louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01936493: Biologic Predictors of Leiomyoma Treatment Outcomes
Official title: Biologic Predictors of Leiomyoma Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Leiomyomas
Fibroids
Uterine Fibroids
Myomas
Keywords: Uterine leiomyomas (fibroids or myomas)
Uterine fibroids
Fibroids
Uterine leiomyomas
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.

Brief summary: The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.

Detailed description: There is little information to predict outcomes of leiomyoma therapies. It is clear that both environmental exposures and genetic predisposition influence disease manifestations. Our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. Specifically we will collect serum aliquots, genomic DNA and information using a genetic epidemiology questionnaire. In the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.

Eligibility criteria: Inclusion Criteria:

1. Able and willing to give consent
2. Age 18 or older
3. Presence of known uterine leiomyoma

Exclusion Criteria:

1. Suspected malignancy

Primary outcomes:
measure: Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic - Rochester, Minnesota
name: Elizabeth A. Stewart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05640193: A Study of LN-144 in People With Metastatic Melanoma to the Brain
Official title: Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic Melanoma
Keywords: LN-144
Non-uveal melanoma
Lifileucel (LN-144)
22-322
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Iovance Biotherapeutics, Inc.
First posted: 2022-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Detailed description: Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

Eligibility criteria: Inclusion Criteria:

1. Metastatic melanoma with asymptomatic brain metastases
2. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
3. Must be ≥ 18 years of age at time of consent
4. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
5. Adequate hematologic parameters and organ function

Exclusion Criteria:

1. Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
2. Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
3. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
4. Symptomatic brain metastases
5. Chronic systemic steroid therapy of \> 10 mg/day
6. Active medical illness(es) that would pose increased risk for protocol participation
7. Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable
8. Primary immunodeficiency
9. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
10. Pregnant or breastfeeding
11. Patients who cannot receive gadolinium-enhanced MRI.

Primary outcomes:
measure: Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alexander Shoushtari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553293: Nordic Luveris Study
Official title: Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
In Vitro Fertilization
Keywords: infertility
in vitro fertilization
LH supplementation
Benefits
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Viborg, Skive
name: Karolinska University Hospital
name: Helse Fonna
name: Turku Hospital
name: Odense University Hospital
name: Herlev Hospital
name: Holbaek Sygehus
name: Hvidovre University Hospital
First posted: 2007-11-04
Enrollment: 526
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.


Eligibility criteria: Inclusion Criteria:

* Age below 40
* Infertility treatable by IVF or ICSI
* Regular cycles

Exclusion Criteria:

* NA

Primary outcomes:
measure: Ongoing pregnancy rate per started stimulation cycle
timeFrame: ultrasound showing ongoing pregnancy
Secondary outcomes:
measure: Ongoing pregnancy in subgroups of patients with lo0w serum LH levels
timeFrame: ultrasound for ongoing pregnancy in subgroups
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Anders Nyboe Andersen
Study officials:
affiliation: Fertility Clinic Rigshospitalet
name: Anders N Andersen, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: NyboeAndersen A, Humaidan P, Fried G, Hausken J, Antila L, Bangsboll S, Rasmussen PE, Lindenberg S, Bredkjaer HE, Meinertz H; Nordic LH study group. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial. Hum Reprod. 2008 Feb;23(2):427-34. doi: 10.1093/humrep/dem317. Epub 2007 Nov 16.
Clinical trial NCT00442793: A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Official title: A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-03-02
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia requiring dialysis;
* maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening;
* adequate iron status.

Exclusion Criteria:

* previous epoetin treatment within 8 weeks prior to screening;
* failing renal graft in place;
* bleeding episode necessitating transfusion within 8 weeks prior to screening;
* poorly controlled hypertension;
* previous treatment with Mircera.

Primary outcomes:
measure: Hb response rate
timeFrame: Weeks 0-24
measure: Change in Hb concentration between baseline and evaluation period
timeFrame: Months 4-6
Secondary outcomes:
measure: Hb over time
timeFrame: Throughout study
measure: Time to Hb response
timeFrame: Throughout study
measure: RBC transfusions
timeFrame: Weeks 0-24
measure: AEs, laboratory parameters, vital signs
timeFrame: Throughout study
measure: Serum concentration of Mircera
timeFrame: Throughout study
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Hong Kong
country: Hong Kong
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05558111: The Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.
Official title: Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients with Orthotopic Sigmoid Neobladder.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthotopic Neobladder
Keywords: Orthotopic neobladder
Functional magnetic resonance imaging
Neuroimaging Study
Lower urinary tract function
Bladder cancer
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 3 months or more after orthotopic neobladder surgery.

Brief summary: Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).


Eligibility criteria: Inclusion Criteria:

1. Being right-handed;
2. 3 months or more after operation;
3. No contraindications to fMIR examination;
4. Voluntarily sign informed consent.

Exclusion Criteria:

1. History of bladder radiotherapy;
2. History of prostate cancer;
3. Suffering from diseases affecting abdominal pressure;
4. History of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy;
5. History of mental disorders, Parkinson's disease, Alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage;
6. Claustrophobia or carrying metal implants that are not suitable for fMRI examination;
7. Diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.);
8. Urethral stricture;
9. Refusing to sign the informed consent form for clinical projects;
10. Other conditions that were not suitable for inclusion according to the investigator's judgment.

Primary outcomes:
measure: The location of brain functional activation areas
timeFrame: 3 months
measure: The peak T-value size of the activation region
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Chunxiao Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587611: Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying
Official title: Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying in Healthy Subjects and Bedridden Gastrostomy-fed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of either elemental liquid diet or standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients receiving gastrostomy feeding.

Detailed description: A randomized, crossover trial using elemental liquid diet or standard semi-solid diet containing 13C sodium acetate as a tracer is performed in both healthy subjects and bedridden gastrostomy-fed patients. 13C breath tests is performed to estimate gastric emptying.

Eligibility criteria: Inclusion Criteria:

* healthy subjects bedridden gastrostomy-fed patients

Exclusion Criteria:

* regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.

Primary outcomes:
measure: Gastric emptying
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00516711: Role of Volatile Anesthetics for Hepatic Protection
Official title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Injury
Keywords: Surgery with Pringle maneuver needed for liver resection
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-08-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).

Detailed description: Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion

Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Patients undergoing liver resection (benign or malignant tumors)

Exclusion Criteria:

* Laparoscopic liver resection coagulopathy (platelets \< 50,000/ml, Quick \< 50%)
* Liver cirrhosis

Primary outcomes:
measure: Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
citation: Beck-Schimmer B, Breitenstein S, Urech S, De Conno E, Wittlinger M, Puhan M, Jochum W, Spahn DR, Graf R, Clavien PA. A randomized controlled trial on pharmacological preconditioning in liver surgery using a volatile anesthetic. Ann Surg. 2008 Dec;248(6):909-18. doi: 10.1097/SLA.0b013e31818f3dda.
Clinical trial NCT01625611: Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Official title: Kappa-PET Imaging and Naltrexone in Alcohol Drinking Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Drinking
Keywords: Alcohol
Drinking
Drinkers
Alcohol Drinking
Naltrexone
Alcohol Dependence
Alcohol Abuse
Alcohol-Related Disorders
Ethanol
Alcoholism
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-06-21
Enrollment: 59
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to increase our knowledge of receptor function in the brains of people who are heavy drinkers and taking naltrexone (NTX), a medication that has been approved for the treatment of alcohol dependence. Receptors are special molecules in the brain to which other molecules (neurotransmitters) attach during the normal every-day workings of the brain. Drugs can bind to those receptor molecules as well. Recent evidence suggests that kappa opioid receptors (KOR's) may play an important role in alcohol drinking behavior. This study will try to determine if naltrexone's ability to attach to these receptors is related to its effectiveness. We will use PET (positron emission tomography) for this study. PET is a type of imaging device found in nuclear medicine. It is used for tracking the presence of injected radioactive materials in the body.


Eligibility criteria: Inclusion Criteria:

* Ages 21-50
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of study medication
* Regular use of other substances

Primary outcomes:
measure: Occupancy of KOR by NTX and Drinking
timeFrame: 6-8 days after treatment with naltrexone
measure: Relationship Between NTX Responsivity and Occupancy of KOR
timeFrame: 6-8 days after treatment with naltrexone
Secondary outcomes:
measure: Baseline KOR Differences
timeFrame: at baseline prior to treatment with naltrexone
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Sac, Cmhc
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Laat B, Goldberg A, Shi J, Tetrault JM, Nabulsi N, Zheng MQ, Najafzadeh S, Gao H, Kapinos M, Ropchan J, O'Malley SS, Huang Y, Morris ED, Krishnan-Sarin S. The Kappa Opioid Receptor Is Associated With Naltrexone-Induced Reduction of Drinking and Craving. Biol Psychiatry. 2019 Dec 1;86(11):864-871. doi: 10.1016/j.biopsych.2019.05.021. Epub 2019 Jun 8.
Clinical trial NCT04700111: Lag of Accommodation With DOT Spectacle Lenses
Official title: Lag of Accommodation With DOT Spectacle Lenses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia, Myopia Progression, Lag of Accommodation, Hyperopic Retinal Blur, Reduction in Contrast
Lead sponsor: SightGlass Vision, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2021-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.


Eligibility criteria: A person is eligible for inclusion in the study if he/she:

1. Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
2. Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
3. Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
4. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
5. Is willing and able to follow instructions.

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study.
2. Have a history of myopia control treatment in the past year.
3. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
4. Has any known active ocular disease and/or infection.
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
7. Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
8. Is a child of a member of the study team.

Primary outcomes:
measure: Best vision sphere
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research and Education
state: Ontario
Study officials:
References: