louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06644274: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies
Official title: The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Malignancies
Keywords: 68Ga-grazytracer PET/CT
gastrointestinal malignancies
Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for gastrointestinal malignancies.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological and clinical diagnosis of gastrointestinal malignancies requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. The patient is in good general condition with an expected survival of \> 6 months.
5. aged 18-75 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction.
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person.

Primary outcomes:
measure: Evaluation the responses to immunotherapy of gastrointestinal malignancies
timeFrame: up to about 10 weeks
measure: Standardized uptake value(SUV)
timeFrame: up to about 10 weeks
measure: Target-to-background ratio(TBR)
timeFrame: up to about 10 weeks
Secondary outcomes:
measure: Progress free survival
timeFrame: 1 years
measure: Overall survival
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04023474: Platelet-Rich Fibrin in the Healing of Regional and Free Flaps
Official title: Role of Platelet-Rich Fibrin in the Healing of Regional and Free Flap Donor Sites for Head and Neck Surgery Patients: A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Disorder
Free Flap
Keywords: Platelet-Rich Fibrin (PRF)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.


Eligibility criteria: Inclusion Criteria:

* Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room.

Exclusion Criteria:

* Patients under 18 years of age
* Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.

Primary outcomes:
measure: Change in healing time at 3 months post-operative
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: Salam Salman, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04078074: Occlusal Stabilization Splints and Sleep Disordered Breathing
Official title: Occlusal Stabilization Splints and Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Bruxism
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 0
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 is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.


Eligibility criteria: Inclusion Criteria:

* diagnosed with sleep bruxism
* prescribed an occlusal splint

Exclusion Criteria:

* Less than 18 years old
* Secondary obstructive sleep apnea diagnosis
* Genetic disease that contributes to possible secondary obstructive sleep apnea
* Patient refuses to sign informed consent document
* Patient does not speak or read English
* More than two missing posterior teeth (excluding third molars)
* Presence of gross malocclusion

Primary outcomes:
measure: Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device
timeFrame: Baseline(without device),with device
measure: Change in pulse as measured by the MediByte device
timeFrame: Baseline(without device),with device
measure: Change in airflow as measured by the MediByte device
timeFrame: Baseline(without device),with device
measure: Change in chest plethysmography as measured by the MediByte device
timeFrame: Baseline(without device),with device
measure: Change in abdomen plethysmography as measured by the MediByte device
timeFrame: Baseline(without device),with device
measure: Change in masticatory muscle activity as measured by the MediByte device
timeFrame: Baseline(without device),with device
Secondary outcomes:
measure: Change in airway anatomy as measured by CBCT
timeFrame: Baseline(without device),with device
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Aaron Glick, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00323674: Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery With Light Weight Mesh
Official title: Prospective Randomized Study to Evaluate the Recovery of a Hernia Inguinalis by a Minimally Invasive Open Preperitoneal Surgery With Polysoft Mesh Versus a Classic Open Surgery According to Modified Lichtenstein Procedure With Light Weight Mesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Hernia Inguinalis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study to evaluate the recovery of a hernia inguinalis by a minimally invasive open preperitoneal surgery with polysoft mesh versus a classic open surgery according to modified Lichtenstein procedure with light weight mesh.


Eligibility criteria: Inclusion Criteria:

* Symptomatic hernia inguinalis
* \> 18 years

Primary outcomes:
measure: Percentage of relapse
timeFrame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
measure: Postoperative pain assessment
timeFrame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
measure: Duration to full recovery (able to do all activities)
timeFrame: Evaluation at day 0, 3 weeks, 3 months, 1 year and 3 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01309074: Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
Official title: Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Epilepsy
Anxiety
Keywords: Anxiety
Epilepsy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2011-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.

Detailed description: Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.

Eligibility criteria: Inclusion Criteria:

* GAD-7 total score above 10.
* Have a diagnosis of a Partial Seizure Disorder.
* Have a Hamilton-A total score 20 and above.
* 18-80 years of age.
* Able to read at a fourth grade level.
* If a woman of childbearing age, agrees to use an acceptable means of birth control.

Exclusion Criteria:

* Unable to understand and sign a consent.
* Unable to follow instructions for the study.
* Displaying current suicidal ideation
* Having psychogenic non-epileptic seizures
* Have a history of drug or alcohol abuse.
* Use of any investigational drug within the last 30 days.
* Hypersensitivity reaction or other serious adverse event to PGB in prior trials.

Primary outcomes:
measure: Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
timeFrame: 27 weeks
Secondary outcomes:
measure: Change in Quality of life measures assessed with the QOLIE-89.
timeFrame: 27 weeks.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Director Laboratory Encephalography
name: Andre M. Kanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05089474: A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Official title: A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: Open Angle Glaucoma, IOP, viscoelastic
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 45
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, open label
Primary purpose: TREATMENT

Brief summary: A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.

Detailed description: A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

1. Able to understand and execute written informed consent
2. Males or female subjects at least 22 years of age.
3. Subjects qualifying for cataract surgery
4. Subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical IOP-lowering medications
5. Subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated IOP of 21-36 mmHg

Exclusion Criteria:

1. Women of child-bearing potential
2. Modified Shaffer angle grade \< 2
3. Patients with severe or advanced glaucoma
4. Intraocular surgery within the last 6 months or laser surgery within the last 3 months
5. BCVA worse than 20/80 in either eye
6. Patients with a previous peripheral iridotomy.
7. Ocular infection or inflammation within the last 6 months.
8. Any medication that would be contraindicated for a glaucoma surgical procedure.

Primary outcomes:
measure: proportion of unmedicated eyes with IOP reduction of > 20% from Baseline at Month 12.
timeFrame: 12 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 months
measure: Mean IOP change
timeFrame: 12 months
measure: Number of topical glaucoma medications
timeFrame: 12 months
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Clinica 20/20
state: CR
city: Santo Domingo
country: Dominican Republic
facility: Centro Laser
state: DR
city: Puebla
country: Mexico
facility: Clinica Laser y Ultrasonido Ocular de Puebla
Study officials:
References:
Clinical trial NCT00174174: Provigil (Modafinil) Study by Taiwan Biotech Co.
Official title: A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy
Cataplexy
Sleep Disorders
Hypersomnolence
Excessive Sleepiness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.


Eligibility criteria: Inclusion Criteria:

* Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled.
* Age of 12 y/o to 55 y/o.
* The liver and kidney functions are within normal limits.
* Meeting the strict criteria of narcolepsy described above.
* Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments.
* Willingness to comply with the protocol and signed the written Informed Consent.

Exclusion Criteria:

* Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper.
* Patients with concomitant neurological disorder and psychiatric disorders.
* Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above.
* Patients with Restless Leg Syndrome \& Periodic Limbs Movements whose index was more than 5 per hour.
* Patients who are pregnant or breast-feeding.

Primary outcomes:
measure: The change from baseline in the sleep latency.
Secondary outcomes:
measure: Patient's assessment of general level of daytime sleepiness on ESS.
measure: Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
measure: Patient's sleep quality evaluated by PSQI.
measure: Safety would be evaluated by tabulating and summarizing all adverse events reported.
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry, National Taiwan University
name: Yue-Joe Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008774: START: Swiss Taxotere Alopecia Prevention Trial
Official title: A Comparison of Different Scalp Cooling Systems for the Prevention of Chemotherapy Induced Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Alopecia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

* Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading)

Secondary objective:

* Compliance to scalp cooling procedure
* Received number of cycles of chemotherapy in each subgroup
* Patient perception of scalp cooling procedure
* Side effects of scalp cooling systems


Eligibility criteria: Inclusion Criteria:

* Any solid tumor malignancy receiving docetaxel (Taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted.
* Performance Status ECOG \<= 2
* Absence of alopecia at inclusion

Exclusion Criteria:

* Chemotherapy regimen including concomitant anthracycline treatment
* Raynaud's disease or phenomenon
* Cold agglutinin disease
* Cryoglobulinemia
* Cryofibrinogenemia
* Scalp metastasis
* Pregnancy or Lactation
* Preexisting alopecia of any grade; notably androgenetic alopecia

Primary outcomes:
measure: Grade III or IV alopecia according to the WHO criteria
timeFrame: D1 of each cycle and D+21 after last cycle of chemotherapy
Secondary outcomes:
measure: Compliance to scalp cooling procedure
timeFrame: D1 of each cycle and D+21 after last cycle of chemotherapy
measure: Side effects of scalp cooling systems
timeFrame: D1 of each cycle and D+21 after last cycle of chemotherapy
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.
Clinical trial NCT03218774: Supervised Fitness Program for Adults With Cerebral Palsy
Official title: Does Participating in a Supervised Fitness Program Extend the Benefits of Episodic Physical Therapy More Than a Home Exercise Program for Adults With Cerebral Palsy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Sheltering Arms Physical Rehabilitation Hospitals
First posted: 2017-07-17
Enrollment: 18
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: The purpose of this study is to compare the effectiveness of 2 community intervention approaches to maintain community mobility and walking speed in adults with cerebral palsy who have previously completed an 8 week course of physical therapy.

Detailed description: The proposed study will address the lifelong need for fitness in adults with cerebral palsy compared to individuals provided with a home exercise program at the end of their individualized physical therapy, individuals in the fitness group will...

Primary Hypothesis:

1. Have higher Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDICAT) scores at the +12 weeks post intervention visit
2. Increase their PEDICAT scores across the study period, while the home fitness group will decrease performance on the PEDICAT.
3. Complete the Timed Up and Go (TUG) more quickly at +12 weeks post intervention

   Secondary Hypothesis (study not powered for these variables):
4. Walk further on the Six Minute Walk Test (6MWT) at the +12 weeks post intervention visit

Eligibility criteria: Inclusion Criteria:

* Adults with cerebral palsy Gross Motor Function Classification System (GMFCS) level I, II, or III
* Completion of episode of physical therapy provided by the Developmental Disabilities program at Sheltering Arms within the one month prior to the baseline assessment
* Lives within the community in their own home or group housing

Exclusion Criteria:

* GMFCS level IV or V
* Unable to follow two-step directions
* Adults who have a medical or legal power of attorney who sign their health authorization

Primary outcomes:
measure: Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Testing Version (PEDICAT) score
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in Timed Up and Go (TUG) score
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change in six-minute walk test (6MWT)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Mechanicsville
country: United States
facility: Sheltering Arms
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Stacey C Dusing, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
References: