louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02008539: Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
Official title: Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Gastrointestinal Cancer
Lead sponsor: Apceth GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 13
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: To evaluate the safety and tolerability of MSC_apceth_101.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
* Premature or scheduled termination of standard therapy
* Progressive disease as clinically assessed by the investigator
* Max. tumour lesion ≤ 5 cm
* Adequate organ function
* Ability of patient to understand character and individual consequences of clinical trial
* Age ≥ 18 years
* Written informed consent must be available before any study specific procedure is performed

Exclusion Criteria:

* Patients with severe heart diseases
* Clinical significant ischemic disease during the last 4 weeks before Visit 1
* Severe lung disease
* Symptomatic peritoneal carcinomatosis
* Symptomatic pleural or pericardial effusion
* Serious uncontrolled acute infections less than 3 weeks before Visit 1
* Known dependency on alcohol or other drugs
* Patients requiring corticoids in doses above the Cushing threshold
* Known liver fibrosis or liver cirrhosis
* Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
* Female patient who is pregnant or breast feeding
* Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose

Primary outcomes:
measure: Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
timeFrame: day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich
Study officials:
References:
Clinical trial NCT02342639: Rifaximin Therapy in Chronic Kidney Disease
Official title: Impact of Rifaximin Therapy on Intestinal Byproducts in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2015-01-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if Rifaximin decreases serum and urine levels of bacterial byproducts and inflammatory markers in patients with chronic kidney disease and to evaluate changes in the bacterial content of the stool from these individuals.


Eligibility criteria: Inclusion Criteria:

* Chronic kidney disease with eGFR ≤ 39 ml/min/1.73m2

Exclusion Criteria:

* Patients with normal renal function or those with less advanced kidney disease
* Inability or unwillingness to provide consent
* Patients undergoing hemodialysis or peritoneal dialysis therapy or those who have undergone organ transplant
* Patients who may be pregnant
* Hemodynamically unstable patients
* Patients with liver failure, pancreatic insufficiency, or inflammatory bowel disease
* Patients with ongoing or recent infection and those with history of C-diff infection
* Patients with abnormal bowel structure secondary to surgical or anatomic variations
* Patients on certain medications including immunosuppressants, antidiarrheal agents, bile acid sequestrants and current or recent (within the last 3 months) use of antibiotics

Primary outcomes:
measure: Change in Serum Trimethylamine N-oxide (TMAO)
timeFrame: Change from baseline to Day 11
Secondary outcomes:
measure: C-reactive Protein
timeFrame: Change from baseline to Day 11
measure: Change in Serum Interleukin-6 (IL-6)
timeFrame: Change from baseline to day 11
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jason Stubbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kimber C, Zhang S, Johnson C, West RE 3rd, Prokopienko AJ, Mahnken JD, Yu AS, Hoofnagle AN, Ir D, Robertson CE, Miyazaki M, Chonchol M, Jovanovich A, Kestenbaum B, Frank DN, Nolin TD, Stubbs JR. Randomized, Placebo-Controlled Trial of Rifaximin Therapy for Lowering Gut-Derived Cardiovascular Toxins and Inflammation in CKD. Kidney360. 2020 Nov;1(11):1206-1216. doi: 10.34067/kid.0003942020. Epub 2020 Nov 25.
Clinical trial NCT02182739: Observational Study of Meloxicam in Any Labeled Indication
Official title: Programa de Experiencia Therapéutica Personalizada (Personalized Therapeutic Experience Program)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 13039
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care

Brief summary: Evaluation on the amelioration of symptom intensity of the indication and to evaluate drug tolerability.


Eligibility criteria: Inclusion Criteria:

* Patients according to the physicians medical criteria on the labeled indications for Meloxicam

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in assessment of intensity of pain on a 4-point verbal rating scale
timeFrame: up to 1 year
measure: Assessment of tolerability on a 4-point scale
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02033486: Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Official title: Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: diffuse optical tomography
digital breast tomosynthesis
breast cancer
solid benign lesions
cysts
malignant lesions
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-01-10
Enrollment: 375
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. However, mammography only reveals the breast structure, and cannot say much about the breast physiological state. We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to DBT alone.


Eligibility criteria: Inclusion Criteria:

* Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either

  * scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.
  * presenting for breast cancer treatment

Exclusion Criteria:

* Under 30 years old or over 80 years old
* Is pregnant or thinks she may become pregnant.
* Open wounds on breast
* Breast implants
* Any condition that impairs the ability to give informed consent

Primary outcomes:
measure: Area under the curve for distinguishing benign vs malignant lesions
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Stefan Carp
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stefan A Carp, PhD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Mansi Saksena, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552422: Domperidone for Gastroparesis in Solid Organ Transplantation
Official title: Domperidone for Gastroparesis Associated With Solid Organ Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroparesis
Gastroesophageal Reflux
Keywords: gastroparesis
gastroesophageal reflux
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-11-01
Enrollment: 6
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 purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

Detailed description: After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients.

Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth.

We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).

Eligibility criteria: Inclusion Criteria:

* gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
* signed informed consent

Exclusion Criteria:

* serious cardiac arrhythmias
* clinically significant bradycardia, sinus node dysfunction, or heart block.
* prolonged QTc
* clinically significant electrolyte disorders.
* gastrointestinal hemorrhage or obstruction.
* prolactinoma
* pregnant or breast feeding female
* known allergy to domperidone.

Primary outcomes:
measure: Symptomatic Improvement
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: David J Lederer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05346822: The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
Official title: The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthritis
Keywords: integrated rehabilitation
total knee arthroplasty
personalized medicine
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.

Detailed description: This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.

We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.

Eligibility criteria: Inclusion Criteria

* Patients over 65 years of age
* Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
* Patients are able to understand the study and express opinions clearly
* Patients are willing to participate in this study and provide informed consents

Exclusion Criteria

* Patients with inflammatory joint disease
* Patients with neurosensory system disease (such as stroke or parkinsonism)
* Patients have intellectual impairment, or dementia.

Primary outcomes:
measure: Visual Analogue Pain Score (VAS)
timeFrame: From admission to 3 months after surgery
measure: State-trait Anxiety Inventory (STAI)
timeFrame: From admission to 3 months after surgery
measure: American Knee Society Scores(AKS)
timeFrame: From admission to 3 months after surgery
measure: WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)
timeFrame: From admission to 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT05662722: Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
Official title: Use of Infrared Thermography in the Measurement of Facial Blood Flow After the Application of Percutaneous Needle Electrolysis (PNE) on the Concha of the Ear
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Headache
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical random assignment
Primary purpose: TREATMENT

Brief summary: Headache is a very frequent symptom among the world population, the adult population with an active headache disorder are 46% for headache in general, 11% for migraine, 42% for tension-type headache and 3% for chronic daily headache. There are different therapeutic approaches for the improvement of headache. Transcutaneous stimulation of the auricular vagal nerve is being used for the treatment of headache due to the involvement of the vagus nerve in inflammation and pain modulation. On the other hand, galvanic current has shown a measurable effect by increasing parasympathetic activity. The objective of this clinical trial is to stimulate the auricular vagal nerve with galvanic current using a needle as an electrode that will be inserted into the concha of the ear. As a tool for measuring results, infrared thermography will be used to observe changes in facial skin temperature, since patients with high sympathetic activity present a characteristic pattern of "cold nose" and/or "cold patch". In addition, variables that record changes in autonomic activity such as skin conductance and heart rate variability will be collected.


Eligibility criteria: Inclusion Criteria:

* Headache with a frequency of at least one monthly episode.
* Present the "cold nose" and/or "cold patch" pattern

Exclusion Criteria:

* Do not present a "cold nose" and/or "cold patch" pattern
* Pregnant women
* Subjects with facial alterations that may affect facial vascularization (sinusitis, allergies...)
* Patients with belonephobia or allergy to metals or any material used in the procedure.

Primary outcomes:
measure: Skin temperature
timeFrame: Change from Baseline up to 30 minutes
measure: Headache Impact Test (HIT-6)
timeFrame: Change from Baseline up to 30 minutes
Secondary outcomes:
measure: Skin bioimpedance
timeFrame: Change from Baseline up to 30 minutes
measure: Heart rate variability
timeFrame: Change from Baseline up to 30 minutes
measure: Numerical Rating Scale
timeFrame: Change from Baseline up to three months
measure: Patients global impressions scale:
timeFrame: Change from Baseline up to three months
measure: Pittsburg Sleep Quality Index score
timeFrame: Change from Baseline up to three months
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Physioterapy and Pain center research
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01775722: Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
Official title: Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port-Wine Stain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Candela Corporation
name: Beckman Laser Institute University of California Irvine
First posted: 2013-01-25
Enrollment: 22
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.

Detailed description: The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.

Eligibility criteria: Inclusion Criteria:

1. Port Wine Stain suitable for comparison testing
2. Age \> 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
3. Apparent good health as documented by medical history
4. Ability to understand and carry out subject instructions

Exclusion Criteria:

1. History of photodermatoses or skin cancer
2. Any therapy within the previous two months to the proposed port wine stain treatment sites
3. Current participation in any other investigational drug or device evaluation
4. Concurrent use of known photosensitizing drugs
5. Inability to understand and carry out instructions

Primary outcomes:
measure: Percent Change in Blanching of Port Wine Stain
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: J. Stuart Nelson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07005622: Inspiratory Muscle Training Using the O2 Trainer
Official title: Inspiratory Muscle Training Using the O2 Trainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Muscle Training
Blood Pressure
Keywords: Maximal Respiratory Pressures
Lead sponsor: Sam Houston State University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Able to participate in training 5 days per week

Exclusion Criteria:

* Previous ventilation
* Diagnosed chronic obstructive pulmonary disease (COPD)
* Uncontrolled asthma
* Previous ear drum rupture
* Previous abdominal hernia
* Acute respiratory infection
* Currently pregnant

Primary outcomes:
measure: Maximal Inspiratory Force
timeFrame: Change following 5-6 weeks of training
Secondary outcomes:
measure: Blood Pressure
timeFrame: Change following 5-6 weeks of training
measure: Resting Heart Rate
timeFrame: Change following 5-6 weeks of training
measure: Heart Rate Variability
timeFrame: Change following 5-6 weeks of training
measure: Diaphragm Thickness
timeFrame: Change following 5-6 weeks of training
Other outcomes:
measure: Handgrip strength via handgrip dynamometer
timeFrame: Change following 5-6 weeks of training
Locations:
city: Conroe
country: United States
facility: Sam Houston State University College of Osteopathic Medicine
state: Texas
Study officials:
References: