louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02170961: Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure
Official title: Study of Polymorphisms of Renin Angiotensin Aldosteron Systemv(RAAS) and Matrice Metallo Protesase (MMPs) in Acute Heart Failure (AHF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Keywords: Acute heart failure
RAAS
MMP3
MMP12
Polymorphysm
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute onset dyspnea patients

Brief summary: this study aim to investigate the:

* association of RAAS polymorphisms and AHF
* association of MMP 3 and 12 polymorphisms and AHF

Detailed description: Heart failure can be defined as a complex clinical syndrome that results from any structural or functional disorder of the heart, with impairment of ability to fill the ventricles or eject blood. The main event of the IC is dyspnea and fatigue, which limit exercise tolerance and induces water retention.

The renin angiotensin aldosterone system governs the salt and water homeostasis in the body. Renin is a proteolytic enzyme secreted by the juxtaglomerular apparatus of the kidney (area near the glomeruli). Renin has no direct action on the organism, but that is part of the renin-angiotensin system or the renin-angiotensin-aldosterone system is known.

To date, few published studies have examined the association between the polymorphism AGT M235T \* and cardiac dysfunction; and available results are contradictory. What is not known yet is the ratio of this polymorphism with the prognosis of heart failure.

Eligibility criteria: Inclusion Criteria:

* aged more than 18 year old.
* acute non traumatic dyspnea .

Exclusion Criteria:

* ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours
* a history of a heart transplant, pericardial effusion, chest wall deformity suspected of causing dyspnea
* coma, shock,MV,vasopressor drugs
* arrhythmia serious and sustained,
* pace maker
* severe mitral valve disease,

Primary outcomes:
measure: mortality RAAS
timeFrame: one year
Secondary outcomes:
measure: association between RAAS polymorphism and AHF
timeFrame: at admission (an average of 1 day)
measure: association between MMP polymorphism and AHF
timeFrame: at admission (average of 1 day)
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Samir
state: Emergency Department Monastir, Tunisia 5000
Study officials:
affiliation: University of Monastir
name: Nouira Samir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05517161: Roll for Intervention - TBI Group Treatment
Official title: Roll for Intervention - a Critical Look at the Practicability of Table-top Roll Playing Games as Communication Intervention for Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Communication Disorder, Social
Lead sponsor: Moravian University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: individuals who have received a brain injury at least 1 year prior to enrollment.

Group 2: age, education and gender matched individuals who have no history of neurological difficulties

Brief summary: Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus

Detailed description: Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol.

Eligibility criteria: Inclusion Criteria:

* moderate to severe TBI more than 1 year ago

Exclusion Criteria:

* other neurological diagnoses prior to TBI

Primary outcomes:
measure: Goal Attainament Scaling - change over time
timeFrame: Week 2, 3,4,5,6,7, 8 and 9 of the 10week study protocol
Secondary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status Update
timeFrame: During week 1 and week 10 of the 10 week protocol
measure: Functional Assessment of Verbal Reasoning and Executive Strategies
timeFrame: During week 1 and week 10 of the 10 week protocol
measure: Sydney psychosocial reintegration scale version 2 (SPRS-2)
timeFrame: During week 1 and week 10 of the 10 week protocol
measure: Satisfaction with life scale (SWLS)
timeFrame: During week 1 and week 10 of the 10 week protocol
measure: Latrobe Communication Questionnaire (LCQ)
timeFrame: During week 1 and week 10 of the 10 week protocol
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Moravian University
state: Pennsylvania
Study officials:
affiliation: Moravian University
name: Louise C Keegan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365961: Hip Scope Fascia-iliaca (FI) Block Study
Official title: Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Dysplasia
Femoroacetabular Impingement
Acetabular Labrum Tear
Keywords: Hip Arthroscopy
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 84
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: Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.


Eligibility criteria: Inclusion Criteria:

* Scheduled for outpatient hip arthroscopy
* American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

* Prior surgery on ipsilateral hip
* ASA 4-6
* Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
* Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
* Allergy to amide local anesthetics
* Contraindication to regional anesthesia
* BMI \> 40
* Females who are pregnant or plan to get pregnant during the course of the study

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 3 Months
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 3 Months
Other outcomes:
measure: Time in PACU
timeFrame: Duration of PACU stay in minutes from end of surgery to discharge from PACA
measure: Total Number of Episodes of Nausea and Vomiting
timeFrame: From end of surgery to discharge from PACU
measure: Hospital Readmission
timeFrame: 3 months
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
state: South Carolina
Study officials:
affiliation: Greenville Anesthesiology - Greenville Health System
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.
Clinical trial NCT04215861: Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
Official title: Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Liver Cancer
Stomach Cancer
Breast Cancer
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 18-80 years old;
* The patient whose tumor (tissue or cell) was first diagnosed by pathology;
* Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
* Have relevant indications for treatment and have no contraindications;

Brief summary: Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.

Detailed description: Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral

Eligibility criteria: Inclusion Criteria:

* 18-80 years old;
* The patient whose tumor (tissue or cell) was first diagnosed by pathology;
* Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
* Have relevant indications for treatment and have no contraindications;

Exclusion Criteria:

* Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.);
* Other circumstances considered inappropriate by the researcher to participate in the study;

Primary outcomes:
measure: Raman spectra
timeFrame: the 1st day before operation
measure: Raman spectra
timeFrame: the 1st day after operation
Secondary outcomes:
measure: progression-free survival
timeFrame: through study completion, an average of 1 year
measure: overall survival
timeFrame: through study completion, an average of 1 year
measure: objective response rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Xiaonan Cui, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297361: The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B12 Deficiency
Folic Acid Deficiency
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vitamin B12 deficiency is more widespread in the population than has been assumed so far. Since a deficiency in this vitamin can lead to irreversible neurological damage, early diagnosis is essential. Vitamin B12 is synthesized exclusively in micro-organisms, and in humans it is an essential component in methyl group transfer and cell division. The vitamin is crucially involved in the proliferation, maturation, and regeneration of neural cells. In combination with folic acid, as an enzymatic essential cofactor in the metabolism of homocysteine, vitamin B12 maintains low homocysteine levels. The aim of the present study is to investigate the relationship between religious origin and age, and Vitamin B12 and Folic acid plasma levels in non Jewish population in Western Galilee. The investigators assumption is that the results of the study will contribute to early detection and treatment of Vitamin B12 and Folic acid deficiencies in order to prevent long term complications.


Eligibility criteria: Inclusion Criteria:

* Age:18 and older
* Able to understand and to sign informed consent

Exclusion Criteria:

* Gastrointistinal Diseases
* Malignancy
* Psychiatric disorders
* Pregnancy
* Treatment with Vit B12 or Folic acid

Primary outcomes:
measure: The number of participants of each religious origin group with folic acid deficiency
timeFrame: 10 months
measure: The number of participants of each age group with Vitamin B12 deficiency
timeFrame: 10 months
measure: The number of participants of each age group with folic acid deficiency
timeFrame: 10 months
measure: The number of participants of each religious origin group with Vitamin B12 deficiency
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Yassif
country: Israel
facility: Clalit health services
Study officials:
References:
Clinical trial NCT06949761: A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Official title: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination with Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation.

The study includes Phase Ib (combination therapy with dose escalation stage) and Phase II (expansion stage). The study will includes a total of 4 cohorts:

Phase Ib will enroll subjects in 4 cohorts (cohorts 1-4). Subjects will be allocated to appropriate cohorts by the investigator according to specific indications and treated with the corresponding combination regimen for safety and tolerability assessment. The Bayesian optimal interval (BOIN) design will be used for dose escalation and MTD determination.

In Phase II, according to the results of the Phase Ib and SMC decision, 1-2 appropriate dose groups will be selected. In the dose group(s), the sample size (including subjects in the dose escalation stage) will be increased to 20 for each indication according to the cohort for expansion to further evaluate the efficacy of QLC1101 combination therapy in the treatment of subjects with advanced solid tumors harboring KRAS G12D mutations


Eligibility criteria: Inclusion Criteria:

* Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.
* Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy
* The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1
* ECOG PS score: 0 or 1

Exclusion Criteria:

* Subjects who have been previously treated with inhibitors for KRAS G12D mutations
* Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study
* Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening

Primary outcomes:
measure: adverse events
timeFrame: from first dose to 90 days after last dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00656461: Phase 1 Study of MKC-1 in Patients With Advanced Cancer
Official title: Phase 1 Study of MKC-1 in Patients With Advanced or Metastatic Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Advanced cancer
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 24
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: This is an open-label study to determine the highest dose of MKC-1 that may be administered daily on a continuous basis for patients with advanced or refractory solid tumors.


Eligibility criteria: Inclusion Criteria:

* Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
* Age greater than or equal to 18 years.
* ECOG performance status ≤1
* ANC greater than or equal to 1,500/mm3;
* Platelets greater than or equal to 100,000/mm3
* creatinine ≤1.5 times institutional upper limit of normal (ULN)
* T Bili within normal limits;
* AST and ALT less than or equal to 2.5 times ULN; and
* albumin greater than or equal to 3.0 g/dL
* have measurable disease by RECIST, radiographically evaluable disease, or detectable disease
* women of child-bearing potential and men must agree to use adequate contraception
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Have previously received MKC-1.
* Have received radiation to greater than 25% of the bone marrow.
* Have had anti-cancer therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Are concurrently receiving any other investigational agents while on study.
* Have known brain metastases
* Have any condition that impairs the ability to swallow and retain MKC-1 capsules.
* Uncontrolled intercurrent illness
* Are pregnant or breastfeeding
* HIV-positive patients
* Patients with uncontrolled diabetes

Primary outcomes:
measure: Determine the maximum tolerated dose (MTD) of MKC-1 administered orally twice a day (bid) continuously in patients with advanced or refractory solid tumors.
timeFrame: Throughout study participation
Secondary outcomes:
measure: Determine evidence of benefit in cancer patients when MKC-1 is administered orally twice a day (bid) continuously by evaluating tumor response and/or tumor marker improvement.
timeFrame: During study participation
Other outcomes:
Locations:
city: Madison
country: United States
facility: U. of Wisconsin Paul P. Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: U. of Wisconsin
name: Glenn Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909961: A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years
Official title: A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis
Bone Mineral Density
Biomarkers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 118
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal osteoporosis
* Patients who has a low bone mineral density at hip or vertebral
* Patients who has an osteoporotic fracture at hip or vertebra

Exclusion Criteria:

* Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
* Known metabolic bone disease excluding osteoporosis.
* Serious systemic disorder treated with drugs interfering with bone metabolism.
* Significant liver or renal failure
* Pathologic fracture in the examined body area or elsewhere.
* Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
* Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Efficacy - BMD
timeFrame: 1 year
Secondary outcomes:
measure: Efficacy - Biochemical markers
timeFrame: 6 months
measure: Safety - Rate of adverse events and serious adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Novartis Investigational site
city: Antalya
country: Turkey
facility: Novartis Investigative site
city: Istanbul
country: Turkey
facility: Novartis Investigational site
city: Izmir
country: Turkey
facility: Novartis Investigative site
city: Kayseri
country: Turkey
facility: Novartis Investigative site
city: Konya
country: Turkey
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: