louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03371537: Study of Hemodynamic Conditions Measured During Hepatectomy
Official title: Study of Hemodynamic Conditions Measured During Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Dysfunction
Circulatory; Change
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 9
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: Patient undergoing laparotomy for liver resection

Brief summary: Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation.

The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.

It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function.

The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.

Detailed description: Measurements of flow rates in the portal vein and the hepatic artery by different transit times are available thanks to the Medistim VeriQTM system that the investigators already use routinely in the context of liver transplantation when performing hepatectomies.

Eligibility criteria: Inclusion Criteria:

* patient 18 years or more
* Patient undergoing laparotomy for liver resection

Exclusion Criteria:

* Patient under tutorship or curatorship
* Pregnant or lactating woman
* Difficulties in understanding French
* Patient operated by laparoscopy
* Patient having objected to the processing of his data

Primary outcomes:
measure: Liver vessel debit
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS
Study officials:
affiliation: University Hospital, Tours
name: Ephrem SALAME, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365337: Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters
Official title: Influence of Serum Vitamin D Levels on Embryo Morphokinetic Parameters in Women Undergoing Controlled Ovarian Hyperstimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: Vitamin D
time lapse monitoring
embryo
Lead sponsor: Bahceci Clinic
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: participants will be recruited among infertile women who is seeking for IVF treatment and fullfilling the inclusion criteria.

Brief summary: The aim of this study is observing the relation between serum Vitamin D levels and morphokinesis of time lapse monitored Day 5 embryo in between 18 and 38 years age women undergoing controlled ovarian hyperstimulation (COH) because of unexplained or tubal factor infertility. Individuals will be divided into 2 groups according to serum vitamin D levels as normal or low , and the influence of those levels in morphokinetic parameters of embryos will be identified.

Detailed description: Up to date there are few studies questioning the serum Vitamin D deficiency as a negative factor for pregnancy rates in women undergoing COH cycles and also are displaying different and inconclusive results. This dedicated negative affects may be mediated through endometrial and/or ovarial factors. In experimental animal models Vitamin D receptors have been found in endometrium and ovaries and deficient levels might have been a cause of impaired folliculogenesis. In one of human study Vitamin D has been suggested as a positive regulator of anti- Mullerian hormone (AMH) production. Therefore, we aimed to clarify the affects of Vitamin D on folliculogenesis, oogenesis and embryo quality in COH cycles by using time lapse monitoring.

Eligibility criteria: Inclusion Criteria:

* 18 years to 38 years age, 2 or less in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) attempt history, Unexplained or tubal factor infertility, Serum Follicle Stimulating Hormone (FSH) \< 10, Antral Follicule Count (AFC)\> 6-8

Exclusion Criteria:

* Male factor infertility, Presence of endometriosis or adenomyosis,Diminished ovarian reserve

Primary outcomes:
measure: time to 2 pronucleus (PN) membrane breakdown, first cleavage and 3, 4, 5, 6, 7, and 8 cells stages, morula and blastocyst stage (t2, t3, t4, t5, t6, t7, t8, t Morula (M), t Blastocyst (B) )
timeFrame: between 17 and 120 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceci Fulya IVF Center
state: Fulya
Study officials:
References:
citation: Dennis NA, Houghton LA, Jones GT, van Rij AM, Morgan K, McLennan IS. The level of serum anti-Mullerian hormone correlates with vitamin D status in men and women but not in boys. J Clin Endocrinol Metab. 2012 Jul;97(7):2450-5. doi: 10.1210/jc.2012-1213. Epub 2012 Apr 16.
Clinical trial NCT01894737: The Effect of Creatine on Muscle Loss
Official title: The Effect of Creatine Supplementation on Muscle Loss During Immobilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to determine the effect of creatine supplementation on muscle mass loss during short-term immobilisation in healthy, young people.

Detailed description: Seven days of one-legged knee immobilisation in young subjects with creatine or Placebo supplementation. A randomly selected leg is immobilized for seven days. Muscle mass and strength will be determined and muscle biopsies will be collected before and immediately after immobilisation. A week after the cast is removed we will assess any differences in recovery between intervention groups.

Eligibility criteria: Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* (Family) history of thrombosis
* Smoking
* Recent surgery
* Performing regular resistance training more than once per week in the past year
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Current systemic use of corticosteroids, growth hormone, testosterone, immunosuppressants or insulin
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
* Use of anti-coagulants
* Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)

Primary outcomes:
measure: change in quadriceps muscle cross-sectional area (CSA)
timeFrame: Before and after 1 week of immobilisation, and after 1 week of recovery
Secondary outcomes:
measure: change in muscle fiber type specific CSA
timeFrame: Before and after 1 week of immobilisation, and after 1 week of recovery
measure: change in muscle strength
timeFrame: before and after 1 week of immobilisation, and after 1 week of recovery
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Luc van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Backx EMP, Hangelbroek R, Snijders T, Verscheijden ML, Verdijk LB, de Groot LCPGM, van Loon LJC. Creatine Loading Does Not Preserve Muscle Mass or Strength During Leg Immobilization in Healthy, Young Males: A Randomized Controlled Trial. Sports Med. 2017 Aug;47(8):1661-1671. doi: 10.1007/s40279-016-0670-2.
citation: Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.
Clinical trial NCT05760937: A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single, Ascending Doses of BMS-986447 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Pharmacokinetics
Pharmacodynamics
Healthy Participants
BMS-986447
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18 and 30 kilograms per metered square (kg/m\^2), inclusive.
* Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory determinations.
* A negative COVID-19 test, which will be performed in the manner mandated by the clinical side where the study is being conducted, at screening and check-in Day -2.

Exclusion Criteria:

* Participant has any condition that confounds the ability to interpret data from the study.
* Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study.
* Any major surgery or planned surgery (except gastrointestinal \[GI\] surgery, as described below) within 12 weeks of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 59 days
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to 59 days
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 34 days
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to 35 days
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to 35 days
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to 34 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 72 hours postdose
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 72 hours postdose
measure: Apparent terminal phase half-life (T-Half)
timeFrame: Up to 72 hours postdose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06360237: Olezarsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
Official title: Olezarsen (ISIS 678354) Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Familial Chylomicronemia Syndrome
Keywords: Familial Chylomicronemia
Familial Lipoprotein Lipase Deficiency
Hyperlipoproteinemias
Familial Hyperlipoproteinemia Type 1
Hyperlipoproteinemia Type 1
Hyperchylomicronemia, Familial
Lipoprotein Lipase Deficiency, Familial
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the Expanded Access Program is to provide pre-approval access of olezarsen to eligible patients with Familial Chylomicronemia Syndrome (FCS).

Detailed description: The Expanded Access Program (EAP) is intended to provide pre-approval access to olezarsen for eligible patients with FCS who have limited or no available treatment options. This program is open in the United States and operates under the individual patient (also referred to as single patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the instructions at https://www.ionispharma.com/patients/expanded-access-policy/

Eligibility criteria: Inclusion Criteria:

* Has a diagnosis of FCS as determined by the sponsoring physician. Ionis will review each application to determine eligibility based on documentation of validated genetic or clinical diagnosis.

  o Documented loss of function mutations (homozygous, compound / double heterozygous) in genes such as LPL, GPIHBP1, APOA5, APOC2 or LMF1) or clinically validated diagnosis of FCS.
* Resides in and is a resident of the United States.
* Willing to follow a diet comprising ≤20 g fat per day.

Exclusion Criteria:

* Has any new or worsening of existing conditions which, in the opinion of the physician, would make the patient unsuitable for treatment with olezarsen.
* Olezarsen naïve patients with baseline platelet count \<100x109/L at qualification.
* Estimated GFR (eGFR) \<30 mL/min/1.73 m2.
* Secondary factors are the cause of triglyceride elevations.
* Is currently hospitalized in an acute emergency setting.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Expanded Access Site
state: California
Study officials:
References:
Clinical trial NCT04351737: Dextenza for Post-operative Treatment of Pterygium
Official title: DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation ComparEd to StandaRd of Care Topical Cortico-Steroid Treatment In PatientS Who Undergo BilaTeral Pterygium Surgery PERSIST Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pterygium of Both Eyes
Lead sponsor: Brandon Eye Associates, PA
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.
Primary purpose: TREATMENT

Brief summary: DEXTENZA for the Treatment of Post-Surgical Pain and Inflammation Compared to Standard of Care Topical Cortico-steroid Treatment in Patients who Undergo Bilateral Pterygium Surgery

Detailed description: In patients who undergo bilateral pterygium surgery, eyes will be randomized to receive either DEXTENZA at baseline, Month 1 and Month 2 or prednisolone x 3 months. Both eyes will receive antibiotic drops four times per day for two weeks and Maxitrol ointment at bedtime for two weeks following surgery.

Eligibility criteria: Inclusion Criteria: patients with bilateral pterygium -

Exclusion Criteria: none

-

Primary outcomes:
measure: Patient pain level follow pterygium removal
timeFrame: 2 months
measure: inflammation
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Brandon Eye Associates
state: Florida
Study officials:
References:
Clinical trial NCT03595137: The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial
Official title: The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. sono with simple needle guide device group
2. sono only group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients


Eligibility criteria: Inclusion Criteria:

1. adult ( ≧19 years old)
2. patients undergoing elective surgery

Exclusion Criteria:

1. emergency surgery
2. patients under cervical immobilization
3. anatomical abnormality for Right internal jugular vein catheterization
4. infection or hematoma at puncture site
5. patients who did not need internal jugular vein catheterization

Primary outcomes:
measure: First access success rate
timeFrame: up to 5 minutes after insertion of puncture needle
Secondary outcomes:
measure: insertion time
timeFrame: 10 minutes after the beginning of the procedure
measure: complication rate
timeFrame: 24 hours after surgery
measure: ease of procedure
timeFrame: 10 minutes after the beginning of the procedure
measure: the number of separate skin puncture
timeFrame: 10 minutes after the beginning of the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02044237: Online Treatment of Trichotillomania
Official title: Decoupling as Internet Based Intervention: an Randomized Controlled Study to Treat Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Alexithymia
Quality of Life
Keywords: trichotillomania
online therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Novartis
name: Julia Bangerter-Rhyner Foundation Bale switzerland
First posted: 2014-01-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Online study for patients with trichotillomania. 4 main hypothesis.

1. Alexithymia and Trichotillomania correlated and regression analyses find association between them
2. we will be able to find patient who have never been treated before. Those will suffer to the same amount as previously treated patients
3. Decoupling will be more helpful than progressive muscle relaxation
4. different constructs of emotion regulation will show different trait and state characteristics in patients with trichotillomania

Detailed description: Randomized controlled trial with about 100 participants.

Eligibility criteria: Inclusion Criteria:

* suffering from trichotillomania 18 to 65 years old

Exclusion Criteria:

* current drug or alcohol addiction current psychosis

Primary outcomes:
measure: Severity of trichotillomania
timeFrame: 7 months
Secondary outcomes:
measure: alexithymia
timeFrame: 7 months
Other outcomes:
measure: Quality of life
timeFrame: 7 months
Locations:
city: Zurich
country: Switzerland
facility: University of
Study officials:
affiliation: University of Zurich
name: Michael Rufer, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moritz S, Treszl A, Rufer M. A randomized controlled trial of a novel self-help technique for impulse control disorders: a study on nail-biting. Behav Modif. 2011 Sep;35(5):468-85. doi: 10.1177/0145445511409395. Epub 2011 Jun 8.
Clinical trial NCT01851837: Exercise Time in Sedentary Middle-aged Female
Official title: Response Of Weight And Lipid Profile To Exercise Time In Sedentary Overweight/Obese Middle-Aged And Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 115
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The exercise time is an important factor among the medical guides for weight loss; however, there is still little knowledge about exercise duration paths in middle-aged and older women. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Detailed description: Participants included sedentary women (age 45-75 years) with overweight or obesity (n= 115). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria: Inclusion Criteria:

* Sedentary lifestyle
* Good Health
* Weight stability

Exclusion Criteria:

\*Abnormality or history of Disease

Primary outcomes:
measure: HDL-c
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Member of Scientific Board in Physical Education and Sport Sciences
name: Mohammadreza Rezaeipour, M.D.
role: PRINCIPAL_INVESTIGATOR
References: