louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01840735: Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-5737 in Subjects With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: CF
Cystic Fibrosis
PK
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.


Eligibility criteria: Inclusion Criteria:

* Males or females, ≥ 18 years of age, at Screening
* Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria, with at least 1 of the following: Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR Abnormal nasal transepithelial potential difference (NPD) test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane conductance regulator (CFTR) gene AND 1 or more accompanying clinical features consistent with CF
* FEV1 ≥ 40% and ≤ 90% predicted
* BMI ≥ 19 and ≤ 30 kg/m2
* Clinically stable with no evidence of significant new or acute respiratory symptoms
* Chest radiograph without significant acute findings; or chest radiograph, CT, or MRI obtained and interpreted within 90 days prior to enrollment, without acute findings and no significant intercurrent illness; chronic, stable findings are allowed
* History of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year =

  1 pack-year) and non-smokers of at least 60 days duration prior to Screening
* Estimated creatinine clearance ≥ 80 mL/min at Screening
* Negative drug tests; including alcohol
* Hepatitis B, C, \& HIV Negative
* Surgically sterile or ≥ 12 months post-menopausal
* Non-pregnant females

Exclusion Criteria:

* Experienced symptoms of recent acute upper or lower respiratory tract infection or acute pulmonary exacerbation requiring treatment within 2 weeks prior to Screening
* Plasma potassium ≥ 5 mEq/L
* Changes in chronic azithromycin use, bronchodilator (BD), dornase alfa, HS, physiotherapy technique or regimen, antibiotics or corticosteroid medications within 28 days prior to Screening
* History of sputum or throat swab culture yielding Burkholderia species within 2 years of Screening

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of GS-5737
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Compass Research Phase 1, LLC
state: Florida
Study officials:
References:
Clinical trial NCT01182935: Elevated Triglyceride Levels and Later Type 2 Diabetes
Official title: Elevated Triglyceride Levels and Later Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: vitamin D
triglycerides
type 2 diabetes
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 3509
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants in the 4 Tromsø study 1994 and with elevated serum triglyceride levels

Brief summary: Subjects with elevated serum triglycerides in the 4th Tromso study in 1994/1995 were re-examined with an oral glucose tolerance test to see predictive value of triglycerides regarding development of type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* participants in the 4 Tromso study 1994 and with elevated serum triglyceride levels

Exclusion Criteria:

* type 2 diabetes

Primary outcomes:
measure: Number of subjects with type 2 diabetes diagnosed with oral glucose tolerance test (OGTT)
timeFrame: At study enrollment in 2010
Secondary outcomes:
measure: The relation between serum 25(OH)D levels and blood glucose levels at OGTT
timeFrame: At study enrollment in 2010
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Univesity of Tromsø
Study officials:
affiliation: University of Tromso
name: rolf jorde, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06914258: Effects of Inhibition Compression Versus Scapular Mobilization Technique on Shoulder in Patients With Mastectomy
Official title: Effects of Inhibition Compression Versus Scapular Mobilization Technique on Shoulder in Patients With Mastectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mastectomy; Lymphedema
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.

Detailed description: The study aims to observe the effectiveness of inhibition compression therapy versus scapular mobilization on shoulder in patients with mastectomy. By investigating the effectiveness of inhibition compression therapy versus scapular mobilization, this study can contribute to improved pain management, enhanced quality of life, and reduced healthcare utilization for breast cancer survivors. It will be randomized control trial (RCT). The study will be conduct in Gujranwala institute of nuclear medicine. It will be non-probability convenience sampling technique. Duration of the study will be 6 months after the approval of synopsis

Eligibility criteria: Inclusion Criteria:

* Age 40 to 75 years (42)
* unilateral breast cancer followed by chemotherapy or radiations. (27)
* modified radical mastectomy surgery (27)
* limited ROM of shoulder
* Female

Exclusion Criteria:

* Patients with recurrent breast cancer (42)
* History of ischemic heart disease
* History of high blood pressure
* History of other surgery
* Any neurological issue

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 12 Months
measure: Constant-Murley Shoulder Outcome Score
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrānwāla
country: Pakistan
facility: Gujranwala institute of nuclear medicine
Study officials:
References:
Clinical trial NCT00518258: Neuroimaging Studies of Depression in Parkinson's Disease
Official title: Neuroimaging Studies of Depression in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Magnetic Resonance Imaging (MRI)
neuropsychological assessment
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2007-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology clinics, community sample

Brief summary: The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.

Detailed description: Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications.

Eligibility criteria: Inclusion Criteria:

* right-handed
* willing/able to undergo magnetic resonance imaging (MRI)

Exclusion Criteria:

* history of neurological condition other than Parkinson's disease
* history of psychiatric condition other than depression
* history of substance abuse/dependence

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Lee X. Blonder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795258: Oral Health Assessment of Children in CP Class
Official title: Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Oral hygiene
Public Health
Children
Prevention
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 671
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: first-grade student enrolled in a school in a zone REP/REP+

Brief summary: Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).


Eligibility criteria: Inclusion criteria:

* Be a first-grade student enrolled in a school in a zone REP/REP+
* Have a parental permission
* Good understanding of the French language

Exclusion criteria:

- lack of parental permission

Primary outcomes:
measure: Presence of decay on each tooth present in the mouth
timeFrame: 1 day
measure: Presence of care on each tooth present in the mouth
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Camille INQUIMBERT, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00462358: A Study of ARRY-520 in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2007-04-19
Enrollment: 41
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 a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.

This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).


Eligibility criteria: Key Inclusion Criteria:

* Histological or cytological evidence of malignancy.
* Advanced solid tumors that have recurred or progressed following standard therapy(ies).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Adequate hematology counts and serum chemistry values.
* Additional criteria exist.

Key Exclusion Criteria:

* Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
* Major surgery within 28 days prior to the first dose of study drug.
* Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to \<5% of the bone marrow).
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
* Additional criteria exist.

Primary outcomes:
measure: Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.
timeFrame: Part 1
measure: Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
timeFrame: Part 1 and Part 2
Secondary outcomes:
measure: Characterize the pharmacokinetics of the study drug.
timeFrame: Part 1 and Part 2
measure: Assess the efficacy of the study drug in terms of tumor response.
timeFrame: Part 1 and Part 2
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Marlene and Stewart Greenebaum Cancer Center
state: Maryland
city: Detroit
country: United States
facility: Wayne State University, Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02171858: Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke
Official title: Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
National Institutes of Health Stroke Scale
Serum High Sensitivity C-Reactive Protein
Keywords: Stroke
National Institutes of Health Stroke Scale
Serum high sensitivity C-Reactive Protein
Lead sponsor: Hospital Central Sur de Alta Especialidad
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affiliated to Petróleos Mexicanos medical system of any gender between 18 and 80 years old suspected of acute phase stroke who arrive to emergency room at our hospital

Brief summary: Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.


Eligibility criteria: Inclusion Criteria:

* Patients suspected of acute phase stroke who arrive to emergency room at our hospital
* Patients affiliated to Petróleos Mexicanos medical system
* Patients of any gender
* Patients between 18 and 80 years old

Exclusion Criteria:

* Stroke provoked by angiographic procedure
* Pregnancy
* Patient under chemotherapy or radiotherapy
* Recently surgery or trauma among last 30 days
* Heparin usage
* Stroke and/ or thrombolysis history
* Active infection
* Liver disease

Primary outcomes:
measure: Measure of serum High sensitivity C-Reactive Protein level
timeFrame: within the first 8 hours since admission to hospital
Secondary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: within the first 4 hours since admission to emergency room
Other outcomes:
measure: Stroke extension
timeFrame: within the first 4 hours since admission to emergency room
measure: Origin of stroke
timeFrame: origin will be diagnosed during the hospital stay expecting no more than 1 week
measure: Hospital stay
timeFrame: hospital stay is expected for no more than 1 week unless intensive care unit is needed
Locations:
city: Mexico city
country: Mexico
facility: Hospital Central Sur Alta Especialidad
state: Tlalpan
Study officials:
References:
Clinical trial NCT04947358: Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia
Official title: Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Longitudinal Observational Study With 6 Months Follow-up
Lead sponsor: S Form Pharma
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for unexpected respiratory difficulty

Brief summary: The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.


Eligibility criteria: Inclusion Criteria:

* Patients admitted for unexpected respiratory difficulty
* Patient admitted to the emergency department
* One of the following 3 criteria have to be present at admission to the ER:
* O2 \< or = 95%
* Respiratory rate RR \> or = 20
* Suffocation sensation

Exclusion Criteria:

* Patients \<18 years old and\> 85 years' old
* Pregnancy
* History of allergic asthma at early age
* Diagnosis retained of pulmonary embolism
* Patients with heart failure (HF) with left ventricular ejection fraction LVEF \<40% are known beforehand or discovered at admission to ER
* known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk

Primary outcomes:
measure: Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital
timeFrame: 3 months
Secondary outcomes:
measure: Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital
timeFrame: 6 months
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: ER, Fattouma Bourguiba Hospital
Study officials:
References:
Clinical trial NCT03113058: "Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
Official title: "Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adoptive Treatment for Hepatitis B With γδT Cells
Keywords: HBV infection,γδT cells,Adoptive treatment
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
Collaborators: name: Guagnzhou Qiaokang Hospital
First posted: 2017-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and anti-HBV efficacy of γδT cells.

Detailed description: In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.

Eligibility criteria: Inclusion Criteria:

* 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads\>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.

Exclusion Criteria:

* 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment

Primary outcomes:
measure: DNA copy number
timeFrame: 6 months
measure: Negative conversion rate of HbeAg
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guagnzhou Qiaokang Hospital
state: Guangdong
Study officials:
References: