louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01197859: Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens
Official title: Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Correction
Lead sponsor: Contamac Ltd
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

Detailed description: The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Eligibility criteria: Inclusion Criteria:

* existing contact lens wearer
* read and signed statement of informed consent
* has clear central cornea
* requires spherical distance correction

Exclusion Criteria:

* has worn RGP contact lenses within the last 30 days
* is using any ocular medication
* has had refractive surgery
* has an infectious disease
* is pregnant or lactating
* is participating in another clinical research study

Primary outcomes:
measure: Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Vision Care Research
state: Surry
Study officials:
affiliation: Vision Care Research
name: Graeme Young
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03197259: Chronic Lymphocytic Leukemia Registry Study - Multicenter Prospective National Study
Official title: Turkish Chronic Lymphocytic Leukemia Study Group Registry - Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Del(17P)
Keywords: CLL, del(17p)
Lead sponsor: Izmir Hematologic Diseases and Cancer Research Help Association
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed as CLL

Brief summary: A prospective, multicenter national observational study for patients diagnosed as chronic lymphocytic leukemia across 25 centers in Turkey

Detailed description: The purpose of this study is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as CLL
* 18 years or older
* Able and willing to provide the written informed consent

Exclusion Criteria:

* Younger than 18 years

Primary outcomes:
measure: First line therapy therapy protocol distrubition
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylum Medical Favulty
Study officials:
affiliation: Dokuz Eylum Medical Faculty
name: Fatih Demirkan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02893059: Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases
Official title: Evaluation of a Data Collection Tool in Clinical Research: Comparison Between the Data Collected by Patient Diary and Data From Medical Administrative Databases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Case Report Form
Declaration Bias
Health Insurance Database
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of incident and prevalent cases of patients with chronic disease (diabetes, rheumatoid arthritis, chronic renal failure) or incident cases of prostate cancer, breast cance or colorectal cancer.

Brief summary: The main objective of this study is to estimate the reporting bias of patients in terms of prescripted drug and care consumption by comparing data collected in a patient diary and database of health insurance .


Eligibility criteria: Inclusion Criteria:

* incident and prevalent cases of patients with type I or type II diabetes. arthritis:
* incident and prevalent cases of rheumatoid arthritis patients defined according to the ACR-EULAR criteria 2010 (Aletaha D et al, 2010).

Renal failure :

• incident and prevalent cases of patients with kidney disease stage 3 or 4, transplanted or not.

Prostate cancer :

• Incident cases of patients with prostate cancer regardless of the stage at diagnosis (positive prostate biopsy).

Breast cancer :

• Incident cases of patients with breast cancer regardless of the stage at diagnosis (biopsy positive breast).

Colorectal cancer :

• Incident cases of patients with colorectal cancer regardless of the stage at diagnosis (colonoscopy and polyp biopsy positive).

Exclusion Criteria:

- The subject participates in an experimental study of research affecting the therapeutic management of the patient.

* The subject is exclusion period determined by a previous study.
* The subject is under judicial protection, guardianship or curatorship.
* It is not possible to give informed about information
* The subject does not read French and is not autonomous filling a questionnaire.
* The patient has psychiatric disorders.
* The subject is an emergency.
* Monitoring between patient visits than 6 months.

Primary outcomes:
measure: comparison of data collected in a patient diary and data stored in the database of health insurance
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Nimes
name: christel castelli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00894959: Efficacy and Safety of Sodium Heparin in Patients
Official title: Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Keywords: heparin cardiac surgery
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is verify, through a randomized, single-blind, multicentre, parallel and comparative study, the effectiveness of heparin sodium of porcine origin in patients undergoing heart surgery at that require the aid of cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on the strengths of markers of coagulation TCA, TTPA, Anti-Xa, heparin bioavailable and loss of excessive blood (bleeding) at the end of the surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients aged above 18 years;
* Patients with cardiac surgery and requiring movement; AND
* Extracorporeal.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical changes (eg myeloproliferative syndromes, anemia Hb \<11.0 g / dL,
* Platelets \< 150,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (rTTPA\> 1.40);
* Patients with renal dysfunction (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with history of heparin-induced thrombocytopenia;
* Tables infection (eg endocarditis, infection of immune human (HIV), hepatitis B and C, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet (clopidogrel and ticlopidine) for less than 7 days;
* Use of acetylsalicylic acid is less than 5 days;
* Use of low molecular weight heparin for less than 24 hours; OR
* Use of non-fractioned heparin for less than 12 hours.

Primary outcomes:
measure: Comparison of TTPA, Anti-Xa and ACT
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
measure: Comparison of bleeding
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Secondary outcomes:
measure: Adverse reactions
timeFrame: Pre - Operative (T0) Pre Heparinization (T1) Top of Extracorporeal (T2) Period Intraoperative (T3) Termination Extracorporeal (T4) Postoperative
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL clinica pesquisa e desenvolvimento ltda
state: SP
Study officials:
References:
Clinical trial NCT06867159: Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques in Iliotibial Band Syndrome
Official title: Comparison of Effects of Autogenic Inhibition and Reciprocal Inhibition Muscle Energy Techniques on Iliotibial Band Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Iliotibial Band Syndrome
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Comparison of effects of autogenic inhibition and reciprocal inhibition muscle energy techniques on iliotibial band syndrome

Detailed description: A single-blinded randomized control trial will be conducted over a period of one year in Foundation University Islamabad. Forty participants will be assigned to two groups: Group A (AI) and Group B (RI), with 20 participants each. The AI technique will involve a maximal isometric contraction of the target muscle followed by a stretch, while the RI technique will involve a maximal isometric contraction of the antagonist muscle followed by a similar stretching protocol. Both groups will perform the exercises 3 times per week for 2 weeks. Pain, Hip range of motion (ROM) and lower extremity function will be assessed using Numeric Pain Rating Scale (NPRS), goniometer and Lower Extremity Functional Scale (LEFS) respectively.

The outcomes will be measured in terms of improvements in pain score (NPRS), hip range of motion (ROM), and overall lower extremity function.

Eligibility criteria: Inclusion Criteria

* Both male and female participants
* Age : 19-45years (8)
* Lateral knee pain (\>3 months)
* Tenderness over lateral femoral condyle
* Positive Flexibility Tests
* Modified Ober's test (9)
* Length assessment of Tensor Fasciae Latae and Iliotibial Band (10)
* Positive Pain Provocation Tests
* Renne's test
* Noble's Compression test (11) \*(individuals with 3 positive tests out of above mentioned 4 tests will be included)

Exclusion Criteria

* Recent lower limb or pelvic girdle surgery within the past 3 months
* Lower limb fractures or trauma within the past year.
* Multiple lower limb surgeries (\>2)
* Presence of any structural or postural disorders (kyphosis or severe scoliosis)
* Neurological disorders
* Hip and knee Osteoarthritis
* Rheumatoid Arthritis
* Pregnancy

Primary outcomes:
measure: Pain severity
timeFrame: 2 weeks
measure: Range of motion
timeFrame: 2 weeks
measure: Functional status of lower limb
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physcial Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT00272259: Robots for Stroke Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Stroke
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
First posted: 2006-01-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators are looking for individuals who have suffered a stroke to participate in an experiment examining the use of robotics in rehabilitation. They are trying to develop a robotic environment for hands after having had a stroke. Participants will interact with up to two small robots and a visual display. The experiment involves minimal risk and may involve testing sessions over multiple weeks. Subjects must be at least 1 year post-stroke and have difficulty picking up small objects.

For more information, contact: Bambi Brewer, CMU Ph.D. Student, 412-241-9423 or bambi@andrew.cmu.edu.


Eligibility criteria: Inclusion Criteria:

* At least 1 year post-stroke
* Difficulty picking up small objects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Yoky Matsuoka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Carnegie Mellon University
name: Roberta Klatzky, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01026259: Local Warming of Surgical Incisions
Official title: Local Warming: Effects on Wound Infection and Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Wound Infection
Keywords: Surgical site infection
wound healing
tissue oxygen
angiogenesis
flow cytometry
immunohistochemistry
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if local warming of surgical wounds improves healing and helps prevent infection. The investigators want to see if warming surgical incisions improves oxygen levels and healing in skin close to the incision.

Detailed description: Surgical site infections (SSI) account for 37% of US hospital infections and increase morbidity and cost. High rates (10-22%) of SSI are associated with colorectal surgery and obesity. Bacterial resistance requires oxygen and higher tissue oxygen limits infection in general surgery patients. Control of core and local temperature may increase infection resistance by modulating perfusion, oxygenation, angiogenesis and immune cell responses. Perioperative hypothermia reduces tissue oxygen while normothermia lowers SSI rates. Warming injured tissues locally may offer additional benefit. Warming incisions immediately after surgery and intermittently for two days after gastric bypass or colectomy surgery reduced infection rates in a pilot sample. Systematic study of clinical outcomes and potential mechanisms in a larger study is lacking and is the focus of the current study.

Eligibility criteria: Inclusion Criteria:

* 18 and older,
* scheduled for bariatric, colon or gynecological surgery,
* able to speak and read English.

Exclusion Criteria:

* glucocorticoids greater than 5 mg per day,
* albumin below 3.0,
* creatinine above 2.5 mg/dl,
* history of pulmonary edema.

Primary outcomes:
measure: Surgical site infection
timeFrame: Within 6 weeks of the surgical procedure
Secondary outcomes:
measure: Wound tissue response
timeFrame: First 9 days after surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT05538559: Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth
Official title: The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Primary Teeth
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure


Eligibility criteria: Inclusion Criteria:

* Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System\[ICDAS\].
* The access of the carious lesion has to be large enough to allow the penetration of the excavator
* Children with behavior rating 3 or 4 according to the Frankl scale

Exclusion Criteria:

* Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
* Proximal caries evidenced by bitewing x-ray

Primary outcomes:
measure: Time taken for caries removal
timeFrame: Through procedure completion
measure: Efficacy of caries removal
timeFrame: Through procedure completion
measure: Child pain perception
timeFrame: Through procedure completion
measure: Child behavior
timeFrame: Through procedure completion
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03964259: Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Official title: Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Acute Lymphoblastic Leukemia
Pediatric Cancer
Pediatric ALL
Pediatric Lymphoma
Keywords: High Dose Methotrexate
HDMTX
Intravenous Fluids
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study uses a prospective randomized controlled crossover study design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.

Detailed description: This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of lymphoma or acute lymphoblastic leukemia
* Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
* Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
* Patients of childbearing potential must have a negative pregnancy test (serum or urine)
* Lactating female patients must agree not to nurse a child while on this trial
* All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable

Exclusion Criteria:

* Trisomy 21
* History of dialysis within 30 days prior to study registration or currently on dialysis
* Polyuric renal dysfunction
* Pregnancy
* Known or suspected pleural effusion
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Primary outcomes:
measure: Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
timeFrame: 63 Days
Secondary outcomes:
measure: Markers of kidney toxicity
timeFrame: 84 Days
measure: Markers of fluid overload
timeFrame: 84 Days
measure: Effects on therapy delays
timeFrame: 84 Days
measure: Effects on development of severe mucositis
timeFrame: 84 Days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/ Massey Cancer Center/ Children's Hospital of Richmond
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Cady P Noda, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06877559: Balloon-Assisted Enteroscopic Treatment for Phytobezoar
Official title: Analysis of the Safety and Efficacy of Balloon-Assisted Enteroscopic Treatment for Phytobezoar
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Phytobezoar; Intestine
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with small intestinal phytobezoar

Brief summary: By reviewing a case series of patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital, we analyzed the safety and efficacy of this technique.


Eligibility criteria: Inclusion Criteria:

* Retrospectively collect data from patients who underwent balloon-assisted enteroscopic treatment for phytobezoar at our hospital.

Exclusion Criteria:

* Patients with incomplete clinical data.

Primary outcomes:
measure: Efficacy of Balloon-Assisted Enteroscopic treatment for Phytobezoar
timeFrame: 3 months
Secondary outcomes:
measure: Safety of Balloon-Assisted Enteroscopic treatment for Phytobezoar
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of shandong university
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo
role: STUDY_DIRECTOR
References: