louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03941457: Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Official title: Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Asclepius Technology Company Group (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed metastatic pancreatic adenocarcinoma
2. Patients aged between 18 and 75
3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than 3 months
6. Subjects must have measurable disease as defined by RECIST 1.1 criteria
7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10\^9/L, Platelets ≥ 70×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration
8. Karnofsky score ≥ 60
9. Ability to give informed consent

Exclusion Criteria:

1. Previously treated with any gene therapy products
2. Patients who are receiving any other investigational agents
3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
6. Concurrent opportunistic infections

Primary outcomes:
measure: Occurrence of treatment related adverse events as assessed by CTCAE v4.03
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Radiology, Shanghai Ruijin Hospital
Study officials:
References:
Clinical trial NCT05717257: Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)
Official title: Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dapagliflozin Adverse Reaction
Efficacy
Systemic Right Ventricle
Keywords: heart failure
dapagliflozin
systemic right ventricle
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the treatment or control group
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Detailed description: This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.

Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.

Eligibility criteria: Inclusion Criteria:

* Age≥18years
* Optimal medical therapy or at least 3months
* Systemic right ventricle ejection fraction≤40%, assessed on echocardiography

Exclusion Criteria:

* Univentricular physiology
* Systolic blood pressure\<90mmHg
* Glomerular filtration rate(GFR)\<30ml/min

Primary outcomes:
measure: Adverse Events
timeFrame: 1 year
measure: Nt-proBNP
timeFrame: 1 year
measure: Systemic right ventricle fractional area change
timeFrame: 1 year
measure: Systemic right ventricle global longitudinal strain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Adult Congenital Heart Disease, Monaldi Hospital
Study officials:
References:
Clinical trial NCT02780557: How Parents Can Help Babies Learn to Talk With Picture Books.
Official title: A Randomised Control Trial to Test the Effect of Parent Contingent Talk During Shared Book Reading on Infant Language Learning.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Language Development
Keywords: Vocabulary
Book reading
Infancy
Parenting
Lead sponsor: University of Sheffield
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 156
Sex: ALL
Minimum age (years): 11
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to test whether giving parents advice about book reading is effective in promoting language learning for infants from a range of socio-economic backgrounds.

Detailed description: Children from disadvantaged families tend to have limited language skills compared to their advantaged peers. While many factors contribute to language ability, two aspects of the early caregiving environment are known to be correlated with child language outcomes 1) caregiver-child book reading and 2) caregiver contingent talk. Contingent talk refers to a style of communication whereby the caregiver talks about what is in their infant's current focus of attention. This style of talking can be facilitated when parents read books with their babies. The aim of this research is to establish whether asking parents to engage in contingent talk in the context of book reading promotes vocabulary learning. This study will compare the effects of an intervention to promote contingent talk against a control where parents are given books but not given any training in how to read them in a contingent manner. The study will include children from socio-economically advantaged and disadvantaged families.

Eligibility criteria: Inclusion Criteria:

Infants must be:

* first born and singletons
* full term (i.e. born no more than 3 weeks prematurely)
* with birth weight over 2.5 kg.

Primary caregivers must:

* work less than 24 hours per week (i.e., be the caregiver the child spends most time with)
* be raising their child as monolingual English speakers.

Exclusion criteria:

Neither caregivers nor infants must have any significant known physical, mental or learning disability.

Primary outcomes:
measure: Change in infant expressive vocabulary
timeFrame: Baseline: 11 months, outcome: 15 months
Secondary outcomes:
measure: Change in caregiver reported frequency of reading
timeFrame: Baseline: 11 months, outcome: 15 months
measure: Infant Real Time Language Understanding: Accuracy
timeFrame: 15 months
measure: Infant Real Time Language Understanding: Reaction Time
timeFrame: 15 months
Other outcomes:
measure: Change in caregiver contingent talk while book reading
timeFrame: Baseline: 11 months, outcome: 15 months
Locations:
city: Sheffield
country: United Kingdom
facility: University of Sheffield
state: South Yorkshire
Study officials:
affiliation: University of Sheffield
name: Danielle E Matthews, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06953557: Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity
Official title: Evaluation of the Salivary-free Amino Acids Levels With Caries Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dental Caries
Keywords: Salivary -free amino acid measurment
Lead sponsor: Al-Mustansiriyah University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in both genders in 8-10 years old

Brief summary: This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility

Detailed description: 80 healthy children (8-10 years old) will be recruited from primary schools of Baghdad city/ Iraq, will be classified according to their level of caries activity (high caries activity, n = 40; negative caries activity, n = 40). Total stimulated and unstimulated saliva will be collected to estimate the caries activity by using the Snyder test, and Amino acid analysis of the saliva will be performed by reversed phase - high performance liquid chromatography (RP-HPLC), respectively.

Eligibility criteria: Inclusion Criteria:

* Children aged (8,9,10) years with different caries
* Absence of signs of gingivitis or periodontal disease.

Exclusion Criteria:

* Children out the range of age
* Children with any systemic discases.
* Children with appliances in the mouth.
* Children with appliances in the mouth.
* Children with antibiotic treatment or any other drug over the last two weeks. B

Primary outcomes:
measure: Salivary-free amino acid analysis
timeFrame: Baseline :unstimulated saliva collection for salivary glycine , proline , lysine and alanine measurement
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00957957: Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
Official title: Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Diabetes Mellitus Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Morbidly obese type 2 diabetic patients

Brief summary: This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Documented type 2 diabetes with total disease duration ≤10 years
* BMI of at least 35 kg/m\^2
* Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG)

Exclusion Criteria:

* Any illness that might confound the results of the study or pose additional risk to the patient by participation
* History of stroke, seizures, or other major neurological disorder
* History of cancer
* Patient uses or has used any medication that can alter body weight
* Patient is unwilling or unable to follow study procedures

Primary outcomes:
measure: Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change from baseline in PYY measured by dMS 4 weeks after RYGBP
timeFrame: Baseline and week 4
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV. Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes. BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.
Clinical trial NCT04595357: "Iris Shelf" Technique for Intraocular Foreign Bodies Removal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Injuries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique at Assiut University hospitals and Al-Forsan eye center, Assiut; Egypt in the period between January 2016 and December 2019.

Brief summary: Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis.

When presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe "Iris shelf" technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.


Eligibility criteria: Inclusion Criteria:

- posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using "Iris shelf" technique

Exclusion Criteria:

* Any other surgical technique for posterior segment IOFB removal

Primary outcomes:
measure: corrected distance visual acuity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04974957: Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Official title: A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
2. Failed with prior systemic treatments.
3. Measurable disease, as defined by RECIST v1.1
4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Symptomatic, untreated or active central nervous system metastases.
3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
4. With any active autoimmune disease or history of autoimmune disease.
5. Inadequately controlled hypertension.
6. Tumor infiltration into the great vessels on imaging.
7. History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
8. Uncontrolled tumor-related pain.
9. Patients with active hepatitis B or hepatitis C
10. Severe infections within 4 weeks prior to initiation of study treatment.
11. Active tuberculosis within one year prior to initiation of study treatment.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Disease control rate (DCR)
timeFrame: 2 years
measure: Duration of response (DOR)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01693757: Functional Outcome Anterior Cruciate Ligament Reconstruction
Official title: Comparison of Functional Outcome Measures of Anterior Cruciate Ligament Reconstruction Using Either Patellar Tendon or Hamstring Tendon Grafts and Controls in Competitive Soccer Players: A Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications of Surgical Procedures or Medical Care
Keywords: Anterior Cruciate Ligament
Hamstrings versus patellar tendon
Hop test
Return to sports
Lead sponsor: University of Social Welfare and Rehabilitation Science
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 63
Sex: MALE
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with ACL deficiency were invited to participate in a randomized trial comparing ACLR with either a BPTB or STG graft.

Brief summary: The purpose of this study is to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

Detailed description: The choice of graft for anterior cruciate ligament reconstruction (ACLR) remains controversial. Despite the need for outcome studies comparing bone-patellar tendon-bone (BPTB) with semitendinosus and gracilis tendon (STG), few studies have evaluated functional outcomes. The objective of the current study was to compare hop performance and jump landing strategy in soccer players with higher level sports activities after ACLR using either BPTB or STG and controls.

Eligibility criteria: Inclusion Criteria:

* ACLR and controls.

Exclusion Criteria:

* Musculoskeletal injuries

Primary outcomes:
measure: Hop values for the both legs in Single, 6-m, Cross-over and Triple hops
timeFrame: Patients were followed up to 8 months post-surgery
Secondary outcomes:
measure: Landing and Take-off Ground Reaction Forces
timeFrame: Patients were followed up to 8 months post-surgery
measure: Strength of Quadriceps and Hamstrings
timeFrame: Patients were followed up to 8 months post-surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: USWR
Study officials:
affiliation: USWR
name: Mahyar Salavati, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03342157: Docusate/Senna for the Treatment of Diabetic Gastroparesis
Official title: Pilot Study for the Efficacy and Tolerability of Senokot-S in the Treatment of Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Gastroparesis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years, male and non-pregnant, non-lactating females
* Diagnosis of type 1 or type 2 diabetes mellitus
* Clinical diagnosis of diabetic gastroparesis

Exclusion Criteria:

* Diagnosed idiopathic gastroparesis
* A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
* A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed rectal bleeding
* Gastrointestinal cancer
* Any active cancer
* Prior gastric surgery
* End-stage heart disease, liver disease, lung disease
* Known or suspected drug abuse
* Any condition requiring use of daily narcotics
* Concurrent usage of mineral oil or products containing mineral oil
* Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna

Primary outcomes:
measure: Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD)
timeFrame: 28 days
Secondary outcomes:
measure: Frequency of Use of Breakthrough Medication
timeFrame: 28 days
measure: Frequency of Bowel Movements
timeFrame: 28 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bradley Gose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05624957: Lidocaine Irrigation in Shoulder Arthroscopy
Official title: Efficacy of Lidocaine Saline Irrigation in Patients Undergoing Shoulder Arthroscopy: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Analgesia
Keywords: Postoperative pain
Lidocaine
Shoulder arthroscopy
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Arthroscopic shoulder surgery is often associated with severe postoperative pain that is often significant enough to interfere with initial recovery and rehabilitation. The pain that can be difficult to manage without large dose of opioid.

The study aim to explore the effect of continuous irrigation of fluids mixed with lidocaine and epinephrine for analgesic consumption and postoperative pain after shoulder arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Age 20-60
* Both genders
* Shoulder arthroscopy
* ASA I-III

Exclusion Criteria:

* Drug allergy
* Psychiatric disorder
* Opioid dependence
* Liver disease
* Patient refuse

Primary outcomes:
measure: total analgesic consumption
timeFrame: 24 hours
Secondary outcomes:
measure: first analgesic request
timeFrame: 24 hours
measure: Visual analogue pain score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Minia University, faculty of medicine
name: hassan m. hetta, lecturer
role: PRINCIPAL_INVESTIGATOR
References: