louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00531544: A SU011248 Expanded Access Protocol for Systemic Therapy of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Official title: A SU011248 Expanded Access Protocol for Metastatic RCC Patients Who Are Ineligible for Participation in Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-19
Enrollment: 350
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: A SU011248 expanded access protocol for systemic therapy of patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic Renal Cell Carcinoma who are ineligible for participation in other SU011248 protocols but may derive benefit from treatment with SU011248

Primary outcomes:
measure: Efficacy
timeFrame: 2001-2012
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC, Riyadh, Saudi Arabia
name: Shouki Bazarbashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06711744: ISQ Differences Between Different Implants in Post-extraction Sockets
Official title: Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Healing
Implant Stability
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design


Eligibility criteria: Inclusion Criteria:

* Patients (at least 18 years old) presenting with failing tooth.
* no recession of gingival contour of tooth to be extracted
* no periodontal bone loss of neighboring teeth
* no implants in neighboring teeth
* class I extraction socket (intact buccal wall)
* atraumatic extraction of the tooth with intact socket walls remaining.

Exclusion Criteria:

* deep bite (severe II class)
* systemic disease (diabetes, osteoporosis)
* heavy smokers (more than 10 cigarettes/day)

Primary outcomes:
measure: IMPLANT STABILITY QUOTIENT
timeFrame: Monthly from T0 (implant insertion) to T12 (12 months after implant placement)
Secondary outcomes:
measure: Insertion torque
timeFrame: At implant placement
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Paolo Carosi
state: RM
Study officials:
References:
Clinical trial NCT00565344: Medicaid Disenrollment: Intrastate Emergency Department Impact
Official title: Medicaid Disenrollment: Intrastate Emergency Department Impact
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medicaid Enrollment Status
Keywords: Medicaid
Disenrollment
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2007-11-29
Enrollment: 5000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be obtained through two datbases. All patients visiting an ED in Tennessee over a 3 year period are included.

Brief summary: We will obtain data from the robust Agency for Healthcare Reimbursement and Quality (AHRQ) Healthcare Utilization Project (HCUP), as well as from the State of Tennessee. If our hypotheses are true, such data will provide strong evidence that Medicaid disenrollment has a negetive health impact on uninsured populations. The data may also provide evidence for increased public funding of safety-net EDs after Medicaid disenrollment.


Eligibility criteria: Inclusion Criteria:

* data will be obtained from the Agency for Healthcare Reimbursement and Quality (AHRQ) Healthcare Utilization Project (HCUP)

Exclusion Criteria:

* n/a

Primary outcomes:
measure: The proportion of ED visits from uninsured and TennCare patients after TennCare disenrollment
timeFrame: Upon record review
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Benjamin S Heavrin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318344: Evaluation of Atuna Racemosa Toxicity
Official title: Evaluation of Atuna Racemosa Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For thousands of years people in the South Pacific have used Atuna racemosa extract as a topical anti-inflammatory. We, the researchers at the Mayo Clinic, have shown this extract to also have antibacterial properties. While this extract has been used for decades in the South Pacific, a controlled clinical trial to evaluate toxicity has never been performed.


Eligibility criteria: The subjects will be 20 healthy male and non-pregnant, non-lactating, female volunteers of ages 18 - 65. No subject will be excluded based on minority status.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric J. Buenz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05949892: Heart-health Promotion
Official title: Efficacy of The Expanded Health Belief Model-Based Intervention in Enhancing Heart-Health Preventive Behaviors Among High School Female Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Expanded Health Belief Model, Heart-Health-Preventive Behaviors, High School Female Students
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 144
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The researchers intend to use the Expanded Health Belief Model in enhancing heart-health preventive behaviors among high school female students

Detailed description: The study intervention will be derived from the Expanded Health Belief Model which includes adhering to healthy diet, encouraging healthy weight, nutrition, and physical activity stress management, and smoking cessation and smoking avoidance.

Eligibility criteria: Inclusion Criteria:

* High school female students who do not experience any psychiatric-mental disorder

Exclusion Criteria:

* High school female students who experience any psychiatric-mental disorder

Primary outcomes:
measure: Behavioral Intention Scale for Adherence to Heart-Health Preventive Behaviors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
Study officials:
References:
Clinical trial NCT00005892: Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Myelodysplastic Syndrome and Acute Leukemia Related to Fanconi's Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fanconi's Anemia
Myelodysplastic Syndromes
Leukemia, Nonlymphocytic, Acute
Leukemia, Lymphocytic, Acute
Keywords: Fanconi's anemia
acute leukemia
acute lymphocytic leukemia
acute myeloid leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia
adult acute myeloid leukemia in remission
aplastic anemia
childhood acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia
childhood acute myeloid leukemia in remission
de novo myelodysplastic syndrome
hematologic disorders
hematopoietic/lymphoid cancer
leukemia
myelodysplastic syndrome
oncologic disorders
previously treated myelodysplastic syndrome
rare disease
secondary myelodysplastic syndrome
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-06-05
Sex: ALL
Minimum age (years): 0
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and radiotherapy in terms of improving survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with myelodysplastic syndrome and acute leukemia related to Fanconi's anemia.

Detailed description: PROTOCOL OUTLINE:

Patients receive cyclophosphamide IV over 1-2 hours on day -6 through -3 and total body radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Eligibility criteria: * Diagnosis of Fanconi's anemia with the family history and typical phenotype including: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility
* Evidence of Fanconi's myelodysplastic syndrome Bone marrow dysplasia of all 3 marrow cell lines AND Clonal cytogenetic abnormalities demonstrable in marrow cells
* First complete remission following therapy for Fanconi's acute leukemia allowed
* Must have related histocompatible donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview University Medical Center
state: Minnesota
Study officials:
affiliation: Fairview University Medical Center
name: Daniel J. Weisdorf
role: STUDY_CHAIR
References:
Clinical trial NCT00163592: Post-Marketing Surveillance of TISSUCOL for Hemostasis in Subjects Undergoing Vascular Reconstruction With Polytetrafluoroethylene (PTFE) Prosthesis
Official title: Non- Interventional Study of Tissucol® for Hemostasis in Subjects With Femoral Vascular Anastomosis Undergoing Vascular Reconstruction With PTFE Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Vascular Anastomosis
Keywords: Vascular reconstruction
Polytetraflouroethylene (PTFE) prosthesis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: OTHER

Brief summary: This study investigates if the time to hemostasis can be reduced by application of Tissucol® onto femoral vascular anastomoses with PTFE prostheses compared to standard methods, such as compression with swabs.


Eligibility criteria: Subjects with femoral vascular anastomosis and bleeding suture holes after vessel reconstruction with a PTFE prosthesis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Landeskrankenhaus Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: General Hospital (AKH) Salzburg
city: Leonberg
country: Germany
facility: Leonberg Hospital, Department of Vascular Surgery
city: Magdeburg
country: Germany
facility: University Clinics of Magdeburg, Department of Vascular Surgery
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd, Department of Vascular Surgery
Study officials:
affiliation: University Clinics of Magdeburg, Germany
name: Thomas Bürger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03030092: Maximal Strength Training Following Hip Fracture Surgery: Impact on Muscle Mass, Balance, Walking Efficiency and Bone Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Lead sponsor: Molde University College
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
First posted: 2017-01-24
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One group will receive today's standard rehabilitation program following hip fracture surgery. The intervention group will have maximal strength training incorporated in their program. It consists of 3 training sessions per week for 8 weeks, where 4-5 repetitions over 4 sets for leg press and abduction resistance exercise at \~85% of maximal strength is carried out. Muscle strength, balance and bone density will be compared between the groups following the 8-week rehabilitation period. The feasibility of the intervention for the patient group will be evaluated based on compliance with training program and possible adverse events related to the operated hip.


Eligibility criteria: Inclusion Criteria:

* age over 65, hip fracture surgery

Exclusion Criteria:

* COPD, Heart failure, Dementia

Primary outcomes:
measure: Muscle strength
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
measure: Bone Density
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
citation: Berg OK, Stutzer JM, Hoff J, Wang E. Early Maximal Strength Training Improves Leg Strength and Postural Stability in Elderly Following Hip Fracture Surgery. Geriatr Orthop Surg Rehabil. 2021 Apr 30;12:21514593211015103. doi: 10.1177/21514593211015103. eCollection 2021.
Clinical trial NCT05715892: Examining Patterns in the Involvement of Gastric Bypass Patients in Clinical Studies
Official title: An Observational Study Investigating The Experiences of Patients In Gastric Bypass Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastric Bypass
Weight Loss Surgery
Keywords: gastric bypass
weight loss surgery
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric bypass patients who are actively considering participating in an observational clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Clinical trial participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about gastric bypass clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The information collected from this study can be used to improve patient experience and outcomes for future patients and an opportunity to contribute to the advancement of medical knowledge and treatments for gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
* Capable of giving signed informed consent.

Exclusion Criteria:

* ECOG score of 4
* Ineligible for gastric bypass surgery
* Pregnant women or women actively seeking to become pregnant.

Primary outcomes:
measure: Number of patients who decide to participate in a gastric bypass clinical study
timeFrame: 3 months
measure: Rate of gastric bypass patients who remain until trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.
citation: Fisher BL, Barber AE. Gastric bypass procedures. Eur J Gastroenterol Hepatol. 1999 Feb;11(2):93-7. doi: 10.1097/00042737-199902000-00007.
citation: Collins BJ, Miyashita T, Schweitzer M, Magnuson T, Harmon JW. Gastric bypass: why Roux-en-Y? A review of experimental data. Arch Surg. 2007 Oct;142(10):1000-3; discussion 1004. doi: 10.1001/archsurg.142.10.1000.
Clinical trial NCT04462692: An Observational Study in Children With CLN2 Batten Disease
Official title: A Prospective, Observational Study to Evaluate Ocular Disease Progression in Children With CLN2 Batten Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)
Keywords: CLN2, Batten Disease
Lead sponsor: REGENXBIO Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with CLN2 Batten disease undergoing current standard of care for their condition.

Brief summary: This is a prospective, longitudinal natural history study to document the progression of ocular manifestations of CLN2 disease among a community-dwelling population of pediatric participants affected by this disease.

Detailed description: CLN2 is a rare disease with limited available ocular natural history data. While current standard of care slows motor degeneration, it is not known to treat the ocular manifestations of disease. This study is planned to document, through prospective data collection, ocular disease progression in children with a clinical presentation consistent with CLN2 Batten disease undergoing current standard of care for their condition. No investigational product is administered in this observational study.

Eligibility criteria: Inclusion Criteria:

A participant is eligible to be included in the study only if all of the following criteria apply:

1. His or her legal guardian(s) is(are) willing and able to provide them written, signed informed consent.
2. Has documented diagnosis of CLN2 disease due to TPP1 deficiency, or has a relative clinically diagnosed with CLN2 with the same mutation as the participant
3. Is currently receiving biweekly ERT treatment with cerliponase alfa

Exclusion Criteria:

A participant is excluded from the study if any of the following criteria apply:

1. Has had prior treatment with an adeno-associated virus-based AAV gene therapy
2. Is currently participating in a clinical trial of investigational product for the treatment of CLN2 disease

Primary outcomes:
measure: Change in retinal structure in children with CLN2 Batten disease
timeFrame: 96 weeks
Secondary outcomes:
measure: Change in visual function
timeFrame: 96 weeks
measure: Change in visual function
timeFrame: 96 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04042792: Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Official title: Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate (ADA in PiRD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Keywords: pharmacokinetics
pharmacodynamics
Adalimumab
methotrexate
drug-drug interaction
trough ADA concentration
peak ADA concentration
Pediatric inflammatory rheumatic diseases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 28
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PiRD patients treated with ADA for medical reasons at the University Children's Hospital Basel/ Switzerland and at the University Children's Hospital of Tuebingen/ Germany

Brief summary: This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO)
* Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks
* Exclusion of chronic infections
* No parallel treatment with other biologic medications
* Available patient history since ADA start
* No pregnancy
* Ability to comply with the entire study protocol
* Willingness to participate with signed informed consent

Exclusion Criteria:

* Other rheumatic inflammatory diseases
* Age \< 2 years or \>18 years
* PiRD patients and parents with cognitive impairments preventing to understand study requirements
* Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy

Primary outcomes:
measure: ADA concentration (in mg/L)
timeFrame: at study inclusion
measure: ADA concentration (in mg/L)
timeFrame: during regular clinical follow up 3-6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Children's Hospital Tubingen
city: Basel
country: Switzerland
facility: University of Basel Children's Hospital
Study officials:
affiliation: University Children's Hospital Basel (UKBB), University of Basel
name: Marc Pfister, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268692: Neoadjuvant Chemotherapy for Pancreatic Cancer Followed by GS and GnP
Official title: Neoadjuvant Chemotherapy for Pancreatic Cancer; GS vs. GnP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pancreatic Adenocarcinoma
Keywords: Neoadjuvant
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The effect of neoadjuvant chemotherapy for pancreatic cancer was gradually established. However it has been not clarified which regimen of neoadjuvant treatment for pancreatic cancer is the best.

Detailed description: gemcitabine plus S-1 versus gemcitabine plus nab-paclitaxel

Eligibility criteria: Inclusion Criteria:

elective pancreatectomy for pancreatic cancer

Exclusion Criteria:

a previous cancer surgery a body weight loss of \>10% during the 6 months before surgery the presence of distant metastases seriously impaired function of vital organs because of respiratory, renal, or heart disease.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: adverse events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Kochi
country: Japan
facility: Takehiro Okabayashi
Study officials:
References: