louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06295757: Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures
Official title: Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use
Cigarette Smoking
Nicotine Dependence
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.


Eligibility criteria: Inclusion Criteria:

* Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO \> 8 ppm or NicAlert test of 6)
* Engaging in relighting for at least half of their CPD
* No smoking quit attempts in the past month nor intentions to quit in the next month
* Stable medical or psychiatric conditions with systolic blood pressure \< 160, diastolic blood pressure \< 100 and heart rate \< 105 bpm

Exclusion Criteria:

* Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month
* Currently trying or planning to quit smoking in the next month
* Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.

Primary outcomes:
measure: Average Nicotine Level
timeFrame: 1 month
Secondary outcomes:
measure: Average Puff Volume
timeFrame: 1 month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Irina Stepanov, PhD
state: Minnesota
Study officials:
References:
Clinical trial NCT02822157: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer
Official title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ovarian Epithelial Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2016-07-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Eligibility criteria: Inclusion Criteria:

* with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
* At least 1 previous line of chemotherapy
* Measurable disease
* Patients have a normal organ and bone marrow function measured within 28 days of randomization
* WHO 0-2

Exclusion Criteria:

* Primary platinum-refractory disease
* Known hypersensitivity to olaparib
* Resting ECG with QTc \> 470 msec
* Concomitant use of known potent CYP3A4 inhibitors
* Symptomatic uncontrolled brain metastases
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication

Primary outcomes:
measure: Overall Objective Response
timeFrame: 1 year after end inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ignace Vergote
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
Clinical trial NCT04302857: Tractography Pilot Study Leipzig
Official title: Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Neoplasm
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Standard cohort of neurosurgical patients

Brief summary: In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.

Detailed description: Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).

Eligibility criteria: Inclusion Criteria:

* intracranial lesion
* elective neurosurgical procedure

Exclusion Criteria:

* MRI not applicable
* cerebral ischemia during study period
* pregnancy during study period
* encephalitis during study period
* spontaneous intracerebral hemorrhage during study period

Primary outcomes:
measure: Neurological Performance
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig University Hospital, Department of Neurosurgery
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Jürgen Meixensberger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00034957: Study of the Efficacy of an Investigational Drug in Adult Patients With Non Small-Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Keywords: Pharmacia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary goal of the study is to evaluate an investigational drug's effectiveness as a treatment for Non small-cell lung cancer (NSCLC)


Eligibility criteria: Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria: Eligible patients must be at least 18 years of age with a diagnosis of NSCLC that has gotten worse during or after treatment with platinum-based chemotherapy. Patients must have at least one tumor that can be evaluated by the doctor during the investigational drug treatment. Any side-effects from prior chemotherapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function.

Exclusion Criteria: Any of the following will exclude patients from study participation: receipt of more than 1 prior regimen of chemotherapy for NSCLC (repeat of the same chemotherapy at different points in time count as 1 regimen). Irradiation to 25% or more of bone marrow, prior high dose chemotherapy with bone marrow or stem cell support, current participation in other clinical trials, pregnant or breast-feeding women, known HIV-positive or AIDS-related illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Research Center
state: California
city: Greenbrae
country: United States
facility: Research Center
state: California
city: Los Angeles
country: United States
facility: Research Center
state: California
city: Rancho Mirage
country: United States
facility: Research Center
state: California
city: Chicago
country: United States
facility: Research Center
state: Illinois
city: Louisville
country: United States
facility: Research Center
state: Kentucky
city: West Boylston
country: United States
facility: Research Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Center
state: Michigan
city: Lebanon
country: United States
facility: Research Center
state: New Hampshire
city: Nashville
country: United States
facility: Research Center
state: Tennessee
city: Arlington
country: United States
facility: Research Center
state: Texas
city: Dallas
country: United States
facility: Research Center
state: Texas
Study officials:
References:
Clinical trial NCT00006057: Diagnostic and Screening Study of Genetic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tay-Sachs Disease
Porphyria, Erythropoietic
Leukodystrophy, Globoid Cell
Metabolism, Inborn Errors
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2000-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Determine the phenotypic heterogeneity of patients with genetic disorders including their clinical spectrum and natural history.

II. Develop and evaluate novel methods for the treatment of genetic disorders including metabolic manipulation, enzyme manipulation, enzyme replacement, enzyme transplantation, and gene transfer techniques in these patients.

III. Develop and evaluate methods for the prenatal diagnosis of genetic disorders using improved cytogenetic, biochemical, and nucleic acid techniques and amniotic fluid cells or chorionic villi in these patients.

Detailed description: PROTOCOL OUTLINE:

Patients are evaluated annually or biannually, depending on disease status and progression. Patients undergo a complete medical history, an extensive family pedigree, and a physical examination. Patients undergo general laboratory, imaging, physiologic, and clinical laboratory studies according to their disease type. Patients undergo specialized laboratory studies including plasma and leukocyte enzyme assays, quantitative urinary mucopolysaccharides and oligosaccharides, urine and plasma glycolipids, plasma and urine amino acids, urine organic acids, lymphoblastoid culture, DNA isolation from peripheral leukocytes, skin biopsy for fibroblast culture (if indicated), and medical photography. Patients also receive consultations with various specialties including ophthalmology, ENT, cardiology, pulmonary, gastroenterology/nutrition, hematology, neurology, orthopedics, rehabilitation medicine/physical therapy, and dermatology.

Eligibility criteria: * Suspected diagnosis (homozygous or heterozygous) of a genetic disorder including, but not limited to, one of the following: Tay-Sachs disease (adult form) Congenital erythropoietic porphyria Galactosemia Mitochondrial myopathy Globoid cell leukodystrophy (Krabbe disease) Methylmalonic acidemia Isovaleric acidemia Morquio type A Glycogen storage disease type 1AB Ornithine aminotransferase deficiency Ceroid lipofuscinosis Glutaric aciduria type 1 Citrullinemia Other malformation syndromes, lysosomal storage disorders, or peroxisomal disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Judith P. Willner
role: STUDY_CHAIR
References:
Clinical trial NCT01758757: Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Official title: Comparison of Small-gauge and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Proliferative diabetic retinopathy
Vitrectomy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 347
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

Detailed description: The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.

Eligibility criteria: Inclusion Criteria:

* The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months

Exclusion Criteria:

* The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.

Primary outcomes:
measure: Incidence of retinal breaks
timeFrame: One year
Secondary outcomes:
measure: Incidence of neovascular glaucoma
timeFrame: One Year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: STUDY_CHAIR
References:
citation: Yokota R, Inoue M, Itoh Y, Rii T, Hirota K, Hirakata A. Comparison of microinsicion vitrectomy and conventional 20-gauge vitrectomy for severe proliferative diabetic retinopathy. Jpn J Ophthalmol. 2015 Sep;59(5):288-94. doi: 10.1007/s10384-015-0396-y. Epub 2015 Jul 23.
Clinical trial NCT04457557: Local Anesthetic Concentration and Rebound Pain
Official title: Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rebound Pain
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine
Primary purpose: TREATMENT

Brief summary: The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

Detailed description: Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.

The mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

Eligibility criteria: Inclusion Criteria:

* Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain

Exclusion Criteria:

* Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
* Diabetic neuropathy
* Adverse drug reaction history to ropivacaine, fentanyl
* Impaired coagulation

Primary outcomes:
measure: Rebound pain score
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: total postoperative fentanyl dose
timeFrame: 48 hours after surgery
measure: fentanyl bolus injection time
timeFrame: 48 hours after surgery
measure: Subjective satisfaction
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501457: The Effect of Different Muscle Training on Activities of Daily Living in COPD
Official title: Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality of Life
Anxiety
Keywords: COPD
Pulmonary rehabilitation
Neuromuscular electrical stimulation
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.


Eligibility criteria: Inclusion Criteria:

* Being between 18-75 years old,
* Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
* PaO2 \>55 mm Hg, PaCO2 \<45 mmHg in room air.

Exclusion Criteria:

* Exacerbation,
* Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
* Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
* Musculoskeletal disorder (conditions affecting exercise ability),
* Difficulty communicating.

Primary outcomes:
measure: 6 Minute Walk Test (6 MWT):
timeFrame: 4 weeks
Secondary outcomes:
measure: Modified Borg Scale (MBS):
timeFrame: 4 weeks
measure: St. George's Respiratory Questionnaire (SGRQ):
timeFrame: 4 weeks
measure: Beck Depression Inventory (BDI):
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Hititi University Sungurlu Vocational School
Study officials:
affiliation: HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL
name: Ahmet Payas, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05682157: Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial
Official title: Use of the Paula Method of Muscle Exercises Among Patients With Low Anterior Resection Syndrome After Sphincter-sparing Rectal Resection Using an Integrative Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Keywords: Paula Method
Sphincter sparing rectal resection
Anal incontinence
Rectal Cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.


Eligibility criteria: Inclusion Criteria:

* patients 6-18 months post restorative surgery (either resection with a primary functional anastomosis or after the closure of a temporary ileostomy following curative surgery for rectal cancer) and, if applicable, at least one month post last adjuvant chemotherapy treatment
* LARS score of 21 or greater
* age 18 or older
* able to read and write in Hebrew or English
* able and willing to comply with the study requirements.

Exclusion Criteria:

* Chronic anal incontinence prior to surgery
* inability to perform exercises due to cognitive or physical limitations
* actively engaged in pelvic floor muscle exercises
* pregnancy.

Primary outcomes:
measure: Change in LARS score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Noam Shussman, MD
role: PRINCIPAL_INVESTIGATOR
References: