louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02075281: Effect of LAPS-Exendin on Body Weight in Obese Population
Official title: A 20-week, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial to Assess the Safety and Efficacy of HM11260C on Body Weight in Obese Subjects Without Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal dose and regimen of HM11260C, in combination with a hypocaloric diet, to reduce weight in obese subjects who are otherwise considered in stable health.

Detailed description: Phase 2 study

Eligibility criteria: 1. Inclusion Criteria:

   * Age: 18 years to 65 years
   * Genders: male and female
   * healthy obese population
   * non-diabetes
   * stable body weight for at least 3 months prior to screening
2. Exclusion Criteria

   * Pregnant or nursing (lactating) women
   * Drug-induced obesity
   * Diabetes mellitus (type 1, 2, and other)
   * Previous surgical treatment for obesity
   * Any known history of severe gastrointestinal (GI) disease or intolerance
   * Known history of pancreatitis with presence of raised serum amylase and lipase
   * History of suicide attempts or recent history (within 2 years prior to screening) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor s (SNRIs), antipsychotics, and lithium.

Primary outcomes:
measure: Change from baseline in body weight at 20 weeks
timeFrame: 20 weeks from baseline
Secondary outcomes:
measure: Number of participants with adverse event
timeFrame: during 20 weeks of treatment and follow-up period
measure: Change from baseline in HbA1c and fasting plasma glucose level at 20 week
timeFrame: 20 weeks from baseline
measure: Change from baseline in blood lipid profile (e.g., cholesterol, and LDL-C level) at 20 week
timeFrame: 20 weeks from baseline
Other outcomes:
measure: Change from baseline in waist circumference at 20 week
timeFrame: 20 weeks after baseline
measure: Change from baseline in β-cell function at 20 week
timeFrame: 20 week from baseline
Locations:
city: Los angeles
country: United States
facility: Hanmi pharmaceutical
state: California
Study officials:
affiliation: Hanmi pharmaceuticals
name: Hanmi pharmaceuticals Hanmi pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655681: Prevention of Post Operative Bone Loss in Children
Official title: Prevention of Post Operative Bone Loss in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Cerebral Palsy
Spina Bifida
Osteopenia
Osteogenesis Imperfecta
Keywords: pediatric osteoporosis
pediatric osteopenia
pamidronate
post operative osteopenia
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2008-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density

Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.

Detailed description: Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora

Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D

Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group

Repeat DXA scan after end of immobilization or non-weightbearing

Eligibility criteria: Inclusion Criteria:

* chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
* lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks

Exclusion Criteria:

* creatinine \>1.2
* prior bisphosphonate exposure
* orthopaedic implants in distal femoral precluding DXA scan
* inability to cooperate with DXA scan

Primary outcomes:
measure: Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
timeFrame: Preoperative to post-operative DXA scan (4-12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Carrie Tingley Hospital
state: New Mexico
Study officials:
affiliation: University of New Mexico Carrie Tingley Hospital
name: Elizabeth A Szalay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03397381: Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate
Official title: Outcome of Arterio-venous Fistula for Adult Hemodialysis Patients in Assiut Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Renal Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic renal Failure on regular dialysis

Brief summary: identification of the factors that affect the outcome of arteriovenous fistula in chronic renal failure patients that newly established regular dialysis in Assiut Governorate

1. To study the factors that influence the outcome of AVF
2. To evaluate the vascular complications of AVF as occlusion, rupture, aneurysmal dilation and hand ischemia


Eligibility criteria: Inclusion Criteria:

* all adult hemodialysis Patients in Assiut Government are eligible for enrollment if they are newly dialyzed via AVF and agree to participate in the study

Exclusion Criteria:

* Patients are not dialyzed with AVF

Primary outcomes:
measure: the number of new renal failure patients with failed arteriovenous fistula as measured with arteriovenous duplex ultrasound imaging peak systolic velocity and end-diastolic velocity in Assiut Governorate
timeFrame: 3 years
Secondary outcomes:
measure: the number deaths of renal failure patients on regular dialysis related to AVF complications in Assiut Governorate
timeFrame: 3 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hanan
Study officials:
affiliation: Assiut University
name: Hanan S Mahrous, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stolic R. Most important chronic complications of arteriovenous fistulas for hemodialysis. Med Princ Pract. 2013;22(3):220-8. doi: 10.1159/000343669. Epub 2012 Nov 2.
citation: Lok CE. Fistula first initiative: advantages and pitfalls. Clin J Am Soc Nephrol. 2007 Sep;2(5):1043-53. doi: 10.2215/CJN.01080307. Epub 2007 Aug 16. No abstract available.
citation: Valliant A, McComb K. Vascular Access Monitoring and Surveillance: An Update. Adv Chronic Kidney Dis. 2015 Nov;22(6):446-52. doi: 10.1053/j.ackd.2015.06.002.
citation: Hammes M. Hemodynamic and biologic determinates of arteriovenous fistula outcomes in renal failure patients. Biomed Res Int. 2015;2015:171674. doi: 10.1155/2015/171674. Epub 2015 Oct 1.
citation: Padberg FT Jr, Calligaro KD, Sidawy AN. Complications of arteriovenous hemodialysis access: recognition and management. J Vasc Surg. 2008 Nov;48(5 Suppl):55S-80S. doi: 10.1016/j.jvs.2008.08.067.
Clinical trial NCT06381895: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer
Official title: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Radiomics
Immunotherapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-04-24
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: PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed primary bladder cancers

Brief summary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age;
2. Performing TURB-t or RC during 2010-2022;
3. The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;
4. Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;

Exclusion Criteria:

1. Patients with distant metastasis;
2. Combined with other malignant tumors or malignant tumor treatment history
3. Malignant tumors of upper urinary tract;
4. Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;
5. Other situations in which the researcher considers it inappropriate to participate in this study.

Primary outcomes:
measure: Tumour-infiltrating lymphocytes (TIL)
timeFrame: 1 year
Secondary outcomes:
measure: overall survival
timeFrame: 1 year
measure: cancer-specific survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
affiliation: Medical Ethics Committee, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
name: Liushan Ou
role: STUDY_CHAIR
References:
Clinical trial NCT01562795: Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Official title: Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Dry Eye Syndrome
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with topical corticosteroids.


Eligibility criteria: Inclusion Criteria:

* moderate to severe dry eye syndrome
* tear film breakup time \>0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
* corneal staining≥3 scores

Exclusion Criteria:

* allergic to any composition of the drugs under experiment
* previous use of anti-inflammatory drugs or immunosuppressive agent
* viral,bacterial or fungal infection of the eye
* eyelid anomaly
* glaucoma or high IOP
* significant meibomian gland dysfunction

Primary outcomes:
measure: tear osmolarity
timeFrame: Day 0, Day 14
Secondary outcomes:
measure: corneal staining
timeFrame: 0 day,7th day and 14th day after treatment
measure: Schirmer test(without anaesthesia)
timeFrame: 0 day,7th day,14th day after treatment
measure: tear film breakup time(TBUT)
timeFrame: 0 day,7th day and 14th day after treatment
measure: meibomian gland function
timeFrame: 0 day,7th day and 14th day after treatment
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Wei Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00559195: Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
Official title: Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
anemia
fatigue
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.

PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.

Detailed description: OBJECTIVES:

Primary

* Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.

Secondary

* Evaluate the impact of epoetin beta on hemoglobin level (increase \> 2 g/dL).

OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.

Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed malignant solid tumor

  * No hematologic malignancy
* Hemoglobin \< 10.5 g/dL (anemic)
* Receiving palliative care only

PATIENT CHARACTERISTICS:

* Life expectancy \> 6 months
* Negative pregnancy test
* Fertile patients must use effective contraception
* No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)
* No uncontrolled hypertension
* No allergy to any drugs or components used in the study
* Not a prisoner or under guardianship or trusteeship
* No mental disability that impairs a clear understanding of the study requirements

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)
* More than 1 month since prior and no concurrent participation in another clinical trial

Primary outcomes:
measure: Fatigue
measure: Quality of life
Secondary outcomes:
measure: Hemoglobin level
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
Study officials:
affiliation: Centre Hospital Regional Universitaire de Limoges
name: Jean-Luc Labourey
role: STUDY_CHAIR
References:
Clinical trial NCT06050395: The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Official title: The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.


Eligibility criteria: Inclusion Criteria:

* Men or women 18 years of age or more
* Newly diagnosed, in place tumors of the pancreas
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
* Able to speak and read English
* Able to consume food orally
* Chemotherapy naive
* Scheduled to receive treatment with chemotherapy
* Able to provide verbal informed consent

Exclusion Criteria:

* Women who are pregnant
* Pancreatic cancer not the primary diagnosis
* Patients on enteral or parental nutrition
* Patients with metastatic pancreatic cancer
* Patients with evidence of impeding bowel obstruction
* Patients presenting with ascites

Primary outcomes:
measure: Recruitment Rate -Feasibility
timeFrame: Up to 8 months
measure: Retention Rate - Feasibility
timeFrame: at 12 weeks
measure: Adherence - Feasibility
timeFrame: at 12 weeks
Secondary outcomes:
measure: Participant Satisfaction with Overall Program- Acceptability
timeFrame: at 12 weeks
measure: Participant intent to continue using skills- Acceptability
timeFrame: at 12 weeks
measure: Participant perception of utility of knowledge gained - Acceptability
timeFrame: at 12 weeks
Other outcomes:
measure: Treatment Effect - Quality of Life
timeFrame: at Baseline, and at 6 and 12 weeks
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Sylvia Crowder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308295: A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Official title: A Pilot Study of Fish Oil Supplementation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease Patients on Hemodialysis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to determine whether the American Heart Association-recommended fish oil dose is efficacious, safe, and tolerable in hemodialysis patients. The secondary objective is to test the effects of fish oil supplementation on inflammatory and cardiovascular markers.


Eligibility criteria: Exclusion Criteria:

1. Age \<18
2. Pregnant individuals
3. Fish oil or omega-3 supplementation in past 6 months
4. Fish, corn, soybean, gelatin, or vanilla allergies
5. Currently enrolled in a dietary or investigational drug study
6. Life expectancy \< 3 months
7. Ongoing active illness requiring hospitalization
8. Malabsorption syndromes
9. Chronic heparin or coumadin anticoagulation (??)
10. Active bleeding issues

Primary outcomes:
measure: To determine whether AHA-recommended fish oil therapy beneficially affects the pro-inflammatory/anti-inflammatory blood fatty acid balance
Secondary outcomes:
measure: To test the safety and tolerability of fish oil therapy in hemodialysis patients
measure: To measure the effects of fish oil treatment on cardiovascular and inflammatory risk factors
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Nephrology Clinics
state: Indiana
city: Indianapolis
country: United States
facility: VeteransAdministration Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Allon Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618395: Bioavailability Study of SPARC001 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bioavailability study

Detailed description: Bioavailability, safety and tolerability

Eligibility criteria: Inclusion Criteria:

* Adult, male and female volunteers, 18 to 55 years of age
* Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening
* Female subjects must have a negative serum pregnancy test
* Medically healthy on the basis of medical history and physical examination

Exclusion Criteria:

* Females who are pregnant, lactating, or likely to become pregnant during the study
* Life-time history and/or recent evidence of alcohol
* History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations
* Subjects with any condition in which an opioid is contraindicated

Primary outcomes:
measure: Maximum plasma hydrocodone and acetaminophen concentration (Cmax)
timeFrame: 17 days
Secondary outcomes:
measure: AUC extrapolated to infinity (AUC0 ∞)
timeFrame: 17 days
measure: Time to Cmax (tmax)
timeFrame: 17 days
measure: Elimination half-life (t½)
timeFrame: 17 days
measure: Treatment emergent adverse event
timeFrame: 17 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04351295: Efficacy of Faviprevir in COVID-19 Treatment
Official title: Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 92
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: Faviprevir in COVID-19 treatment

Detailed description: Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment

Eligibility criteria: Inclusion Criteria:

* Patients with covid 19

Exclusion Criteria:

* Allergy or contraindications to faviprevir

Primary outcomes:
measure: Number of patients with mortality or need for mechanical ventilation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Ainshams University
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dabbous HM, Abd-Elsalam S, El-Sayed MH, Sherief AF, Ebeid FFS, El Ghafar MSA, Soliman S, Elbahnasawy M, Badawi R, Tageldin MA. Efficacy of favipiravir in COVID-19 treatment: a multi-center randomized study. Arch Virol. 2021 Mar;166(3):949-954. doi: 10.1007/s00705-021-04956-9. Epub 2021 Jan 25.