louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06036888: DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome
Official title: DEFILE-QoL5 - Evaluation de la Prise en Charge Chirurgicale à 5 Ans du Syndrome du défilé Thoraco-brachial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Outlet Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed for thoraco-brachial outlet syndrome and treated surgically in the department of university Angers hospital in 2016

Brief summary: The study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the University Hospital of Angers for the management of a thoraco-brachial outlet syndrome. It includes all vascular and neurological manifestations related to intermittent or permanent compression of the vasculo-nervous bundle of the upper limb. Before and after the operation, these patients had agreed to complete the quality of life questionnaires, the Disabilities of the Arm, Shoulder and Hand questionary (DASH) and the Short-Form 12 (SF-12). The objective of the present study is to evaluate the long-term quality of life, using the questionnaires mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet syndrome and who participated in the DEFILE-QoL study in 2016.

Detailed description: All patients included in the DEFILE-QoL study (in 2016) receive an information letter. Without opposition from them after 4 weeks, they are contacted by telephone. The telephone interview begins with an explanation of the study and a time to answer any questions from the patient.

If they agree to participate, they answer the DASH and the SF-12 questionnaires, for an estimated duration of 15 minutes. Following the telephone interview, the patient's participation in the study was terminated.

The date of the information and the patient's non-objection are documented in the patient's source file.

Eligibility criteria: Inclusion Criteria:

* Adult
* having participated in the initial study : "DEFILE-QoL"

Exclusion Criteria:

* opposing participation in the research
* unable to answer questionnaires

Primary outcomes:
measure: Quality of life scores
timeFrame: at least 5 years after surgery
Secondary outcomes:
measure: Factors associated with poor long-term clinical outcome
timeFrame: at least 5 years after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Myriam AMMI
state: Maine Et Loire
Study officials:
affiliation: University hospital of Angers
name: Cécile Jaglin-Grimonprez
role: STUDY_DIRECTOR
References:
Clinical trial NCT01381588: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
Official title: The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 1136
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women

Brief summary: This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled.

Detailed description: This is an observational study to investigate the prevalence of osteoporotic fractures in post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine X-ray and answer to a few questions. Their medical record will be reviewed and relevant clinical findings will be collected.

Eligibility criteria: Inclusion Criteria:

* Subjects who were diagnosed post menopausal state
* Subjects over 50 years old
* The Definition of Post Menopause Women : Women whose last menstruation was over 12months ago
* Subjects who visit orthopedic surgery
* Subjects who have informed consents

Exclusion Criteria:

* Subjects who are not confirmed as post menopause state
* Subjects who do not understand the contents of questionnaire
* Subjects over 80 years old
* Subjects experienced any high energy fracture (including trash and fall) within 3 months.
* Subjects experienced a fracture except vertebral fracture within 6 months
* Unable to evaluate L-spine BMD over 2 levels because of spinal fracture or instrumentation for L-spine 1-4.
* Unable to evaluate BMD at both femur because of hip fracture or instrumentation.

Primary outcomes:
measure: The prevalence of OVCFs confirmed by history and X-ray
timeFrame: 1 day
Secondary outcomes:
measure: The prevalence of asymptomatic (or missed) fractures
timeFrame: 1 day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03530488: The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy
Official title: The Value of Endocervical and Endometrial Lidocaine Flushing Before Office Hystroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain During Hystroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: women candidate for office hystroscopy were randomized to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline before office hystroscopy

Detailed description: Patients were asked to urinate to evacuate the bladder. Posterior vaginal retractor was introduced to expose the cervix and ( embryo transfer catheter was introduced throught the cervix passing the internal os and intrauterine and intracervical instillation of to either flushing of the endocervix and endometrium with 4 ml lidocaine 2% diluted in 15 ml normal saline or 19 ml normal saline.

After 5 mins the procedure was started A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.

Post procedure pain management by optional dose of 75 mg of diclofenac potassium when requested.

Eligibility criteria: Inclusion Criteria:

* all women indicated for office hysteroscopy for evaluation of the uterine cavity eg: AUB, infertility

Exclusion Criteria:

* Women allergic to local anesthesia those required operative hysteroscopy under general anesthesia pelvic inflammatory disease known cervical malignancy profuse uterine bleeding, marked cervical stenosis recent uterine perforation previous cervical surgery and neurological disorders affecting evaluation of pain using other products that could affect the consistency of the cervix such as local estrogen, misoprostol or laminaire are contraindications for office hystroscopy

Primary outcomes:
measure: Pain assessment during the hysteroscopy
timeFrame: during hystroscopy procedure
Secondary outcomes:
measure: Pain assessment 10 minutes after hysteroscopy
timeFrame: 10 minutes after hysteroscopy
measure: Pain assessment 30 minutes after hysteroscopy
timeFrame: 30 minutes after hysteroscopy
measure: Pain assessment 60 minutes after hysteroscopy
timeFrame: 60 minutes after hysteroscopy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shoab AY, Maged AM, Ramadan W, Dahab S, Deeb WS, Ali YZA, Mostafa WAI, Hussein EA. The value of endocervical and endometrial lidocaine flushing before office hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2020 Jan;148(1):113-117. doi: 10.1002/ijgo.12992. Epub 2019 Oct 19.
Clinical trial NCT05931588: Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Official title: Effect of Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Fatigue
Keywords: Pilates
maternal fatigue
maternal functioning
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue, maternal functioning and quality of life.

Detailed description: the effect of Pilates exercises in reducing postpartum fatigue is not well known however in recent study Pilates exercises alone was quantified which was based on home exercises and had a positive effect, it was conducted in primiparas women, there was also possibility of recall bias due to self report nature of data

Eligibility criteria: Inclusion Criteria:

* Multiparous females
* Age 18 to 45 years
* Females with vaginal delivery
* Two weeks after Spontaneous Vaginal Delivery
* Fatigue score of \>11 on Fatigue Assessment scale

Exclusion Criteria:

* Postpartum depression score greater or equal to 10 , based on the Edinburgh Postnatal Depression scale (EPDS)
* Postpartum anemia
* Generalized Anxiety Disorders
* Chronic illnesses (Diabetes /hypothyroidism)

Primary outcomes:
measure: postnatal maternal fatigue
timeFrame: 8 Week
Secondary outcomes:
measure: barkin indexmaternal functioning
timeFrame: 8 Week
measure: postnatal quality of life
timeFrame: 8 Week
Other outcomes:
measure: generalized anxiety scale
timeFrame: 8 Week
measure: • Edinburgh postnatal depression scale (EPDS)
timeFrame: 8 Week
Locations:
city: Rawalpindi
country: Pakistan
facility: Imrana nasir family clinic
state: Punjab
Study officials:
affiliation: riphah internation university
name: Summra Andleeb, MS(OMPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01619488: Laparoscopic Adjustable Gastric Banding in Adolescents
Official title: Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Lap-Band
morbid obesity
adolescents
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 57
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

Detailed description: This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Eligibility criteria: Inclusion Criteria:

* ages 14-19
* BMI \> 35
* history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
* confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.

Exclusion Criteria:

* history of congenital or acquired anomalies of the GI tract.
* history of esophageal motility disorders
* uncontrolled psychiatric problems
* previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
* uncontrolled eating disorders

Primary outcomes:
measure: Total Weight Loss
timeFrame: Up to five years post surgery.
Secondary outcomes:
measure: Insulin Resistance
timeFrame: Baseline
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: A I duPont Hospital for Children/Nemours Children's Clinic
state: Delaware
Study officials:
affiliation: A I duPont Hospital for Children; Nemours Children's Clinic
name: Kirk Reichard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03717688: The Effects of Neprilysin on Glucagon-like Peptide-1
Official title: The Effects of Neprilysin on Glucagon-like Peptide-1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Heart Failure
Keywords: GLP-1
Neprilysin
DPP-4
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participants are on 4 study days with wash out period of minimum 2 weeks randomized to 4 intervention arms
Primary purpose: TREATMENT

Brief summary: In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of a neprilysin inhibitor

Detailed description: Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of GLP-1

Eligibility criteria: Inclusion Criteria:

* men
* body mass index between 20-25

Exclusion Criteria:

* acute diseases within the two weeks
* chronic diseases
* smoker
* alcoholism, drug addiction or recent weight loss
* blood donation within the last 3 months

Primary outcomes:
measure: GLP-1
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
Secondary outcomes:
measure: C-peptide
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
measure: Glucagon
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
Other outcomes:
measure: Blood glucose
timeFrame: 3 hours after treatment and during the subsequent standardized meal
measure: GIP
timeFrame: 3 hours after treatment ( during the subsequent standardized meal)
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
References:
citation: Wewer Albrechtsen NJ, Mark PD, Terzic D, Hansen LH, Andersen UO, Hartmann B, Carr RD, Gustafsson F, Deacon CF, Holst JJ, Goetze JP, Plomgaard P. Sacubitril/Valsartan Augments Postprandial Plasma Concentrations of Active GLP-1 When Combined With Sitagliptin in Men. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3868-3876. doi: 10.1210/jc.2019-00515.
citation: Thonsgaard S, Prickett TCR, Hansen LH, Wewer Albrechtsen NJ, Andersen UO, Terzic D, Plomgaard P, Gustafsson F, Goetze JP, Mark PD. Circulating Concentrations of C-Type Natriuretic Peptides Increase with Sacubitril/Valsartan Treatment in Healthy Young Men. Clin Chem. 2022 May 18;68(5):713-720. doi: 10.1093/clinchem/hvac005.
Clinical trial NCT01219088: Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw
Official title: Post Operative Pain Control Among Intrathecal 0.1 mg Morphine, Femoral Nerve Block, or Periarticular Infiltration of 20 mL of 0.25% Bupivacaine in Patients Post Intramedullary Hip Screw
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Femoral Neck Fractures
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Falls are a common problem in elderly patients resulting fractured femur, which require early operation. Adequate postoperative pain control will provide good recovery. The investigators will compare the efficacy of postoperative pain control among intrathecal morphine, femoral nerve block, and periarticular infiltration with bupivacaine in patients undergone intramedullary hip screw under spinal anesthesia.

Detailed description: Study methods :

Every patients without any exclusion criteria will be performed spinal anesthesia by 0.5% heavy bupivacaine then divided into 4 groups

1. Controlled group : spinal anesthesia alone
2. Femoral nerve block by 20 mL of 0.25% bupivacaine before spinal anesthesia
3. Spinal anesthesia plus 0.1 mg morphine intrathecally
4. Spinal anesthesia plus periarticular infiltration with 20 mL of 0.25% bupivacaine

All patients will receive postoperative intravenous patient controlled analgesia (IV PCA) morphine for 48 hours.

Data collection

1. Demographic data
2. Pain score : preoperative, 3 hours postoperative in the 1st six hours, 12 hours postoperative by visual analog scoring system (VASS)
3. Patient global assessment and patient satisfactory VASS at 24 and 48 hours postoperative
4. The amount of morphine at 24 and 48 hours postoperative and the time of the 1st dose

Eligibility criteria: Inclusion Criteria:

* 18-90 years old
* good consciousness, well co-operated, can use PCA machine
* ASA class 1-3
* no contraindication of spinal anesthesia
* accept for spinal anesthesia
* body weight \> 30 kg
* BMI 20-35 kg/m2
* no history of research-drug allergy

Exclusion Criteria:

* previous history of hip surgery (the same side)
* pathological fractured such as severe infection, bone cancer

Primary outcomes:
measure: The amount of morphine consumption.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Efficacy of pain control
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Thitima Chinachoti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Clinical trial NCT03761888: Nicardipine and Labetalol Effects on Cerebral Hemodynamics in Preeclampsia
Official title: How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia Severe
Lead sponsor: Hopital Antoine Beclere
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with severe preeclampsia and antihypertensive drug administrated by i.v. route

Brief summary: Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.


Eligibility criteria: Inclusion Criteria:

* Aged up to 18 years
* patient with severe preeclampsia defined by Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after 20 weeks of amenorrhea, associated with neurologic troubles, eclampsia of epigastric pain.
* Decision by clinician to introduce an antihypertensive therapy by oral route : either labetalol or nicardipine

Exclusion Criteria:

* history of intracranial expansive processus, surgery or vascular disease
* infectious state on probe placement
* unilateral anophthalmia

Primary outcomes:
measure: Change of values obtained by ultrasonography optic nerve sheath measurement from baseline to 2 hours post starting infusion of nicardipine or labetalol.
timeFrame: just before treatment and 2 hours after
Secondary outcomes:
measure: variation of diastolic and systolic velocities in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route
timeFrame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
measure: variation of PI in middle cerebral artery before and after administration of either labetalol or nicardipine by i.v. route
timeFrame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
measure: proportion of pathologic PI in middle cerebral artery in each group
timeFrame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
measure: proportion of optic nerve sheath up to 5.8 mm in each group
timeFrame: just before treatment and at 30 minutes to 60 minutes, 2 hours to 3 hours and 6 hours to 8 hours
measure: values of optic nerve sheath diameter in each group
timeFrame: At 30 minutes to 60 minutes and 6 hours to 8 hours
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Béclère
Study officials:
References: