louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04949087: Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)
Official title: Prospective, Double Blind, Randomized Control Trial Comparing the Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Shoulder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 200
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 efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.


Eligibility criteria: Inclusion Criteria:

* Patient ≥18y.o. of age
* Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation.
* Baseline pain level of VAS \>4

Exclusion Criteria:

* Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)
* Ipsilateral shoulder surgery within 1 year
* Any glenohumeral joint injection within 3 months
* Allergy to lidocaine
* Known pregnancy
* Workers compensation case regarding shoulder

Primary outcomes:
measure: Visual Analog Scale-Pain (VAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT04065087: Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma
Official title: A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Newly Diagnosed Glioblastoma
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 1: sequential dose escalation Phase 2: randomized, placebo controlled, parallel arm
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2, randomized, placebo-controlled study to evaluate safety, tolerability, anti-tumor activity and impact on absolute lymphocyte count of GX-I7 plus adjuvant temozolomide combination regimen in patients with newly diagnosed with glioblastoma who completed standard concurrent chemo-radiation therapy (CCRT)

Detailed description: In dose escalation stage (Phase 1 part), low/intermediate/high dose of GX-I7 will be administered in combination with adjuvant temozolomide to find recommended phase 2 dose.

Phase 2 part will be randomized, placebo controlled study and GX-I7 or Placebo will be administered in combination with adjuvant temozolomide treatment.

Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form (ICF)
2. Age ≥ 19 years
3. Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
4. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, requiring concurrent chemo-radiotherapy (CCRT) and adjuvant temozolomide chemotherapy with curative intent
5. Karnofsky score ≥ 60
6. Life expectancy \> 12 weeks

Exclusion Criteria:

1. Gliomatosis cerebri
2. Isocitrate dehydrogenase 1 \& 2 mutation
3. Pregnant or breast feeding women

Primary outcomes:
measure: lymphocyte count
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Progression free survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent Hospital
Study officials:
References:
Clinical trial NCT07006987: HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women
Official title: Clinical Study for HerResolve™ in Detecting the Presence of Endometriosis Among Symptomatic Women of Ages 18-49 Years Considering Laparoscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To demonstrate the performance of the non-invasive blood-based test in detecting endometriosis as compared to diagnostic laparoscopy
Primary purpose: DIAGNOSTIC

Brief summary: Endometriosis (EMS) is a common gynecological disease that affects 176 million girls and women globally. EMS affects 5-10% of women and adolescents within the reproductive age range of 15-49 years, and for those facing infertility, this figure may climb up to 50%. EMS can start at the first menstrual period and last until menopause. Shockingly, between 50% and 80% of women grappling with pelvic pain are found to have EMS. The formation of scar tissue (adhesions, fibrosis) within the pelvis and other parts of the body can cause severe pain and lead to infertility.


Eligibility criteria: Inclusion Criteria:

* Females aged 18 to 49 with mild to severe symptoms of pelvic pain and/or abnormal bleeding.
* Diagnostic laparoscopy is scheduled with histology on any visually suspected endometriosis, and all reports (surgical and pathology) to confirm a positive result. If no visually suspicious endometriotic lesions are seen, biopsies from random areas during the laparoscopy procedure to confirm a negative histopathology result.
* Blood drawn during secretory or proliferative phase of the menstrual cycle
* Provide written informed consent to participate in the study and provide medical history on medications.

Exclusion Criteria:

* Patients who object to medical history collection and data requests
* Patients with cancer and/or undergoing chemotherapy and/or radiotherapy
* Patients who are unable or do not undergo laparoscopic surgery
* Patients participating in additional interventional clinical studies
* Pregnant, lactating, or subjects who are not healthy enough for blood donation.
* Blood drawn during menses or ovulation phase of menstrual cycle
* Females who are post-menopausa

Primary outcomes:
measure: Detecting endometriosis as compared to diagnostic laparoscopy
timeFrame: 1 week
Secondary outcomes:
measure: Performance Objective:
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT03148587: Medical Abortion Self-Confirmation (MASC)
Official title: Medication Abortion Self-Confirmation (MASC): Comparison of Two Home Pregnancy Tests as an Alternative to Office Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Abortion
Keywords: abortion
medical abortion
mifepristone
pregnancy test
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to investigate the ability of participants to perform and accurately interpret the multi-level pregnancy test and the low sensitivity pregnancy test following medication abortion, without routine provider contact.


Eligibility criteria: Inclusion Criteria:

* Gestational age of less than or equal to 63 days
* English speaking
* Determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria
* In the judgement of the site investigator, she is capable of giving informed consent and she has signed the study informed consent or assent form

Exclusion Criteria:

* Allergy to mifepristone and/or misoprostol
* Non-english speaking
* Inability to access internet

Primary outcomes:
measure: Correct interpretation of pregnancy test
timeFrame: 4 weeks after taking medication abortion medication, mifepristone
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT01949987: Does Oral Intake Decreases Postoperative Pain Score in Children
Official title: The Effect of Oral Intake on Pain Score in Children Undergoing Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Postoperative Pain
Lead sponsor: Ibaraki Children's Hospital
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Pain score after inguinal hernia repair surgery in children decreased as time passed in previous studies. Postoperative oral intake is usually resumed two hours after minor surgery in most of institutions, that may influence children's behavior and pain score.

A recent study suggest that oral intake one hour after minor surgery does not increase the incidence of postoperative nausea and vomiting.

The investigators primary endpoint is to clarify whether postoperative oral intake influences postoperative pain score in children.


Eligibility criteria: Inclusion Criteria:

* 18 month to 12 years old children undergoing elective unilateral inguinal hernia repair surgery

Exclusion Criteria:

* neurological disease, developmental delay

Primary outcomes:
measure: whether oral intake influences postoperative pain score in children
timeFrame: 90 minutes after surgery
Secondary outcomes:
measure: postoperative nausea and vomiting
timeFrame: 4 hours on average
Other outcomes:
Locations:
city: Mito
country: Japan
facility: Ibaraki Children's Hospital
state: Ibaraki
Study officials:
affiliation: Ibaraki Children's Hospital
name: Kazuhiko Okuyama, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06194487: Efficacy Evaluation of Collagen Drink Products
Official title: Efficacy Evaluation of Collagen Drink Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 91
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess MAXI Collagen drink on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 35-65 years old

Exclusion Criteria:

* Subject with skin surface damage larger than $50 coin area.
* Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
* Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
* Students who are currently taking courses taught by the principal investigator of this trial.

Primary outcomes:
measure: The change of skin collagen density
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin elasticity
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin moisture
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin texture
timeFrame: Day 0, Day 7, Day 28
Secondary outcomes:
measure: The change of transepidermal water loss (TEWL)
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin wrinkles
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin pores
timeFrame: Day 0, Day 7, Day 28
measure: The change of skin colour
timeFrame: Day 0, Day 7, Day 28
measure: The change of self-assessment skin condition
timeFrame: Day 0, Day 7, Day 28
Other outcomes:
measure: The change of liver function biomarkers (GOT, GPT) of blood
timeFrame: Day 0, Day 28
measure: The change of renal function biomarkers (creatinine, BUN) of blood
timeFrame: Day 0, Day 28
measure: The change of fasting blood glucose
timeFrame: Day 0, Day 28
Locations:
city: Taichung City
country: Taiwan
facility: Department of Applied Cosmetology, Hungkuang University
Study officials:
affiliation: Department of Applied Cosmetology, Hungkuang University
name: Tzu Fang Hsu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04702087: Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects
Official title: Randomized, Placebo-controlled Clinical Study to Evaluate the Effect of 2 Months of Nutritional Support Based on Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 (OLEP Study) on Muscle Mass in Sarcopenic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Elderly
Omega 3
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
Collaborators: name: Abiogen Pharma
First posted: 2021-01-08
Enrollment: 54
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.


Eligibility criteria: Inclusion Criteria:

* Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
* Body Mass Index between 20 and 30 Kg/m2

Exclusion Criteria:

* severe renal failure (glomerular filtration rate \< 30 mL/min)
* moderate to severe liver failure (Child-Pugh class B or C)
* endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
* known psychiatric disorders
* cancer (over the past 5 years)
* hypersensitivity to any component of the investigational nutritional supplement and
* taking to protein/amino acid supplements (up to 3 months before starting the study)
* patients unable to take oral therapy
* receiving or with indication for artificial nutrition
* who had been included in another clinical nutrition trial

Primary outcomes:
measure: Changes on muscle mass
timeFrame: Baseline / 30 days / 60 days
Secondary outcomes:
measure: Changes on body composition
timeFrame: Baseline / 30 days / 60 days
measure: Changes on physical performancy
timeFrame: Baseline / 60 days
measure: Changes on physical performancy
timeFrame: Baseline / 60 days
measure: Changes on functional status
timeFrame: Baseline / 60 days
measure: Changes on functional status
timeFrame: Baseline / 60 days
measure: Changes on muscle strength
timeFrame: Baseline / 30 days / 60 days
measure: Changes on Quality of life
timeFrame: Baseline / 60 days
measure: Changes on mood
timeFrame: Baseline / 60 days
measure: Changes on blood pressure
timeFrame: Baseline / 60 days
measure: Changes on plasma free essential amino acids
timeFrame: Baseline / 60 days
measure: Changes on safety parameters
timeFrame: Baseline / 60 days
measure: Changes on safety parameters
timeFrame: Baseline / 60 days
measure: Changes on safety parameters
timeFrame: Baseline / 60 days
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
affiliation: Fondazione Casemiro Mondino
name: Mariangela Rondanelli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06076187: Protein Digestion After Bariatric Surgery in Older Adults
Official title: Protein Digestion After Bariatric Surgery in Older Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overweight and Obesity
Bariatric Surgery Candidate
Aging
Protein Malabsorption
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with overweight, obesity or after bariatric surgery

Brief summary: The goal of this clinical trial is to investigate protein digestibility after bariatric surgery.

Does protein digestibility decrease after Roux-en-Y-Gastric Bypass? Does protein digestibility decrease after Sleeve Gastrectomy surgery? Does protein digestibility effect the ability to meet protein requirements?

Detailed description: Purpose of clinical trial is to investigate the digestion of dietary protein in older patients who have undergone Roux-and-Y Bypass (RYGB) or sleeve gastrectomy (SG) surgery. The primary objective is to compare dietary protein digestion during a test meal who have previously undergone a RYGB surgery, SG surgery, or control patients, using a dual stable-isotope method. The secondary objectives are to investigate the relationship between protein intake corrected for protein digestion and skeletal muscle mass, and to investigate the relationship between the rate of free amino acid appearance and protein digestion.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Group 1,2,3: Age 65 years or older
* Group 4,5,6: Age 18 to 65 years
* Group 1,2,4,5: Previous bariatric surgery for obesity 1 - 10 years ago
* Group 3,6: No previous weight loss surgery

Exclusion Criteria:

* Current diagnosis of cancer
* Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
* Immobility
* Neuromuscular degenerative conditions
* Gastrointestinal conditions including coeliac disease, Crohn's disease, previous resection of the small intestine, gastroparesis
* Unable to follow the procedures of the studies due to cognitive impairment such as diagnosed dementia.
* Allergy/intolerance to milk, or soy or spirulina

Primary outcomes:
measure: The proportion of dietary protein digested as measured by the dual-isotope method.
timeFrame: 3,5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen KU Leuven
state: Flemish Brabant
city: Leuven
country: Belgium
facility: UZLeuven
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT04793087: Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis (COCON)
Official title: Post-COntrast 3D SE T1 Versus Coronal SE T1-WI MRI in Detecting Optic Neuritis in Patients Presenting With Acute Visual Loss and Otherwise Normal Ophthalmological Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Neuritis
Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with visual acuity loss explored by MRI between january 2018 and january 2020

Brief summary: 3D FLAIR, 3D T1 FAT SAT, coronal T2 and coronal T1 dixon sequences were usually used to assess visual deficits in MRI. Optic nerve examination is preferably performed using a coronal T2 sequence in order to detect a hypersignal suggestive of inflammation whereas brain examination is preferably performed using a 3D T1 sequence to highlight signs of spatial dissemination and lesions suggestive of multiple slerosis (MS). No study has yet investigated the detection capabilities of 3D T1 for the detection of optic nerve inflammation. The objective of this retrospective study was to determine whether a single 3D T1 sequence allows simultaneous exploration of the optic nerve and the brain for the positive diagnosis of optic neuropathy and/or MS.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Decrease in visual acuity explored in MRI between january 2018 and january 2020

Exclusion Criteria:

* Past history of episode of Optic neuritis

Primary outcomes:
measure: Detection of optic neuropathies using MRI
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References:
Clinical trial NCT03297554: Healthy Kids Pilot
Official title: Healthy Kids Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to 30 parent/child dyads will be recruited to participate in an m-Health intervention (delivered over smartphone, iPad/Tablet, or desktop/laptop) to promote healthy behaviors and healthy weight among children and their parents.


Eligibility criteria: Inclusion Criteria for Child:

* Have at least one participating parent
* Have a BMI percentile \> 85
* Be physically capable of exercise
* Be free of diseases that affect metabolism, body weight, and food intake, including type 1 or type 2 diabetes, HIV/AIDS, and cancer

Inclusion Criteria for Parent:

* Have a smartphone
* Be willing to use the smartphone for the mHealth intervention

Exclusion Criteria for Child:

* Significant cardiovascular disease or disorders via self-report from parent
* Other significant medical problems that would prevent them from engaging in regular physical activity.

Primary outcomes:
measure: Acceptability/feasibility of the mHealth approach
timeFrame: Week 0 to Week 14-16
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Amanda Staiano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedical Research Center
name: Corby Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staiano AE, Shanley JR, Kihm H, Hawkins KR, Self-Brown S, Hochsmann C, Osborne MC, LeBlanc MM, Apolzan JW, Martin CK. Digital Tools to Support Family-Based Weight Management for Children: Mixed Methods Pilot and Feasibility Study. JMIR Pediatr Parent. 2021 Jan 7;4(1):e24714. doi: 10.2196/24714.