louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01141686: Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers
Official title: Non Small Cell Lung Cancer Evaluation According to Pre-determined Drug-targeting Tumor Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 90
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: lung cancer patient in wanfang hospital

Brief summary: Evaluate chemotherapy related tumor markers on non small cell lung cancer by fluorescent in situ hybridization and immunohistochemistry, targets to be studied include EGFR, c-MET, topoisomerase II, p53, topoisomerase I, thymidylate synthase, ERCC1, tau, c-myc, RRM1, class III tubulin. These targets have been chosen because they are targets for chemotherapeutic agents that are currently used in clinical management of these diseases. In total 50 specimen will be studied, approximately one third have mutations/deletions of the EGFR gene.To attempt to establish a correlation between the pre-selected tumor markers and response to chemotherapy, and thus to be able to create a clinically useful classification that would provide clinical guidance for selection of the most effective chemotherapy for a individual patient, and thus be able to logically design more effective clinical trials for the future.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed lung cancer who received standard platinum-containing doublet chemotherapy followed by EGFR tyrosine kinase inhibitors.

Exclusion Criteria:

* non

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hsin-Gjin Eugene Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238886: Radical Cystectomy, Nutrition and Convalescence
Official title: RADICAL CYSTECTOMY, NUTRITION AND CONVALESCENCE: CAN GOAL-DIRECTED POSTOPERATIVE NUTRITIONAL THERAPY REDUCE THE CONVALESCENCE PERIOD FOR PATIENTS UNDERGOING RADICAL CYSTECTOMY (RC)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Bladder Neoplasms
Cystectomy
Bladder Cancer
Keywords: Quality of Life
Enteral nutrition
Nutrition Therapy
Parenteral nutrition, total
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a goal directed nutritional intervention can reduce the convalescence period for patients undergoing radical cystectomy (RC).

The aim is to examine the effect on quality of life of a standard nutritional strategy of resting the bowel till clear signs of bowel recovery and feeding orally after bowel recovery versus a goal-directed nutritional intervention combining oral intake and parenteral nutrition, in patients undergoing RC.

Detailed description: The study is a randomized controlled trial. Inclusion criteria: Bladder cancer, ability to give an informed consent. Exclusion criteria: Previous radiation therapy at the pelvic area, ureterocutaneostomy or robot-assisted surgery. The intervention aims to secure that 75% of the patient's total energy and protein needs are met during hospitalization.

Primary outcome: Quality of Life, using the EORTC QLQ-C30 and BLM30 questionnaire. Secondary outcomes: Body-weight, Hand Grip strength, biochemical measures, length of hospital stay, time to bowel recovery. The follow-up period is 12 weeks. Statistical analysis is performed in collaboration with a statistician.

Eligibility criteria: Inclusion Criteria:

* Bladder cancer
* Ability to give an informed consent

Exclusion Criteria:

* Previous radiation therapy at the pelvic area
* Ureterocutaneostomy
* Robot-assisted surgery

Primary outcomes:
measure: Health related quality of life (HRQoL) using the EORTC QLQ-C30 and BLM30 (one combined questionnaire)
timeFrame: meassured pre-operatively + 6 and 12 weeks following surgery
Secondary outcomes:
measure: Body weight
timeFrame: preoperatively, 6 and 12 weeks postop
measure: hand grip strength
timeFrame: pre-operatively, 6 days and 6 weeks postop
measure: length of hospital stay
timeFrame: 12 week follow-up
measure: Time to bowel recovery
timeFrame: 12 week follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of Urology. University Hospital Rigshospitalet, Copenhagen Denmark
Study officials:
References:
Clinical trial NCT05803486: Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
Official title: Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correlation Between Quadratus Lumborum , Pelvic Floor Muscles and Diaphragm in Patients With Urinary Incontinence
Lead sponsor: Deraya University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs

Brief summary: The purpose of this study is to investigate Correlation between quadratus lumborum , pelvic floor muscles and diaphragm in patients with urinary incontinence

Detailed description: 50 patients were distributed randomly into two groups. The first group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female The second group measured ultrasound imaging for quadratus lumborum , pelvic floor muscles and diaphragm urinary incontinence female normal females.

Patients examined with medical ultrasound imaging .

Eligibility criteria: Inclusion Criteria:

* - Their ages varied from 30to 40years, their body mass index (BMI) was 25-30 kg/m2 and a number of parities ≤ three normal vaginal deliveries, at least two years and Subjects hadn't received drugs , urinary incontinence mild or modrate

Exclusion Criteria:

- 1. History of spinal surgery or spinal fracture. 2. Volunteers with a history of a recto-vaginal or vesico-vaginal fistula, undiagnosed uterine bleeding urinary tract infection, diabetes, intrauterine device, chest and/or cardiac disease and using any drugs for urinary incontinence 3. Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer.

4. A history of bronchial asthma or any chest disease. 5. Uncontrolled diabetes or hypertension. 6. Patients with peacemaker or any metal implant on the treated area. 7. Cancer or patient with past history of tumor excision.

Primary outcomes:
measure: Force of contraction of pelvic floor muscles
timeFrame: 2 months
Secondary outcomes:
measure: diaphragm excursion
timeFrame: 2 months
Other outcomes:
measure: quadratus lumborum thickness
timeFrame: 2 months
Locations:
city: Minya
country: Egypt
facility: Deraya university
Study officials:
affiliation: Deraya University
name: doaa A.Nasser abdelhady
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269786: Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment
Official title: Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with liver cirrhosis and portal hyprtension with esophagel varisces

Brief summary: laboratory and ultrasongraphicc changes after endoscopical varices treatment


Eligibility criteria: Inclusion Criteria:

* patients with liver cirrhosis and portal hyprtension with esophagel varisces

Exclusion Criteria:

* 1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant

Primary outcomes:
measure: Changes in liver function tests
timeFrame: 6 months
measure: Ultrasonographic changes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01262586: Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
Official title: Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type II Diabetes Mellitus
Keywords: Type II Diabetes Mellitus
Vildagliptin
Glimepiride
Continuous glucose monitoring
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients on stable metformin
* 18-70 years old
* Willing to perform at least 4 capillary blood glucose tests per day

Exclusion Criteria:

* Type 2 diabetes patients on any other antidiabetic treatment
* Patients listed in other trials
* Patients with significant diabetic organ disease or complications.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Glycemic profiles between vildagliptin and glimepiride
timeFrame: Baseline and treatment Day 5, 24hr continuous glucose measurements
Secondary outcomes:
measure: Glucose Fluctuation before and during treatment
timeFrame: Baseline and treatment Day 5, 24hr continuous measurements
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: He YL, Foteinos G, Neelakantham S, Mattapalli D, Kulmatycki K, Forst T, Taylor A. Differential effects of vildagliptin and glimepiride on glucose fluctuations in patients with type 2 diabetes mellitus assessed using continuous glucose monitoring. Diabetes Obes Metab. 2013 Dec;15(12):1111-9. doi: 10.1111/dom.12146. Epub 2013 Jul 14.
Clinical trial NCT04264663: Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin
Official title: Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Allergic
Penicillin
Rescue Therapy
Tetracycline
Furazolidone
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Detailed description: Helicobacter pylori(H.pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and tinidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 12months
Secondary outcomes:
measure: The rate of improving dyspepsia symptoms after Helicobacter pylori eradication
timeFrame: 12months
measure: The rate of adverse events happening
timeFrame: 12months
measure: The rate of good compliance
timeFrame: 12months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771663: Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement
Official title: Variability of SpO2 Measurements Depending on the Choice of Finger for Sensor Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Hypercapnia
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional single blinded randomized crossover prospective study
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia.

Detailed description: The aim of the project is to experimentally determine the effect of the choice of finger for the placement of a pulse oximeter sensor on the results of measuring peripheral blood oxygen saturation (SpO2) in a healthy person with short-term hypoxia and hypercapnia. This is an intervention prospective study that will take place at the Faculty of Biomedical Engineering, especially on FBMI students. The experiment consists of two phases, in which in the first phase, the volunteers will inhale the hypoxic mixture for five minutes after the stabilization phase. In the second phase, volunteers inhale a hypoxic and hypercapnic mixture. During the experiment, non-invasive SpO2 measurements will be performed continuously on individual fingers of both volunteer hands.

Eligibility criteria: Inclusion Criteria:

* Passing the initial examination, which will determine the following data: finger circumference, heart rate, blood pressure and blood oxygen saturation

Exclusion Criteria:

* post-traumatic conditions of the upper limbs affecting the perfusion of the fingers or injuries or skin diseases on the fingers.
* pneumothorax or a condition after cardiovascular surgery.
* anemia, bradycardia, hemoglobinopathy or other diseases of the cardiovascular system, pregnancy, diabetes, hypotension or hypertension.

Primary outcomes:
measure: Does it depend on which finger is the sensor placed for SpO2 values?
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University in Prague, FBMI
name: Karel Roubík
role: STUDY_DIRECTOR
References:
citation: Rafl J, Kulhanek F, Kudrna P, Ort V, Roubik K. Response time of indirectly accessed gas exchange depends on measurement method. Biomed Tech (Berl). 2018 Nov 27;63(6):647-655. doi: 10.1515/bmt-2017-0070.
Clinical trial NCT03344263: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
Official title: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vigilance Dysfunction
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20-70 years
* Memory disorders without memory problems in episodic memory
* Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure

  * Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10)
  * Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h)

Exclusion Criteria:

* Age \<20 years or ≥ 70 years
* Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
* Dysthyroidism
* Severe depression, schizophrenia, bipolar disorder
* Treatment with an effect on cognition: hypnotics, sedative
* Chronic Obstructive Pulmonary Disease
* Chronic alcoholism, other addictions
* Contraindications to Magnetic Resonance Imaging
* Refusal of equipment

Primary outcomes:
measure: Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP
timeFrame: After 6 months of continuous positive airways pressure in the OSAHS patient
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: service de neurologie CHU DE POITIERS
Study officials:
References:
Clinical trial NCT00239863: Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients
Official title: A Two-year Extension to a One-year, Multicenter, Partially Blinded, Double-dummy, Randomized Study to Evaluate the Efficacy and Safety of FTY720 Combined With Reduced-dose or Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids Versus Mycophenolate Mofetil Combined With Full-dose Cyclosporine, USP [Modified] (Novartis Brand) and Corticosteroids, in de Novo Adult Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Transplantation, kidney,organ transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of FTY720 versus mycophenolate mofetil (MMF, Roche brand) combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.


Eligibility criteria: Inclusion Criteria

* Completion of core study

Exclusion Criteria

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
measure: Permanent resumption of dialysis within 36 months post transplant
measure: Surgical removal of graft within 36 months post transplant
measure: Death within 36 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 36 months post transplant
measure: Serum creatinine, calculated creatinine clearance and urine-protein/creatinine rati at Months 18, 24, 30 and 36 o
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
measure: Absolute lymphocyte count at Month 18, 24, 30 and 36.
Secondary outcomes:
measure: Physical examinations at Months 18, 24, 30 and 36
measure: Vital signs at Months 18, 24, 30 and 36
measure: Electrocardiogram at Months 24 and 36
measure: Chest X-ray Months 24 and 36
measure: Safety laboratory tests 18, 24, 30 and 36
measure: Ophthalmic evaluations 18, 24, 30 and 36
measure: AEs and SAEs
measure: FTY720/CsA levels at Months 18, 24, 30 and 36
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00006163: Computer-assisted Diabetes Self-management Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
self-management
randomized trial
RE-AIM evaluation
participation
maintenance
community resources
dietary change
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-08-09
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This project evaluates the effectiveness of different aspects of a program to assist type 2 diabetes patients with dietary changes. It evaluates the effectiveness of Personalized Self-Management Training and Community Resources support, using a randomized design. This study will also evaluate what percent of patients are willing to participate in such a program, and what percent of primary care physicians are willing to recommend it to their patients.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Diagnosed for at least one year
* Patient of a primary care provider

Exclusion Criteria:

* No telephone
* Not speaking English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: AMC Cancer Research center
state: Colorado
Study officials:
References:
citation: Glasgow RE, La Chance PA, Toobert DJ, Brown J, Hampson SE, Riddle MC. Long-term effects and costs of brief behavioural dietary intervention for patients with diabetes delivered from the medical office. Patient Educ Couns. 1997 Nov;32(3):175-84. doi: 10.1016/s0738-3991(97)00039-6.