louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02460354: Metformin and Congenital Nephrogenic Diabetes Insipidus
Official title: Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Insipidus
Keywords: Congenital nephrogenic diabetes insipidus
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).

Detailed description: Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.

Eligibility criteria: Inclusion Criteria:

* Males with a documented mutation in the vasopressin type 2 receptor (V2R)
* Willing to provide consent and/or assent as appropriate
* Capable of providing urine samples as dictated by the protocol

Exclusion Criteria:

* Urinary incontinence
* Subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than Nephrogenic Diabetes Insipidus (NDI)
* Subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (GFR) \<80 ml/min/1.73 m\^2)
* Subjects with acquired NDI

Primary outcomes:
measure: Change in mean urine osmolality
timeFrame: Baseline, 7 hours
Secondary outcomes:
measure: Change in mean urine volume
timeFrame: Baseline, 7 hours
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Childen's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Larry Greenbaum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Titilayo Ilori, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06704854: Influence of Acute Daily Workload Changes on Low-frequency Fatigue Morning Scores
Official title: Influence of Acute Daily Workload Changes on Low-frequency Fatigue Morning Scores Throughout an In-season Soccer Microcycle
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fatigue Intensity
Keywords: fatigue
low-frequency fatigue
soccer
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 20
Sex: MALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elite soccer players competing at the highest national level

Brief summary: In recent years, the increased demands of both training and competition have heightened the need of load monitoring among soccer players. However, adopting metrics that comprehensively capture the intricacies of neuromuscular fatigue remains a challenge. Assessing low-frequency fatigue may contribute to fill this gap, as it provides an objective measure to evaluate muscle function readiness. Thus, the aim of this study was to examine whether variability in low-frequency fatigue morning scores are related to training external load acute changes throughout the in-season microcycle.


Eligibility criteria: Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* injured athletes

Primary outcomes:
measure: low-frequency fatigue
timeFrame: Day 1 (0 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05987254: Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients
Official title: Comparison Between Peri-Capsular Nerve Group and Supra Inguinal Fascia Iliaca BLOCK for Analgesia and Ease of Positioning During Neuraxial Anesthesia in Hip Fracture Patients: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Hip Fractures
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Severe pain associated with fractured hip often results in difficulty during positioning for spinal anesthesia (SA). Among many regional analgesic techniques, the fascia iliaca compartment block (FICB) is popular among anesthesiologists to provide immediate as well as postoperative analgesia in hip fractures. Recently, the pericapsular nerve group (PENG) block has been proposed to provide effective analgesia in hip fracture patients. However, comparative studies between PENG and FICB are lacking.


Eligibility criteria: Inclusion Criteria:

* 40 years and above with hip fracture with persistent pain and scheduled for surgery under spinal anesthesia (SA)

Exclusion Criteria:

* any contraindications to SA or peripheral nerve blocks, history of ischaemic heart disease, patients on opioids for chronic pain and patients with significant cognitive impairment. Patients who had no pain while sitting by themselves (resting pain less than 4 on NRS) for SA without any support were also excluded.

Primary outcomes:
measure: NRS
timeFrame: 30 minute postoperative
measure: The ease of spinal positioning (EOSP)
timeFrame: Thirty minutes after the blocks
Secondary outcomes:
measure: amount of tramadol used
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Haney Baumey
city: Cairo
country: Egypt
facility: Facualty of Pharmacy, Al Azhar University
city: Tanta
country: Egypt
facility: Neveen Kohaf
Study officials:
References:
Clinical trial NCT00772954: Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
Official title: A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of Two Doses of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Adult Volunteers (18 - 55 Years)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Keywords: Clostridium difficile diarrhea
Clostridium difficile toxoid vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.

Detailed description: This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Eligibility criteria: Inclusion Criteria:

* Adult males or females, 18 - 55 years in good general health

Exclusion Criteria:

* Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening
* Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication
* Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Primary outcomes:
measure: Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
timeFrame: Day 0 up to 70 days post first vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis N Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569854: Genetic Influence on Statin Pharmacodynamics
Official title: An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hyperlipidemia
Hypercholesterolemia
Dyslipidemia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2012-04-03
Enrollment: 0
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: Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

Brief summary: The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)


Eligibility criteria: Inclusion Criteria:

* recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin

Exclusion Criteria:

* concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism

Primary outcomes:
measure: carotid intimal media thickness (CIMT)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joseph P Kitzmiller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01959854: Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye
Official title: Evaluation of Xanthan Gum Eye Drops in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2% xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of oxidative stress.

Detailed description: Oxidative stress is the result of an imbalance between the production of reactive oxygen species (ROS) and antioxidant systems . The eye is constantly exposed to solar UV radiation which is the major inducer of ROS production and therefore oxidative stress has been implicated in the pathogenesis of several eye disease, including dry eye. Xanthan gum is a complex exopolysaccharide utilized as a food additive. Its chemical structure shows a capacity to react with ROS indicating a role as an anti-oxidative molecule.

In the present study aging patients with dry eye will be enrolled. Signs and symptoms of dry eye as well as levels of oxidative stress in tear will be evaluated afte 30 days of treatment with eye drops containing carboxymethylcellulose or xanthan gum.

Eligibility criteria: Inclusion Criteria:

* Ocular Surface Disease Index \> 12\<23 and age \>59 yrs

Exclusion Criteria:

* contact lens wear and use of other ophthalmic solutions with the exception of artificial tears

Primary outcomes:
measure: Ocular surface disease index (OSDI)
timeFrame: change from baseline OSDI at 30 days
Secondary outcomes:
measure: Visual analogue rating scale (VARS)
timeFrame: change from baseline VARS at 30 days
measure: Fluorescein staining
timeFrame: change from baseline staining at 30 days
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina (ITALY)
name: Pasquale Aragona, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114854: A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
Official title: A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 69
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: This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.


Eligibility criteria: Inclusion Criteria:

1. Adult male or female patients with epilepsy on stable doses of topiramate.
2. Able to voluntarily provide written informed consent to participate in the study.
3. Use of an effective form of birth control if of child-bearing potential.

Exclusion Criteria:

1. Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
2. Recent or recurrent suicidal thoughts or ideation.
3. Clinically significant medical condition that may affect the safety of the subject.
4. Females who are pregnant or lactating.

Primary outcomes:
measure: relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
timeFrame: 2 weeks
Secondary outcomes:
measure: relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Kyle Patrick
state: Arizona
city: Little Rock
country: United States
facility: Victor Biton
state: Arkansas
city: National City
country: United States
facility: Mohammed Bari
state: California
city: Fort Lauderdale
country: United States
facility: Dr. Segal
state: Florida
city: Gainesville
country: United States
facility: Dr. Sackellares
state: Florida
city: Atlanta
country: United States
facility: James Kiely
state: Georgia
city: Wichita
country: United States
facility: Bassem El-Nabbout
state: Kansas
city: Lexington
country: United States
facility: Dr. Chumley
state: Kentucky
city: Oklahoma City
country: United States
facility: Dr. Fisher
state: Oklahoma
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Paolo Baroldi, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01226654: Quantitative Imaging and Proton Spectroscopy in Multiple Sclerosis
Official title: Quantitative MR Imaging and Proton Spectroscopy in MS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Quantitative Imaging of Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-10-22
Enrollment: 69
Sex: ALL
Minimum age (years): 7
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to detect changes in the brain that may be associated with multiple sclerosis. Results will be compared to age matched controls. Investigators will assess lesions by measuring T2 and T1 enhanced lesion volumes and magnetization transfer ratio histogram parameters (MTRHP) in patients with relapsing-remitting and secondary-progressive disease. This data will be correlated to total brain parenchymal volume as well as identifying the effect of MS lesions on the gray and white matter, volumetric disability, including Kurtzke Expanded Disability Status Scale (EDSS) and a specific battery of neuropsychological tests. Quantitative analysis of whole brain N-acetylaspartate (WBNAA), a reproducible measure of viable neuron number, using 1H MRS and compare the results to age-matched controls over duration of 5 years.


Eligibility criteria: Inclusion Criteria:

1. Patients with known MS diagnosis
2. Age 7-110 years
3. Males or females

Exclusion Criteria:

1. Medically unstable
2. Artificial implants in the body
3. Pregnant

Normal Controls

Primary outcomes:
measure: Assess the MS lesions using Magnetization transfer ratio histogram parameters and compare it to total brain parenchymal volume
timeFrame: 5 years
Secondary outcomes:
measure: Quantitative analysis of whole brain N-acetylaspartate (WBNAA)
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Yulin Ge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ge Y, Zohrabian VM, Osa EO, Xu J, Jaggi H, Herbert J, Haacke EM, Grossman RI. Diminished visibility of cerebral venous vasculature in multiple sclerosis by susceptibility-weighted imaging at 3.0 Tesla. J Magn Reson Imaging. 2009 May;29(5):1190-4. doi: 10.1002/jmri.21758.
Clinical trial NCT02357654: GnRH for Luteal Support in IVF/ICSI/FET Cycles
Official title: GnRH for Luteal Support in IVF/ICSI/FET Cycles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertility
Lead sponsor: University Reproductive Associates
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old.

Exclusion Criteria:

* day 3 transfers

Primary outcomes:
measure: Live birth per transfer
timeFrame: 9 months
Secondary outcomes:
measure: implantation rates
timeFrame: 4 weeks
measure: clinical pregnancy
timeFrame: 4 weeks
measure: rates of OHSS
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hasbrouck Heights
country: United States
facility: University Reproductive Associates
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Peter G McGovern, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD009154. doi: 10.1002/14651858.CD009154.pub2.
citation: Oliveira JB, Baruffi R, Petersen CG, Mauri AL, Cavagna M, Franco JG Jr. Administration of single-dose GnRH agonist in the luteal phase in ICSI cycles: a meta-analysis. Reprod Biol Endocrinol. 2010 Sep 8;8:107. doi: 10.1186/1477-7827-8-107.
Clinical trial NCT03021954: Platelet Rich Plasma in Levator Ani Muscle Trauma
Official title: The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pelvic Floor Disorders
Keywords: platelet rich plasma
levator ani muscle
post-partum trauma
ballooning trauma
levator ani muscle strength
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2017-01-16
Enrollment: 116
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.

Detailed description: This study aims to see if PRP has a beneficial effect on the repair of pelvic floor muscle damage in primipara. Therefore, this single-blinded randomized clinical trial compares the pelvic floor muscle repair in primipara following labor between the interventional group who received intramuscular PRP injection in levator ani muscle and the control group, as assessed by ultrasonography, perineometry. The ultrasonography outcome measures include lower hiatal area during Valsalva. The assessments are performed at multiple time points, which are before labor, 24-48 hours post-labor, 40 days post-labor, and 3 months post-labor.

Eligibility criteria: Inclusion Criteria:

* primigravida, in third trimester pregnancy
* plan to do vaginal birth
* have a clear address and telephone number that can be contacted
* consent to participate in this study

Exclusion Criteria:

* history of pelvic floor disorder before pregnancy
* history of pelvic surgery
* avulsion of levator ani muscle (seen in USG)
* unstable hemodynamic
* trombocytopenia (\< 150,000)
* anemia (Hb\< 10)
* sepsis
* infection on perineum
* corticosteroid intake within last 2 weeks
* smoking
* hematopoetic or bone cancer
* delivery by c-section
* no perineoraphy after birth

Primary outcomes:
measure: Changes of Levator Hiatal Area During Valsava
timeFrame: Baseline (third trimester), 40 days post-partum, 3 months post-partum
measure: Changes in Pelvic Floor Muscle Contraction
timeFrame: Baseline (third trimester), 40 days post partum, and 3 months post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Primary Care Centre
state: DKI Jakarta
Study officials:
affiliation: FKUI/RSCM
name: Fernandi Moegni, MD,OBGYN(C)
role: PRINCIPAL_INVESTIGATOR
References: