louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02307994: Clinical Research on Effectiveness and Safety of Treatment of Severe Oligospermia or Azoospermia With uFSH
Official title: Effectiveness and Safety of uFSH for Severe Oligospermia or Azoospermia:A Multi-center,Open,Randomized,Interventional,and Phase4 Trial in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oligospermia
Azoospermia
Keywords: infertility
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 180
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether uFSH is effective and safe in the treatment of male patients with severe oligospermia or azoospermia.


Eligibility criteria: Inclusion Criteria:

* Male subjects aged 20\~35.
* They accorded with diagnostic criteria of severe oligospermia or azoospermia.
* They had'nt been treated with drug which could improve sperm count and quality one month before observation，otherwise,they should have a elution for 1 month before the study.

Exclusion Criteria:

* Gram-positive bacteria ,Chlamydia trachomatis,Ureaplasmaurealyticum,or mycoplasma hominis were detected in their semen.
* Subjects addicted to drug，tobacco，or alcohol.
* Subjects had heat,chemicals,radioactive material,or toxic contact history within a year.
* Subjects were under treatment of gonadotropin,anabolic steroid,chemotherapeutic drugs,or nonsteroidal anti-inflammatory drugs .
* Subjects combined with cardiovascular, liver, kidney ,or hematopoietic system severe primary disease,or mental disease.
* Subjects were allergic or on uFSH allergy,or under the treatment of other drugs for infertility .
* Subjects did not meet the inclusion criteria, did not according to the prescribed medication, were unable to judge the efficacy ,had incomplete information, or affected the efficacy or safety judgment.
* Subjects were IHH patients

Primary outcomes:
measure: Sperm density
timeFrame: 6 month
measure: (A + B)grade sperm and sperm activity rate
timeFrame: 6 month
measure: A grade sperm
timeFrame: 6 month
measure: semen volume
timeFrame: 6 month
measure: sex hormone levels
timeFrame: 6 month
measure: testis volume
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Hui Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00874094: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Official title: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nasolabial Folds
Keywords: nasolabial folds
platelet rich plasma
fibrin matrix
facial rhytids
dermal filler
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 15
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.


Eligibility criteria: Inclusion Criteria:

* healthy adults
* aged 25- 75 years
* with moderate to severe nasolabial folds

Exclusion Criteria:

* pregnant
* allergy to local anesthetics
* history of bleeding disorder
* active infection at the treatment site
* injectable filler in the nasolabial folds within past year

Primary outcomes:
measure: Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment.
timeFrame: Difference in Measurements taken Pre-treatment and 12 weeks after treatment.
Secondary outcomes:
measure: Difference in Wrinkle Assessment Scores Between Pre-treatment and 1 Week
timeFrame: pre-treatment to 1 week after treatment
measure: Difference in Wrinkle Assessment Score Between Pretreatment and 2 Weeks
timeFrame: Pre-treatment to 2 weeks after treatment
measure: Difference in Wrinkle Assessment Score Between Pretreatment and 6 Weeks
timeFrame: Pre-treatment to 6 weeks after treatment
Other outcomes:
Locations:
city: Chappaqua
country: United States
facility: The New York Eye & Ear Infirmary- Otolaryngology Faculty practice satellite
state: New York
Study officials:
affiliation: The New York Eye & Ear Infirmary
name: Anthony P Sclafani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sclafani AP. Platelet-rich fibrin matrix for improvement of deep nasolabial folds. J Cosmet Dermatol. 2010 Mar;9(1):66-71. doi: 10.1111/j.1473-2165.2010.00486.x.
Clinical trial NCT00451594: High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
Official title: A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: ITP
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2007-03-23
Enrollment: 157
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the long term effects of pulse high dose dexamethasone and conventional dose prednisolone in treatment of adult patients with ITP.

Detailed description: Patients will be randomized to one of two study arms:

dexamethasone 40 mg po daily for 4 consecutive days. If the platelet count drops below 30X109/L after response within 6 months, another four-day course of dexamethasone will be given, followed by 15 mg of prednisone daily, with gradual tapering (Arm 1).

Prednisone 1 mg/kg po daily for 4-8 weeks, the drug is then decreased slowly over another few weeks (Arm 2).

Eligibility criteria: Inclusion Criteria :

* a true thrombocytopenia on blood smear
* adequate megakaryopoiesis on bone marrow examination
* the absence of clinically apparent associated conditions or cause of thrombocytopenia
* Age over 16 years
* A platelet count of less than 30x109/L

Exclusion criteria :

* previous treatment for ITP.
* other causes of thrombocytopenia such as HIV infection, lymphproliferative disease, liver disease, or definite SLE.
* Patients with life threatening bleeding and pregnant women should be excluded.

Primary outcomes:
measure: response rate and platelet count
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Daegu Catholic Univertity Hospital, ROK
name: Sung Hwa Bae, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center, ROK
name: Jung-Hee Lee, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06093594: Investigating Participation Patterns Among Stage IV Melanoma Patients
Official title: Understanding Patient Engagement Trends in Stage IV Melanoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stage IV Melanoma
Keywords: Stage IV Melanoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stage IV melanoma who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of stage IV melanoma
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Inability to perform regular electronic reporting

Primary outcomes:
measure: Number of stage IV melanoma patients who decide to enroll in a clinical research
timeFrame: 3 months
measure: Rate of stage IV melanoma patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Scott JF, Conic RZ, Thompson CL, Gerstenblith MR, Bordeaux JS. Stage IV melanoma of unknown primary: A population-based study in the United States from 1973 to 2014. J Am Acad Dermatol. 2018 Aug;79(2):258-265.e4. doi: 10.1016/j.jaad.2018.03.021. Epub 2018 Mar 23.
citation: Wevers KP, Hoekstra HJ. Stage IV melanoma: completely resectable patients are scarce. Ann Surg Oncol. 2013 Jul;20(7):2352-6. doi: 10.1245/s10434-013-2881-1. Epub 2013 Feb 8.
citation: Luen S, Wong SW, Mar V, Kelly JW, McLean C, McArthur GA, Haydon A. Primary Tumor Thickness is a Prognostic Factor in Stage IV Melanoma: A Retrospective Study of Primary Tumor Characteristics. Am J Clin Oncol. 2018 Jan;41(1):90-94. doi: 10.1097/COC.0000000000000226.
Clinical trial NCT00603694: Hippocampal Radiation Exposure and Memory
Official title: Hippocampal Radiation Exposure and Memory: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriovenous Malformation
Schwannoma
Trigeminal Neuralgia
Keywords: Hippocampus
Memory
Radiation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have consented to GK radiosurgery or cranial radiation.

Brief summary: Neurocognitive impairment as a result of gamma knife radiosurgery has not been well studied and is poorly understood. Radiosurgery to the base of skull for the treatment of benign and malignant disorders may consequently impair memory function. There is a need to evaluate changes in memory function that may be associated with such exposures.

In this pilot study, we will investigate changes in hippocampal-dependent memory function in 10 patients receiving a low SRS dose to the hippocampus. We will also investigate such changes in a no-dose control group and a high-dose control group. This study will provide preliminary estimates of variance in memory changes associated with radiation exposure, and will then permit us to design future studies with the appropriate sample size justification.


Eligibility criteria: Inclusion Criteria:

* Patients planned for radiosurgery for benign disorders (Groups 1\&2).
* Patients planned for prophylactic cranial irradiation (Group 3)

Exclusion Criteria:

* Previous cranial radiation
* Severe psychiatric disorder
* Severe cognitive or memory impairment (MMSE \< 21)
* Non-English speaking, which will potentially make memory testing difficult and unreliable.
* Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures
* Patients on steroid medications.
* Left hand dominant patients
* Dose exposure to left hippocampus \>0.5Gy and \<2Gy. We will attempt to estimate dose to hippocampus prior to enrollment using pre-planning on diagnostic imaging to minimize exclusion of patients due to dose exposure \>0.5 Gy and \< 2Gy following baseline memory testing.
* Benzodiazepine or narcotics given on the day of radiotherapy/radiosurgery prior to completion of the study procedures
* Previous brain surgery within one year prior to radiosurgery
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Joey & Toby Tanenbaum Gamma Knife Centre, Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT01539694: A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Official title: A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments.
* Be adapted wearers of soft contact lenses and wear a lens in each eye.
* Be presbyopic and require near add correction in each eye.
* Have no active ocular disease or allergic conjunctivitis.
* Must not be using any topical ocular medications.

Exclusion Criteria:

* Any Grade 2 or greater finding during the slit lamp examination.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study products.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.

Primary outcomes:
measure: Visual Acuity
timeFrame: At 1 week follow up
Secondary outcomes:
measure: Symptoms/Complaints
timeFrame: At 1 week follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Gerard Cairns, PhD, MCOptom
role: STUDY_DIRECTOR
References:
Clinical trial NCT02752594: Consumption of Probiotics on Salivary Bacteria Causing Dental Caries
Official title: Evaluation of the Consumption of Probiotics on the Bacteria Causing Dental Caries: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Caries
Keywords: probiotic
mutans streptococci
bacillus coagulans
caries
Lead sponsor: Sharda University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dental caries is a multifactorial disease effecting majority of the human population.One of the etiological factor causing dental caries is salivary mutans streptococci. Reducing the levels of this bacteria in the saliva can significantly reduce the incidence of dental caries. A non-invasive intervention, such as the administration of probiotics reduced the salivary mutans streptococci levels.

Detailed description: 40 candidates were selected from a pre-determined group and were randomly assigned to two groups. Group A (n=20) was administered probiotic drink and Group B (n=20) was administered placebo for 14 consecutive days. Saliva was collected on day 1 and day 15 to compare the salivary mutans streptococci levels.

Eligibility criteria: Inclusion Criteria:

* Decayed Missing Filled Surfaces less than or equal to 6
* Brushes twice daily

Exclusion Criteria:

* undergoing orthodontic treatment
* topical fluoride therapy in the past 2 yrs
* using sugar free gums

Primary outcomes:
measure: counts of streptococcus mutans after the consumption of probiotic
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sharda University
name: G. RATNA VELUGU, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265394: Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
Official title: A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Amyloid
Magnetic resonance imaging
Positron Emission Tomography
Standard uptake value ratios
Healthy Subjects
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
name: Medpace, Inc.
First posted: 2010-12-23
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.


Eligibility criteria: Inclusion Criteria:

* The subject age is 18 to 40 years.
* The subject has no evidence of thinking or memory problems by medical history.
* The subject has a normal MRI scan.
* The subject's general health is adequate to comply with study procedures.
* The subject is willing and able to participate in all study procedures.

Exclusion Criteria:

* The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
* The subject has a contraindication for (cannot undergo) MRI.
* The subject has a history of head injury with loss of consciousness.
* The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
* The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Primary outcomes:
measure: Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
timeFrame: PET scans performed on patients 90 minutes post Flutemetmol Administration
Secondary outcomes:
measure: Measurement of Amyloid Content in Different Parts of the Brain
timeFrame: PET scans performed on patients 90 minutes post Flutemetmol Administration
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Paul Sherwin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01897194: Using EEG to Study Coma in the Neurocritical Care Unit
Official title: A Wireless EEG Patch Device for Continuous Electrographic Monitoring and Study of Coma in the Neurocritical Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coma
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neuro Critical Care Patients

Brief summary: Despite its clinical significance, the pathophysiology of coma is still under investigation and the physiology of emergence from coma remains a mystery. Furthermore, predictors of emergence from coma, despite their obvious clinical value, remain un-established. Because of its low arousal state and hypothesized parallel neurophysiological mechanisms, sleep has been studied as both an animal and human model of coma, and awakening from sleep has likewise been studied as a surrogate of coma emergence. In this study, we will determine whether certain electrographic patterns, known as spectral shifts, which have correlates in normal sleep, are predictive of eventual awakening from coma and the time course of this emergence. To detect spectral shifts in comatose patients, EEG monitoring must be performed for several days. Quick, simple, and reliable EEG recording in the ICU will be enhanced by a small device that can be easily and properly positioned on the head by hospital personnel and which lacks cumbersome cables or receivers. Traditional EEG monitoring requires placement of up to 25 wires, which can impede efficient intensive patient care. Our hypothesis is that we can detect a difference in spectral shifts in comatose patients who will eventually emerge from coma as compared to comatose patients who do not wake up and that a wireless EEG patch-type device can effectively make this distinction.


Eligibility criteria: Inclusion Criteria: All patients with brain injuries admitted to the neurocritical care unit will be screened for enrollment. The estimated enrollment will be for 100 patients. 90 patients will be comatose with Glascow Coma Scale \< 9. The other 10 patients will be control, non-comatose patients for quality control of the device. Consent for inclusion will be obtained from the patient or next of kin for all enrolled patients.

Exclusion Criteria: None

Primary outcomes:
measure: Emergence from coma
timeFrame: 1 year post admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: