louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03665103: Laser-assisted ICSI Versus Conventional ICSI
Official title: Laser-assisted ICSI Effect on Degeneration Rate After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-11
Enrollment: 966
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Degeneration rate after ICSI is expectable but decreasing it is a goal. Laser-assisted ICSI can serve to decrease this degeneration rate.


Eligibility criteria: Inclusion Criteria:

* all ICSI cycles

Exclusion Criteria:

* no exclusion

Primary outcomes:
measure: oocyte survival after injection
timeFrame: 6 days of culture
Secondary outcomes:
measure: blastocyst formation rate
timeFrame: 6 days of culture
measure: embryo utilization rate
timeFrame: 6 days of culture
measure: clinical pregnancy rate
timeFrame: four weeks after embryo transfer
measure: ongoing pregnancy rate
timeFrame: Twelve weeks of gestation
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
citation: Fawzy M, Emad M, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Elsuity MA, Rashed H, Sabry M. A randomized controlled trial of laser-assisted ICSI. Hum Reprod. 2020 Dec 1;35(12):2692-2700. doi: 10.1093/humrep/deaa160.
Clinical trial NCT04735003: Transcatheter Interventions for Tricuspid Insufficiency in Italy
Official title: TRans-catheter Interventions for triCuspid Valve Insufficiency: the iTalian Multicentre Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: San Raffaele University Hospital, Italy
First posted: 2021-02-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with significant tricuspid regurgitation who need transcatheter tricuspid valve intervention.

Brief summary: This is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. The aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in Italian centres.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis)
2. Patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation.

Exclusion Criteria:

1. Valve anatomy unsuitable for transcatheter tricuspid valve interventions.
2. Subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.

Primary outcomes:
measure: All-cause death
timeFrame: 1-year
measure: Cardiovascular death or heart failure hospitalization
timeFrame: 1-year
Secondary outcomes:
measure: Changes in tricuspid regurgitation degree
timeFrame: 30-day, 1-year and 5-year
measure: Changes in NYHA class
timeFrame: 30-day, 1-year and 5-year
measure: Changes in right ventricular dimensions and function
timeFrame: 30-day, 1-year and 5-year
measure: Changes in liver and kidney function
timeFrame: 30-day, 1-year and 5-year
measure: Changes in medical therapy (i.e. diuretic dose)
timeFrame: 30-day, 1-year and 5-year
measure: All-cause death
timeFrame: 30-day
measure: All-cause death
timeFrame: 5-year
measure: Cardiovascular death or heart failure hospitalization
timeFrame: 30-day
measure: Cardiovascular death or heart failure hospitalization
timeFrame: 5-year
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Marianna Adamo
state: Lombardia
Study officials:
References:
Clinical trial NCT00816803: Cell Transplant in Spinal Cord Injury Patients
Official title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Spinal Cord Injury
Keywords: Spinal cord injury
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
name: Medical Military Academy, Egypt
name: Alexandria University
First posted: 2009-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.


Eligibility criteria: Inclusion Criteria:

* Traumatic spinal cord injury
* No concomitant systemic disease
* No progress on physiotherapy for at least 6 months
* Duration of injury from 10 months to 3 years

Exclusion Criteria:

* Non-traumatic spinal cord injury whether transverse myelitis or demyelination
* Concomitant systemic disease
* Progress can be observed on physiotherapy
* Acute injury or duration of injury less than 10 months

Primary outcomes:
measure: Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
timeFrame: 18 months
Secondary outcomes:
measure: Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University School of Medicine
Study officials:
References:
citation: El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.
Clinical trial NCT02645903: Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
Official title: Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy: Randomized Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: transversus abdominis plane block
living liver transplantation
postoperative analgesia
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 50
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: Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.

Detailed description: This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.

Eligibility criteria: Inclusion Criteria:

* Liver transplantation donors

Exclusion Criteria:

* Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance

Primary outcomes:
measure: pain scores (at movement and at rest)
timeFrame: postoperatively at 24 hours
Secondary outcomes:
measure: morphine consumption
timeFrame: postoperatively at 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University
name: Mehmet Ali Erdogan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
Clinical trial NCT01852903: Comparative Bioavailability of Two Forms of Vitamin C
Official title: A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: vitamin C
calcium ascorbate
ascorbic acid
bioavailability
Lead sponsor: NBTY, Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
name: Moyad, Mark MD MPH
First posted: 2013-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by laboratory results and medical history
* Females not of child bearing potential
* BMI 18-30 kg/m2
* Agrees to consume a low vitamin C diet
* Non-smoker or ex-smoker \>1 year

Exclusion Criteria:

* Pregnant, breastfeeding, or planning to become pregnant during the trial
* Alcohol \>2 drinks per day; alcohol or drug abuse within the past year
* Cardiac conditions
* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
* History irritable bowel syndrome, malabsorption or significant GI disease
* History of kidney stones
* Use of medications known to interact with vitamin C
* Use of supplements containing vitamin C
* Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
* History of or current diagnosis of cancer
* Uncontrolled hypertension
* History of diabetes, renal disease and/or liver disease
* Unstable psychiatric disorder
* History of or current immunocompromise
* History of hemochromatosis or hemoglobinopathies
* Participation in a clinical research trial \<30 days
* Use of acute medication w/in 72 hours of intervention
* Unstable medications \<90 days
* Abnormal liver function
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Anemia of any etiology
* Blood donation w/in the last 2 months
* Allergy or sensitivity to test articles, foods or beverages provided during the study
* Cognitive impairment and/or unable to give informed consent

Primary outcomes:
measure: Plasma and leukocyte vitamin C concentration
timeFrame: 0, 2, 4, 8 and 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Synergize Inc
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale R Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitmesser SH, Ye Q, Evans M, Combs M. Determination of plasma and leukocyte vitamin C concentrations in a randomized, double-blind, placebo-controlled trial with Ester-C((R)). Springerplus. 2016 Jul 25;5(1):1161. doi: 10.1186/s40064-016-2605-7. eCollection 2016.
Clinical trial NCT02640703: Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Official title: Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premature Birth
Intermittent Hypoxiema
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination.

Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.

Detailed description: Intervention: First hexavalent vaccination given to very preterm infants either in the evening or in the morning.

Primary outcome: rate of desaturations (SpO2 \<80%) and bradycardias (Pulse rate \<100/min) in first 24 h following vaccination in evening vs. morning vaccination group Secondary outcomes: cytokine levels (IL 6, IL 1ß, CRP) measured 24 h after vaccination, pertussis- and haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age, in evening vs. morning vaccination group

Eligibility criteria: Inclusion Criteria:

* gestational Age: 26+0 to 30+6 Weeks of gestational age

Exclusion Criteria:

* bronchopulmonary dysplasia
* periventricular leukomalacia
* intraventricular hemorrhage \>°2
* congenital malformations

Primary outcomes:
measure: Number of hypoxia and bradycardia events
timeFrame: 72 hours
Secondary outcomes:
measure: Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination
timeFrame: Before vaccination and at the age of 4 months (corrected age)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Childrens Hospital
Study officials:
affiliation: Dept. of Neonatology, Tuebingen University Hospital
name: Christian F. Poets, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833403: Metabolomic Analysis of Hepatic Insulin Resistance
Official title: Metabolomic Analysis of Hepatic Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: bariatric surgery, l
liver insulin resistance,
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to show that it is possible to identify the specific types of fats in blood, adipose tissue, and liver tissue. The study doctors hope to use the analysis of these fats to learn more about nonalcoholic fatty liver disease (NFLD). Nonalcoholic fatty liver disease is the accumulation of fat in the liver of people who have minimal alcohol exposure. Nonalcoholic Fatty Liver Disease is associated with obesity and insulin resistance, and predicts development of Type 2 Diabetes. The study doctors are interested in looking at the relationship between liver fat and insulin resistance.


Eligibility criteria: Inclusion Criteria:

Subjects eligible to participate in the study will be:

1. Adults over age 18;
2. Patients enrolled in the bariatric surgery clinic who are planning to undergo and have insurance approval for bariatric surgery;
3. Insulin sensitive (based on HOMA-IR calculated from screening labs) OR insulin resistant (based on HOMA-IR and or personal history of diet controlled diabetes)
4. Able and willing to give informed consent.

Exclusion Criteria

The following will exclude subjects from study participation:

1. Clinically significant medical issues outside of diabetes (eg, pregnancy, cardiovascular disease, uncontrolled pulmonary disease). If female and of child bearing potential, a pregnancy test will be performed and confirmed negative prior to participation in the study and prior to the scheduled glucose clamp procedure.
2. A history of hematologic (platelets \<100 x107/L), hepatic (liver function tests \[LFTs\] \>2X upper limit of normal), renal (Creatinine \>1.5 mg/dL), pulmonary/ cardiac abnormalities (ie, abnormal electrocardiogram \[EKG\]).
3. Use of anti-diabetes medication, anticoagulants, or medication that might alter lipids. If the subject has a history of diabetes, it should be controlled by diet alone.
4. Inflammatory or celiac intestinal disease;
5. Untreated thyroid disease;
6. Excessive alcohol use, illicit drug use, or active untreated psychiatric disease.

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: Baseline
measure: Insulin Sensitivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Lisa Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02395003: Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents
Official title: Study to Investigate Adipocyte Cell and Lipid Turnover in Obese Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Obesity
Keywords: Obesity
Pediatric
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-03-20
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese adolescents

Brief summary: Insulin Resistance is the best predictor of whether the obese adolescent will develop type 2 diabetes. The present studies will focus on determining what might cause fat to accumulate in the subcutaneous fat regions and lead to local inflammation, causing insulin resistance to develop in obese adolescents.

Detailed description: The purpose of this study is to test whether the reduced transcription of key lipogenic/adipogenic genes in abdominal subcutaneous adipose tissue (SAT) in obese adolescents with a High VAT/SAT (visceral adipose tissue/subcutaneous adipose tissue) ratio translates functionally into a reduced in vivo triglyceride (TG) synthesis and adipocyte proliferation, which in turn will contribute to ectopic fat accumulation and insulin resistance (IR). To test whether the storage capacity of gluteal SAT is linked to the level of VAT/SAT fat distribution in obese adolescents. To explore if changes in dietary fat intake (palmitate intake) alters ceramide concentration in both plasma and adipose tissue (AT) and the Inflammasome complex in the different fat distribution phenotypes and their associations with IR.

Eligibility criteria: Inclusion Criteria:

* Overweight (85-95th% age and gender specific) or Obese (\>95th% age and gender specific)
* Ages 12-18 years
* Absence of any endocrinopathy
* Absence of any therapy with medication known to alter glucose metabolism (i.e.: Oral steroids, certain psychiatric medications such as Xeleca, Lithium, Paxil)
* English Speaking subjects

Exclusion Criteria:

* Any disease known to alter glucose metabolism (T2DM)
* Diuretic Medication
* Pregnant or breastfeeding
* Type 1 or 2 diabetes

Primary outcomes:
measure: Fat Biopsies
timeFrame: Baseline
Secondary outcomes:
measure: MRI
timeFrame: Baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
affiliation: Yale University
name: Sonia Caprio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597203: Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial
Official title: Efficacy and Safety of Using Combination of 755-nm Picosecond Alexandrite Laser and 2% Hydroquinone Compared With 2% Hydroquinone Alone for the Treatment of Melasma: a Randomized Split-face Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Melasma
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 20
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: This study aims to assess the efficacy and safety of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone compared with 2% hydroquinone alone for the treatment of melasma: A randomized split-face controlled trial


Eligibility criteria: Inclusion Criteria:

* Both male and female age 18-60 years
* Melasma on both cheeks - epidermal or mixed type
* Fitzpatrick Skin type III-V

Exclusion Criteria:

* History of retinoid or other keratolytic drugs used within 6 months before enrolled
* History of keloid
* photosensitivity
* Immunocompromised host

Primary outcomes:
measure: Modified melasma area and severity index score(mMASI) - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma of using combination of 755-nm picosecond alexandrite laser and 2% hydroquinone
timeFrame: 6 months
measure: Melanin index measured by Mexameter® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
timeFrame: 6 months
measure: Average melanin measured by Antera3D® - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
timeFrame: 6 months
measure: Patient satisfaction quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
timeFrame: 6 months
measure: Physician evaluation quartile score - comparing between Picosecond laser 755 nm with 2%HQ and 2%HQ alone for treatment of melasma
timeFrame: 6 months
Secondary outcomes:
measure: Safety of using combination of 755-nm picosecond alexandrite laser
timeFrame: 6 months
measure: Safety of using 2% hydroquinone
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
References:
citation: Manuskiatti W, Yan C, Gulfan MCB, Techapichetvanich T, Wanitphakdeedecha R. Combination of a 755-nm picosecond laser and hydroquinone 2% cream versus hydroquinone 2% cream alone for the treatment of melasma: A randomized, split-face, and controlled trial. Lasers Surg Med. 2022 Dec;54(10):1245-1250. doi: 10.1002/lsm.23615. Epub 2022 Nov 8.