorder of Glucolipide Metabolism：diabetes mellitus, hypertriglyceridemia, BMI\>30

Primary outcomes:
measure: mortality
timeFrame: up to 28 days
Secondary outcomes:
measure: The incidence of MODS
timeFrame: through study completion, an average of 1 year
measure: The incidence of IPN
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05088382: Period Tracker at Home Study
Official title: Period Tracker at Home Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menstrual Cycles
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2021-10-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between the ages of 18 to 45 represent the intended user of the product

Brief summary: This study will assess the usability of a Period Tracker product when used by lay users in their own homes.


Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Menstrual cycles are 21-60 days long
* Seeking to predict when her next period will start
* Seeking to give informed consent and comply with the investigational procedures
* Has a compatible iPhone with internet access that they are willing to use for the study (iPhone 7+ and iOS 13 and above)

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Used Clearblue® me (Period Tracker app), Persona Contraception Monitor or Clearblue Advanced Fertility Monitor within the last six months
* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
* Is a qualified or trainee healthcare professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
* Using hormone replacement medications containing LH or hCG (e.g. Pregnyl®)
* Is currently seeking to conceive
* Has been diagnosed with polycystic ovarian syndrome (PCOS)
* Has PCOS symptoms e.g. very irregular cycles, hirsutism \*Immediate relatives are defined as parents, children, siblings or partner/spouse

Primary outcomes:
measure: Usability of the Period Tracker device when used at home
timeFrame: 28 days (approximately 1 menstrual cycle)
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
affiliation: SPD Development Company
name: Jackie Boxer
role: PRINCIPAL_INVESTIGATOR
affiliation: SPD Development Company
name: Raniero Zazzeroni
role: STUDY_DIRECTOR
References:
Clinical trial NCT06987682: Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
Official title: Stimulating Postural Control to Augment Rehabilitation After Cerebral Stroke (SPARC): a Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: functional electrical stimulation
transcutaneous spinal cord stimulation
postural control
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: People living with stroke have a high risk of falling and this risk increases as mobility improves over the first year post-stroke. Despite the high number of falls, there is a lack of interventions to prevent falls after stroke. One possible solution is to alter nerve activity through delivery of a stimulus, such as electrical stimulation. The purpose of this study is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures of combining electrical stimulation with balance training.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or greater
* Diagnosed with a middle cerebral artery stroke \>1 year ago
* Community-dwelling (i.e. not living in long-term care or other inpatient setting)
* Able to stand independently for 60 seconds
* Able to understand spoken English

Exclusion Criteria:

* Any condition other than stroke that significantly affects their postural control (e.g. vestibular disorder, vision loss)
* A prior lower extremity fragility fracture
* A planned injection of botulinum toxin to the legs during the intervention period
* Peripheral nerve damage in the legs
* Contraindications for FES (i.e. implanted electronic device, active cancer or radiation in past six months, uncontrolled epilepsy, skin rash/wound at an electrode site, pregnancy, active deep vein thrombosis)
* Contraindications for TMS (i.e. seizures, metal in the head)
* Previous participation in FES or tSCS within the past 2 years (May affect blinding integrity. Likely uncommon; FES is rarely used in Canada post-stroke.)

Primary outcomes:
measure: Mini-Balance Evaluation Systems Test
timeFrame: From enrollment to the 12-week post-intervention follow-up
measure: Activities-specific Balance Confidence Scale
timeFrame: From enrollment to the 12-week post-intervention follow-up
measure: Strength of the trunk and affected lower limb
timeFrame: From enrollment to the 12-week post-intervention follow-up
Secondary outcomes:
measure: Gait and standing spatiotemporal data
timeFrame: From enrollment to the 12-week post-intervention follow-up
measure: Corticospinal excitability of the affected soleus and tibialis anterior
timeFrame: From enrollment to the 12-week post-intervention follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: KITE Research Institute, Toronto Rehabilitation Institute - University Health Network
state: Ontario
Study officials:
References:
Clinical trial NCT04032782: A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects
Official title: A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136(Efpegerglucagon) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacology
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in healthy subjects.

The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6 active, 2 placebo).


Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 18.5 and ≤ 27 kg/m2 and with a weight ≥ 50 kg

Exclusion Criteria:

* with personal or family history of hypercoagulability or thromboembolic disease
* has had treatment with any incretin therapy
* has FPG \< 70 or \> 110 mg/dL

Primary outcomes:
measure: Adverse Event
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01774682: Kinematics of Obese Patients Perambulation
Official title: Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Morbid Obesity
Surgical Management by Laparoscopic Sleeve Gastrectomy
Keywords: obesity
surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

Detailed description: Laparoscopic Sleeve gastrectomy is the standard surgical procedure for the treatment of obese patients. Even the surgery is well described, there is no available study about its influence on the functional parameters of patients perambulation.

Eligibility criteria: Inclusion Criteria:

* BMI between 40 and 60 kg/m2 or BMI \> 35 kg/m2 with at least one comorbidity
* no weight loss
* between 18 and 65 years old
* history of obesity \> 5 ans

Exclusion Criteria:

* history of bariatric surgery
* major cardiac insufficiency
* pregnancy or breastfeeding
* no social welfare

Primary outcomes:
measure: 6-minute walk test
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: quality of life
timeFrame: 6 months after the surgery
measure: BAROS score
timeFrame: 6 months after the surgery
measure: quality of life with the Mooreheald-Ardelt questionnaire
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
Study officials:
affiliation: CHU Amiens
name: abdennaceur dhahri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rebibo L, Fuks D, Verhaeghe P, Deguines JB, Dhahri A, Regimbeau JM. Repeat sleeve gastrectomy compared with primary sleeve gastrectomy: a single-center, matched case study. Obes Surg. 2012 Dec;22(12):1909-15. doi: 10.1007/s11695-012-0779-9.
citation: Rebibo L, Dhahri A, Verhaeghe P, Regimbeau JM. Early gastric fistula after laparoscopic sleeve gastrectomy: surgical management. J Visc Surg. 2012 Oct;149(5):e319-24. doi: 10.1016/j.jviscsurg.2012.07.004. Epub 2012 Aug 9. No abstract available.
citation: Pequignot A, Dhahri A, Verhaeghe P, Desailloud R, Lalau JD, Regimbeau JM. Efficiency of laparoscopic sleeve gastrectomy on metabolic syndrome disorders: two years results. J Visc Surg. 2012 Oct;149(5):e350-5. doi: 10.1016/j.jviscsurg.2012.06.005. Epub 2012 Jul 17.
citation: Rebibo L, Mensah E, Verhaeghe P, Dhahri A, Cosse C, Diouf M, Regimbeau JM. Simultaneous gastric band removal and sleeve gastrectomy: a comparison with front-line sleeve gastrectomy. Obes Surg. 2012 Sep;22(9):1420-6. doi: 10.1007/s11695-012-0689-x.
citation: Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
Clinical trial NCT06331182: Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain
Official title: Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Ketamine
External Oblique Intercostal Plane Block
Post Thoracotomy Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Detailed description: Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.

As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Patients with neurological or intellectual disability.
* Infection at the injection site.
* Opioid addiction.
* Allergic reaction to local anesthetics.
* Coagulation abnormalities.
* Drug abuse.
* Pregnancy.
* Severe liver and/or renal failure.
* Uncontrolled hypertension.
* Severe cardiovascular problems.
* Diabetes mellitus.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 48 hours postoperative.
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperative
measure: Total morphine consumption in the 1st 24hr and 48 hr
timeFrame: 48 hours postoperatively.
measure: Degree of pain
timeFrame: 48 hours postoperatively.
measure: Heart rate
timeFrame: Till the end of surgery.
measure: Mean arterial blood
timeFrame: Till the end of surgery.
measure: The incidence of adverse events
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbia
Study officials:
affiliation: Tanta University
name: Mohammed S Elsharkawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037582: A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects
Official title: Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 155
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male subjects with good general health as judged by the Investigator
* Body weight of 65.0-95.0 kg (both inclusive)
* Body Mass Index (BMI) of 18.5-27.5 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the Investigator
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Primary outcomes:
measure: Number and severity of adverse events (AEs) recorded
timeFrame: from dosing to Day 22
Secondary outcomes:
measure: The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound
timeFrame: from 0 to 504 hours
Other outcomes:
Locations:
city: Harrow
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: Granhall C, Donsmark M, Blicher TM, Golor G, Sondergaard FL, Thomsen M, Baekdal TA. Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2019 Jun;58(6):781-791. doi: 10.1007/s40262-018-0728-4.
Clinical trial NCT06637982: Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting
Official title: Extended Platelet Rich Fibrin in Mandibular Alveolar Ridge Splitting With Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ridge Splitting
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty two healthy implants will be selected from the outpatient clinic of the oral and maxillofacial department of Mansoura university to be included in this study for replacement of lost posterior teeth with limited bone width.


Eligibility criteria: Inclusion Criteria:

* Patient age 18 years old and older.
* Patient's cooperation, motivation and good oral hygiene.
* Atrophic posterior mandible of horizontal alveolar dimension range between 3 - 6 mm at the crest, with minimum 10 mm vertical height from the alveolar crest to the superior border of the inferior alveolar canal.
* Absence of undercuts in buccal aspect of the ridge.
* Favorable occlusion and no parafunctional habits.
* Patients able to comply with the required recall visits.
* No gender preface in selection of the patients.
* Acceptable inter-arch space for the future prosthesis.

Exclusion Criteria:

* Any pathological condition at the site of surgery.
* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
* Patient taking drugs that could affect bone healing process as immunosuppressive drugs and bisphosphonates.
* Heavy smoking and alcoholism.
* Parafunctional habits such as bruxism and clenching.
* Signs of acute infection or pus discharge.
* Untreated periodontal disease or bad oral hygiene.

Primary outcomes:
measure: implant stability
timeFrame: 9 months
measure: alveolar ridge width
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura, Egypt
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT04815382: Effects of a Dynamic Upper Limb Orthosis in Patients With Parkinson's Disease
Official title: Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Tremor, Limb
Rigidity, Muscle
Keywords: Parkinson Disease
Tremor
Rigidity
Upper Limb
Dynamic Orthosis
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2021-03-25
Enrollment: 40
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: This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity

Detailed description: Objective: To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.

Design and setting: A randomized controlled clinical trial of two parallel groups.

Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)

. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson's disease according to "brain bank" criteria
* Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale

Exclusion Criteria:

* Moderate cognitive or language impairment
* Musculoskeletal or dermatological diseases in the upper limb
* Impossibility of follow-up for 6 months
* Difficulty to attend to assessment visits
* Allergy to glove composition

Primary outcomes:
measure: Rigidity of the upper limb
timeFrame: 3 months
measure: Tremor of the upper limb
timeFrame: 3 months
Secondary outcomes:
measure: Manual dexterity of the upper limb
timeFrame: 3 months
measure: Daily Living Activities
timeFrame: 3 months
measure: Emotional state and quality of life.
timeFrame: 3 months
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Universitary of Burgos
Study officials:
affiliation: University of Burgos
name: Raúl Soto-Cámara, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Burgos
name: Jeronimo Javier González-Bernal, PhD
role: PRINCIPAL_INVESTIGATOR
References: