louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00907569: Hypofractionated Radiotherapy for Limited Stage Small Cell Lung Cancer
Official title: A Clinical Trial of Increased Chest Radiotherapy Dose for Limited Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasm
Small Cell Carcinoma
Keywords: Small cell lung cancer
radiotherapy dose escalation
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2009-05-22
Enrollment: 2
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: It is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. In this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. The investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

Detailed description: The ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. Strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for LS-SCLC. Hypofractionation (giving higher than standard daily doses) facilitates both of these goals. In this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with LS-SCLC.

Eligibility criteria: Inclusion Criteria:

* limited stage small cell lung cancer
* adequate pulmonary function test (FEV1 \>1.0 L, DLCO \>50%)
* signed study consent
* age at least 18 years
* Karnofsky performance status as least 70%
* eligible to receive standard concurrent small cell cancer chemotherapy

Exclusion Criteria:

* extensive stage disease
* mixed non small cell and small cell histology
* inadequate pulmonary function tests
* not eligible for concurrent chemotherapy
* subtotal or total tumor resection
* previous chest/neck radiotherapy
* prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years
* pregnant
* prior chemotherapy for another malignancy
* patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Primary outcomes:
measure: 2-year overall survival
timeFrame: 2011
Secondary outcomes:
measure: Quality of life
timeFrame: 2011
measure: Patterns of Failure
timeFrame: 2011
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References:
Clinical trial NCT05679869: Effects of Natural Sounds on Attention Restoration in Virtual Reality
Official title: Effects of Natural Sounds on Attention Restoration in Virtual Reality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Fatigue
Mental Fatigue
Behavioral Performance
Heart Rate Variability
Working Memory
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
Collaborators: name: National Research Foundation, Singapore
name: Ministry of National Development, Singapore
name: Housing and Development Board, Singapore
First posted: 2023-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.

Detailed description: The investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. This generates the prediction that exposure to natural sounds in the context of a noisy environment will have greater restorative effects on attention (i.e., physiological) as compared to the control group (exposed to noise only). Individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility criteria: Inclusion Criteria:

* Singapore-based
* Non-clinical
* 18-35years

Exclusion Criteria:

* Individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing
* Individuals with a history of ear, developmental, neurological, or psychiatric disorder

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: 1 day (during fatiguing task and sound intervention)
measure: Change in Fatigue State Questionnaire
timeFrame: baseline, up to 2 mins after fatiguing task and up to 2 mins after sound intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Cultural Science Innovations, Nanyang Technological University
Study officials:
References:
Clinical trial NCT04329169: Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration
Official title: Digital Assessment of a Full Digital Implant-Prosthetic Workflow for a Prefabricated Single Implant-Supported Restoration (A Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-04-01
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the present study was to evaluate the accuracy of a prefabricated digitally planned provisional restoration on a single- implant placed with a fully guided surgical protocol.

Detailed description: Fifteen dental implants were placed in partially edentulous patients with single bounded lower posterior edentulous area selected from those admitted to the Prosthodontics Department, Faculty of Dentistry, Alexandria University. A full digital implant-prosthetic protocol was followed and a quantitative evaluation of the accuracy of the protocol was performed using computer software and superimposition of the planned and post-operative images was done.

Eligibility criteria: Inclusion Criteria:

* Patients missing lower first molar unilaterally or bilaterally.
* Presence of full or nearly full complement of opposing natural teeth.

Exclusion Criteria:

* If teeth adjacent to the planned implant site showed infections, endodontic or periodontal problems.
* Patients with a debilitating systemic disease, bone diseases, radiotherapy or chemotherapy.

Primary outcomes:
measure: 3D- Deviation of the implant
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Muhammed Badee, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mariam Bahgat, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Haitham Ismail, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Yassmin Tahamawy, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Naema Ammar, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04275869: Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women
Official title: Efficacy of an Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Infertility, Female
Keywords: infertility
obesity
physical activity
nutrition
internet
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de la Plana
First posted: 2020-02-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity and overweight are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.

Aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment

Detailed description: Weight management problems (being obese or overweight) are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.

Aim: to evaluate the effectiveness of a 3-month internet-based program focusing on the promotion of healthy lifestyles (especially weight loss and healthy eating and physical exercise habits) in women who also have a diagnosis of infertility and are on the waiting list for IVF treatment.

Design: randomised controlled trial Setting: Hospital La Plana (Villarreal)

Eligibility criteria: Inclusion Criteria:

* women of childbearing age
* overweight (BMI \> 25 kg/m2) or obese (BMI \> 30 kg/m2)
* diagnosed with primary infertility -access to the internet-

Exclusion Criteria:

* over 40 years
* morbid or extreme obesity (BMI \> 40 kg/m2)
* bilateral obstruction of the fallopian tubes
* endometriosis
* women whose partner has a severe male factor (oligoasthenoteratozoospermia).

Primary outcomes:
measure: Spontaneous clinical pregnancy rate
timeFrame: 12 months
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: 12 months
measure: Abdominal perimeter
timeFrame: 12 months
measure: Mediterranean Diet Adherence
timeFrame: 12 months
measure: Physical activity level
timeFrame: 12 months
Other outcomes:
Locations:
city: Castellón De La Plana
country: Spain
facility: Hospital La Plana de Villarreal
state: Castellón
Study officials:
affiliation: Cardenal Herrera University
name: JUAN FRANCISCO L PÁRRAGA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00794469: Water Induced Thermogenesis in Obese Children
Official title: Water Induced Thermogenesis in Obese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Resting metabolic rate
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Eden Springs
First posted: 2008-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese children participating in a lifestyle education and weight management program.

Brief summary: Drinking water is largely advocated for obesity prevention and management. Recent studies have suggested that water has a thermogenic effect, this has not been examined in children. In this study, we will measure the resting metabolic rate of 21 obese children before, and during drinking cold (4 degrees centigrade)water for up to 60 minutes.


Eligibility criteria: Inclusion Criteria:

* obesity
* agreement and informed consent

Exclusion Criteria:

* non-agreement

Primary outcomes:
measure: Post-drinking Metabolic Rate
timeFrame: 1 hour
measure: Baseline Metabolic Rate
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Optimal Sport Medicine Center
Study officials:
References:
citation: Boschmann M, Steiniger J, Hille U, Tank J, Adams F, Sharma AM, Klaus S, Luft FC, Jordan J. Water-induced thermogenesis. J Clin Endocrinol Metab. 2003 Dec;88(12):6015-9. doi: 10.1210/jc.2003-030780.
Clinical trial NCT00643669: 24 Hour IOP Lowering Efficacy of AL-3789
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 25
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: The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant, intend to become pregnant, breastfeeding.
* Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
* Any form of glaucoma other than open-angle glaucoma.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Intraocular Pressure (IOP)
timeFrame: Day 28, Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Inglewood
state: California
Study officials:
References:
Clinical trial NCT03581669: Acetabular Cerclage and Total Hip Arthroplasty in the Treatment of Acetabular Fractures in Elderly Patients.
Official title: Acetabular Cerclage and Total Hip Arthroplasty in the Treatment of Acetabular Fractures in Elderly Patients.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Elderly
Acetabular Fractures
Cerclage Acetabular Fractures
Total Hip Arthroplasty
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients who sustained an acetabular fracture

Brief summary: We want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* elderly (\>60Years)
* acetabular fracture

Exclusion Criteria:

* Revision surgery

Primary outcomes:
measure: harris hip score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: LEuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Vanderschot Paul, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Molenaers Guy, MD, Phd
role: STUDY_CHAIR
References:
citation: Mouhsine E, Garofalo R, Borens O, Blanc CH, Wettstein M, Leyvraz PF. Cable fixation and early total hip arthroplasty in the treatment of acetabular fractures in elderly patients. J Arthroplasty. 2004 Apr;19(3):344-8. doi: 10.1016/j.arth.2003.08.020.
Clinical trial NCT02333669: Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
Official title: Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Distress Syndrome
Keywords: Lung fluid absorption disorders
Neonatal respiratory distress syndrome
Single nucleotide polymorphism
SCNN1A
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 249
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newborns with RDS are consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility. The control blood samples, which are collected from healthy neonatal umbilical cord blood, are obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas.

Brief summary: Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing evidence has demonstrated that these lung disorders might be an important cause of neonatal respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function, particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of SCNN1A are associated with NRDS, we conducted a case-control study to investigate the NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).


Eligibility criteria: Inclusion Criteria:

* Newborns with RDS

Exclusion Criteria:

* The infants were excluded if they had any congenital malformation, inherited metabolic abnormalities, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia

Primary outcomes:
measure: Genotype distributions of target SNPs in RDS group and Control group
timeFrame: within 28 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of pediatrics, Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Yuan Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04669769: Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis
Official title: Retrospective Analysis of Outcomes After Surgery for Deep Infiltrating Endometriosis of the Bowel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Deep Endometriosis
Bowel Endometriosis
Reproductive Issues
Complication
Keywords: endometriosis
deep endometriosis
bowel endometriosis
conception
ART
spontaneous conception
pregnancy rate
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated because of deep Infiltrating bowel endometriosis at the endometriosis Center, University Hospital Muenster, Germany starting 2009

Brief summary: identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART


Eligibility criteria: Inclusion Criteria:

* deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate

Exclusion Criteria:

* declines participation

Primary outcomes:
measure: complications
timeFrame: up to 10 years
Secondary outcomes:
measure: pregnancy rate
timeFrame: up to 10 years
measure: live birth
timeFrame: up to 10 years
measure: pain recurrence
timeFrame: up to 10 years
measure: disease recurrence
timeFrame: up to 10 years
measure: recurrent surgery
timeFrame: up to 10 years
measure: pregnancy rate with ongoing bowel endometriosis
timeFrame: up to 10 years
measure: live birth with ongoing bowel endometriosis
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Münster
country: Germany
facility: University Hospital Muenster
state: NRW
Study officials:
affiliation: University Hospital Muenster, Germany
name: Sebastian D Schaefer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02132169: A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Disease (Including Allergic Conjunctivitis)
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 512
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).


Eligibility criteria: Inclusion Criteria:

* at least 2 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study

Primary outcomes:
measure: Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
measure: Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
measure: Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)
timeFrame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Secondary outcomes:
measure: Safety of AC 170 0.024% Compared to Its Vehicle
timeFrame: Up to 12 Weeks
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora, Inc.
state: Massachusetts
Study officials:
affiliation: Philadelphia Eye Associates
name: Stacey L Ackerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Andover Eye Associates
name: Dawn K De Castro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apex Eye
name: Edward J Meier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seidenberg Protzko Eye Associates
name: Eugene E Protzko, MD
role: PRINCIPAL_INVESTIGATOR
References: