louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03815747: MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Official title: MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tone Increased
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2019-01-24
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years
* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Fever
* Pregnancy
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia

Primary outcomes:
measure: Effectiveness of the device for toning of buttocks according to MRI images
timeFrame: 7 months
Secondary outcomes:
measure: Subject's satisfaction with study treatment
timeFrame: 7 months
measure: Side effects and adverse events (AE) associated with the study device
timeFrame: 7 months
Other outcomes:
Locations:
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
Study officials:
References:
Clinical trial NCT05848947: SIR-Spheres Study to Calculate the Radiation-Absorbed Dose of 99mTc-MAA
Official title: Study to Calculate the Radiation-Absorbed Dose of Technetium-99m Macroaggregated Albumin (99mTc-MAA) to the Whole Body and Non-Liver Critical Organs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasm
Keywords: Technetium-99m macroaggregated-albumin (99mTc-MAA)
SIR-Spheres Y90 resin microspheres treatment
Lead sponsor: Sirtex Medical
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2023-05-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this interventional clinical trial is to evaluate the dose of radiation of Technetium-99m macroaggregated-albumin (99mTc-MAA) after an intra-arterial injection to the whole body and non-liver critical organs in patients who are undergoing evaluation for SIR-Spheres treatment for hepatocellular carcinoma.

Detailed description: The investigation is a prospective, single center, open label, single-arm study. Patients enrolled in the study will have 3 imaging scans taken after 99mTc-MAA injection, the final of which will occur between 18 and 24 hours post-injection.

Eligibility criteria: Inclusion Criteria:

1. Willing, able, and mentally competent to provide written informed consent
2. Age 18 or older at the time of consent
3. Patients who are being evaluated for SIR-Spheres treatment eligibility

Exclusion Criteria:

1. Patients who are contraindicated for SIR-Spheres treatment
2. Patients who are contraindicated for 99mTc-MAA per the manufacturer's package insert

Primary outcomes:
measure: Mean Absorbed Dose (Gy) for the Whole Body
timeFrame: 18-24 hours
measure: Mean Absorbed Dose (Gy) for Critical Non-liver Organs
timeFrame: 18-24 hours
measure: Mean Activity (Bq) for the Whole Body
timeFrame: 18-24 hours
measure: Mean Activity (Bq) for Critical Non-liver Organs
timeFrame: 18-24 hours
measure: Effective Dose (Gy) for the Whole Body
timeFrame: 18-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Inland Imaging
state: Washington
Study officials:
affiliation: Inland Imaging
name: Douglas Murrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gates VL, Singh N, Lewandowski RJ, Spies S, Salem R. Intraarterial Hepatic SPECT/CT Imaging Using 99mTc-Macroaggregated Albumin in Preparation for Radioembolization. J Nucl Med. 2015 Aug;56(8):1157-62. doi: 10.2967/jnumed.114.153346. Epub 2015 Jun 18.
citation: Kappadath SC, Lopez BP. Organ-level internal dosimetry for intra-hepatic-arterial administration of 99m Tc-macroaggregated albumin. Med Phys. 2022 Aug;49(8):5504-5512. doi: 10.1002/mp.15726. Epub 2022 Jun 6.
citation: McCollough CH, Bushberg JT, Fletcher JG, Eckel LJ. Answers to Common Questions About the Use and Safety of CT Scans. Mayo Clin Proc. 2015 Oct;90(10):1380-92. doi: 10.1016/j.mayocp.2015.07.011.
Clinical trial NCT00990847: Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
Official title: The Efficacy of Nebulized Procaterol Versus Nebulized Salbutamol for the Treatment of Moderate Acute Asthma: a Randomized, Double-blind, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate Acute Asthma
Lead sponsor: PT Otsuka Indonesia
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of nebule procaterol with nebule salbutamol in the treatment of moderate acute asthma.


Eligibility criteria: Inclusion Criteria:

1. Patients with moderate acute asthma according to Global Initiative for Asthma (GINA) 1998 (Appendix 1). Patients with moderate acute asthma according to Modified Global Initiative for Asthma (GINA) 1998 (Patients with asthma score 5 - 11; PEFR ≤ 80% predicted)
2. Patients of both gender aged 15 to 60 years
3. Patients still have the ability to undergo examinations and give written informed consent

Exclusion Criteria:

1. Pregnant and lactating women
2. Smokers
3. Patients with heart disease, hyperthyroidism, diabetes mellitus, COPD or other chronic diseases
4. Patients with signs of severe infections

Primary outcomes:
measure: Difference 5% from baseline in peak expiratory flow rate (PEFR)
timeFrame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
Secondary outcomes:
measure: Difference 5% from baseline in asthma score
timeFrame: 3 times every 20 minutes (at 0, 20 and 40 minutes)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia/ Persahabatan Hospital
Study officials:
affiliation: Department of Pulmonology and Respiratory Medicine, Faculty of Medicine University of Indonesia/ Persahabatan Hospital
name: Hadiarto Mangunnegoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06358547: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years
Official title: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years - a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 590
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women.


Eligibility criteria: Inclusion Criteria:

* Women aged 37-41 years with a male partner, a female partner og undergoing fertility with no partner.
* Anti Müllerian Hormone (AMH) ≥6.28 pmol/L (AMH should be measured no more than one year prior to study inclusion). The optimal is to use the Elecsys® Assay. If other assays are used this should be reported to the investigator and the AMH cut-off level may appropriately be changed so that it corresponds to the cut-off used in the Elecsys® Assay.
* IVF/ICSI cycle number 1-5 (previous IVF/ICSI cycles will not count if the woman is recruited after an IVF/ICSI/FET-delivery).

Exclusion Criteria:

* PGT-SR or PGT-M.
* Testicular sperm aspiration (TESA), testicular sperm extraction (TESE), micro-TESE (or cryopreserved sperm from these procedures).
* Males with severely compromised semen quality (\<1 million progressively motile sperm cells following gradient centrifugation).
* Endometriosis stage three or four.
* Women with severe thyroid disease (women can be included if they have normal thyroid levels on relevant medication).
* Severe co-morbidity; diabetes mellitus type 1 (DM1), Mb Crohn or Colitis ulcerosa, systemic lupus erythematosus (SLE), HIV, Hepatitis B/C, or dysregulated thyroid disease.
* ≥2 previous ART treatment without blastocyst formation.

Primary outcomes:
measure: Live birth rate per first embryo transfer
timeFrame: Approximately 12 months after inclusion of the last patient
measure: Cumulative live birth rate after one complete ART treatment
timeFrame: Approximately 18 months after inclusion of the last patient
Secondary outcomes:
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT06699147: Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S
Official title: Multicenter, Prospective, Observational Study to Evaluate the Post-marketing Efficacy and Safety of Eptq S and Eptq Lidocaine S Applied to the Facial Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasolabial Folds
Mid Face Volume Loss
Lip Volume Enhancement
Keywords: Hyaluronic acid filler
facial region
Lead sponsor: Jetema Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 238
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Beauty Bar Clinics and 8 other clinics in South Korea

Brief summary: This study in multi-center, prospective and observational study. The purpose of this study is to observe effects and safety of hyaluronic acid filler series, eptq S and eptq Lidocaine S, for facial volume and folds.

Detailed description: Participants for this study are treated with eptq S and eptq Lidocaine S for smoothing nasolabial folds or volumizing mid-face or lips. Treating period is around 24 weeks. Facial volume and wrinkle condition, participants' satisfaction, and safety would be assessed.

Eligibility criteria: Inclusion Criteria:

* Male and Female adults aged 19 years and older.
* Meet one of the following among individuals who want temporary improvement of facial wrinkles and volume.

  1. Wrinkle Severity Rating Scale score 3 or 4 for Nasolabial fold.
  2. Mid-Face Volume Deficit Scale score 3 or greater.
  3. Medicis Lip Fullness Scale score 1-2. In cases of 2-1) and 2-2), participants must meet both sides (right and left) to be eligible for enrollment.

     For 3), the Medicis Lip Fullness Scale scores 1-2 at the target sites for procedures (upper lip, lower lip, up \& down) eligible for enrollment
* Voluntarily agree to participate in this observational study in written consent form.

Exclusion Criteria:

* Received anti-thrombotics (except low-dose aspirin \[100 mg, maximum 300 mg/day\]) within 2 weeks from screening.
* Currently have or have a history of bleeding disorder.
* applied graft/prosthesis or biomaterials, including hyaluronic acid, polycaprolactone, collagen filler, lifting (threads, laser, etc.), and Botulinum toxin, at the site for indication within 24 weeks from screening.
* Skin disorder or wound infection on the face that affects this study
* Have history of side effects of EMLA cream or equivalent lidocaine agent.
* History of hypersensitivity to hyaluronic acid agent(s).
* Other contraindications as per the \[Precautions for Use\] in the approved label for the study device.
* Determined as not eligible for the study by the investigator.

Primary outcomes:
measure: Nasolabial Folds
timeFrame: 24 weeks
measure: Mid-Face Volume
timeFrame: 24 weeks
measure: Lip Volume
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement satisfaction assessment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinics
Study officials:
References:
Clinical trial NCT01443247: Role of Andi-d in Dengue Fever: a Pilot Study
Official title: Role of Andi-d in Dengue Fever: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dengue Fever
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2011-09-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the role of anti-d in dengue fever.

Detailed description: This study was conducted in pgimer. Patients presenting with fever and thrombocytopenia in emergency medical opd / medicine opd were screened and all dengue serology positive patients were evaluated for enrolment into the study. We had proposed to enroll 30 patients with diagnosed dengue haemorrhagic fever. the diagnosis of the dengue fever was based upon the clinical history ,general physical examination and the lab tests : thrombocytopenia ( platelet count ≤ 20,000 ) ,and a positive dengue serology.

STUDY DESIGN : It was an open label inteventional study . one group of 15 patients ( intervention group ) received platelet support along with injection anti-d in a dose of 50 µg/kg (250IU/kg) intravenously while the other group of 15 ( control group) received platelet support only . a base line platelet count of all the participant of both the study groups was taken and then the level of platelets at 12 , 24 , 36 , and 48hr post treatment initiation was noted. The patients were followed till the time of discharge .

Eligibility criteria: inclusion criteria:

* fever and thrombocytopenia with/without bleeding manifestations
* dengue serology positive patients
* platelet count ≤ 20,000/mm3
* Rh positive patients
* willing to give written informed consent

exclusion criteria:

* dengue serology positive but platelet count \> 20,000/mm3
* Rh negative patients
* pregnant females

Primary outcomes:
measure: to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm
timeFrame: 1 YEAR
Secondary outcomes:
measure: the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research , Chandigarh , India
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: deepak thakur, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830047: Effect of Laser in Treatment of Vulval Warts
Official title: Effect of nd Yag Laser in Treatment of Vulval Warts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulval Wart
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2019-02-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: applying laser for treatment of vulval warts
Primary purpose: TREATMENT

Brief summary: Vulval warts is a magor problem that affects women .

Detailed description: The causative organism for vulval warts is human papilloma virus There are many treatment modalities that can trat these warts

Eligibility criteria: Inclusion Criteria:

* women who have vulval warts
* Age between 18- 40 years

Exclusion Criteria:

* warts that were previously treated by surgery or cryotherapy

Primary outcomes:
measure: The number of women who will be completely cured by laser beam
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00585247: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Official title: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port Wine Stain
Keywords: birthmarks
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-01-03
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Port wine stains are red birthmarks that without treatment persist for a lifetime. They are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. Treating Port wine stains is difficult. The standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. The growth of additional blood vessels (angiogenesis) following the Laser treatment is likely an important factor in why these lesions persist despite therapy.

Detailed description: Imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. It has been used to successfully treat other vascular growths such as hemangiomas. The research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. The imiquimod 5% cream cream apply to Port wine stains everyday for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Port Wine Stain birthmark
* Male and female subjects of any age who are in good health.
* Fitzpatrick skin type I-VI

Exclusion Criteria:

* Pregnant or lactating
* History of cutaneous photosensitivity
* History of hypersensitivity to imiquimod 5% cream or any of its components
* History of photodermatoses

Primary outcomes:
measure: Change From Baseline in a* and E at 8 Weeks
timeFrame: 8 weeks baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical and Surgical Cilnic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Kristen M Kelly, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tremaine AM, Armstrong J, Huang YC, Elkeeb L, Ortiz A, Harris R, Choi B, Kelly KM. Enhanced port-wine stain lightening achieved with combined treatment of selective photothermolysis and imiquimod. J Am Acad Dermatol. 2012 Apr;66(4):634-41. doi: 10.1016/j.jaad.2011.11.958. Epub 2012 Jan 14.
Clinical trial NCT02507947: SPECTAmel: Screening Patients With Melanoma Tumors for Efficient Clinical Trial Access
Official title: SPECTAmel: Screening Patients With Melanoma Tumors for Efficient Clinical Trial Access
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Melanoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2015-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically confirmed melanoma of any stage

Brief summary: SPECTAmel is a standardized, quality-assured molecular screening platform for tumor characterization and storage of human biological material (HBM) for the purpose of integrating new biomarkers into clinical trials and optimizing access of patients to therapeutic biomarker-driven clinical trials. HBM and clinical/pathological data are collected from consenting patients.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed melanoma of any stage (the steering committee will decide on which stage to include at any particular time point during this trial, this will be communicated appropriately to all participating sites)
* Mandatory availability of adequate human biological material (HBM): FFPE tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery/biopsy; minimal amount requested is detailed in the HBM guidelines; if feasible, inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional;
* Age ≥ 18 years;
* At least three months life-expectancy;
* Written informed consent according to ICH/GCP and national/local regulations;
* Absence of any active malignancy, except pT1-2 prostatic cancer Gleason score \< 6, or carcinoma in situ of the cervix, in the 5 years before study entry;
* Absence of exclusion criteria like active hepatitis B/C or HIV, second malignancies, no severe organ dysfunction or other comorbidities that may prevent inclusion into clinical trials.
* Central confirmation of human biological material (HBM) adequacy for step 2:
* Centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening.

Exclusion Criteria:

* active hepatitis B/C or HIV
* second malignancies
* severe organ dysfunction or other comorbidities

Primary outcomes:
measure: Number of screened patients
timeFrame: 5 years
measure: Number of downstream clinical trials;
timeFrame: 5 years
measure: Number of patients enrolled in the downstream therapeutic trials
timeFrame: 5 years
measure: Number of exploratory/future research projects
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Caroline Robert, MD, PhD
role: STUDY_CHAIR
References: