louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01846689: An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease
Official title: An Open-label Trial of an Erythropoietin Stimulating System to Determine Increased Red Blood Cell Production in Subjects Diagnosed With Anemia of Chronic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anemia of Chronic Disease
Lead sponsor: Targeted Medical Pharma
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 30
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: The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.


Eligibility criteria: Inclusion Criteria:

1. M/F patients 18 years old and over, non-pregnant/lactating
2. Hemoglobin \< 10 female,\<11 male
3. Ferritin \> upper limit of normal for lab indicative of chronic anemia
4. Anemia of chronic disease
5. Crt. \< 3.0

Exclusion Criteria:

1. Currently taking other amino acid formulations.
2. Pregnant or unwilling to use adequate birth control for the duration of the study.
3. Excessive alcohol or illicit drug use.
4. Unwilling or unable to sign informed consent.
5. Myocardial infarction within the last 6 months.
6. Patients ever having taken or currently taking an erythropoietin medication.
7. Iron deficiency (add criteria).
8. On dialysis.
9. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years.
10. Liver cirrhosis (add criteria).

Primary outcomes:
measure: Hemoglogin/Hematocrit
timeFrame: 28 Days
Secondary outcomes:
measure: Red blood cell count
timeFrame: 28 Days
measure: Reticulocyte count
timeFrame: 28 days
measure: IGF-1
timeFrame: 28 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Targeted Medical Pharma
state: California
Study officials:
References:
Clinical trial NCT04041089: Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy
Official title: Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Cortical Atrophy
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.

The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.


Eligibility criteria: Inclusion Criteria:

* Age \>50 years old
* Male or Female
* Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
* MMS\>15
* Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
* Anti-Alzheimer's and psychotropic treatments stable for one month, if taken by the patient
* Affiliation to a social security system

Exclusion Criteria:

* Uncorrected visual disorders with non-degenerative etiology (AV\<0.5)
* Person under the protection of justice
* Pregnant women (a pregnancy test will be performed in premenopausal women)

Primary outcomes:
measure: Effectiveness evaluation
timeFrame: At week 34
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
state: Alpes-Maritime
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: MOUTON Aurélie, Ph
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942589: Effect of Portion-control Training on Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behaviors
Keywords: Portion Size
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-24
Enrollment: 105
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether food intake in response to large portion sizes differs between women who have received portion-control training and women who have not received such training. In a crossover design, women come to the laboratory on four occasions to eat a lunch of seven foods varying in energy density. Across meals, all foods are varied in portion size (100%, 125%, 150%, or 175% of baseline amounts). Food and energy intake is determined for each meal. Participants are from two groups: women who completed a one-year weight-loss trial in which they were trained in portion-control strategies, and women who had not received such training (community controls).


Eligibility criteria: Inclusion Criteria:

* Participant in the Portion-Control Strategies Trial (NCT01474759) OR
* Community control who regularly eats three meals per day

Exclusion Criteria:

* Score on the Eating Attitudes Test indicating symptoms of disordered eating
* Score on the Zung or Beck questionnaires indicating symptoms of depression
* Food allergies or restrictions
* Dislike for foods served in the study

Primary outcomes:
measure: Difference in energy intake across subject groups
timeFrame: Weeks 1, 2, 3, and 4
measure: Difference in intake by weight across subject groups
timeFrame: Weeks 1, 2, 3, and 4
measure: Difference in energy density consumed across subject groups
timeFrame: Weeks 1, 2, 3, and 4
Secondary outcomes:
measure: Ratings of hunger and satiety across subject groups
timeFrame: Weeks 1, 2, 3, and 4
Other outcomes:
measure: Ratings of food taste across subject groups
timeFrame: Week 5
measure: Ratings of food healthfulness across subject groups
timeFrame: Week 5
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06816589: Using ChatGPT As a Job Coach for Adults with Autism Spectrum Disorder
Official title: Using ChatGPT As a Job Coach for Adults with Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism
Job Interview Performance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effectiveness of the ChatGPT-based job coach in helping ASD individuals prepare for job application, job interview, and interpersonal skills in workplaces. The main questions aim to answer are:

How can we develop a ChatGPT-based job coach system to assist individuals with autism spectrum disorder (ASD) in job applications, job interviews, and interpersonal skills in workplaces?

How effective is the ChatGPT-based job coach in helping ASD individuals (n=30) prepare for job applications, job interviews, and interpersonal skills in workplaces? What clinical correlates are associated with better effectiveness, and what are the interaction patterns between ASD adults and the ChatGPT platform?

Participants will complete assessment questionnaires (evaluating autism traits and empathy, approximately 30 minutes) and a one-hour job interview practice. Please follow the recommendations to use ChatGPT for completing your job resume, job type discussions, job interview preparation and practice, explanation of Asperger's traits for the workplace, and workplace social discussions. After one week of practice, you will fill out the assessment questionnaires and complete the job interview practice again.


Eligibility criteria: Inclusion Criteria:

* Young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5;
* is motivated to have a job
* is able to use the ChatGPT on the computer under instruction (e.g., typing questions) and is able to provide feedback to the research team
* has a full-scale IQ \> 70 on WAIS-IV
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
* agree to audio and video recording during the interview rehearsal.

Exclusion Criteria:

* A history of major psychiatric disorders (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases
* visual impairment and/or hearing impairment that would preclude participation in the study
* refuse audio and video recording during the interview rehearsal.

Primary outcomes:
measure: the score of job interview role-play performance (JIRP)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03552289: Cook Enforcer Post-Market Study
Official title: Randomized Clinical Study to Evaluate the Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter in Treatment of Arteriovenous Dialysis Access Circuit Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: Dialysis
Renal
Hemodialysis
Stenosis(es)
Transluminal
Percutaneous Transluminal Angioplasty
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 211
Sex: ALL
Minimum age (years): 18
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 evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.


Eligibility criteria: Inclusion Criteria:

* Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)

Exclusion Criteria:

* Less than 18 years old
* Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
* Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
* Scheduled for a kidney transplant
* Stent or stent graft in the arteriovenous (AV) dialysis access circuit

Primary outcomes:
measure: Percent of Lesions Requiring Adjunctive Treatment
timeFrame: Immediately following treatment of stenoses of a mature native arteriovenous dialysis access circuit fistula or graft, up to approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Kideny Disease & Hypertension Surgery Center
state: Arizona
city: Darien
country: United States
facility: The Vascular Experts
state: Connecticut
city: Newark
country: United States
facility: Delaware Kidney/Nephrology Associates, PA
state: Delaware
city: Roanoke
country: United States
facility: Fairlawn Surgery Center
state: Virginia
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT00183989: Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Official title: A Pilot Phase II Trial of Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done in order to determine the effectiveness of the combination of fludarabine, mitoxantrone, and rituximab in patients with mantle cell lymphoma. All three drugs,fludarabine, mitoxantrone, and rituximab have been approved by the U.S. Food and Drug Administration (FDA)for the treatment of certain types of lymphoma. Rituximab is a drug (called a monoclonal antibody) which has anti-tumor activity on certain types of lymphoma. The combination of chemotherapy (fludarabine and mitoxantrone) with rituximab has not yet been investigated in patients with mantle cell lymphoma and therefore the combination in investigational.


Eligibility criteria: Inclusion Criteria:

* Pathologic diagnosis of Non-Hodgkin's Lymphoma of the mantle cell sub-type lymphoma only, as determined by morphologic assessment and consistent immunophemotypic markers
* Newly diagnosed and patients who have received prior treatment are eligible
* Measurable or evaluable disease
* Karnofsky performance status greater or equal to 50%
* Men and women, age greater or equal to 18 years old
* AGC greater or equal to 1.0; platelets greater or equal to 75,000; Hemoglobin greater or equal to 8.0 (unless because of lymphomatous infiltration of the marrow)
* Creatinine less than 2.0; bilirubin less than 2.0; SGOT less than 3 times upper limit of normal (unless elevations are due to lymphomatous involvement)
* Women of child bearing potential must have negative pregnancy test within 14 days of study entry.
* Signed informed consent

Exclusion Criteria:

* History of congestive heart failure or significant cardiac disease
* Prior exposure to either fludarabine or mitoxantrone. Prior exposure to rituximab allowed
* Active infection
* HIV seropositive
* Pregnant or lactating females
* Second active malignancy, other than squamous cell skin cancer,in-situ cervical cancer, or history of other cancer diagnosed within the preceding 5 years
* Presence of psychological or emotional disorders which would make valid informed consent impossible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Alexandra M. Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00222989: PPI Versus Placebo in Severe Functional Heartburn
Official title: PPI Versus Placebo in Severe Functional Heartburn
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: GERD
Keywords: GERD
PPI
Functional heartburn
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Proton Pump Inhibitors are no better than placebo in relieving GERD symptoms in patients with functional Heartburn.


Eligibility criteria: Inclusion Criteria:

* Heartburn twice a week for at least 2 years. Normal EGD and 24hr pH study.

Exclusion Criteria:

* \<18yrs of age,pregnant, unable or unwilling to give consent, allergic to PPI, previous gastric or esophageal surgery, past hx of erosive GERD, unwilling or unable to stop acid suppression meds

Primary outcomes:
measure: Difference in GERD controll PPI vs Placebo based on a validated GERD questionnarir.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: LA
country: United States
facility: USC Keck School of Medicine
state: California
Study officials:
affiliation: University of Southern California
name: Michael M Kline, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322789: Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Official title: Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Insulin-Dependent
Keywords: Diabetes mellitus
Stem cells
Autologous stem cell transplantation
Autoimmune diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.

Detailed description: Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
* Less than 6 weeks from diagnosis

Exclusion Criteria:

* Previous diabetic ketoacidosis
* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Active infectious disease
* Previous or present neoplastic disease

Primary outcomes:
measure: AUC C-peptide levels during mixed meal tolerance test
timeFrame: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)
measure: Safety
timeFrame: Every 6 months until death
Secondary outcomes:
measure: Daily insulin use
timeFrame: Daily (course of study is 7 years)
measure: Hemoglobin A1C
timeFrame: 3 months
measure: Anti-GAD titres
timeFrame: Every 6 months
measure: Immunologic reconstitution parameters
timeFrame: Yearly (course of study is 7 years)
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University Hospital, School of Medicine of Ribeirão Preto, Brazil
name: Julio Voltarelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, School of Medicine of Ribeirão Preto, Brazil
name: Carlos E Couri, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01863589: Drug Use Investigation for HEPSERA (Adefovir) Tablet
Official title: Drug Use Investigation for HEPSERA (Adefovir) Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic hepatitis B or hepatic cirrhosis B who are confirmed of hepatic function abnormality with continuous re-proliferation of hepatitis B virus while treated with lamivudine

Brief summary: This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.


Eligibility criteria: Inclusion Criteria:

* Subjects with chronic hepatitis B or hepatic cirrhosis B
* Subjects treated with adefovir tablets

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of adverse drug reactions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06288789: Turkish Validity and Reliability of the Social Frailty Index
Official title: Turkish Validity and Reliability of the Social Frailty Index in the Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Frailty
Quality of Life
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 186
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \&#34;Social Frailty Index\&#34;, Social Inclusion Scale, Older people\&#39;s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \&#34;Social Frailty Index\&#34;, older adults who do not receive any treatment will be tested and re-tested at one-week intervals.


Eligibility criteria: Inclusion Criteria:

* Getting a score of 6 or above on the Hodkinson Mental Test

Exclusion Criteria:

* -Having another chronic disease that can cause pain
* Having a neurological disease
* Being blind
* Having an orthopedic, neurological or mental disability

Primary outcomes:
measure: Social Frailty Index
timeFrame: 10 minutes
Secondary outcomes:
measure: Socıal Inclusıon Scale
timeFrame: 10 minutes
measure: Older people's quality of life-brief (OPQOL-brief)
timeFrame: 8 minutes
measure: Lubben Social Network Scale
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Elif Gur Kabul
state: Merkez
Study officials:
References: