louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01121562: Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
Official title: A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neuroendocrine Tumors
Keywords: Neuroendocrine tumors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.


Eligibility criteria: Inclusion Criteria:

* Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)

Exclusion Criteria:

* Patients with poorly differentiated neuroendocrine cancer are not eligible

Primary outcomes:
measure: Clinical Benefit Response Rate (CBR)
timeFrame: Up to 799 days of treatment
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 799 days of treatment
measure: Tumor Shrinkage
timeFrame: Up to 799 days of treatment
measure: Progression-free Survival (PFS)
timeFrame: Up to 799 days of treatment
measure: Overall Survival (OS)
timeFrame: Up to 3 years from the last subject registration to the study
measure: Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).
timeFrame: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Central Hospital
state: Aichi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Osaka
country: Japan
facility: Osaka Police Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27.
Clinical trial NCT02478762: Glycemic Objectives of Women With Gestational Diabetes Mellitus
Official title: Reevaluation of the Glycemic Objectives of Women With Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gestational Diabetes Mellitus
Keywords: Foetal glycated hemoglobin
Glycemic objectives treatment
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a previous study, the investigators established the dosage of foetal glycated hemoglobin (FGH). It represents the mean of blood sugar 4-6 before the delivery. The investigators also compared the FGH of newborn of women with and without gestational diabetes mellitus (GDM) and determined that newborn of women with GDM had significantly higher FGH that newborn of women without GDM.

In this study, the investigators want to compare the FGH of newborn of GDM women randomized to a group reaching the Canadian Diabetes Association recommended blood glucose objectives treatment (fasting: 5.3 mmol/L and 2-hour after meals: 6.7 mmol/L) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/L and 2-hour after meals: 5.9 mmol/L)


Eligibility criteria: Inclusion Criteria:

* gestational age between 15 and 32 weeks since last menstrual date,
* received education on gestational diabetes mellitus,
* able to read and understand French.

Exclusion Criteria:

* known type 1 or type 2 diabetes,
* treatment interfering woth glucose metabolism,
* deficit may hinder the understanding of the study.

Primary outcomes:
measure: Foetal glycated hemoglobin
timeFrame: At delivery
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: End of pregnancy
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013962: Vitamin D Metabolism and the Williams Syndrome
Official title: Vitamin D Metabolism and the Williams Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Williams Syndrome
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-04-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL

Brief summary: The Williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies, mental retardation and other congenital defects are sometimes associated with abnormal vitamin D and calcium metabolism. Whereas some patients have been reported to show increased sensitivity to vitamin D or an exaggerated response of serum 25-hydroxyvitamin D {25(OH)D} to administration of vitamin D and to have hypercalcemia caused by increased circulating 1,25-dihydroxyvitamin D{1,25(OH)2D} in infancy and early childhood, most patients have normal calcium metabolism and normal values for circulating 25(OH)D and 1,25(OH)2D. We propose to carry out further studies of vitamin D metabolism to elucidate the mechanism(s) for abnormal vitamin D metabolism. We will determine the response of serum 1,25(OH)2D to administration of 1,25(OH)2D3. Measurement of the 1,25(OH)2D in the patients compared to normal subjects will be the primary outcome.


Eligibility criteria: Age 18 years to 50 years of age, patients and normal subjects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03364062: Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure
Official title: A Multi-center Study on Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Keywords: Blood Pressure
shoulder replacement
proximal humeral fracture
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Harbin Medical University
name: Dalian Medical University
name: Taoyuan General Hospital
First posted: 2017-12-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with three or four part of proximal humeral fracture, receive shoulder replacement

Brief summary: To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

Detailed description: A total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in Department of Orthopedics and Trauma，Peking University People's Hospital．The blood pressure data are collected from patients' anesthesia records. Both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period A), 0-5 min after using cement (time period B), 5-10 min after using cement (time period C) and 10-15min after using cement (time period D). The data of blood pressure are collected according to anesthesia records．

Eligibility criteria: Inclusion Criteria:

•patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement

Exclusion Criteria:

* pathologic fracture
* severe hypertension or hypotension

Primary outcomes:
measure: Change from Baseline Systolic Blood Pressure
timeFrame: Change from Baseline Systolic Blood Pressure at 15 mins
Secondary outcomes:
measure: Change from Baseline Diastolic Blood Pressure
timeFrame: Change from Baseline Diastolic Blood Pressure at 15 mins
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Yichong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03360162: Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
Official title: Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Horton Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 46
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients aged more than 55 years old who are suspected of giant arteritis

Brief summary: The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed.


Eligibility criteria: Inclusion Criteria:

* patients with suspicious giant arteritis

Exclusion Criteria:

* patients who have already been treated or diagnosed for giant arteritis

Primary outcomes:
measure: Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler
timeFrame: 2 months
Secondary outcomes:
measure: evaluation of the halo sign in giant arteritis using B mode ultrasonography
timeFrame: 2 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04485962: Treatment of Patients With Skin Burns Using Keratinocytes and Skin Fibroblasts
Official title: Treatment of Patients With Skin Burns Using Autologous Keratinocytes and Skin Fibroblasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Burns
Keywords: burns
fibroblasts
keratinocytes
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
First posted: 2020-07-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of patients with burns of the skin of the 2nd degree using: autologous keratinocytes and skin fibroblasts mixed with collagen gel 7% (tissue equivalent of the skin)

Detailed description: Treatment of patients with burns of the skin of the 2nd degree by applying a wound covering with layer-by-layer cultured autologous keratinocytes and fibroblasts in collagen gel

Eligibility criteria: Inclusion Criteria:

* skin burns of the 2nd degree

Exclusion Criteria:

* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders
* pregnancy

Primary outcomes:
measure: Number of cured patients
timeFrame: 1 month
measure: Number of patients with treatment-related adverse events
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor Volotovski, Prof
role: STUDY_DIRECTOR
affiliation: Head of the plastic surgery and combustiology
name: Vladimir Podgaiskiy, Prof
role: STUDY_DIRECTOR
affiliation: Dean of the plastic surgery and combustiology
name: Alexey Chasnoit, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Lead Researcher of Institute of Biophysics and Cell Engineering
name: Zinaida Kvacheva, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224662: A Pilot Study to Explore the Role of Gut Flora in Gout
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Gout
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gout
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2020-01-13
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: Patients who have been diagnosed with Gout

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Gout

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of Gout by a physician

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Sabine Hazan
state: California
Study officials:
References:
Clinical trial NCT05129462: Consistency of PD-L1 Detecting Method Between E1L3N and 22C3 Monoclonal Antibodies in NSCLC Patients
Official title: Consistency of Immunohistochemical Detecting Assays Using E1L3N and 22C3 Monoclonal Antibodies for Detection of PD-L1 Expression in NSCLC Patients: A Prospective CONFIDENCE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer who have previously received single-agent K therapy

Brief summary: Evaluated the correlation between the qualitative test results of Xiamen Aide PD-L1 antibody reagent (immunohistochemistry) and the efficacy of Keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent


Eligibility criteria: Inclusion Criteria:

1. ≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received K-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged;
2. Able to provide FFPE samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm

Exclusion Criteria:

1. Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \<100);
2. K-drug mono-therapy is neoadjuvant therapy or adjuvant therapy;
3. Other situations that the investigator thinks are not suitable for participating in this clinical study

Primary outcomes:
measure: Consistency
timeFrame: August 2018- September 2021
Secondary outcomes:
measure: PFS
timeFrame: August 2018- September 2021
measure: ORR
timeFrame: August 2018- September 2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05609162: Treatments for Brain Metastases With Poor Prognostic Factors
Official title: Effects of Local and Systemic Treatments in Brain Metastases With Poor Prognostic Factors: Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Metastases
Keywords: Brain Metastases
local treatments
systemic treatments
poor prognosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Cancer Hospital of Guangxi Medical University
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: First Affiliated Hospital of Guangxi Medical University
First posted: 2022-11-08
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital clients from Sun Yat-sen University Cancer Center, Guangxi Medical University Cancer Hospital, The People's Hospital Of Guangxi Zhuang Autonomous Region, and the First Affiliated Hospital of Guangxi Medical University will be selected.

Brief summary: The goal of this observational study is to learn about treatments in brain metastases with poor prognostic factors. The main questions it aims to answer are:

* What kind of local treatment provides a survival benefit for patients with poor prognostic factors?
* What kind of systemic treatment provides a survival benefit for patients with poor prognostic factors?
* Will the combination of local treatment and systemic treatment provide a survival benefit for patients with poor prognostic factors?

Participants will be asked to provide personal information about their living status, symptoms, and disease control during the follow-up.


Eligibility criteria: Inclusion Criteria:

1. Evidence of pathological diagnosis of primary tumor;
2. Brain metastases confirmed by enhanced magnetic resonance imaging;
3. Complete clinical information

Exclusion Criteria:

1. Survival time less than 30 days;
2. If surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery;
3. Incomplete clinical data;
4. Patients with 2 or more types of tumors.

Primary outcomes:
measure: OS
timeFrame: From date of first follow-up until the date of documented death from any cause, assessed up to 120 months
Secondary outcomes:
measure: PFS
timeFrame: From date of first follow-up until the date of first documented progression, assessed up to 120 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT06068062: Implementing OSCE in Team Based Learning Format for Teaching Clinical Skills to Undergraduate Medical Students
Official title: Implementing OSCE in Team Based Learning Format for Teaching Clinical Skills to Undergraduate Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSCE (Objective Structured Clinical Examination)
TBL (Team Based Learning)
Teaching Clinical Skills to Undergraduate Medical Students
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 23
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of using OSCE(objective structured clinical exam) on principles of TBL (team based learning) in teaching clinical skills to undergraduate medical students. The main question it aims to answer is whether using OSCE on TBL format is an effective role for teaching clinical skills in undergraduate medical students.

4th year MBBS students included in study after informed written consent. By simple random sampling students divided into two groups i.e. Experimental and control group.

Control group was named Group A while the interventional group was Group B. Control group (Group A) underwent traditional teaching of skills as routinely carried out in gynecology department during clinical clerkship of three weeks. Group B underwent intervention in the form of learning session where OSCE was implemented on principles of Team-based learning. Both groups had pre-test at start of study in the form of two OSCE stations with pre-validated checklists, to check their baseline knowledge. Post-test on same stations was taken after traditional teaching for group A and intervention for group B. The groups were later crossed over so no student was devoid of the learning experience.


Eligibility criteria: Inclusion Criteria:

* Willing students of 4th year MBBS HITEC-IMS Taxila who passed their professional exam

Exclusion Criteria:

* • Dropouts and students not willing to participate

  * Students who failed in professional exam and have to appear in supplementary exam.

Primary outcomes:
measure: Scores of OSCE stations
timeFrame: 4 weeks (at the end of intervention for experimental group and at the end of clerkship for control group
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Hitec-Ims
state: Punjab
Study officials:
affiliation: Assistant Professor Gynae/Obs
name: Ayesha Akram, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06103162: Comparison of Different Feeding Appliances for Cleft Palate Babies
Official title: Comparison of Different Feeding Appliances for Cleft Palate Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Palate
Keywords: feeding appliance ,flexible, rigid
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

Detailed description: This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.

Eligibility criteria: Inclusion Criteria:

* Infants with age range from 1-15 days.
* Unilateral cleft palate.
* Medically free subjects.
* Both males and females.

Exclusion Criteria:

* Patients older than 15 days.
* Syndromic patients with other defects in addition to cleft lip and palate.
* Patients with bilateral cleft lip and palate.
* Patients with previous presurgical infant orthopedic treatment.
* Medically compromised patients.-

Primary outcomes:
measure: The feeding efficiency
timeFrame: during 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: faculty of dentistry Tanta University
Study officials:
affiliation: faculty of dentistry tanta university
name: Amel AE salem
role: PRINCIPAL_INVESTIGATOR
References: