louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01000129: Adaptive Planning in Bladder Cancer
Official title: Adaptive - Predictive Planning for Hypofractionated Bladder Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Radiotherapy
Bladder cancer
Adaptive planning
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2009-10-22
Enrollment: 32
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: To demonstrate that radiotherapy treatments for bladder cancer can be delivered with greater accuracy using a new planning method and that this method can be used simply and effectively by those delivering treatment.

Detailed description: This study integrates a novel adaptive planning methodology, Adaptive-Planning Organ LOcalisation (A-POLO), with optimised margins and cone beam CT technology for improving the accuracy of radiotherapy treatment delivery.

The previous study (CCR2873, REC 07/Q0801/13) evaluated the use of cone beam CT in radiotherapy for bladder cancer. A larger than expected number of bladder radiotherapy treatments were seen to have been delivered with some element of geographic miss. Using the novel adaptive planning method these fractions of radiotherapy could have been correctly treated. The feasibility of this method has been proven in the previous study, particularly it has been shown that this method is appropriate and provides a simple solution to the problem. It can be carried out by the radiographers at the treatment unit without adding extra time to the treatment.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Histologically confirmed invasive carcinoma of the bladder
* Patient planned to receive hypofractionated radiotherapy to the bladder.
* No previous pelvic radiotherapy
* Written informed consent given according to ICH/GCP and national/local regulations.

Exclusion Criteria:

* Urinary catheter in situ: the presence of a urinary catheter degrades cone beam image quality and thus images would not be evaluable. Patients with a urinary catheter would not be expected to show variation in bladder filling.

Primary outcomes:
measure: Assessment performed online at the treatment unit & verified offline by additional observer. Primary endpoint is met if there is greater than 75% concordance between the assessment made online & offline.
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dr Robert Huddart
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051129: Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)
Official title: An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related
Keywords: AMD
anecortave acetate
wet AMD
age-related macular degeneration
Macular Degeneration
Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
Enrollment: 291
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under 50 years.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean change from baseline in logMAR visual acuity score at 12 months
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00855829: A Feasibility Study Designed to Assess the Efficacy of the ActiLady Device in Adult Female Subjects With Dysmenorrhea
Official title: A Single-Center, Randomized, Controlled, Double-Blind Feasibility Study Designed to Assess the Safety Performance of ActiLady Prototype in Adult Female Subjects With Dysmenorrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dysmenorrhea
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: ActiLady refers is employing targeted pressure waves, with the goal of reducing the pain associated with menstruation (clinically known as dysmenorrhea).


Eligibility criteria: Inclusion Criteria:

1. Women aged 18-35 years
2. Regular menstrual cycles (26-35 days); average duration of menstruation ≥5 days for the 4 months preceding the beginning of the trial.
3. Dysmenorrhea pain score \>50mm on a 100mm visual analog scale (VAS) for the maximum abdominal pain
4. Analgesic use during every menstrual cycle
5. Non-pregnant, with no intentions to get pregnant during the clinical trial
6. Agrees not to use oral contraceptives or an intrauterine device (IUD) during the trial period
7. Agrees not to use analgesics, except during permitted period (16:00-04:00 the next day, daily)
8. Consents to the use of pads or other vaginal devices throughout the trial period
9. Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
10. Signed written informed consent form (ICF) to participate in the study

Exclusion Criteria:

1. Pregnant or lactating women
2. Used hormonal and/or oral contraceptives in the preceding 4 months
3. Use of an IUD in the preceding 4 months
4. Previous diagnosis of secondary dysmenorrhea
5. Urinary incontinence
6. Duration of menstruation is \<5 days
7. Subjects with a known sensitivity to mechanical vibrations and/or silicone
8. Participation in current or recent clinical trial within 30 days prior to baseline visit

Primary outcomes:
measure: To evaluate the safety of a novel method and device called ActiLady.
timeFrame: 6 months
Secondary outcomes:
measure: * Evaluate the pain-reducing effect of ActiLady on dysmenorrhea. * Study the relationship between menses flux and dysmenorrhea. [Time Frame: 6 months] [Designated as safety issue: No ] * Optimize treatment procedure and wave form.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02937129: Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department
Official title: Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Keywords: Infrared tympanic thermometer
Axillary thermometer
Mercury glass thermometer
Adult emergency department
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Febrile patients defined by a cut off of 37.5°C measured by axillary mercury thermometer were enrolled. Patients who meet the exclusion criteria were excluded.

Brief summary: The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.


Eligibility criteria: Inclusion Criteria:

* Above 37.5°C measured by axillary mercury thermometer

Exclusion Criteria:

1. otitis external/media
2. soft-tissue infection over the axillary fossa and forehead
3. complete occlusion by earwax
4. severe illness
5. trauma

Primary outcomes:
measure: The body temperatures of fever patients measured by the infrared tympanic thermometer
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04465929: Expanded Access - Autologous Human Schwann Cells in Peripheral Nerve Repair
Official title: Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Peripheral Nerve Injuries
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-07-10
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 16
Standard ages: CHILD

Brief summary: Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).


Eligibility criteria: Inclusion Criteria:

* Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
* Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;

Exclusion Criteria:

* Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
* Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
* Persons with severe peripheral nerve injury gap length \> 10 cm in length;
* Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
* Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
* Presence of disease that might interfere with participant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Allan D. Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02241629: Levo Phencynonate Hydrochloride for the Prevention of Seasickness
Official title: Levo Phencynonate Hydrochloridefor the Prevention of Motion Sickness (Seasickness): a Randomized, Double-blind, Placebo Controlled, Multicenter,PhaseⅡClinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Motion Sickness
Keywords: motion sickness
Lead sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Sponsor class: INDUSTRY
First posted: 2014-09-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A double-blind, randomized, placebo controlled, multicenter, dose-finding phaseⅡclinical superiority study.

Detailed description: The trial is composed by 3 parts: 1) On-boat screening period for seasickness and safety tests will be evaluated in minus one day. 2) 4 weeks of washout period to eliminate the impact of voyage experience. 3) On-boat drug testing period. The subjects will be administered the drug before voyage. The seasickness symptoms will be evaluated during voyage. The safety test will be conducted before and after one day of on-boat testing.

Eligibility criteria: Inclusion Criteria:

* Subjects fulfilling the diagnostic criteria for motion sickness
* Have medical history for motion sickness
* During screening, the severity of sea sickness is assessed as moderate or above according to sea sickness severity scale.
* Adults for 18-55 years, male or female.
* Agree to participate the study and can sign the ICF independently.

Exclusion Criteria:

* Be allergic to the study drug or be allergic constitution
* ALT, AST≥ 1.5 times of ULN, Scr\>ULN, or other clinical significant lab values.
* Abnormal ECG which is clinical significant judged by investigators, including: QTc\>normal range
* Have medical history for urination disorder
* Have headache, vertigo, dizziness or nsomnia caused by other diseases than motion sickness.
* Have active gastrointestinal diseases or overweight (BMI≥24kg/m2 )
* Have internal ear disease which may disturb the evaluation of motion sickness.
* Have glaucoma or posterior circulation ischemia
* Have anxiety, depression or other mental disease that investigator considering inadaptable to participate the study.
* Participated in other studies within the past 3 months.

Primary outcomes:
measure: the symptoms of seasickness
timeFrame: Two hours of voyage
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Qingdao municipal hospital
state: Shandong
Study officials:
affiliation: Qingdao Municipal Hospital
name: Weiguo Xue
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059329: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Official title: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Seizures (With or Without Secondary Generalized Seizures)
Primary Generalized Tonic-clonic Seizures
Keywords: adult epilepsy participants
partial seizures
primary generalized Tonic-clonic seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 3809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice

Brief summary: The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

1. unknown adverse drug reactions (ADRs);
2. occurrence of ADRs;
3. factors that are likely to affect safety and efficacy;
4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).


Eligibility criteria: Inclusion Criteria:

* Epilepsy participants at least 18 years of age with:

  * Partial seizures (with or without secondary generalized seizures)
  * Primary generalized Tonic-clonic seizures

Exclusion Criteria:

* Participants previously treated with Fycompa

Primary outcomes:
measure: Number of participants with any serious adverse event
timeFrame: from 0 to 52 weeks
measure: Number of participants with any non-serious adverse event
timeFrame: from 0 to 52 weeks
Secondary outcomes:
measure: Number of participants experiencing seizures
timeFrame: from 0 to 52 weeks
measure: Overall improvement rating in seizure frequency
timeFrame: from 0 to 52 weeks
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department. Medical Division
name: Kenta Sumitomo
role: STUDY_DIRECTOR
References:
citation: Inoue Y, Sumitomo K, Matsutani K, Ishii M. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022 Feb 1;24(1):123-132. doi: 10.1684/epd.2021.1369.
Clinical trial NCT06638229: Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain
Official title: Investigation of the Effectiveness of Electrotherapy Treatment for the Spine in Individuals with Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
electrotherapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. The participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. The treatment group received electrotherapy using the StimaWELL 120MTRS system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. The study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old,
* LBP for more than three months,
* Pain of 3 or more according to the Numeric Pain Scale
* being literate

Exclusion Criteria:

* having a pacemaker,
* body mass index greater than 30,
* pathologies of the cervical or lumbar region,
* cervical radiculopathy, thoracic outlet syndrome, malignant conditions,
* systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases,
* history of surgery on the spine or upper extremities,
* acute infection

Primary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: Before and after 4 weeks of treatment
Secondary outcomes:
measure: Numeric Pain Scale
timeFrame: Before and after 4 weeks of treatment
measure: Oswestry Disability Index
timeFrame: Before and after 4 weeks of treatment
measure: Nottingham Health Profile
timeFrame: Before and after 4 weeks of treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Özlem Ülger, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030729: Macular Thickness Measurements Using Retinal-thickness OCT
Official title: Macular Thickness Measurements Using RTOCT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Diabetic Retinopathy
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. AMD population - intermediate and advanced AMD (with active and non-active CNV)
2. DR population. Patient with and without DME

Brief summary: Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)


Eligibility criteria: Inclusion Criteria:

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans

Exclusion Criteria:

1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE

Primary outcomes:
measure: Comparison between retinal measurements, done by the RTOCT device and a commercial OCT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
References:
Clinical trial NCT01132729: Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Valacyclovir Caplets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Zoster
Shingles
Genital Herpes
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACs Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACs Institute, Ltd.
name: Alan Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References: