louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01167998: Early Diagnosis of Malignant Transformation of Pigmentary Skin Lesions
Official title: Early Diagnosis of Malignant Melanoma Transformation in Pigmentary Skin Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Melanoma
Pigmented Nevi
Skin Neoplasm
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 20
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: Healthy individuals above 18 years of age with pignented skin lesions indicated for excision

Brief summary: Malignant Melanoma is a deadly skin cancer that can be cured if diagnosed early. To date atypical pigmented skin lesions are diagnosed by appearance alone and many moles and lesions are excised unnecessarily and on the other hand malignant lesions are missed and diagnosed too late. In this study a protein conjugated to a florescent dye is spread on a suspicious pigmented lesion, the hypothesis is that this protein binds to malignant cells only and thus with a special camera that picks up the dye we can find pigmented lesions with early malignant transformation.


Eligibility criteria: Inclusion Criteria:

* pigmented lesion indicated for surgical excision
* over 18 years of age

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: : Hadassah Medical Organization,
Study officials:
References:
Clinical trial NCT02566798: Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
Official title: Anti-inflammatory Effect of Serum of Osteoarthritis Patients After Administration of the Oléogrape®SEED, an Extract of Grape and Olive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Osteoarthritis is a degenerative disease that affects a growing proportion of the population. There is currently no treatment to halt this process. The aim of the research is in particular to find treatments targeting the molecular origins of osteoarthritis focusing especially on the inflammatory component of the disease. That is why research is looking to the development of preventive treatments like nutraceuticals. This project aims to determine the anti-inflammatory properties of sera of patients who received supplementation of their diet with an extract of grape and olive: the Oléogrape®SEED. Sera and synovial fluid will be collected during visits for hyaluronic acid injections in OA patients. These sera will be tested in vitro in a model of inflamed chondrocytes.


Eligibility criteria: Inclusion Criteria:

* 50 years old and over
* Patients with knee osteoarthritis (ACR criteria)
* Patients requiring injection of hyaluronic acid (no corticosteroid associated)
* Radiological stage of knee osteoarthritis 1, 2 or 3 (Kellgren-Lawrence)
* Informed consent form signed

Exclusion Criteria:

* younger than 50 years
* protected adult
* Pregnant woman
* Radiological Stage 4 osteoarthritis (Kellgren-Lawrence)
* knee osteoarthritis secondary to arthritis
* Taking a long term treatment of osteoarthritis (Piasclédine®, Diacéréine®, glucosamine, chondroitin)
* inflammatory pathology other than osteoarthritis
* Taking anti-inflammatory medications
* Refusal to participate in the study
* Use of food supplements with anti-inflammatory properties
* Arthroscopy less than 6 months
* corticosteroid injection \<3 months
* INR\> 4 or TCA\> 2 (anticoagulants)
* Being allergic to lactose

Primary outcomes:
measure: biochemical assays of NO production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
timeFrame: 7 days
measure: biochemical assays of PGE2 production in the cell culture supernatant to measure the anti-inflammatory action of patients' sera
timeFrame: 7 days
Secondary outcomes:
measure: qualitative evaluation by mass spectrometry to assess the bioavailability of polyphenols in the patients' sera
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00222898: Cancer Detection in Pancreatic Cysts
Official title: Pancreatic Cyst DNA Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cyst
Pancreatic Pseudocyst
Pancreatic Neoplasm
Keywords: Pancreatic Cyst
PANDA Study
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: VA Pittsburgh Healthcare System
name: American Society for Gastrointestinal Endoscopy
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to assist with early and accurate diagnosis of cancer in pancreatic cysts based on the analysis of DNA obtained by endoscopic ultrasound guided fine needle aspiration

Detailed description: The study of pancreatic diseases is hindered by the organ's deep seated location and especially lack of symptoms during the early stages of disease development and progression e.g. pancreatic cancer. This is particularly true of pancreatic cysts, the variety and the malignant potential of which encompass a broad spectrum. The radiological features distinguishing a benign from a pre-malignant to a frankly malignant cyst in the pancreas are frequently underwhelming and have lead to the clinical practice of sampling all but the most obvious. The yield of the aspirate in turn is frequently not of a quality upon which a clinical decision can be based.

Most would agree that the best approach for management of pancreatic cystic neoplasm lies in early diagnosis, ideally at a precancerous stage. The effectiveness and applicability of this study is the based on the ability of the cyst DNA analysis to stratify the patients at risk of developing pancreatic cancer based on the extent of accumulated mutational damage.

Eligibility criteria: Inclusion Criteria:

* Previously scheduled for Endoscopic ULtrasound for evaluation of pancreatic cyst

Exclusion Criteria:

* Any condition that would preclude safe performance of EUS/FNA

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University - Purdue University Indianapolis
state: Indiana
city: Boston
country: United States
facility: Partners HealthCare System
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Pittsburgh
name: Asif Khalid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105698: Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg
Official title: Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet Under Fed and Fasting Conditions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Gemigliptin and Dapagliflozin 50/10 mg Fixed Dose Combination Film-coated Tablet under Fed and Fasting Conditions in Healthy Volunteers

Detailed description: \[Objectives\]

* Primary: To investigate the food-effect bioavailability of absorption of gemigliptin and dapagliflozin 50/10 mg fixed dose combination film-coated tablet in healthy subjects under fed and fasting conditions
* Secondary: To evaluate safety of investigational product under fed and fasting conditions

Eligibility criteria: Inclusion Criteria:

* Male and female, healthy volunteers aged 18-55 years, body mass index between 18.0 to 30.0 kg/m2. All of them should be able to complete the clinical study including the follow-up and capable of providing written informed consent.

Exclusion Criteria:

* History serious hypersensitivity reactions
* History or evidence of clinically significant renal, hepatic, gastrointestinal
* Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
* History about administration of first dose or second dose of COVID-19 vaccine within 30 days prior to check-in in each Period
* History or evidence of family diabetes
* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma
* etc.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
measure: Area under the plasma concentrationup up to the last measurable concentration (AUC0-tlast)
timeFrame: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
measure: Area under the plasma concentration-time curve to from time 0 to infinite(AUC0-∞)
timeFrame: Blood samples will be collected at time 0.00 and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00,12.00, 24.00, 48.00
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03800498: Shalamar Institute of Health Sciences
Official title: Shalamar Institute of Health Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Didactic Intervention Regarding (DASH) on Hypertension
Lead sponsor: Allama Iqbal Open University Islamabad
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Didactic intervention regarding Dietary Approach to Stop Hypertension (DASH) on Hypertensive Patients Blood Pressure, Knowledge and Attitude at a Tertiary Hospital of Lahore

Detailed description: Objective: To explore the effect of didactic intervention regarding dietary approach to stop hypertension (DASH) on hypertensive patients blood pressure, knowledge and attitude.

Study Design: Randomized controlled trial Place and Duration of Study: Punjab Institute of Cardiology (PIC) Lahore. From June 2018 to Oct 2018.

Methodology: Seventy volunteers aged 20-60 years attending regularly outpatient department at Punjab institute of cardiology Lahore, with systolic \> 130 mm hg, diastolic \> 80 mm hg were selected and assigned into 2 groups, i.e. Intervention and control, by simple random lottery method. For twelve weeks, only intervention group were given DASH education. Both groups were checked for DASH knowledge, attitude, and systolic diastolic blood pressure, before and after education session. Pre-tested questionnaire was used for demographic, attitude and knowledge data collection.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patient aged 20-60 years attending regularly at Punjab institute of cardiology outpatient department Lahore
* systolic \> 130 mm hg
* diastolic \> 80 mm hg.

Exclusion Criteria:

* Less than 20 years age
* patient diagnosed with secondary hypertension
* any mental and physical ailment that may interfere the intervention like deafness and blindness.

Primary outcomes:
measure: Pre-tested questionnaire was used
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Nazia
state: Punjab
Study officials:
affiliation: Shalamar Institute of Health Sciences
name: Zaheer Ahmad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05959798: High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation
Official title: High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: Safety and Acute Procedural Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with documented paroxysmal atrial fibrillation, not previously treated by left atrial catheter ablation

Brief summary: High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome


Eligibility criteria: Inclusion Criteria:

* symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
* effective oral anticoagulation

Exclusion Criteria:

* any prior left atrial ablation procedure
* presence of left atrial thrombus
* secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
* any prior oesophageal or gastric surgery

Primary outcomes:
measure: Number of reconnected pulmonary veins 20 minutes after ablation in comparison of both ablation groups
timeFrame: Acute endpoint
Secondary outcomes:
measure: Time to first documented recurrence of atrial fibrillation after a 6-week blanking period.
timeFrame: 12 months after ablation
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
affiliation: Deutsches Herzzentrum München, Abt. für Elektrophysiologie
name: Isabel Deisenhofer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03180398: Multi-parametric Magnetic Resonance Imaging for Prostate Cancer Patients
Official title: Pilot Study of Using Multi-parametric Magnetic Resonance Imaging for Organ Delineation and Tumor Response Assessment of Prostate Cancer Patients Being Treated With Radiation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 9
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of implement multi-parametric MR imaging for organ delineation and tumor response assessment of prostate cancer patients being treated with radiation therapy.

Detailed description: The study aims to generate intraprostatic lesions maps based on imaging, perform the treatment planning to compute the highest feasible simultaneous boosting dose to intraprostatic lesion and characterize longitudinal changes in imaging characteristics.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma

Exclusion Criteria:

* Patients with metal fragments or implanted devices such as pacemakers and aneurysm clips are not eligible for the study considering

Primary outcomes:
measure: Detection of Imaging Biomarkers to Localize the Intraprostatic Lesions and Predict Radiation Treatment Response
timeFrame: 2 years
measure: Tumor Response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT03844698: Association Between Cancer and Sarcoidosis
Official title: Outcome Study of Sarcoidosis: a New Paraneoplastic Syndrome in Patient With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Cancer
Keywords: sarcoidosis, cancer, paraneoplastic, treatment, outcome
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer who were seeking or receiving medical care at the University of Miami that satisfy the inclusion and exclusion criteria of study are eligible to participate.

Brief summary: The purpose of this study is to develop a clinical dataset of sarcoidosis patients with a diagnosis of cancer who are categorized by date of birth, sex, race/ethnicity, clinical information, laboratory and imaging information, time of sarcoidosis onset, cancer type and treatment, time of cancer diagnosis, stage and grade.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Sarcoidosis following cancer
* Granulomatous reaction must be proven by pathology

Exclusion Criteria:

. Aged younger than 18 years old.

Primary outcomes:
measure: Pathology Proven Sarcoidosis In Patients with Cancer
timeFrame: up to 10 years
Secondary outcomes:
measure: Cancer Cytogenetics and Sarcoidosis
timeFrame: up to 10 years
measure: Treatment Requirement of Sarcoidosis
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Mehdi Mirsaeidi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murthi M, Yoshioka K, Cho JH, Arias S, Danna E, Zaw M, Holt G, Tatsumi K, Kawasaki T, Mirsaeidi M. Presence of concurrent sarcoid-like granulomas indicates better survival in cancer patients: a retrospective cohort study. ERJ Open Res. 2020 Oct 26;6(4):00061-2020. doi: 10.1183/23120541.00061-2020. eCollection 2020 Oct.
Clinical trial NCT00996398: Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial
Official title: Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Joint Position Sense
Keywords: Cryotherapy
Joint Position Sense
Proprioception
Pre Cooling
Knee Injury
Physical Therapy Modalities
Physical Therapy Techniques
Weightbearing
NonWeightbearing
Randomised Control Trial
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this project is to assess the effect of cold water immersion on knee joint re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion, had previously been shown to improve athletic performance however, debate exists within the existing literature regarding whether proprioception, in the form or joint position sense, is effected post treatment.

Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).

Alternate hypothesis (H1): Water immersion has an effect on joint position sense.

Detailed description: This was a prospective, randomised, cross-over design where volunteers acted as their own controls. The volunteers were immersed at two temperatures (detailed below) and these sessions were separated by six to ten days. The order of the testing was randomly assigned using a random number generator. Ethical approval of the design of this trial was gained from the University of Limerick's Research Ethics Committee and signed informed consent was gained from each participant before any data collection took place.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects between the ages of 18 and 40 who complete both a Par-Q test and sign an informed consent form.

Exclusion Criteria:

* Potential subjects who do not complete a Par-Q questionnaire or provide written consent. Subjects with any ankle or knee injuries in the past twelve months.
* Students who have a recent history of ear or vestibular conditions.
* Subjects who will not be available to attend all sessions.
* Subjects who are under the age of 18 or over the age of 40.
* Subjects who aren't comfortable with being blind-folded or videotaped during testing.
* Those who are sensitive to cold exposure or show signs of a contraindication to cryotherapy.

Primary outcomes:
measure: Knee Joint Position Sense
timeFrame: 10 minutes pre and 5 minutes post immersion
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
Study officials:
affiliation: University of Limerick
name: Alan E Donnelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00672698: Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery
Official title: Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery: Comparative Study of Elective Vascular, Digestive and Biliary Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: PERIPHERAL VASCULAR DISEASES
Digestive Diseases
BILIARY TRACT DISEASES
Keywords: SURGICAL RISK
ELDERLY
MAJOR SURGERY
P-POSSUM
SAPS II
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients older than 65 years of age submitted to elective surgery at our institution

Brief summary: The purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.


Eligibility criteria: Inclusion Criteria:

* Patients older than 65 years of age
* All necessary data to calculate p-possum and saps II

Exclusion Criteria:

* Patients with incomplete data

Primary outcomes:
measure: Mortality
timeFrame: 1 YEAR
Secondary outcomes:
measure: Morbidity
timeFrame: 1 MONTH
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital De La Serena
state: Iv Region
Study officials:
affiliation: Hospital de La Serena
name: Marceloa A Beltran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: