louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06966063: Additive Effects of 4-7-8 Breathing Technique With Standard Management on Dyspnea, Pulmonary Function and Quality of Life in Patients With COPD.
Official title: Additive Effects of 4-7-8 Breathing Technique With Standard Management on Dyspnea, Pulmonary Function and Quality of Life in Patients With COPD.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Dyspnea
Keywords: Dyspnea
pulmonary function
quality of life
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.

Breathing exercises help to manage dyspnea and reduced pulmonary function often seen in COPD patients. To handle respiratory complications COPD patients are advised to practice breathing techniques in conjunction with their prescribed medications.

Detailed description: COPD is a very common chronic respiratory disease with symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.

Breathing exercises help to manage dyspnea associated with COPD. In order to manage respiratory conditions COPD patients are encouraged for nasal breathing techniques along with standard management. Hence the objective of the study is to compare the effects of 4-7-8 breathing along with standard management versus standard management alone on dyspnea, pulmonary function, and quality of life in patients with COPD.

Eligibility criteria: Inclusion Criteria:

* Adults: aged (40-64 years)
* Gender: Both males and females
* Grade1- Grade 1-3 on Modified MRC dyspnea scale
* COPD mild and moderate according to GOLD classification
* Mild: FEV1 \> 80% predicted
* Moderate: FEV1 \>50% predicted

Exclusion Criteria:

* Severe and very severe stage of COPD according to GOLD classification.
* Patients having Acute exacerbation of COPD.
* Patients diagnosed with acute infections.
* Patients unable to follow commands/ instructions.

Primary outcomes:
measure: Dyspnea
timeFrame: 4 weeks
measure: pulmonary function
timeFrame: 4 weeks
measure: Quality of Life of COPD patients
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT06492863: Gene Therapy(FT-003) for Wet AMD
Official title: A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: FT-003
nAMD
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Eye Hospital
name: The First Affiliated Hospital of Soochow University
name: Peking Union Medical College Hospital
name: Beijing Hospital
First posted: 2024-07-09
Enrollment: 78
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Detailed description: FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients 50-80 years old at the time of signing the ICF;
* Clinically diagnosed with nAMD;
* Presence of active CNV
* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion Criteria:

* •Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Primary outcomes:
measure: Safety and tolerability after FT-003 injection
timeFrame: At Week 12
Secondary outcomes:
measure: To evaluate the efficacy after FT-003 injection
timeFrame: At Week 24
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin,China
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Xiaorong Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01249963: Enteral Nutrition Product in Mild Acute Pancreatitis
Official title: Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Enteral Nutrition
Keywords: acute pancreatitis
enteral nutrition
nutritional status
pancreas
T-Diet plus Atémpero
Lead sponsor: Vegenat, S.A.
Sponsor class: INDUSTRY
First posted: 2010-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product.

The main objectives of this project are:

* Comparing the tolerance of both preparations.
* Comparing the evolution of nutritional status in both groups.
* Comparing the evolution of inflammatory parameters in both groups

Detailed description: Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 with Mild Acute Pancreatitis.

Exclusion Criteria:

* Patients with Several Acute Pancreatitis
* Patients with life expectancy less than 48 hours.
* Renal (creatinin \> 2,5 mg/dl) or kidney failure (GOT/GPT\>2 from laboratory normal value)
* Patients with diabetes mellitus prior to acute pancreatitis.
* To take part in another study.
* Pregnant patients
* Informed consent absence.

Primary outcomes:
measure: Acceptance, Tolerance and Nutritional Status
timeFrame: 1 year
Secondary outcomes:
measure: Inflammatory parameters evolution and EN complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón
Study officials:
affiliation: Hospital Universitario Gregorio Marañón
name: Pilar García-Peris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992263: Vitamin D Supplementation and TB
Official title: A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Vitamin D
Immunity
Keywords: tuberculosis
vitamin D
immunity
Lead sponsor: Cornell University
Sponsor class: OTHER
Collaborators: name: Arogyavaram Medical Centre
First posted: 2013-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.

Detailed description: In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.

Eligibility criteria: Inclusion Criteria:

* Active TB diagnosis by GeneXpert
* HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay \[ELISA\] results)

Exclusion Criteria:

* Children (\<18 years of age)
* 60 years of age
* Pregnant at baseline
* Other severe complications or illnesses requiring hospitalization
* Received TB treatment for greater than 4 weeks in the past 5 years
* Refused to participate
* Residing in a geographic location \> 1 hour from AMC (by public transit)

Primary outcomes:
measure: Immune function
timeFrame: One year
measure: Cell-mediated immunological markers
timeFrame: One year
measure: Vitamin D status
timeFrame: One year
Secondary outcomes:
measure: TB treatment outcomes
timeFrame: One year
measure: HIV disease progression
timeFrame: One year
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
city: Madanapalle
country: India
facility: Arogyavaram Medical Centre (AMC)
Study officials:
affiliation: Cornell University (U.S.)
name: Saurabh Mehta, MBBS, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arogyavaram Medical Centre (India)
name: Wesley Bonam, BSc, MBBS, FAIMS, MRSH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873663: Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Official title: Biomarkers for the Detection of Heavy Alcohol Use in Patients With and Without Liver Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Liver Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease.

Detailed description: The investigators will test the validity of biomarkers for the detection of heavy alcohol use in patients with and without liver disease.

The investigators will test the validity of carbohydrate deficient transferrin (CDT)(using capillary zone electrophoresis) in blood and ethyl glucuronide (EtG)(using Liquid Chromatography-MS-MS) in hair in patients with heavy alcohol use, moderate alcohol use and patients who do not drink alcohol.

Eligibility criteria: Inclusion Criteria:

* patients who do not drink alcohol, moderate drinkers (between 0 and 60 g a day) and patients who drink 60 or more grams alcohol a day

Exclusion criteria

* refusal for inclusion

Primary outcomes:
measure: level of disialotransferrin in blood (expressed as percentage di-sialotransferrin) and ethyl glucuronide (expressed in pg/mg) in hair
timeFrame: single determination at inclusion (both on the same day, when patient is seen at the outpatient clinic or when admitted to the hospital) without follow-up
Secondary outcomes:
measure: influence of the stage of liver and renal impairment on serum CDT and hair EtG
timeFrame: on the basis of a single determination which is done for the standard care (when patient is seen at the outpatient clinic or when admitted to the hospital)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jef Verbeek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046863: Pilot Study for Automated Deep Brain Stimulation Programming
Official title: DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Tremor
Bradykinesia
Keywords: Parkinson's disease
Tremor
Bradykinesia
Deep brain stimulation
Kinesia
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Cincinnati
First posted: 2014-01-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease
* Implanted deep brain stimulation system awaiting initial programming session

Exclusion Criteria:

* Subjects with significant psychiatric illness or dementia
* Significant cognitive impairment

Primary outcomes:
measure: Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming
timeFrame: Within two days of standard clinical DBS programming session
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Department of Neurology
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies
name: Dustin A Heldman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heldman DA, Pulliam CL, Urrea Mendoza E, Gartner M, Giuffrida JP, Montgomery EB Jr, Espay AJ, Revilla FJ. Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. Neuromodulation. 2016 Feb;19(2):127-32. doi: 10.1111/ner.12372. Epub 2015 Dec 1.
Clinical trial NCT00401063: Usefulness of Acupuncture in Cancer Pain and Quality of Life
Official title: Acupuncture Case Series: Cancer Pain and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pain
Keywords: Cancer
Acupuncture
Cancer Pain
Quality of life
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2006-11-17
Enrollment: 11
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: The purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite.

Detailed description: After receiving permission from the attending physician each study participant who meets the inclusion criteria will then undergo a physical examination and fill out several questionnaires. Each participant will undergo one to three treatments per week for a period of eight weeks. There will be one follow-up visit on the twelfth week. Participation in this study is free of charge, including all exams, treatment and informational material.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cancer by an MD/oncologist
* Age of 18 or older
* Baseline pain score of 3 or above on 0-10 rating scale
* In the evaluation of the treating physician or medically-qualified investigator, the patient's pain syndrome is the result of underlying cancer or cancer treatment
* Being ambulatory
* Permission from the treating physician (MD/oncologist)
* Platelet count of 50,000 or greater

Exclusion Criteria:

* Acupuncture treatment in past four weeks
* Neutropenia defined as ANC (absolute neutrophil count) \< 1000/ml
* Inability to obtain permission from the treating physician
* Unwillingness to sign informed consent form
* Involvement in litigation
* Simultaneous infection with HIV or Hepatitis C virus
* Unable to present for follow up

Primary outcomes:
measure: EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
timeFrame: Every two weeks, 0, 2, 4, 6, 8 and 12
measure: Visual Analogue Scale
timeFrame: Every two weeks, 0,2,4,6,8, and 12 weeks
Secondary outcomes:
measure: BDI Psychological Assessment
timeFrame: Every two weeks, 0, 2, 4, 6, 8 and 12 weeks
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: University Health Center
state: California
city: Whittier
country: United States
facility: Southern California University of Health Sciences
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Sivarama P Vinjamury, MD, MAOM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06568263: Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
Official title: Celiac Disease and Quality of Life in Children and Adolescents (CeliaQLife)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Celiac Disease in Children
Nutritional Deficiency
Quality of Life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2024-08-23
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age: 6-18 years

Brief summary: Celiac disease is a disorder commonly diagnosed during childhood. The treatment is a lifelong gluten-free diet. Both the condition and the diet can influence the children's physical and emotional well-being.

The main goal of this observational study is to learn about nutritional status in a group of children with celiac disease compared to a group of healthy children.

The nutritional assessment includes information on diet, biochemical measurement, and body composition. Quality of life will also be assessed.

The study can contribute to ensure good health and well-being in children on a gluten-free diet.

Detailed description: * A 24-hour dietary recall will be done by a clinical dietician to assess intake of energy and micro- and macronutrients.
* Blood will be drawn for assessment of vitamin- and mineral status.
* Feces and urine samples will be collected to measure gluten immunogenic peptides (GIP) to assess exposure to gluten.
* A self-developed interview will be used for assessment of adherence to the gluten-free diet and compared with the results from a 11-item questionnaire.
* Weight and height will be measured.
* Bone mineral density and body composition will be measured by dual-energy x-ray absorptiometry (DXA).
* Health-related quality of life (QOL) will be measured by the PedsQL.

Eligibility criteria: Inclusion Criteria:

* eating a regular diet

Exclusion Criteria:

-

Primary outcomes:
measure: Iron deficiency will be assessed from hemoglobin and ferritin in children with celiac disease and in healthy children. Differences in the prevalences of iron deficiency between children with celiac disease and healthy children will be described.
timeFrame: All participants will be assessed once. The study time frame is from August 2024 until December 2025.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: Oslo University Hospital
name: Janne A Kvammen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617863: Hemodynamics During the Soccer Championship 2012
Official title: Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion During the European Soccer Championship 2012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Cardiomyopathy
Angina, Unstable
Myocardial Infarction
Angina, Stable
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany
name: Universitätsklinikum Erlangen, Erlangen, Bayern, Germany
name: Universitätsklinikum Eppendedorf, Hamburg, Germany
name: UKSH Campus Kiel, Kiel, Germany
First posted: 2012-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, clinical employees, students

Brief summary: The purpose of this study is to determine in soccer fans whether and to which extend positive or negative emotions during the European soccer Championship affects Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion.


Eligibility criteria: Inclusion Criteria:

Best fit:

* cardiomyopathy "severe myocardial disease leading to heart failure"
* Angina, stable for at least 7 days
* Myocardial infarction during 4 weeks before inclusion, actually stable condition
* Angina, Stable, CCS II-IV

Exclusion Criteria:

* not interested in soccer championship
* age \<18y
* dementia
* atrial tachycardia
* drug/alcohol abuse
* chronic kidney disease, stage 5
* pulmonary/tricuspid valve insufficiency/stenoses
* non compliant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald
state: Mecklenburg-Vorpommern
city: Lübeck
country: Germany
facility: UKSH-Lübeck
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Universitätsklinikum Eppendorf
Study officials:
affiliation: UKSH- Lübeck Medizinische Klinik 2
name: Michael Reppel, PD. Dr. med
role: STUDY_DIRECTOR
References: