louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03656640: Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases
Official title: A Prospective, Multicenter Observational Trial Assessing the Safety and Efficacy of Gammanorm® in Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Autoimmune Diseases
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2018-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women over 18 prescribed Gammanorm with autoimmune disease or any other off-label use of Gammanorm who are willing to participate in the study

Brief summary: This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.


Eligibility criteria: Inclusion Criteria:

1. Adult man or woman older than 18 years,
2. Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®,
3. Patient who has a prescription of Gammanorm® treatment for immunomodulation,
4. Patient accepting to participate in the study by oral consent after having received oral and written information on the study.

Exclusion Criteria:

1. Patient treated with Gammanorm® for immune substitution, or other authorized use
2. Patient who refuses to participate in the study.

Primary outcomes:
measure: Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.
timeFrame: 24 months
Secondary outcomes:
measure: SMOG score
timeFrame: 24 months
measure: Rankin score
timeFrame: 24 months
measure: MRC
timeFrame: 24 months
measure: ONLS
timeFrame: 24 months
measure: Muscular Testings and Myositis Functional Rating Scale
timeFrame: 24 months
measure: Evaluate treatment compliance
timeFrame: 24 months
measure: Evaluate reasons for stopping the treatment
timeFrame: 24 months
measure: Patient satisfaction regarding Gammanorm
timeFrame: 24 months
measure: Patient Quality of Life regarding Gammanorm
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP - Pitie Salpetriere
city: Rouen
country: France
facility: Chu de Rouen - Bois Guillaume
city: Fort-de-France
country: Martinique
facility: CHU de la Martinique- Hopital Pierre Zobda Quitman
Study officials:
References:
Clinical trial NCT00179140: The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
Official title: The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
* Adequately dialyzed (Kt/V \> 1.4).
* Age \> 18 years old.
* Properly functioning AV Graft

Exclusion Criteria:

* Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
* Pregnant women.
* Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.

Primary outcomes:
measure: increase in lean body mass
timeFrame: 13 months
Secondary outcomes:
measure: improve physical functioning
timeFrame: 13 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Clinical trial NCT00004840: Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2000-02-25
Enrollment: 996
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing hormone to women in premature labor to improve pulmonary outcomes in preterm infants.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to receive antenatal thyrotropin-releasing hormone or placebo.

Patients receive thyrotropin-releasing hormone or placebo intravenously over 20 minutes every 8 hours for 4 doses.

Infants are assessed for survival and chronic lung disease until day 28 after birth, and again at 36 postmenstrual weeks.

Eligibility criteria: * Pregnant women in active labor with 24-29 weeks gestation
* Not eligible if any of the following is present: Bleeding Infection Hypertension (greater than 140/90 mmHg) Fetus with hydrops or life-threatening anomalies One dead fetus in multiple pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Roberta A. Ballard
role: STUDY_CHAIR
References:
Clinical trial NCT04643340: Imaging During Subliminal Perception
Official title: Functional Imaging During Subliminal Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: functional MRI
subliminal perception
EEG
neurofeedback
attention
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2020-11-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g. with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal perception affects connectivity in the brain.

Further, it is not known if real-time (rt) fMRI neurofeedback of brain areas involved in subliminal perception can lead to supra-threshold perception.

For attention tasks, the investigators hypothesize that functional connectivity strength is mediated by the insular cortex during both supra-threshold and subliminal perception.

Additionally, the investigators hypothesize that rt-fMRI neurofeedback training should alter neuronal and behavioral responses.

Detailed description: In this project, using healthy adults, the investigators have 2 aims:

1. Apply electroencephalography (EEG) and fMRI before and after rt-fMRI neurofeedback during attention tasks to identify brain regions involved in subliminal and supraliminal perception.
2. Apply functional connectivity analyses during these tasks.

Eligibility criteria: Inclusion Criteria:

* Healthy adults (\> 18 \< 80 years), which can read and sign the informed consent form
* Male and female
* Right-handed

Exclusion Criteria:

* metallic items in the body (i.e. eye splinter, MR incompatible implants)
* pacemaker
* claustrophobia
* pregnant participants
* participants suffering from a degenerative disorder of the Central Nervous System, such as Stroke, Multiple Sclerosis, Parkinson's Disease, Alzheimer's Disease and Huntington's Disease and with major psychiatric disorders such as schizophrenia, depression, or anxiety disorder
* Drug intake (psychopharmaca)

Primary outcomes:
measure: fMRI during supra-threshold and subliminal perception
timeFrame: 2020 - 2022
measure: rt-fMRI activity
timeFrame: 2020 - 2022
Secondary outcomes:
measure: Functional connectivity
timeFrame: 2020 - 2022
measure: EEG activity
timeFrame: 2020 - 2022
measure: fMRI task performance
timeFrame: 2020 - 2022
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University Hospital, Zürich
name: Lars Michels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03399240: Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Official title: Clinical Evaluation of the Accuracy of Vitastiq Device for Tracking Vitamin and Mineral Trend in Human Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Conditions
Lead sponsor: Vitastiq d.o.o.
Sponsor class: INDUSTRY
Collaborators: name: MEDEDUS, Ljubljana, Slovenia
name: Adria Lab, Ljubljana, Slovenia
name: Vizera d.o.o.
name: Faculty of Pharmacy, Ljubljana, Slovenia
First posted: 2018-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single site evaluation study of Vitastiq device accuracy in healthy men and women in ratio 1:1 (approximately) aged between 18 and 64 years. A total of 45 Vitastiq personal devices will be used by volunteers for two months. The Vitastiq device will be evaluated during three site visits: on day 1, 29 ± 4 days and 57 ± 4 days. During site visit days, blood sampling will be collected and analysed and readings using Vitastiq device will be performed. Data will be analysed retrospectively to evaluate Vitastiq performance compared to blood tests results.


Eligibility criteria: Inclusion Criteria:

* Informed consent form (ICF) is signed by a volunteer
* Age between 18 and 64 years at the time of the signature of ICF
* A body mass index (BMI) between 18 and 28 kg/m2
* Healthy, meaning absence of any chronic or acute medical therapy for a month prior to the inclusion to the study
* Willing to follow all study procedures, including attending all site visits, and keeping a food diary and diary of activities on a weekly basis

Exclusion Criteria:

* Intake of any drugs to treat chronic disease within 1 month before the beginning and during the study
* Intake of any drugs to treat serious acute disease within 1 month before the beginning of the study and within 5 days of each visit
* Any clinically significant medical history of serious digestive tract, liver, kidney, skin or haematological disease or hormone imbalance
* Pregnant and breastfeeding women
* Women who planning pregnancy during the study
* Inadequate veins (in the opinion of the investigator)
* Known drug or alcohol abuse
* Using any form of nicotine or tobacco
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study or blood donation within 3 months prior to or during this study

Primary outcomes:
measure: Vitastiq device accuracy and performance
timeFrame: 30 minutes
Secondary outcomes:
measure: Vitastiq readings method is repeatable
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Adria Lab d.o.o.
Study officials:
References:
Clinical trial NCT04132440: Patient and Physician Perspectives on Non-Alcoholic Fatty Liver Disease
Official title: Patient and Physician Perspectives on Non-Alcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nonalcoholic Fatty Liver Disease
Physician
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-10-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic patients with NAFLD from the Greater Houston Metropolitan Area and practicing physicians, who are primary care physicians (internal medicine, family medicine, etc.)

Brief summary: This trial studies patient and physician perspectives on non-alcoholic fatty liver disease. Using questionnaires and interviews, this trial may help researchers understand physicians' knowledge about the diagnosis, prognosis, treatment and management of non-alcoholic fatty liver disease, as well as gain an in-depth understanding of Hispanic patients' perceptions about the disease and investigate how cultural factors may play a role in its diagnosis, treatment and management.

Detailed description: PRIMARY OBJECTIVES:

I. Explore the perceptions of non-alcoholic fatty liver disease (NAFLD), including knowledge, current practices for diagnosis and management, and additional disease-related perceptions amongst both primary care physicians.

II. Explore the perceptions of NAFLD, including knowledge, diagnosis and management, and additional disease-related perceptions amongst Hispanic patients.

OUTLINE:

Patients and physicians complete a questionnaire over 5 minutes and an interview over 30-45 minutes about thoughts on NAFLD, including what they know about NAFLD and its diagnosis, management, and monitoring, and other thoughts on NAFLD.

Eligibility criteria: Inclusion Criteria:

* Be a self-reported practicing physician, who is a primary care physician (internal medicine, family medicine, etc.)
* Self-reported Hispanic ethnicity from the Greater Houston Metropolitan Area (patient)
* Have been diagnosed with NAFLD by a doctor (patient)
* Be an adult \>/= 18 (patient)
* Able to speak English (patient)

Exclusion Criteria

-None

Primary outcomes:
measure: Explore the perceptions of NAFLD, including knowledge, current practices for diagnosis and management, and additional disease-related perceptions amongst both primary care physicians (Questionnaire)
timeFrame: Up to 1 year
measure: Explore the perceptions of NAFLD, including knowledge, diagnosis and management, and additional disease-related perceptions amongst Hispanic patients. (Questionnaire)
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02791867: Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
Collaborators: name: University at Buffalo
First posted: 2016-06-07
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.


Eligibility criteria: Inclusion Criteria:

* Age ≥21 years
* Diagnosis of T2DM
* Metformin as first line treatment
* HbA1c ≥7
* Calculated HOMA-IR ≥3.0,
* BMI 25-45
* Triglyceride level ≥ 2.26 mmol/L

Exclusion Criteria:

* Age \<21 years of age
* BMI ≤ 25
* Pregnant
* Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
* Subjects treated with Liraglutide (Victoza®).
* Renal, hepatic or cardiac failure.
* Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
* Subjects diagnosed with Irritable Bowel Syndrome.
* Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
* History of significant gastrointestinal disease.
* Poor venous access.
* Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™

Primary outcomes:
measure: Reduction in Insulin Resistance measured by HOMA-IR
timeFrame: 12 months from intervention
measure: Reduction in glycated Haemoglobin measured: HBA1c
timeFrame: 12 months from intervention
Secondary outcomes:
measure: Reduction in serum triglyceride level (mmol/l)
timeFrame: 12 months from intervention
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dasman DIabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Nadia Zghoul, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo, New York
name: Jerome Schentag, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02006667: A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer
Official title: An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Tract Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 13
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 will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* adult patients with \>=18 years of age;
* metastatic urothelial carcinoma;
* measurable metastases or local recurrent disease;
* no prior chemotherapy for metastatic disease;
* HER2 overexpression (IHC \[2+\] or \[3+\]).

Exclusion Criteria:

* concomitant chemotherapy or immunotherapy;
* active or uncontrolled infection;
* solely CNS metastases;
* clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
* co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
measure: Progression-Free Survival - Time to Event
timeFrame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
measure: Percentage of Participants Who Were Progression Free at 12 and 24 Months
timeFrame: Screening, and Months 12 and 24
Secondary outcomes:
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
measure: Overall Survival - Time to Event
timeFrame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months
measure: Percentage of Participants Surviving at 12 and 24 Months
timeFrame: Screening, and Months 12 and 24
measure: Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
timeFrame: Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months
Other outcomes:
Locations:
city: Aschersleben
country: Germany
city: Dessau
country: Germany
city: Fulda
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Marburg
country: Germany
city: Weiden
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05584267: Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Official title: Multi-omics Evaluation System and Preferred Mode of Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 140
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: This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age on day of signing informed consent
* Histopathology confirmed non-small cell lung cancer
* Asymptomatic brain metastases
* EGFR/ALK ROS1 driver gene mutation negative
* RECIST 1.1 based available assessment of lesions
* ECOG 0-1
* Brain metastases 1-4
* Single lesion ≤4cm

Exclusion Criteria:

* Patients with contraindication of chemotherapy Pregnant or breast feeding women

Primary outcomes:
measure: Intracranial progression-free survival
timeFrame: up to 2 years from enrollment
measure: sPFS
timeFrame: up to 2 years from enrollment
Secondary outcomes:
measure: Objective Response rate
timeFrame: up to 2 years from enrollment
measure: overall survival
timeFrame: up to 2 years from enrollment
measure: number of participants with treatment-related adverse events
timeFrame: up to 2 years from enrollment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: