louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05856409: Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence
Official title: Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 68Ga-FAPI
Ovarian Cancer
Epithelial Ovarian Cancer
Positron Emission Tomography
Keywords: 68Ga-FAPI
PET
ovarian cancer
recurrence detection
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective cohort of patients with clinically suspected recurrent ovarian cancer were enrolled, who underwent paired 68Ga-FAPI and 18F-FDG PET/CT.

Brief summary: This is a prospective study to investigate the potential efficacy of 68Ga-FAPI PET/CT for recurrence detection of epithelial ovarian cancer in comparison with 18F-FDG PET/CT.

Detailed description: Gallium 68-labeled fibroblast-activation protein inhibitor (68Ga-FAPI) has recently been a potential radiotracer for gynecological malignancies,including ovarian cancer. Early detection and localization of sites of recurrence helps to identify ovarian cancer patients who will benefit the most from secondary surgery, chemotherapy, or radiation therapy. Its clinical utility for recurrence detection of epithelial ovarian cancer and histological validation of FAPI findings is not well established.

Eligibility criteria: Inclusion Criteria:

* adult patients (age\>18 and\<80 years)
* patients with clinically suspected recurrent ovarian cancer
* patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for the most proper treatment strategy within 1 week
* patients who did not receive any other treatment 4 weeks before PET imaging

Exclusion Criteria:

* pregnant patients
* patients with poor performance status
* patients unwilling to provide written informed consent

Primary outcomes:
measure: Diagnostic Performance
timeFrame: 1 year
measure: Maximum standardized uptake value（SUVmax）
timeFrame: 1 year
measure: Tumor-to-background ratio (TBR)
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between FAPI expression and SUV in PET
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jianjun Liu, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06814509: Delivering HOPE (Helping Women Optimize Prenatal Equity)
Official title: Delivering HOPE (Helping Women Optimize Prenatal Equity)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Weight Gain
Diet, Healthy
Gestational Hypertension
Gestational Diabetes
Pregnancy Complications
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 1440
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.


Eligibility criteria: Inclusion Criteria:

* Aged 16-44 years
* ≤18 weeks pregnant
* Speak English, Spanish, or Marshallese

Primary outcomes:
measure: Excessive gestational weight gain (EGWG)
timeFrame: Baseline to Post-partum (approx. 40 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04686409: App-based Symptom Tracking After Corona Vaccination (CoCoV)
Official title: App-based Symptom Tracking After Corona Vaccination (CoCoV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adverse Events in COVID-19 Vaccination
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers (≥ 18 years) who received a COVID-19 vaccination.

Brief summary: The study investigates the side effects of different COVID-19 vaccines.

Detailed description: In this observational study side effects of COVID-19 vaccines will be documented using an open-source mobile application. Participants are invited to answer a questionnaire on a daily basis. Common and unknown events are queried and collected. The primary result of this study will be a descriptive analysis of the collected data.

Eligibility criteria: Inclusion Criteria:

* received COVID-19 vaccination
* age ≥ 18 years
* mobile device (iOS or Android)

Exclusion Criteria:

* No knowledge of German or English language
* No written informed consent

Primary outcomes:
measure: Number of participants with treatment-related side effects
timeFrame: 4 weeks
Secondary outcomes:
measure: Distribution and deviation of documented side effects
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University Hospital Ulm
name: Thomas Seufferlein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05175209: The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions.
Official title: The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions in Patients With Ulnar Nerve Entrapment Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulnar Neuropathies
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.


Eligibility criteria: Inclusion Criteria:

* having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
* to be between the ages of 18-65
* be give informed consent

Exclusion Criteria:

* inflammatory arthritis
* hemiplegia
* contractures of shoulder-arm-hand joints

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) score
timeFrame: 10 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
References:
Clinical trial NCT02456909: Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Official title: The Effect of Patient Controlled Analgesia Pump Cues on Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2015-05-29
Enrollment: 176
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To examine whether providing patients with a cue to the availability of pain medication affects patient satisfaction, patient anxiety, PCA efficacy, and safety.

Detailed description: Post-operative pain is primarily managed via Patient-Controlled Analgesia (PCA). The newest PCA pumps can be programmed so that the button is backlit with a green light at the end of the lockout period, and the green light flashes when the medication is being dispensed. No studies have examined whether this type of visual cue would influence satisfaction or other patient outcomes (such as opioid consumption, PCA safety and patient anxiety) in children and adolescents, and no studies have examined whether pediatric patients' perspectives would be similar to those of adults.

Eligibility criteria: Inclusion Criteria:

* 7-18 years
* Opioid naïve
* Scheduled for a surgery for which a PCA is routinely used for post-operative pain management
* At least 1 parent speaks English

Exclusion Criteria:

* Prior experience with PCA
* Cognitive delay precluding independent use of the PCA button
* Current use of anxiolytics or antidepressants
* Patients receiving epidural analgesia

Primary outcomes:
measure: Patient Satisfaction Questionnaire
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Opioid Consumption (Total Amount of Opioid Consumed Post-operatively)
timeFrame: Post-op Days [POD] 0 - 2, up to 72 hours
measure: Anxiety (State Anxiety on POD 1 and POD 2)
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Keri R. Hainsworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02845609: Efficacy of Sialic Acid GNE Related Thrombocytopenia
Official title: A Phase 2 Study to Evaluate the Efficacy of Sialic Acid-Extended Release (SA-ER) Tablets in Patients With GNE Related Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombocytopenia
Keywords: Congenital macrothrombocytopenia
Sialic acid
Bleeding
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is currently studied as a substrate replacement therapy for patients with GNE myopathy. The investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related thrombocytopenia.

Detailed description: The investigators identified 5 affected individuals (3 males and 2 females from three families, age 19-40 years) with GNE-related thrombocytopenia . All subjects will receive 2 gram SA-ER, three times per day for a total daily dose of 6 grams (6,000 mg). The dose should be administered with food (i.e. within 30 minutes of a meal or snack).

Efficacy will be evaluated by improvement in clinical and laboratory assessments. Results from Baseline assessments will be compared with those of post-treatment assessments with efficacy conclusions based on improvement between Baseline and the last scheduled assessment. Safety will be evaluated by the incidence and frequency of adverse events, including clinically significant changes from Baseline to scheduled time points in:

* Vital signs.
* History and physical examination findings.
* Laboratory evaluations.
* Serum uric acid levels and urinary excretion of uric acid.

Eligibility criteria: Inclusion Criteria:

* Patients with GNE-related macrothrombocytopenia in the investigated family

Exclusion Criteria:

* non consenting for this study
* pregnancy

Primary outcomes:
measure: Increase in platelet count from baseline
timeFrame: 3 month
Secondary outcomes:
measure: Incidence and frequency of AEs and SAEs (Safety)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03004209: Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Official title: Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Autoimmune Encephalitis
Keywords: Erythropoietin
Autoimmune encephalitis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.

Detailed description: Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.

We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed autoimmune encephalitis
* Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)

Exclusion Criteria:

* Hemoglobin \> 12g/dL
* Hematochrit \>36%
* Thrombocytosis \> 750K
* AST or ALT \> 120
* HIV (+)
* Allergic reaction upon erythropoietin
* Uncontrolled hypertension
* mRS before the autoimmune encephalitis \> 3
* Breast feeding or pregnancy
* History of ischemic stroke or pulmonary thrombosis
* Refuse to be enrolled

Primary outcomes:
measure: Change from Baseline modified Rankin Scale (mRS) at 12th week
timeFrame: 2nd week, 12th week
Secondary outcomes:
measure: Adverse effect
timeFrame: 2nd week, 4th week, 8th week, 12th week
measure: Quality of Life in Epilepsy Inventory (QOLIE) -31
timeFrame: 2nd week, 4th week, 8th week, 12th week
measure: Mini-Mental State Examination (MMSE)
timeFrame: 2nd week, 4th week, 8th week, 12th week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kon Chu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04039009: Apical Pelvic Support in Infertility Patients
Official title: Apical Pelvic Compartment Support in Infertility Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Pelvic Organ Prolapse
Pelvic Floor Disorders
Keywords: Pelvic organ prolapse
Infertility
Apical pelvic support
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is the patients examined for female infertility.

Brief summary: This study aims to evaluate apical pelvic compartment support in infertility patients at the time of hysteroscopy. Apical pelvic compartment evaluation for pelvic organ prolapse will be performed in infertility patients undergoing hysteroscopy.

Detailed description: The incidence of pelvic organ prolapse in the whole population has been demonstrated several times in previous studies. However, pelvic floor defects in young infertility patients are not known. In this study, a clinical pelvic floor assessment with the pelvic organ quantification system will be performed in infertility patients during standard physical examinations or hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Ages between 18-45
* Patients who cannot become pregnant despite regular sexual intercourse for more than one year

Exclusion Criteria:

* Malignity
* Patients who become pregnant during infertility assessment

Primary outcomes:
measure: Stages of the pelvic organ prolapse
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University Hospital, Department of Obstetrics and Gynecology
state: Ozluce
Study officials:
affiliation: ULUDAG UNIVERSITY HOSPITAL BURSA TURKEY
name: Gurkan Uncu, Prof.
role: STUDY_DIRECTOR
References:
citation: Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
citation: Swift SE. The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care. Am J Obstet Gynecol. 2000 Aug;183(2):277-85. doi: 10.1067/mob.2000.107583.
Clinical trial NCT01093209: Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Official title: Efficacy of the Interferential Laser Therapy in Pain Reduction in Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carpal Tunnel Syndrome
Neuropathic Pain
Keywords: Carpal Tunnel Syndrome
Interferential laser therapy
Low-level laser therapy
Neuropathic pain
Median nerve compression
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 100
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 purpose of this study is to determine the efficacy of the interferential laser therapy in the wrist and hand pain and disability reduction and force improvement in the carpal tunnel syndrome. Subjects are patients diagnosed of carpal tunnel syndrome who have been prescribed laser therapy. Settings: Ramon y Cajal Hospital. Department of Rehabilitation. Physical therapy unit. Electrotherapy section. Occupational Therapy. Department of Neurology.

Detailed description: The spatiotemporal superposition of two independent and opposite beams of laser generates a constructive interference pattern that increases the therapeutic effects in the irradiated tissue. Patient suffering pain from diagnosed carpal tunnel syndrome will receive conventional or interferential laser therapy. This is a comparative randomized and double blind clinical study. Two identical lasers in near infrared range will be used. Frequency of sessions: daily. Irradiated technique: manual, contact and punctual. Pain will be evaluated by visual analog scale at rest and during analytical wrist movement. Disability will be evaluated by the DASH and BOSTON questionnaire. Evaluation will take place at pre and post-treatment times.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of Carpal Tunnel Syndrome by means of an Electromyography Study.
* Patients with or not previous surgery.
* Patients with an age of 18 years or older.
* Patients having a signed informed consent.

Exclusion Criteria:

* Patients with severe hand traumatisms.
* Patients with cervical radiculopathy.
* Patients with Outlet Thoracic Syndrome.
* Patients bearing osteo syntheses material.
* Patients suffering tumoral pathology.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 5 minutes
Secondary outcomes:
measure: Disability Arm Shoulder and Hand questionnaire (DASH)
timeFrame: 15 minutes
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 5 minutes
measure: Dinamometry
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
Study officials:
affiliation: Unit of Physiotherapy
name: Ramon Montes-Molina, PT, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit Biomechanics and Biomaterials
name: Fidel Martinez-Ruiz, Physicist
role: STUDY_DIRECTOR
References:
Clinical trial NCT01302509: Enteral Nutrition in Cancer Patient
Official title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Cancer
Pediatric
Keywords: Nutritional support.
Cancer.
Malnutrition.
Child.
Adolescent
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-02-24
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility criteria: Inclusion Criteria:

* Were chemotherapy, age above one year and malnutrition. A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children26 and ≥ 5th to \< 15th of body mass index (BMI) in adolescents27 were considered as mild malnutrition; and a zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were corticosteroid or hormonal therapy, swallowing abnormalities, parenteral or tube feeding therapy, palliative care and presence of non cancer-related diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: