louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02348060: Outcomes Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease
Official title: Autologous Adipose Stromal Vascular Fraction Outcomes in Chronic Obstructive Pulmonary Disease Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: StemGenex
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on the quality of life of people with chronic obstructive pulmonary disease (COPD). SVF contains multiple cellular components, including stem cells, with both regenerative and anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of COPD. This study is designed to evaluate quality of life changes in individuals with COPD for up to 12 months following SVF treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with chronic obstructive pulmonary disease (COPD)
* Subjects scheduled for a stem cell/SVF treatment
* Subjects willing and able to sign informed consent
* Subjects willing and able to perform follow-up interviews and surveys

Exclusion Criteria:

* Subjects with additional major health condition/disease diagnoses
* Subjects that are pregnant or breastfeeding

Primary outcomes:
measure: Change from Baseline in Overall Quality of Life Over the Course of a 12 Month Period as Measured by the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI)
timeFrame: Baseline, 12 Months
Secondary outcomes:
measure: Change from Baseline in Overall Breathing Comfort at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Dyspnea Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Overall Fatigue at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Fatigue Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Overall Emotional Function at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Emotional Function Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Mastery at Month 12 as Measured by Participants' Responses to the Chronic Respiratory Disease Questionnaire - Self-Administered Individualized (CRQ-SAI) Mastery Subscale
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: StemGenex
state: California
Study officials:
References:
Clinical trial NCT03841760: SUV on PSMA PET/CT in Non-Prostate Tumors
Official title: SUV on PSMA PET/CT in Non-Prostate Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this pilot study is to evaluate if 18F-DCFPyL PET/CT or 68Ga-PSMA-11 PET/CT can be used for detection and staging of PSMA-expressing non-prostate tumor.

Detailed description: Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is over-expressed many fold on prostate cancer cells and other types of cancer. Since PSMA is a new target for molecular therapy, PSMA PET/CT allows assessment for therapy in addition to characterization of tumors and staging. Given the success of PSMA PET/CT for prostate cancer and the increasing number of case reports on PSMA uptake in non-prostate cancer, the aim of this project is to fill this literature gap by documenting the avidity of tumors (by means of SUVmax) based on their PSMA immunostaining (by the pathologist) or based on literature report (peer-reviewed article confirming PSMA expression in a tumor type).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older, able to understand and provide written informed consent
* The patient has a tumor known or suspected to have PSMA expression, as reported in the literature or by positive histopathological staining for PSMA.
* The known or suspected tumor must fall into one of the following categories: carcinoma, sarcoma, or hematologic cancer.
* ECOG performance status 0 - 3, inclusive
* Under referring physician's care
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 40 minutes with the arms above the head and tolerating intravenous cannulation

Exclusion Criteria:

* Patients with neoplasm known in literature to not have PSMA expression, unless patient specific tissue sampling shows PSMA staining on histopathology.
* Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
* Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
* Patients with unmanageable claustrophobia
* Pregnancy

Primary outcomes:
measure: Confirm PSMA PET uptake in tumors studied
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01562860: Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
Official title: The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Median Nerve Compression
Keywords: median nerve
carpal tunnel syndrome
Pronator Teres Release
Lead sponsor: Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor class: OTHER
First posted: 2012-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.


Eligibility criteria: * Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres
* Normal two point discrimination
* Over the age of 18 and under the age of 65

Exclusion Criteria:

* Peripheral neuropathy of the median nerve secondary to trauma
* Presence of thoracic outlet syndrome
* Presence of cervical disk disease
* Under the age of 18 and over the age of 65

Primary outcomes:
measure: Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Christine M. Kleinert Institute for Hand and Microsurgery
state: Kentucky
Study officials:
affiliation: Christine M. Kleinert Institute for Hand and Microsurgery
name: Tuna Ozyurekoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06768060: Mindfulness-based Intervention Prior to External Cephalic Version
Official title: Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women with a Baby in Breech Presentation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breech Presentation in Pregnancy
External Cephalic Version
Keywords: Breech presentation
Pregnancy
External cephalic version
Mindfulness intervention
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Tilburg University
First posted: 2025-01-10
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization stratified for parity.
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.


Eligibility criteria: Inclusion Criteria:

* Pregnant women (18+y).
* With a breech presenting fetus undergoing external cephalic version.
* Dutch/English-speaking or understanding Dutch/English.

Primary outcomes:
measure: Post-intervention external cephalic version success rate
timeFrame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Secondary outcomes:
measure: Post-intervention pain perception
timeFrame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
measure: Post-intervention comfort
timeFrame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Other outcomes:
measure: Baseline mindfulness skills
timeFrame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
measure: Baseline depressive symptoms
timeFrame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
measure: Baseline fear of external cephalic version
timeFrame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
measure: Post-intervention general questions
timeFrame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
measure: Post-intervention evaluation of the intervention
timeFrame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: North Brabant
Study officials:
References:
Clinical trial NCT01175460: S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Official title: Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Esophageal Cancer
Keywords: esophageal Cancer
radiation
s-1
nedaplatin
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.

Detailed description: Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer.

Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.

Eligibility criteria: Inclusion Criteria:

* Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
* Locoregionally advanced carcinoma of esophagus without systemic metastases
* Zubrod Performance Status 0-1;
* Patients ≥ 18 years of age;
* No hypersensitivity to E. coli -derived products;
* AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
* Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
* No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
* Written informed consent.

Exclusion Criteria:

* Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
* Prior systemic chemotherapy or radiation therapy for esophageal cancer

Primary outcomes:
measure: Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
timeFrame: 3 months per patient
Secondary outcomes:
measure: Objective response rate
timeFrame: dependent upon results
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xianghui Du, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04060160: Acne Detection Software (AcneDect)
Official title: Acne Detection Software (AcneDect); AcneDect: a Software to Detect Acne Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acne Lesions
Acne Vulgaris
Keywords: machine learning
self-learning software
image-detecting software
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients within the consultation service of Dermatologische Klinik, Universitätsspital Basel, that meet the inclusion criteria

Brief summary: This study is to create a self-learning software that can detect acne lesions. Patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. After 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. The software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established.


Eligibility criteria: Inclusion Criteria:

* Acne vulgaris

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Pictures to train the AcneDect software
timeFrame: every single day from baseline for 3 months
Secondary outcomes:
measure: AcneDect questionnaire regarding acne burden (Visual Analogue Scale (VAS) scale ranging from "Not bad at all" to "Very bad")
timeFrame: every single day from baseline for 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Dermatologische Klinik; Universitätshospital Basel
name: Alexander A. Navarini, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02130960: Resting Metabolic Rate Reliability
Official title: Resting Metabolic Rate Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resting Metabolic Rate Reliability
Keywords: RMR
Reliability
Obese
Energy Expenditure
Resting Energy Expenditure
Resting Metabolic Rate
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include up to 15 men and 15 women age 18 -65 years old with a BMI of 19 - 40 kg/m2.

Brief summary: This research is being conducted to study the reliability of a method used to measure resting metabolic rate, or how much energy a person expends while at rest.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 years old
* BMI of 19 - 40 kg/m2
* Women must not be pregnant or planning to become pregnant

Exclusion Criteria:

* Age less than 18 or greater than 65
* BMI less than 19 or greater than 40
* Tobacco use
* Taking medications that affect metabolic rate (unless weight stable for past 3 months)
* Any disease that affects the metabolic rate

Primary outcomes:
measure: Resting Metabolic Rate by Indirect Calorimetry
timeFrame: At least 3 days
Secondary outcomes:
measure: Respiratory Quotient Variation
timeFrame: At least 3 days
measure: Sense Wear Mini Armband verses Indirect Calorimetry
timeFrame: At least 3 days
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00316576: Angiotensin-Converting Enzyme Polymorphism and Acute Renal Failure (ECAREA)
Official title: Evaluation of the Impact of the Angiotensin-Converting Enzyme Insertion/Deletion Polymorphism on the Development of Acute Renal Failure in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Failure, Acute
Critical Illness
Keywords: Kidney failure, Acute
Genetic Polymorphism
Angiotensin-converting enzyme
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2006-04-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients admitted to ICU fore more than 48 hours

Brief summary: Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Detailed description: Associations between angiotensin-converting enzyme gene polymorphism and occurrence and outcome of ARDS, and with respiratory complications post cardiopulmonary bypass have already been demonstrated. Based on physiological effects of angiotensin II, we hypothesized that the I allele of the angiotensin-converting enzyme Insertion/Deletion polymorphism may be associated with a higher risk of acute renal failure in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 yrs
* ICU stay \> 48 hours

Exclusion Criteria:

* Age \< 18 yrs
* Creatinine \> 180 µmol/L
* Absence of consent

Primary outcomes:
measure: Incidence of ARF
timeFrame: During ICU stay
Secondary outcomes:
measure: Mortality
timeFrame: ICU and Hospital mortality
Other outcomes:
Locations:
city: Caen
country: France
facility: Medical Intensive care Unit; Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Damien du Cheyron, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: du Cheyron D, Fradin S, Ramakers M, Terzi N, Guillotin D, Bouchet B, Daubin C, Charbonneau P. Angiotensin converting enzyme insertion/deletion genetic polymorphism: its impact on renal function in critically ill patients. Crit Care Med. 2008 Dec;36(12):3178-83. doi: 10.1097/CCM.0b013e318186a299.
Clinical trial NCT00533676: Endpoint Validation Study (0524A-015)
Official title: A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Flushing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).


Eligibility criteria: Inclusion Criteria:

* Patients must be male or female between 18 to 70 years
* Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control

Exclusion Criteria:

* You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
* You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
* You are sensitive to niacin
* You have a history gout
* You drink more than 2 glasses of alcohol per day and you are not willing to stop
* You don't have access to a telephone

Primary outcomes:
measure: To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF).
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Norquist JM, Watson DJ, Yu Q, Paolini JF, McQuarrie K, Santanello NC. Validation of a questionnaire to assess niacin-induced cutaneous flushing. Curr Med Res Opin. 2007 Jul;23(7):1549-60. doi: 10.1185/030079907x199637.
citation: Paolini JF, Mitchel YB, Reyes R, Thompson-Bell S, Yu Q, Lai E, Watson DJ, Norquist JM, Sisk CM, Bays HE. Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial. Int J Clin Pract. 2008 Jun;62(6):896-904. doi: 10.1111/j.1742-1241.2008.01739.x. Epub 2008 Apr 10.