louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01022398: Vitamin D Replacement: The Effect on Statin-Related Myalgias
Official title: Vitamin D Replacement: The Effect on Statin-Related Myalgias
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HMG-CoA Reductase Inhibitors-related Myalgias
Keywords: Vitamin D3
HMG-CoA reductase inhibitors (statin)-related myalgias
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 4
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to determine if Vitamin D supplementation \[10,000 international units of cholecalciferol (vitamin D3) by mouth weekly\] will decrease the rate of discontinuation of statin therapy due to muscle ache/pain and decrease the occurrence of muscle ache/pain due to statin therapy.


Eligibility criteria: Inclusion Criteria:

* Patients who recently prescribed statins (in the last seven days) or who have had a recent increase in statin dose (in the last seven days)
* Patients aged 19-89 years old
* Men and women (not of childbearing potential)
* Patients receiving statins with concomitant ezetimibe

Exclusion Criteria:

* history of alcoholism or malnutrition
* receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that affect cholesterol levels

Primary outcomes:
measure: Determine if the Replacement of Vitamin D 10,000 IU Weekly Will Decrease the Discontinuation Rate of Statin Therapy and Decrease the Incidence of Statin-related Myalgia in Patients Requiring Statin Therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: The Cardiac Center at Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Susan Schima, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739698: Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Official title: Role of Intraperitoneal Intraoperative Chemotherapy With Paclitaxel in the Surgical Treatment of Peritoneal Carcinomatosis From Ovarian Cancer. Hyperthermia Versus Normothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Carcinomatosis
Keywords: ovarian cancer
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled single-blind clinical trial was performed, in 32 patients diagnosed with peritoneal carcinomatosis from epithelial ovarian cancer, who underwent radical surgery-peritonectomy, achieving an optimal R0-R1 cytoreduction (microscopic tumor residues (R0) or macroscopic tumor residues \< 1cm (R1)) followed by hyperthermia against normothermia intraperitoneal intraoperative chemotherapy with paclitaxel


Eligibility criteria: Inclusion Criteria:

1. age ranged between 18 and 75 years old;
2. histopathologic confirmation of peritoneal carcinomatosis from epithelial ovarian cancer (stage IIIc- FIGO (International Federation of Gynecology and Obstetrics));
3. Karnofsky index \> 70 or performance status ≤2;
4. informed consent form filled out correctly.

Exclusion Criteria:

1. unfulfillment of inclusion criteria;
2. extraabdominal metastasis or stage IV FIGO (liver, lung, bone, etc);
3. concomitance of another malignant neoplasm;
4. renal, hepatic or cardiovascular dysfunction;
5. intolerance during the treatment; - (6) refusal to participate in the study.

Primary outcomes:
measure: The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)
timeFrame: The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fernandez-Peralbo MA, Priego-Capote F, Luque de Castro MD, Casado-Adam A, Arjona-Sanchez A, Munoz-Casares FC. LC-MS/MS quantitative analysis of paclitaxel and its major metabolites in serum, plasma and tissue from women with ovarian cancer after intraperitoneal chemotherapy. J Pharm Biomed Anal. 2014 Mar;91:131-7. doi: 10.1016/j.jpba.2013.12.028. Epub 2014 Jan 2.
Clinical trial NCT06044298: Advers Events in Patients Undergoing Gastrointestinal Procedural Sedation
Official title: The Impact of Frailty on Adverse Events in Patients Undergoing Gastrointestinal Procedural Sedation: a Multicentre, Prospective, Observational Study(FRAEPS Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sedation Complication
Frailty
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators intend to include in the study patients aged 60 and above who have been evaluated in the pre-anesthesia clinic prior to procedures (such as endoscopy, colonoscopy, ERCP, PEG, EUS, ESD) and have received sedation by an anesthesiologist.

Brief summary: Investigators will include in our study patients aged 60 and over who have been evaluated in the pre-anesthesia clinic for procedures such as endoscopy, colonoscopy, ERCP, PEG, EUS, and ESD, and who have received sedation by an anesthesiologist. Patients will be assessed for frailty prior to the procedure; during and after the procedure, respiratory monitoring (SpO2, capnography) will be closely observed, and they will be contacted by phone three days later.

Primary goal of the study is to prospectively investigate the incidence of peri-procedural complications (desaturation, bradycardia, hypotension, etc.) in elderly patients undergoing gastrointestinal procedural sedation, and to assess its relationship with detected frailty using the FRAIL scale.Secondary goals of the study are to identify risk factors for adverse events, examine the relationship of these factors with 'ASA score - age and frailty scale', and determine their impact on the incidence of adverse events. Additionally, investigators aim to research the effects of capnography-based respiratory monitoring on adverse events.


Eligibility criteria: Inclusion Criteria:

* 60 years and older patients
* ASA physical state I -IV
* Patients who are qualified to give written informed consent
* Elective gastrointestinal interventions performed under the care of the anesthesia team (such as gastroscopy, colonoscopy).

Exclusion Criteria:

* ASA IV patients
* Patients using sedative agents / Patients already sedated for other purposes
* Non-consenting patients
* Patients with any upper airway obstructive pathology or a history of difficult airway
* Emergency procedures

Primary outcomes:
measure: Advers event,fraility
timeFrame: first day
Secondary outcomes:
measure: Precedural advers event
timeFrame: First day
measure: Capnography and side effects
timeFrame: First day
measure: Postprocedural advers event
timeFrame: Third day
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Uludag University
Study officials:
affiliation: Uludag University
name: suna gören
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01395797: Pioglitazone for Heroin and for Nicotine Dependence
Official title: Effects of Pioglitazone, a PPARγ Agonist, on the Abuse Liability of Heroin and of Nicotine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Heroin Dependence
Nicotine Dependence
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Omeros Corporation
First posted: 2011-07-18
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy. Specifically, pioglitazone, a peroxisome proliferator-activated gamma receptor (PPARγ) agonist, will be used as an adjunct to agonist-based treatment.

Detailed description: Although treatments for opioid and for nicotine dependence exist, these medications are not universally effective as many patients are unable to stop using or relapse rapidly, suggesting that treatment with a single agent alone is insufficient to facilitate cessation of use in many patients. Targeting additional pathways that may contribute to the maintenance of drug-taking behaviors or relapse may be a more effective strategy to treat individuals resistant to first-line approaches.

Eligibility criteria: Inclusion Criteria:

* 21-55 years of age
* Physically healthy
* Able to perform study procedures

Exclusion Criteria:

* Pregnancy
* Physical dependence on any other drugs besides caffeine, heroin and nicotine

Primary outcomes:
measure: Drug's Break Point
timeFrame: Following 2 weeks of Pioglitazone (PIO) maintenance.
Secondary outcomes:
measure: Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.
timeFrame: Following 2 weeks of Pioglitazone (PIO) maintenance.
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia University
name: Sandra D. Comer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez S, Jones JD, Vadhan NP, Brandt L, Comer SD, Bisaga A. The acute and repeated effects of cigarette smoking and smoking-related cues on impulsivity. Drug Alcohol Rev. 2021 Jul;40(5):864-868. doi: 10.1111/dar.13206. Epub 2020 Nov 2.
Clinical trial NCT03041597: Dental Implant Supported Removable Dental Prostheses
Official title: An Randomized Controlled Trial Comparing Immediate Loading With Conventional Loading Using Cone-anchored Implant Supported Removable Dental Prostheses, a Two Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Complication
Prosthesis Survival
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2017-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To prospectively monitor the survival rate of Ankylos® dental implants, comparing delayed versus immediate loading, using abutments with the SynCone® concept for implant-supported detachable dental prosthesis (ISDDP) in the edentulous upper jaw.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Extraction sockets should have healed at least 4 months
* Sufficient bone volume to place six implants in the maxilla
* No previous bone augmentation procedures
* The mandible can have any kind of dentition as long as a well-distributed contact relationship with the new prosthesis in the maxilla can be established.
* Accepting to comply with study procedures

Exclusion Criteria:

* Physical or psychological disorders prohibiting implant treatment
* Heavy smoking (\>10 cigarettes/day)
* Present alcohol and/or drug abuse
* Physical handicap that may interfere with the ability to perform oral hygiene

Primary outcomes:
measure: bone loss
timeFrame: Difference between loading and Year two
Secondary outcomes:
measure: probing pocket depth
timeFrame: Difference between loading and Year two
measure: plaque
timeFrame: Difference between loading and Year two
measure: bleeding on probing
timeFrame: Difference between loading and Year two
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06909097: Better Breaks: Strength Breaks vs Walk Breaks for Sedentary Behavior Breaks
Official title: MOV&#39;D Strength Snacks vs Walk Breaks Study: Health Performance Gains Across Domains
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Employees
Keywords: physical activity breaks
prolonged sitting breaks
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the benefits of two different types of 2 minute activity breaks during sedentary workdays for people who sit for long periods of time in sedentary jobs.

Detailed description: For this study, participants are randomly assigned to one of two physical activity breaks and for 8 weeks are to do 4 per day and track their daily breaks and productivity. There are many measurements including: in-person strength assessments at baseline, 1 month, and 2 months; daily tracking of breaks; pre and post oral glucose tolerance tests; pre and post 10-day diet tracking; pre and post 10-day Continuous Glucose Monitoring with a Dexcom; genome with saliva at pre; and -omics at pre and post.

Eligibility criteria: Inclusion Criteria:

-

Identify inclusion criteria.

1. Sedentary occupation (e.g., clerical work, data entry, call center, receptionists)
2. Full time employment remote or on-site
3. Able to safely perform bodyweight squats and lunges
4. Over 30 years old
5. Not currently doing a strength training program
6. Not currently taking planned activity breaks at work
7. Has a smart phone with a camera and unlimited text plans
8. Interested in participating
9. Fluent in English
10. Not currently on insulin or any glucose lowering medication

Exclusion Criteria:

1. Yes to any of the physical activity readiness criteria questionnaire (e.g. cardiac symptoms with increasing heart rate, dizziness upon performing exercise)
2. Participating in another research study on diet, weight loss, or any physical activity.
3. If their doctor has ever said to not strength train
4. Having insulin dependence

Primary outcomes:
measure: Change in average area under the curve for glucose from a 10 day continuous glucose monitors
timeFrame: from baseline to post (8 weeks)
Secondary outcomes:
measure: Change in strength from pre to post
timeFrame: from baseline to 8 weeks
measure: Change in endurance from pre to post
timeFrame: from baseline to 8 weeks
measure: Change in one legged strength from pre to post
timeFrame: from baseline to 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Prevention Research Center
state: California
Study officials:
References:
Clinical trial NCT05752097: [18F]AlF-NOTA-FAPI-04 PET/CT in Inflammation and Fibrosis in Renal Diseases
Official title: Clinical Study of Fibroblast Activating Protein Inhibitor (FAPI) -Mediated 18F Targeted to Evaluate Inflammation and Fibrosis in Renal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 18F-FAPI PET/CT Examination
Renal Puncture Biopsy
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first clinical diagnosis of nephritis or renal fibrosis.

Brief summary: The goal of this observational study is to explore the feasibility of using 18F-labeled FAP molecular probe for PET/CT imaging (18F-FAPI PET/CT) to accurately evaluate inflammation and fibrosis in renal diseases. The main questions it aims to answer are:

* Can 18F-FAPI PET/CT accurately evaluate the inflammation and fibrosis of kidney disease?
* What is the value of 18F-FAPI PET/CT as a non-invasive assessment of inflammation and fibrosis in kidney disease? Participants will receive \[18F\]AlF-NOTA-FAPI-04 PET/CT and renal aspiration biopsy.


Eligibility criteria: Inclusion Criteria:

* The pitients of nephritis or fibrosis disease

Exclusion Criteria:

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg
* Renal biopsy cannot be performed for severe exclotting disease
* Complicated with chronic liver disease, myocardial infarction, stroke, and malignant tumor
* Unable to cooperate with renal puncture biopsy due to language communication or other problems
* Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception
* Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes
* Alcohol allergy
* Patients with significant decrease in urine volume due to disease
* Refusal to sign an informed consent form or inability or unwillingness to comply with the investigator-approved protocol
* Other circumstances deemed inappropriate by the investigator for participation in the study.

Primary outcomes:
measure: Standardized uptake value
timeFrame: 30minutes after PET/CT examination
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
citation: Zhou Y, Yang X, Liu H, Luo W, Liu H, Lv T, Wang J, Qin J, Ou S, Chen Y. Value of [68Ga]Ga-FAPI-04 imaging in the diagnosis of renal fibrosis. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3493-3501. doi: 10.1007/s00259-021-05343-x. Epub 2021 Apr 7.
citation: Conen P, Pennetta F, Dendl K, Hertel F, Vogg A, Haberkorn U, Giesel FL, Mottaghy FM. [68 Ga]Ga-FAPI uptake correlates with the state of chronic kidney disease. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3365-3372. doi: 10.1007/s00259-021-05660-1. Epub 2022 Jan 6.
Clinical trial NCT01632397: Pre-exposure Prophylaxis Adherence Intervention for MSM
Official title: Optimizing Antiretroviral-Based Prevention by Enhancing PrEP Adherence in MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Medication Adherence
Keywords: PrEP
HIV
Adherence
MSM
Men having sex with men
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
First posted: 2012-07-02
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.


Eligibility criteria: Inclusion Criteria:

* male sex at birth
* being 18 years old or older
* testing HIV-negative at screening
* evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
* medically cleared to take the study drug (ambulatory performance \>=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
* able to understand and speak English (for consenting and counseling).

Exclusion Criteria:

* participants who are not able to consent due to psychiatric or cognitive concerns
* those who have already been prescribed PrEP
* having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
* receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
* receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
* active alcohol or drug use that would interfere with study participation
* having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Primary outcomes:
measure: Adherence to PrEP over time
timeFrame: At each of the 7 study visits post PrEP perscrition spread over the duration of the study (up to six months)
Secondary outcomes:
measure: Sexual Risk Compensation
timeFrame: At each of the 9 study visits spread over up to six months.
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Fenway Institute
state: Massachusetts
Study officials:
affiliation: Fenway Health
name: Kenneth Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References: