louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02799446: Effect of Reslizumab in Chronic Rhinosinusitis
Official title: Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sinusitis
Keywords: sinusitis, rhinitis, rhinosinusitis, chronic
Lead sponsor: Allergy and Asthma Clinical Research Inc.
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Willingness and ability to comply with the requirements of the study
3. Female or male patients ages 18-75 at the time of screening
4. A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
5. Elevated blood eosinophils
6. Significant findings on computed tomography (CT) scan

Exclusion Criteria:

1. Unable to sign informed consent form
2. A woman that is pregnant or nursing a child
3. Known hypersensitivity to Reslizumab
4. Active cigarette smoking in the year prior to screening
5. Known underlying immunodeficiency
6. History of alcohol or drug abuse in the year prior to screening

Other criteria may apply. Please contact the investigator for more information

Primary outcomes:
measure: Change in computed tomography (CT) score
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 24 weeks
measure: Smell test
timeFrame: 24 weeks
measure: Endoscopy score
timeFrame: 24 weeks
measure: Adverse events by body system
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research
state: California
Study officials:
affiliation: Allergy and Asthma Clinical Research
name: Joshua Jacobs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00491946: A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Official title: A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cancer
Keywords: Cancer
Actinomycin
Vincristine
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-06-26
Enrollment: 24
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.

Detailed description: There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.

Eligibility criteria: Inclusion Criteria:

* 6 months - 18 years
* Due to receive actinomycin-D as a component of cancer treatment
* Central venous catheter (e.g. Port-a Cath, Broviac)
* Informed consent of parent or legal guardian and patient assent when appropriate

Exclusion Criteria:

* Serious illness other than the primary diagnosis of cancer
* Weight \< 5 kilograms
* Previous participation in CHP-810

Primary outcomes:
measure: Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Research Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01955746: PST Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan
Official title: Parent-sibling Tracing (PST) Linkage Based Analysis in the Family of More Than Two Members With Type 1 Diabetes in Taiwan for Novel HLA and Non-HLA Candidate Risk Alleles Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Genetic Variation of Type 1 Diabetes
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The family of more than one member with T1D

Brief summary: The purpose of this study is to explore the susceptible genes for Type 1 diabetes in Taiwan through the new genetic study methods.

Detailed description: As an unclear autoimmune disorder, the pathogenesis of type 1 diabetes (T1D) remains elusive. Among all the methods for studying diseases pathophysiology, genetic approach has valuable capability as being both hypothesis-testing and hypothesis-generating. Although geo-epidemiological studies show relatively higher prevalence of T1D in Caucasians than in Asians, whether genetic factors identified in T1D of Caucasians are essential for T1D in Asians is not yet clarified. Although the human leukocyte antigen (HLA) genotype variants have been reported to be associated with T1D, the odds ratio (ORs) is relatively low in Taiwan as comparing with western countries, some families are indeed more than one child with T1D. However, the genetic linkage study in T1D is still limited in Taiwan that hampered the drug development or research in T1D. Therefore, we intend to explore the susceptible genes for T1D of Taiwan in this study, which will provide further researcher directions for this disease.

Eligibility criteria: Inclusion Criteria:

1. Type 1 diabetes on the criteria of the American Diabetes Association with a very low C-peptide level (\<0.35 ng/mL) with or without the experience of diabetic ketoacidosis.
2. The subjects whose four grandparents are of Chinese Han origin

Exclusion Criteria:

1. Patients with ages of onset more than 35 years are excluded.
2. The families having any member with known possible type 2 diabetes

Primary outcomes:
measure: Type 1 diabetes gene
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03052946: Bulking Agent Versus Electrostimulation Therapy in Anal Incontinence
Official title: A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Fecal Incontinence
Keywords: fecal incontinence, anorectal manometry, bulking agents
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bulking agents
Primary purpose: TREATMENT

Brief summary: Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).

* Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
* The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative

Detailed description: * Prospective randomized trial
* Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
* Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
* The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative

Eligibility criteria: Inclusion Criteria:

* Moderate fecal incontinence

Exclusion Criteria:

* Severe fecal incontinence
* Pelvic radiotherapy

Primary outcomes:
measure: Fecal incontinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03936946: The 28 Day Challenge
Official title: The 28 Day Challenge
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Anxiety
Stress
Hope
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to Group 1, Group 2, or Group 3. Group 1 begins the 28 day challenge in October (while group 2 acts as a passive control) and Group 2 begins the 28 day challenge 1 months late (while Group 1 receives no further intervention). Group 3 will begin the 28 day challenge concurrent with Group 1, but will listen to different audio clips than Group 1 (blinded).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how a 28 Day Challenge influences mental health and well-being. This is a blinded study. Participants both with and without depression and anxiety, will be included. A moderation analysis will be performed to see whether changes in depression after the intervention are a function of baseline depression and anxiety levels.


Eligibility criteria: Inclusion Criteria:

* English Fluency

Exclusion Criteria:

* Severe hearing impairment

Primary outcomes:
measure: Change in Patient Heath Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 1 months
measure: Change in Patient Heath Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 3 months
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 1 months
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, 3 months
measure: Change in Perceived Stress Scale-10 (PSS-10)
timeFrame: Baseline, 1 months
measure: Change in Perceived Stress Scale-10 (PSS-10)
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Michasel Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925946: Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM
Official title: Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of Type 2 Diabetes Mellitus, Hepatic and Pancreatic Fat: A Two-year Randomized Control Trial in New Delhi, India
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
PreDiabetes
Diet Habit
Keywords: Type 2 Diabetes, Low calorie diet, Asian Indians, hepatic fat, pancreatic fat
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, India
First posted: 2023-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.

Detailed description: Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with T2DM within the previous 3 years
* Age 20-65 years
* BMI \>25-45kg/m2
* HbA1c\> 6.5% at baseline (on current treatment, if any)

Exclusion criteria:

* Recent or screening HbA1c of 9% or higher
* Weight loss of \>5 kg within the previous 6 months
* Significant cardiopulmonary
* Hepatic, or another endocrine disease
* Current participation in any other research drug study in the previous three months
* Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy

Primary outcomes:
measure: Reversal of diabetes
timeFrame: 24 Months
Secondary outcomes:
measure: Muscle strength
timeFrame: 24 Months
measure: Anthropometric assessment
timeFrame: 24 Months
measure: Hepatic and Pancreatic Fat
timeFrame: 24 Months
measure: Body fat
timeFrame: 24 Months
measure: Insulin Resistance
timeFrame: 24 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02955446: Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
Official title: Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies: Continuing Study Drug Administration in Desmoid Patients Receiving Clinical Benefit
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Neoplasm
Desmoid Tumor
Keywords: Refractory Tumors
Advanced Solid Tumors
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: SpringWorks Therapeutics, Inc.
First posted: 2016-11-04
Sex: ALL
Minimum age (years): 16
Maximum age (years): 101
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.

Detailed description: This is an expanded access-physician sponsored trial of PF-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy. This trial is designed for patients who have been on a previous Industry-sponsored phase I trial using PF-03084014 for\> 1 year. The study is designed to evaluate the safety of prolonged oral administration of single agent PF-03084014. There are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options. The goal of this protocol is to allow these subjects, who are clearly benefiting from PF-03084014, to continue to receive it

Eligibility criteria: Inclusion Criteria:

- Patients who are currently enrolled in A8641014 for \> 1 year are eligible

Exclusion Criteria:

* Prior treatment with a gamma secretase inhibitor for treatment of cancer
* Patients taking Tamoxifen
* Patients with active graft versus host disease
* Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
* Patients who are pregnant or breast-feeding
* Patients with clinical evidence of central nervous system disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Wells Messersmith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06317246: Subtypes and Prognostic Factors in Erdheim-Chester Disease
Official title: Subtypes and Prognostic Factors in Erdheim-Chester Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erdheim-Chester Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the pathology are still unknown. Although the disease typically affects adult individuals, cases of pediatric-onset ECD have been described. However, there is a lack of detailed information on the phenotypic characteristics of these patients, and reliable data on response to specific therapies and long-term outcomes are missing. Three patients referred to our reference center for Histiocytosis present a concomitant BRAF-mutated neoplasm. Such an association could be due to the presence of mosaicisms for the BRAF V600E mutation. Mosaicism is a biological event defined as the presence of more than one genetically dissimilar cell population in the same organism and is an increasingly studied field, both in normal and pathological conditions. If proven in ECD as well, this mechanism could contribute to providing answers to the still open questions regarding the development of this disease.


Eligibility criteria: Inclusion Criteria:

* Prevalent and incident patients (adults and pediatric), with histologically confirmed diagnosis of Erdheim-Chester Disease according to the latest diagnostic recommendations;
* Signing of informed consent for study participation.

Exclusion Criteria:

* Patients for whom clinical and imaging data are not available and for whom it is not possible to retrieve histological samples."

Primary outcomes:
measure: Clinical characteristics of patients with Erdheim-Chester Disease
timeFrame: 4 years
measure: Prognostic factors of patients with Erdheim-Chester Disease
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
state: Firenze
city: Parma
country: Italy
facility: AOU Parma
Study officials:
References:
Clinical trial NCT00790946: Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)
Official title: Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Obesity
Keywords: valsartan
Metabolic syndrome
Lead sponsor: Kagoshima University
Sponsor class: OTHER
First posted: 2008-11-14
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.

* Blood pressure control
* Changing of adiponectin and plasminogen activator inhibitor-1
* Influence metabolizing and cardiac function, etc.

Detailed description: The primary endpoints are:

* blood pressure control
* Adiponectin and plasma type1 plasminogen active inhibitor

The secondary endpoints are

* HOMA-IR
* HbA1c
* TNF-α
* IL-6
* Plasma B-type natriuretic peptide
* LVMI
* E/A ratio
* Tei-index
* Apo-J

Eligibility criteria: Inclusion Criteria:

* Out patients with hypertension male and female
* Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
* Waist Surrounding diameter male≧85cm female≧90cm
* Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
* Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol \< 40 mg/dl or fasting blood glucose ≧110 mg/dl
* Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB

Exclusion Criteria:

* Patient who is using ACE-I and ARB
* Serum creatinine ≧ 3 mg/dl
* Liver impairment
* History of allergy to valsartan
* Pregnant women
* Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety

Primary outcomes:
measure: Blood Pressure, Adiponectin and PAI-1 concentration
timeFrame: 1 year
Secondary outcomes:
measure: HOMA-IR
timeFrame: 1 year
measure: HbA1c
timeFrame: 1 year
measure: TNF-α
timeFrame: １ year
measure: IL-6
timeFrame: 1 year
measure: BNP
timeFrame: 1 year
measure: LVMI
timeFrame: 1 year
measure: E/A ratio
timeFrame: 1 year
measure: Tei-index
timeFrame: 1 year
measure: Apo-J
timeFrame: 1 year
Other outcomes:
Locations:
city: Kagoshima
country: Japan
facility: Chuwa Tei,MD,FACC,FAHA
Study officials:
affiliation: Department of Cardiovascular,Respiratory & Metabolic Medicine Granduate School of Medicine Kagoshima University
name: Chuwa Tei, MD, PhD
role: STUDY_CHAIR
References:
citation: Miyata M, Ikeda Y, Nakamura S, Sasaki T, Abe S, Minagoe S, Torii H, Lee S, Tateishi S, Kihara K, Ohba I, Kajiya S, Furusho Y, Hamasaki S, Tei C; Kagoshima Collaborate Trial in Metabolic Syndrome (KACT-MetS) Investigators. Effects of valsartan on fibrinolysis in hypertensive patients with metabolic syndrome. Circ J. 2012;76(4):843-51. doi: 10.1253/circj.cj-12-0153.