louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05205226: Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment
Official title: Efficacy and Safety of Local Radiotherapy for Residual Tumor Lesions During the First-line Treatment of Advanced Non-small Cell Lung Cancer: a Retrospective-real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non driver mutation advanced non-small-cell lung cancer non driver mutation

Brief summary: This study aimed to confirmed that local radiotherapy for residual lesions can significantly prolong the efficacy of chemotherapy combined with immunotherapy in the initial treatment of advanced non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* ≥18，Advanced Non-small Cell Lung Cancer Confirmed by Histopathology Patients received platinum-based chemotherapy combined with immunotherapy

Exclusion Criteria:

* EGFR/ALK/ROS1 driver gene mutation
* Chemotherapy only
* Concurrent radio-chemotherapy
* Surgery
* Single-agent immunotherapy
* No treatment information available

Primary outcomes:
measure: PFS
timeFrame: January 2018 to June 2021
Secondary outcomes:
measure: RT
timeFrame: January 2018 to June 2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang C Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02808026: Study of CS-3150 in Patients With Severe Hypertension
Official title: A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Hypertension
Keywords: severe hypertension
grade III hypertension
mineralocorticoid receptor antagonist
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)

Exclusion Criteria:

* Patients who are suspected hypertensive emergency
* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor)
* eGFR \< 60 mL/min/1.73 m\^2.

Primary outcomes:
measure: Change from baseline in sitting systolic and diastolic blood pressure
timeFrame: Baseline to end of Week 8
Secondary outcomes:
measure: Time course of systolic and diastolic blood pressure
timeFrame: Baseline to end of Week 8
measure: Proportion of patients achieving blood pressure control
timeFrame: Baseline to end of Week 8
Other outcomes:
Locations:
city: Sapporo
country: Japan
Study officials:
References:
Clinical trial NCT00200226: Oral Misoprostol Before Endometrial Biopsy
Official title: Oral Misoprostol Before Endometrial Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Biopsy
Keywords: pain/discomfort
cervical dilatation
side effects
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An endometrial biopsy involves a thin tube being passed through the cervix (opening of the uterus) to obtain a sample of the lining of the uterus. Sometimes there may be discomfort with this procedure especially if the cervix is not dilated or opened. Previous research has suggested that taking a drug called misoprostol may help the cervix to start to dilate or open. This study will see if misoprostol will help open the cervix for an endometrial biopsy, to lessen the discomfort and make the biopsy easier to perform.


Eligibility criteria: Inclusion Criteria:

* women 19 years and older
* planned endometrial biopsy

Exclusion Criteria:

* known hypersensitivity or allery to prostaglandins
* seizure disorder
* liver disease
* known abnormal liver function tests
* pregnancy

Primary outcomes:
measure: pain/discomfort of endometrial biopsy
timeFrame: during procedure
Secondary outcomes:
measure: ease of performing biopsy
timeFrame: during procedure
measure: success of obtaining biopsy
timeFrame: during procedure
measure: potential side effects
timeFrame: time study drug taken until procedure
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Women's Health Centre, Eastern Health
state: Newfoundland and Labrador
city: Dartmouth
country: Canada
facility: Obstetrics and Gynecology Associates
state: Nova Scotia
Study officials:
affiliation: Faculty, Discipline Obstetrics and Gynecology, Memorial University of Newfoundland
name: Joan MG Crane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04301726: Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD
Official title: Efficacy of Deutetrabenazine in Huntington's Disease Patients with Dysphagia: a Randomised, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Huntington Disease
Lead sponsor: Fundacion Huntington Puerto Rico
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled pilot study
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD.

Detailed description: The primary endpoint is the change in swallow function/dysphagia from baseline to maintenance therapy.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of HD
* Symptoms of dysphagia
* Must be able to swallow tablets

Exclusion Criteria:

* Other confounding diseases that affect swallowing
* Depression
* Hepatic impairment
* Renal impairment
* Dementia

Primary outcomes:
measure: Efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.
timeFrame: 18 months
measure: Non-instrumental assessment of the efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.
timeFrame: 18 months
measure: Instrumental assessment of the efficacy of deutetrabenazine to control symptoms of dysphagia associated with Huntington's disease.
timeFrame: 18 months
Secondary outcomes:
measure: Effect of deutetrabenazine on body weight in HD patients.
timeFrame: 18 months
measure: Effect of deutetrabenazine on body mass index in HD patients.
timeFrame: 18 months
measure: Effect of deutetrabenazine on fat distribution in HD patients.
timeFrame: 18 months
Other outcomes:
measure: Effect of deutetrabenazine on quality of life in HD patients.
timeFrame: 18 months
Locations:
city: San Juan
country: Puerto Rico
facility: Fundacion Huntington Puerto Rico, Inc. - Huntington's disease Clinic
Study officials:
References:
Clinical trial NCT00624026: Memantine - Communication Study
Official title: Prospective, Single-arm, Multicenter, Open-label Study to Investigate the Efficacy and Tolerability of the Once Daily (OD) Memantine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 107
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study objective is to evaluate the effects of memantine treatment on communication abilities and other cognitive abilities in moderate to severe DAT patients.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatient at least 50 years of age and at least 8 years of education.
* The patient should have German as a mother-tongue or at least speak the language fluently in order to achieve similar scores in verbal tasks.
* Current diagnosis of probable Alzheimer's disease consistent with NINCDS- ADRDA criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.
* Mini Mental State Examination (MMSE) total score is less than 20
* Patients treated with any acetylcholinesterase inhibitor (AChEI) may be included, when treatment has started at least 6 months prior screening and was stable during the last 3 months.

Exclusion Criteria:

* Any type of evident aphasia, which may interfere with patient's communication difficulties caused by Alzheimer's disease
* History of severe drug allergy, or hypersensitivity, or patients with known hypersensitivity to amantadine, lactose.
* Evidence (including CT/MRI results) of any clinically significant central nervous system disease other than Alzheimer's disease.
* Modified Hachinski Ischemia score greater than 4 at screening.
* Current evidence of clinically significant systemic disease
* Known or suspected history of alcoholism or drug abuse within the past 10 years.
* Previous treatment with memantine or participation in an investigational study with memantine.

Primary outcomes:
measure: To assess the efficacy of the memantine OD IR treatment using the Consortium to establish a registry for Alzheimer's Disease (CERAD-NP) total score
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Central Medical Affairs
Study officials:
affiliation: Center of Neurological Medicine, Goettingen, Germany
name: Joerg B. Schulz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schulz JB, Rainer M, Klunemann HH, Kurz A, Wolf S, Sternberg K, Tennigkeit F. Sustained effects of once-daily memantine treatment on cognition and functional communication skills in patients with moderate to severe Alzheimer's disease: results of a 16-week open-label trial. J Alzheimers Dis. 2011;25(3):463-75. doi: 10.3233/JAD-2011-101929.
Clinical trial NCT00915226: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure
Official title: Regulation of Optic Nerve Head Blood Flow During Combined Changes in Intraocular Pressure and Arterial Blood Pressure.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: Optic disk
Regional blood flow
Autoregulation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-06-05
Enrollment: 0
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in perfusion pressure. The existence of an effective autoregulation in the optic nerve head (ONH) circulation has been shown in animals and humans. Moderate elevation of intraocular pressure (IOP) caused only slight effect on ONH blood flow in monkeys, cats and rabbits. In humans, during an artificial IOP rise using a suction cup method the ONH blood flow maintains almost constant until IOP reaches 40-55 mmHg. During isometric exercise the upper limit of autoregulation appears to be approximately 40% above the baseline ocular perfusion pressure. The mechanism behind ONH blood flow autoregulation is still unknown. The present experiments are designed to improve the investigators' knowledge of the physiology of regulatory mechanisms in ONH circulation, which may be helpful for a better understanding of blood flow abnormalities in glaucoma. This is of importance, because there is an increased evidence, that vascular dysregulation plays a role in the development of glaucomatous damage.


Eligibility criteria: Inclusion Criteria:

* Men aged between 19 and 35 years, nonsmokers
* Body mass index between 15th and 85th percentile (Must et al. 1991)
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 1 Dpt

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Presence of intraocular pathology: ocular hypertension, glaucoma, retinal vasculopathy or other retinal diseases

Primary outcomes:
measure: Ocular perfusion pressure - ONH blood flow relationship
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Elzbieta Polska, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02900326: Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer
Official title: Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Exercise capacity
Mindfulness
Quality of life
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.


Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Having completed the chemotherapy period
* Undergoing radiotherapy and/or hormono therapy

Exclusion Criteria:

* Regular physical activity higher than 4 hours per week.
* Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )

Primary outcomes:
measure: Evolution of V02 max between inclusion and 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: LONSDORFER Evelyne
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242526: Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Official title: Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hiatal Hernia
Keywords: hiatal hernia, recurrence, biologic mesh, synthetic mesh
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Detailed description: Patients will be randomized to either a synthetic (light weight synthetic or biologic (small intestinal submucosa ) mesh group. Endpoints will be measured up to 5 years for the study as a whole, at 6 months and at 60 months. Prior to and following laparoscopic paraesophageal hernia repair, patients will be followed with both subjective and objective measures. Subjective evaluation will include symptomatic/quality of life assessment at 1-, 6-, 24-, and 60- month periods; objective evaluation will include Upper GI study /pH probe study for symptomatic patients and for all patients at 6 and 60 months. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Eligibility criteria: Inclusion Criteria:

* Male or female gender
* Age\>18 years
* Absence of chronic medical conditions that will affect the quality of life survey, such as fibromyalgia, SLE, Crohn's disease, etc.
* Able to give informed consent
* Able and willing to participate in follow-up evaluations
* Upper GI with a documented hiatal hernia greater than 5cm
* Paraesophageal hernia with clinically relevant symptoms such as heartburn, chest pain, regurgitation, dysphagia, postprandial abdominal pain, shortness of breath, or early satiety.

Exclusion Criteria:

* Previous surgery of the esophagus and/or the stomach
* Emergent operation for acute gastric volvulus or strangulation
* Biopsy consistent with malignancy
* Body Mass Index (BMI) over 35kg/m2
* Inability to perform primary closure of crura
* Active smoking

Primary outcomes:
measure: Assess for reappearance of hiatal hernia and reflux
timeFrame: 6 months, 60 months
Secondary outcomes:
measure: Quality of Life questionnaire
timeFrame: Quality of Life will be assessed at these time periods after the hernia repair 1, 6, 24, and 60 months
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
Study officials:
References:
Clinical trial NCT03568526: Sensorimotor Rehabilitation Program in Improving Quality of Life in Patients With Early Stage Breast Cancer
Official title: The Effects of a Sensorimotor Rehabilitation Program on the Upper and Lower Limbs of Persons With Cancer Following Taxane-Based Chemotherapy for Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Stage I Breast Cancer AJCC v7
Stage IA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage II Breast Cancer AJCC v6 and v7
Stage IIA Breast Cancer AJCC v6 and v7
Stage IIB Breast Cancer AJCC v6 and v7
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies how well the sensorimotor rehabilitation program works in improving quality of life in patients with early stage breast cancer. A hand and foot sensory improvement program from occupational and physical therapists may improve patients' function in everyday tasks and overall quality of life.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate the effects of an innovative, new sensorimotor rehabilitation program on persons with cancer following taxane-based chemotherapy for early stage breast cancer.

OUTLINE:

Patients attend 1 therapy session to receive education and training in the use of the home program. Patients then complete exercises over 90 minutes per week for 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Persons with a primary diagnosis of grade 1 or greater peripheral neuropathy of the upper and lower extremities
* Taxane-based chemotherapy for early stage breast cancer
* Diagnosis of early stage breast cancer

Exclusion Criteria:

* Individuals with late stage breast cancer

Primary outcomes:
measure: Identify differences in patients scores using post-test scores on the McGill Pain Questionnaire
timeFrame: Up to 2 years
measure: Evaluate patients using post-test scores on the CIPN-20
timeFrame: Up to 2 years
measure: Assess the differences in patients post-test scores on the Disability of Arm Hand and Shoulder scores
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Amy Darragh, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739557: A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.
Official title: A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome
Keywords: elective TAAA repair
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients entering the hospital for elective TAAA repair

Brief summary: The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.

Detailed description: Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment.

Eligibility criteria: Inclusion Criteria:

* Elective TAAA repair

Exclusion Criteria:

Primary outcomes:
measure: to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10.
timeFrame: 30 days
Secondary outcomes:
measure: To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Univ. of Texas Health Science Center at Houston
name: Kenneth S Helmer, MD
role: PRINCIPAL_INVESTIGATOR
References: