louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00283478: Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
Official title: Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced stage
Lung cancer
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
First posted: 2006-01-30
Enrollment: 20
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: To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer.

Detailed description: RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine alone as second line treatment for advanced non-small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

* newly diagnosed IIIB and IV NSCLC who have failed one prior line of chemo
* Karnofsky score 60% or greater
* patients who will be treated with Gemcitabine

Primary outcomes:
measure: To determine if Iscar improves immune function and quality of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Kentuckiana Cancer Institute
name: Renato V. LaRocca, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04778878: Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
Official title: Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: CIPN, NCS
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving neurotoxic chemotherapy (oxaliplatin, vincristine, or docetaxel) as cancer treatment.

Brief summary: The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen \[FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin\]
3. Age \>18y
4. ECOG 0-2
5. Patient compliant with the study procedures

Exclusion Criteria:

1. Patient not fit/suitable for aforementioned chemotherapy regimen at baseline
2. Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves
3. General vulnerability affecting the participation in the trial

Primary outcomes:
measure: Nerve conductivity
timeFrame: 6 weeks
measure: Nerve conductivity
timeFrame: 12 weeks
measure: Nerve conductivity
timeFrame: 18 weeks
measure: Nerve conductivity
timeFrame: 24 weeks
measure: Neuropathy related pain
timeFrame: 6 weeks
measure: Neuropathy related pain
timeFrame: 12 weeks
measure: Neuropathy related pain
timeFrame: 18 weeks
measure: Neuropathy related pain
timeFrame: 24 weeks
measure: Chemotherapy induced peripheral neuropathy (CIPN)
timeFrame: 6 weeks
measure: Chemotherapy induced peripheral neuropathy (CIPN)
timeFrame: 12 weeks
measure: Chemotherapy induced peripheral neuropathy (CIPN)
timeFrame: 18 weeks
measure: Chemotherapy induced peripheral neuropathy (CIPN)
timeFrame: 24 weeks
measure: Frequency of CIPN by CTCAE
timeFrame: 6 weeks
measure: Frequency of CIPN by CTCAE
timeFrame: 12 weeks
measure: Frequency of CIPN by CTCAE
timeFrame: 18 weeks
measure: Frequency of CIPN by CTCAE
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
References:
Clinical trial NCT03214978: Targeted-sequencing of PTC in Different Stages
Official title: Targeted-sequencing of PTC in Different Stages
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exploratory Study
Keywords: thyroid
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DNA will be extracted from of 40 pairs tumor samples including 40 patients in 4 groups (stage I, II, III and IV)

Brief summary: The prevalence of papillary thyroid micro-carcinoma (PTMC) increased rapidly in recent years but the design of treatment is controversial because a majority of them are indolent. Therefore, to recognize which PTMC is of strong progressive potential which should be operated is very crucial. Fine needle aspiration (FNA) pre-surgery could obtain tumor cells which could be used in genetic analysis. To date, there is no specific way to evaluate the aggressive potential of a PTMC pre-surgery. So, the purpose of this proposal is to screen genetic mutations of the aggressive type of PTMC. The candidate did a whole exome sequencing on 3-3 pairs of PTCs and found some SNPs and Indels in TP53、TTN、PDF. To further investigate those mutations, a target region sequencing will be done in 40 pairs tumor samples. And ultimately to find out which genetic event could contribute to strong aggressive potential of PTC. The mutations details would be design to test the FNA and tissue sample to validate if the genetic testing based on FNA is reliable. The gene test results would be evaluated with sonographic features to predict the potential of small thyroid carcinoma before surgery. This project won't aim to study the function and mechanism of specific genes but just screen them out. So, the fund would cover the fee of the whole study and this study is very likely to achieve the goal.


Eligibility criteria: Inclusion Criteria:

* patients who will receive thyroid resection

Exclusion Criteria:

* patients who has been radiologically treated

Primary outcomes:
measure: types of mutation of targets genes in papillary thyroid carcinomas in different stages
timeFrame: 2018-1-1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01747278: Study of Trimethoprim/Sulfamethoxazole as PCP Prophylaxis in CTD Patients
Official title: The Safety and Effectiveness of Trimethoprim/Sulfamethoxazole as Pneumocystis Carinii Pneumonia (PCP) Prophylaxis in Patients With Connective Tissue Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pneumonia, Pneumocystis
Prevention & Control
Keywords: Pneumocystis carinii pneumonia
prophylaxis
trimethoprim/sulfamethoxazole
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation the efficacy and safety profile of trimethoprim/sulfamethoxazole as Pneumocystis carinii pneumonia (PCP) prophylaxis in Patients With Connective Tissue Diseases (CTD) treated with high-dose glucocorticoids and immunosuppressive agents.

Open-labeled, randomized, prospective single-center clinical trial. Observation period of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years with informed consent
* SLE, Sjögren syndrome, Polymyositis or Dermatomyositis, defined by consensus classification criteria
* concomitant high dose glucocorticoid, defined as \>1mg/kg/d prednisone or equivalent
* concomitant cyclophosphamide, cyclosporine or mycophenolate mofetil

Exclusion Criteria:

* Pregnant or lactating
* WBC\< 4×10\^9/L，PLT\<100×10\^9/L
* Serum ALT or AST \> 2 times upper limit of normal
* Serum creatinine \> 1.5 mg/dL
* Severe hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
* Active infection, including HIV, HCV, HBV, tuberculosis or PCP
* concomitant antibiotics other than trimethoprim/sulfamethoxazole
* Patient with malignancy
* Drug allergy, especially trimethoprim/sulfamethoxazole

Primary outcomes:
measure: Documented PCP infection
timeFrame: 12 weeks.
Secondary outcomes:
measure: PCP-related mortality
timeFrame: 12 weeks
measure: All cause mortality
timeFrame: 12 weeks
measure: Other infections
timeFrame: 12 weeks
measure: PCP-related hospitalization
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deptment of Rheumatology, Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fengchun Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06464978: Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
Official title: The Impact of Stapler Reinforcement Patches Compared to Standard Staplers on Postoperative Complications in Gastrojejunostomy: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Gastrostomy
Anastomotic Leakage
Postoperative Complications
Keywords: Stapler Reinforcement Patch
Gastrojejunostomy
Randomized Controlled Trial
Surgical Outcomes
Complication Prevention
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Guang'an Central Hospital
name: Pengan County People's Hospital
name: Yilong County people's Hospital
name: Nanbu Hospital of County Chinese Medicine
name: Langzhong People's Hospital
First posted: 2024-06-18
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the experimental group receiving the stapler reinforcement patches or the control group undergoing standard procedures without reinforcement patches.
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, randomized controlled study aimed at compareing the impact of stapler reinforcement patches versus standard staplers on postoperative complications in gastrojejunostomy.

Detailed description: This study compares stapler reinforcement patches with standard staplers in gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the effectiveness and safety of these patches in preventing anastomotic leakage and other related complications.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 85 years.
* Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or subtotal gastrectomy.
* ECOG performance status of 0 or 1.
* ASA (American Society of Anesthesiologists) classification of I-III.
* Voluntary signed informed consent from the participant or their legal representative.

Exclusion Criteria:

* Evidence of potential distant metastasis found preoperatively.
* History of other malignancies diagnosed within the past 5 years, or any malignancy treated with chemotherapy or radiotherapy.
* Significant contraindications for surgery (e.g., severe liver or kidney dysfunction).
* Participation in any other clinical trial within the last 6 months.
* Participants or their legal representatives unwilling to sign the informed consent or comply with the study protocol.

Primary outcomes:
measure: Rate of Anastomotic Leakage
timeFrame: 30 days post-surgery
Secondary outcomes:
measure: Rate of Anastomotic Stricture
timeFrame: 3 months post-surgery
measure: Postoperative Bleeding Rate
timeFrame: 30 days post-surgery
measure: Mortality Rate
timeFrame: 30 days post-surgery
measure: Readmission Rate
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Yunhong Tian
state: Sichuan
Study officials:
References:
Clinical trial NCT05431478: Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Official title: Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

Detailed description: In this crossover study, subjects will wear each study lens type for approximately 14 days and attend 7 scheduled visits. The expected duration of subject participation in the study is approximately 28 days (approximately 14 days per each study lens type).

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Best Corrected Visual Acuity of 20/25 Snellen (0.10 logMAR) or better in each eye.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
* Habitual wear of AOHP contact lenses.
* Habitual wear of any daily disposable contact lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Visual Acuity With Study Lenses at Week 1 Follow-Up
timeFrame: Week 1, each wear period. A wear period was approximately 14 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Drs. Giedd, PA
state: Florida
city: Medina
country: United States
facility: Wesley Optometric Consulting
state: Minnesota
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Warwick
country: United States
facility: West Bay Eye Associates
state: Rhode Island
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CDMA Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04754178: Assessment of Skills and Behaviors in Children With Down Syndrome
Official title: Assessment of Skills and Behaviors in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Down Syndrome

Brief summary: Parents of children with Down Syndrome can help in describing children's abilities and behavior. Most of the studies evaluating parents of children with Down Syndrome and other intellectual disabilities have focused on parental stress and coping; Additionally, most research has evaluated the perspectives of mothers rather than fathers. For this reason, in this study we aims to evaluate skills and behaviors in children with Down syndrome through the perception of parents.


Eligibility criteria: Inclusion Criteria:

* Down syndrome childrens
* Age between 0 and 3 years

Exclusion Criteria:

* Other physical or functional impairment that limits the performance of evaluation

Primary outcomes:
measure: Early Motor Questionnaire
timeFrame: Baseline
measure: Montreal's children's Hospital Feeding Scale
timeFrame: Baseline
measure: Feeding Hándicap Índex Children
timeFrame: Baseline
measure: Parent Perceptions of Physical Activity Scale
timeFrame: Baseline
measure: Bayley Scales of Infant and Toddler Development
timeFrame: Baseline
measure: Early Clinical Assessment of Balance
timeFrame: Baseline
measure: Infant Positioning Assessment Tool
timeFrame: Baseline
measure: Asymmetry
timeFrame: Baseline
measure: COMFORT behaviour scale
timeFrame: Baseline
measure: Segmental Assessment of Trunk Control
timeFrame: Baseline
Secondary outcomes:
measure: EuroQol-5D
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Zarit Burden Interview
timeFrame: Baseline
measure: International physical activity questionnaire
timeFrame: Baseline
measure: Charlson comorbidity index
timeFrame: Baseline
measure: Brief Infant Sleep Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Healthy Sciences
Study officials:
References:
Clinical trial NCT04890678: The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
Official title: The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Pressure Sore
Pressure Ulcer, Buttock
Keywords: support surface
Elderly
Nursing home
prevention
treatment
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Care of Sweden AB
First posted: 2021-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.


Eligibility criteria: Inclusion Criteria:

* At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
* Bedbound or chair bound
* Aged ≥ 65

Exclusion Criteria:

* Short-stay residents (expected length of stay ≤14 days)
* End of life care
* Medical contraindication for patient repositioning/turning

Primary outcomes:
measure: Pressure ulcer incidence
timeFrame: 30 days
measure: Pressure ulcer healing
timeFrame: 30 days
Secondary outcomes:
measure: Comfort
timeFrame: 30 days
Other outcomes:
Locations:
city: Asse
country: Belgium
facility: WZC Hof ter Waarbeek
state: Vlaams-Brabant
Study officials:
affiliation: Study Principal Investigator
name: Dimitri Beeckman, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. doi: 10.1186/s13063-016-1703-8.
Clinical trial NCT00978978: Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
Official title: Propofol Versus Midazolam and Fentanyl for Diagnostic and Screening Colonoscopy in Patients With Advanced Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Prospective, randomized-controlled trial (RCT) comparing the use of Propofol and traditional sedation (Midazolam and Fentanyl) for diagnostic and screening endoscopies in patients with liver diseases. The investigators' working hypothesis is that the use of propofol will be translated in a shorter recovery and discharge times with a higher patient satisfaction and a decrease in general complications in the context of patients with advanced liver disease.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients older than 18 and younger than 75 years with advanced liver disease, defined by the presence of liver fibrosis at least F3 and higher in the METAVIR score or with established cirrhosis (Child Pugh A, B and C)

Exclusion Criteria:

* Patients with significant cardiorespiratory disease i.e. advanced respiratory, renal and heart failure (ASA class III or higher except for patients with decompensate liver cirrhosis), obstructive sleep apnea or those with mild degree of liver fibrosis (less than F3)

Primary outcomes:
measure: Safety and efficacy of propofol in liver diseases
timeFrame: At the end of each endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Department of Gastroenterology. Soroka University Medical Center
Study officials:
References: