louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04274413: CFTR Related Pancreatitis Study
Official title: Assessing CFTR Function in Patients With CFTR Related Pancreatitis Using a Novel Sweat Test
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis
CFTR Gene Dysfunction
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: The National Pancreas Foundation
First posted: 2020-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaporimeter TEWL probes, model RG-1
Primary purpose: DIAGNOSTIC

Brief summary: The main causes of acute recurrent pancreatitis (ARP) or chronic pancreatitis (CP) in children are defects in genes that have been associated to pancreatitis. Among these gene defects CFTR gene mutations are commonly found, 34% ARP and 23% CP . Since not every CFTR gene mutations clinically manifest, just identifying these CFTR gene mutations may not help to establish a clear role of this defect in the etiology of the individual ARP/CP. The novel beta-adrenergic sweat secretion test is a very sensitive test to detect small abnormalities in CFTR function in form of a linear gene-function relation. By identifying even mild CFTR defects, in future will help in finding the role of CFTR modulators and providing treatment to these patients.


Eligibility criteria: Inclusion Criteria:

* Age : 4 years and older
* Diagnosis: Acute recurrent pancreatitis or chronic pancreatitis
* History: at least one of the following:

  1. Carry one or two CFTR mutations
  2. Borderline sweat chloride levels
  3. Has Family History of CF
  4. Has had positive CF Newborn screening

     Exclusion Criteria:
* Pregnant females: will be excluded at screening.

Primary outcomes:
measure: Assessment of CFTR function using the Beta Adrenergic Sweat Secretion Test
timeFrame: 60 mins
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06865313: Functional Evaluation After Maxillectomy and Scapular Free Flap Reconstruction
Official title: Total or Subtotal Maxillectomy with Scapular Free Flap Reconstruction: Airway Management, Aesthetic and Functional Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillary Sinus Squamous Cell Carcinoma
Keywords: Maxillectomy
Reconstruction
Scapula
Tracheotomy
Functional
Aesthetic
Lead sponsor: Hôpital de la Croix-Rousse
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with malignant or benign maxillary sinus tumors managed by total maxillectomy and free scapula tip flap reconstruction between January 2015 and July 2023 in the Ear-Nose-Throat (ENT) department of Croix Rousse Hospital in Lyon, France.

Brief summary: The goal of the study is to analyse the functional and aesthetic outcomes after removal of the maxillar bone and reconstruction with part of the scapular bone for people having maxillary tumor


Eligibility criteria: Inclusion Criteria:

* Patient with maxillary sinus tumor
* Treated by maxillectomy with free scapula tip flap reconstruction
* 18 years of age or older

Exclusion Criteria:

* Reconstruction failure
* Carcinomatous recurrence and/or further progression impacting quality of life
* Death

Primary outcomes:
measure: time to resumption of oral feeding
timeFrame: through study completion, an average of 15 days
measure: duration of hospitalization in a continuing care unit
timeFrame: through study completion, an average of 15 days
measure: Tracheotomy
timeFrame: through study completion, an average of 15 days
measure: Hospitalisation time
timeFrame: through study completion, an average of 15 days
Secondary outcomes:
measure: Swallowing assessment with the Functional Oral Intake Scale
timeFrame: through study completion, an average of 2 years
measure: Aesthetic evaluation
timeFrame: through study completion, an average of 2 years
measure: Quality of Life assessment using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (version 3.0) and European Organisation for Research and Treatment of Cancer Head & Neck 43 questionnaires.
timeFrame: through study completion, an average of 2 years
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix Rousse Hospital
Study officials:
affiliation: Hospice Civil de Lyon
name: Carine FUCHSMANN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00371813: An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Multinational Study Of Efficacy And Safety Of Varenicline Tartrate For Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-04
Enrollment: 334
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: To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Eligibility criteria: Inclusion Criteria:

* Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria:

* Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
* Any subject with known severe chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.
Secondary outcomes:
measure: To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shen Yang
country: China
facility: Pfizer Investigational Site
city: Tanjin
country: China
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bangkok
country: Thailand
facility: Pfizer Investigational Site
city: Chiang Mai
country: Thailand
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wang C, Xiao D, Chan KP, Pothirat C, Garza D, Davies S. Varenicline for smoking cessation: a placebo-controlled, randomized study. Respirology. 2009 Apr;14(3):384-92. doi: 10.1111/j.1440-1843.2008.01476.x. Epub 2009 Feb 20.
Clinical trial NCT03920813: Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
Official title: Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms

Detailed description: The investigators' purpose was to identify genetic factors and metabolite concentrations associated with both hematological toxicity in patients with ALL maintained on 6-MP in Chinese.

Eligibility criteria: Inclusion Criteria:

* Patients have been diagnosed with Acute Lymphoblastic Leukemia
* Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy
* Patients received the phase of maintenance therapy that included oral 6-MP (\>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015

Exclusion Criteria:

* Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age \< 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) \[BCR-ABL\], t(4;11) (q21;q23) \[AF4/MLL\], t(1;19) (q23;p13) \[E2A-PBX1\] or other MLL-rearrangements) were removed

Primary outcomes:
measure: Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
timeFrame: at second day after oral administration
measure: Genetic polymorphisms in Chinese patients with ALL
timeFrame: at second day after oral administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00314613: Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Official title: Functional Brain Imaging and Employment in First-Episode Psychotic Patients Treated With Risperdal
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophreniform; Schizophrenia; Schizoaffective Disorders
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2006-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Assured treatment with Risperal CONSTA will provide first-episode patients, who have a greater potential for therapeutic response, with their best opportunity for continued improvement in cognitive function beyond three months of treatment.

Detailed description: First episode patients have a greater potential for therapeutic response than multi-episode patients, and many of them also havea great desire to rejoin the workforce. Unfortunately, first episode patients become non-compliant or intermittently compliant with prescribed antipsychotic treatment at least as frequently as multi-episode patients. We believe that assured treatment with Risperal CONTSTA will provide first episode patients wiwth their best opporutnity for continued improvement in cognitive function beyond 3 months of treatment and that improvements in cognitive function will be associated with a greater likelihood of employment, real-world outcomes, such as independent living, as well as measures of brain function.

Eligibility criteria: Inclusion Criteria:

* male or female between 18-40 years of age
* meet DSM-IV criteria for first-episode schizophreniform, schizophrenia or schizoaffective disorder

Exclusion Criteria:

* pregnant \& breast-feeding women
* patients with known sensitivity to oral Risperdal

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Butner
country: United States
facility: John Umstead Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: William H Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Joseph P McEvoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02602613: AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method
Official title: AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Valcare Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 4
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: A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.


Eligibility criteria: Inclusion Criteria:

* Patient age ≥18
* The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
* NYHA functional capacity ≥2
* The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
* The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
* The patient is willing to provide Informed consent

Exclusion Criteria:

* Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
* Life expectancy of less than twelve months.
* Heavily calcified annulus or leaflets.
* Previous or active endocarditis.
* Active infection.
* A previously implanted prosthetic mitral valve or annuloplasty ring/band.
* The patient is contraindicated to general anesthesia.
* Pregnant (urine HCG test result positive) or lactating patient.
* Drug or alcohol abuse.
* Participation in concomitant research studies of investigational products that will interfere with the study.

Primary outcomes:
measure: Safety - Freedom from major SAE's at 30 days following procedure
timeFrame: 30 days
measure: Technical success of implantation
timeFrame: End of procedure
Secondary outcomes:
measure: Safety - Freedom from major SAE's at 6 months following procedure
timeFrame: 6 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim Hospital
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
Study officials:
References:
Clinical trial NCT01861613: Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Immune Response
Seroprevalence
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Guangxi Center for Disease Control and Prevention
First posted: 2013-05-23
Enrollment: 2040
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.


Eligibility criteria: Inclusion Criteria:

* Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region

Exclusion Criteria for vaccination study:

* acute illness
* immunocompromised conditions
* renal insufficiency
* pregnancy
* allergic history to HB vaccine or yeast
* positive for any of HBsAg, anti-HBs or anti-HBc

Primary outcomes:
measure: Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc
timeFrame: Anti-HBs was assayed at Month 7
Secondary outcomes:
measure: Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students
timeFrame: seroprevalence at baseline
measure: Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
timeFrame: Anti-HBs immune response at Month 1
measure: Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
timeFrame: Anti-HBs immune response at Month 6
measure: Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc
timeFrame: Anti-HBs immune response at Month 20
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Centers for Disease Control and Prevention
state: Guangxi
Study officials:
References:
Clinical trial NCT04062136: Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Official title: Outcomes of Human Umbilical Cord-derived Mesenchymal Stem Cells Transplantation in the Treatment of Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary dysplasia
umbilical cord mesenchymal stem cells
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with bronchopulmonary dysplasia

Detailed description: The purpose of this study is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in 10 patients with bronchopulmonary dysplasia at Vinmec International Hospital, Hanoi, Vietnam

Eligibility criteria: Inclusion Criteria:

* The patient is diagnosis Bronchopulmonary Dysplasia (premature and depends on oxygen until 28 days old
* Gender: either sex
* Year old \< 6 months
* Weight ≥ 2 kg
* Agree to participate in the study.

Exclusion Criteria:

* Severe congenital malformation.
* Other severe conditions (active pulmonary bleeding, evidence of active infections).

Primary outcomes:
measure: Adverse events and serious adverse events
timeFrame: during 9 months post treatment
measure: The proportion of patients win from oxygen
timeFrame: during 9 months post treatment
Secondary outcomes:
measure: The lung fibrosis
timeFrame: at 6 months post treatment
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
References:
citation: Ahn SY, Chang YS, Kim SY, Sung DK, Kim ES, Rime SY, Yu WJ, Choi SJ, Oh WI, Park WS. Long-term (postnatal day 70) outcome and safety of intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells in neonatal hyperoxic lung injury. Yonsei Med J. 2013 Mar 1;54(2):416-24. doi: 10.3349/ymj.2013.54.2.416.
citation: Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.
citation: Liem NT, Anh TL, Thai TTH, Anh BV. Bone Marrow Mononuclear Cells Transplantation in Treatment of Established Bronchopulmonary Dysplasia: A Case Report. Am J Case Rep. 2017 Oct 12;18:1090-1094. doi: 10.12659/ajcr.905244.
Clinical trial NCT04485936: Evaluation of the Effect of Epitomee Device on Gastric Emptying Rate in Healthy Subjects
Official title: Prospective, Single Center, Open-labeled Single Arm Study of Evaluation of the Effect of Tulip Device on Gastric Emptying Rate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Epitomee medical
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of Epitomee Device on Gastric Emptying Rate in healthy subjects

Detailed description: The participants will be enrolled in one investigational site. Subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline).

Following the scintigraphy, the subjects will receive Tulip Device treatment - 2 capsules/day.

After repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.

Eligibility criteria: Inclusion Criteria:

1. 21 ≤ Age \<65 years
2. 20 \< BMI ≤ 40 kg/m2
3. Healthy subject
4. Subject is able and willing to give informed consent
5. Subject is able and willing to participate in the study and follow protocol procedures

Exclusion Criteria:

1. Significant swallowing disorders or difficulty swallowing
2. Suspected GI strictures, fistulas or other GI track obstructions
3. Crohn's disease or diverticulosis
4. Recent GI surgery
5. History of long-standing undigested food in the stomach
6. Known ulcer disease
7. Organic disease associated with gastroparesis such a Parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder
8. Presence of a gastrostomy tube or gastric outlet obstruction
9. History or evidence of any active liver disease
10. Allergy to eggs
11. Treatment with anticholinergic or prokinetic agents
12. Treatment with proton-pump inhibitors
13. Hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as L-thyroxine)
14. Prediabetes or Diabetes
15. Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
16. Pregnancy or breastfeeding
17. Currently participating in an ongoing clinical study

Primary outcomes:
measure: Evaluation of Epitomee device on Gastric half-emptying time
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: The Kamila Gonczarowski Institute of Gastroenterology Assaf Harofeh Medical Center,
name: Haim Shirin, MD
role: PRINCIPAL_INVESTIGATOR
References: