louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03329430: Custom Foot Orthoses & Venous Status
Official title: Influence of Custom Foot Orthoses on Venous Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot
Foot Orthoses
Photoplethysmography
Venous Stasis
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. This is a quasi-experimental study which included 20 healthy subjects. Sociodemographic and medical record data are registered. Furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects.

Exclusion Criteria:

* Prior diagnosed conditions such as neurological, vascular or traumatic disorders.

Primary outcomes:
measure: Venous filling time
timeFrame: Change from Baseline venous filling time at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vila Nova de Famalicão
country: Portugal
facility: Escola Superior de Saúde do Vale do Ave
state: Vila Nova De FamalicÃ£o
Study officials:
References:
Clinical trial NCT02033330: Assessment of Bioavailability of Phenolics From an Orange Peel Extract
Official title: Assessment of Bioavailability of Phenolics From an Orange Peel Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improving Bioavailability
Keywords: phenolics
orange peel
bioavailability
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the bioavailability of a specific orange peel extract is tested. The composition and morphology of the test product is altered compared to the generic product, which is used as a control. Due to intellectual property issues, more information cannot be given at this moment. Also the difference in bioavailability between a capsule and a lozenge is tested. The hypothesis is that the bioavailability of the altered extract will be improved compared to the control.


Eligibility criteria: Inclusion Criteria:

* healthy adults
* BMI 18.5 to 25

Exclusion Criteria:

* pregnancy
* smoking
* alcohol or drug abuse
* use of medication
* use of nutritional supplements
* abnormal liver or kidney function

Primary outcomes:
measure: plasma concentrations of specific phenolics and their metabolites
timeFrame: up to 24 hours
Secondary outcomes:
measure: urine concentrations of specific phenolics and their metabolites
timeFrame: 24 hours
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht University Medical Center
name: Chris Van der Grinten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01773330: High Resolution Manometry for Swallowing
Official title: High Resolution Manometry: Optimizing the Swallow Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Motility Disorder
Keywords: high resolution manometry
provocative swallow
impedence
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is using a new technology known as high resolution manometry which is used to evaluate patients that have trouble swallowing or have chest pain that is not related to the heart. The investigator wants to learn how the different positions of the body, in a lying position, semi-recumbent, sitting position or standing up, and the amount of liquid affects the outcome of the test. This will help the investigator to determine a standardized protocol for patients with trouble swallowing.

Detailed description: The esophageal manometry will be performed in the motility lab at the Shands Endoscopy Center by passing a small tube into the patients nose, down the food pipe and into the stomach. The participants will be instructed to swallow a determined volume of Gatorade,depending on the protocol being followed. All participants will be starting in the supine position followed by semi-recumbent,sitting, then standing up. When the esophageal manometry is finished, the tube is removed and participation in this study is complete.

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Healthy Volunteer
* No clinical evidence of dysphagia

Exclusion Criteria:

* History of prior dysphagia
* Prior esophageal or gastric dysmotility secondary to systemic conditions (scleroderma or diabetes mellitus)
* Known gastrointestinal malignancy
* Use of medications known to affect esophageal or gastric motility (e.g. anticholinergics, opiates, calcium channel blockers)
* Previous esophageal or gastric surgery
* Significant cardiac or respiratory disease
* Pregnancy (a pregnancy test will be performed in women of child-bearing potential)

Primary outcomes:
measure: Normal values for HRM while the patient is in the most physiologic position to stimulate normal eating habits.
timeFrame: up to 1 hour
Secondary outcomes:
measure: Normal HRM values for a 200 ml provocative swallow.
timeFrame: up to 5 minutes
measure: Bolus clearance for each swallow with impedance.
timeFrame: up to 1 hour
measure: Normal size and diameter of esophagus and esophageal distension on a regular basis with the provocative swallow and impedance.
timeFrame: up to 1 hour
measure: Standardization of the testing protocol for HRM and the reliability of volume and number of swallows.
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Endoscopy Center
state: Florida
Study officials:
affiliation: University of Florida
name: Qing Zhang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05172830: Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System
Official title: Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Keywords: EVAR
Endovascular aneurysm repair
Ovation Alto
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
Collaborators: name: University of Patras
name: University Hospital of Crete
name: University Hospital, Alexandroupolis
First posted: 2021-12-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated electively with Ovation Alto™ Abdominal Stent Graft System for Endovascular Aneurysm Repair

Brief summary: This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.


Eligibility criteria: Inclusion Criteria:

* Subject is \> 18 years of age
* Both IFU and non-adherence to IFU
* Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
* Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan

Exclusion Criteria:

* Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
* Life expectancy less than 1 year
* Pregnancy
* Subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.

Primary outcomes:
measure: Treatment success
timeFrame: 12 months
Secondary outcomes:
measure: Number and Classification of Endoleaks
timeFrame: 1 and 12 months
measure: Stent Graft Migration
timeFrame: 1 and 12 months
measure: Abdominal aortic aneurysm sac enlargement
timeFrame: 1 and 12 months
measure: Aortic neck alteration
timeFrame: 1 and 12 months
measure: Freedom from abdominal aortic aneurysm rupture
timeFrame: 1 and 12 months
measure: Number of Secondary Interventions
timeFrame: 1 and 12 months
measure: AAA-related mortality
timeFrame: 1 and 12 months
measure: Device-related Adverse Events (AEs)
timeFrame: 1 and 12 months
measure: Major adverse events
timeFrame: 1 and 12 months
measure: Adherence to instruction for use
timeFrame: 12 months
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larisssa
Study officials:
References:
Clinical trial NCT01192230: Study of Endostatin Combined With Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer Patients
Official title: A Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Objective response rate
Disease control rate
Disease free survival
Overall survival
Quality of Live
Nonsmall cell lung cancer
toxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy and safety of endostatin combined with Docetaxel in advanced Non-Small-Cell Lung Carcinoma (NSCLC) patients failure to first-line or second-line chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed by the histologic, cytologic diagnosis of IIIB (malignant hydrothorax or hydropericardium) or IV non-small cell lung cancer
* ≥ 18 years old
* patients who have received more than one regimen of platinum-based chemotherapy; patients who have received EGFR monoclonal treatment could also be enrolled
* At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
* have an interval of more than 4 weeks from the last chemo- or radio-therapy; 2 weeks from the last targeted therapy
* ECOG 0-2
* Expected life time longer than 3 months
* Normal laboratory values:

  * leucocyte≥ 4×109/L
  * neutrophil≥ 1.5×109/L
  * platelet≥90×109/L
  * Hemoglobin≥ 9g/L
  * ALT and AST ≤3×ULN (≤5×ULN if liver metastasis)
  * serum creatinine\<1.5 mg/dl
  * bilirubin \<1.5×ULN
* No allergy to biological drug
* Sign the consent forms

Exclusion Criteria:

* Patients who have previously received Docetaxel or anti-VEGF inhibitors
* Severe symptomatic heart disease
* Female patients during their pregnant and lactation period, or patients without contraception
* Severe uncontrolled infection
* Uncontrolled neurologic or psychiatric disease; Uncontrolled primary or metastatic brain tumor
* Patients with other malignant tumor,except for basal cell carcinoma,squamous cell carcinoma and carcinoma in situ
* Patients have accepted other clinical trials

Primary outcomes:
measure: Response rate
timeFrame: six weeks
measure: Progression free survival
timeFrame: six weeks
measure: Overall survival
timeFrame: three months
Secondary outcomes:
measure: Quality of Life
timeFrame: six weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University affiliated cancer hospital
name: Jianhua Chang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151930: Long-Term Compassionate Use Study for Continued Administration of SCB01A-01
Official title: Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A-01
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Malignant Solid Tumour
Keywords: Advanced solid tumor failed with standard therapy
Lead sponsor: SynCore Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

Detailed description: This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles of treatment under the SCB01A-01 protocol.

Eligibility criteria: Inclusion Criteria:

Subjects who completed protocol SCB01A-01 and exhibited a favorable response or had no clinical evidence of disease progression (i.e. stable disease, partial response or complete response).

Exclusion Criteria:

Study participants meeting any of the following criteria will be excluded from enrollment:

1. Unwilling or unable to provide informed consent.
2. Unwilling or unable to comply with the requirements of the protocol.
3. Has unresolved toxicities from previous SCB01A-01 protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Shiah HS, Chiang NJ, Lin CC, Yen CJ, Tsai HJ, Wu SY, Su WC, Chang KY, Wang CC, Chang JY, Chen LT. Phase I Dose-Escalation Study of SCB01A, a Microtubule Inhibitor with Vascular Disrupting Activity, in Patients with Advanced Solid Tumors. Oncologist. 2021 Apr;26(4):e567-e579. doi: 10.1002/onco.13612. Epub 2020 Dec 18.
Clinical trial NCT05202730: Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty
Official title: Analgesic Effect of Peripheral Cutaneous Nerve Block of Knee Joint After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Analgesia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Local anesthesia was performed on patients with total knee arthroplasty (TKA) through two different injection sites of local anesthetics and two local anesthetic drug . The pain score of patients after TKA was collected, then the analgesic effect of patients after TKA through two different injection sites and two different local anesthetic drug were analyzed and evaluated.


Eligibility criteria: Inclusion Criteria:

* 1. Patients between the ages of 40-75, who meet the indications for total knee arthroplasty(TKA) surgery, plan to undergo unilateral TKA surgery, can tolerate surgical trauma, and have no surgical contraindications;
* 2. Patients who have good medical obedience and can cooperate to complete the evaluation of various indicators after the operation and continue to receive follow-up;
* 3. There is no contraindications to combined spinal-epidural anesthesia;
* 4. Agree to accept this trial and sign an informed consent form.

Exclusion Criteria:

* 1. Allergic to test drugs;
* 2. Abnormal liver, kidney or heart function;
* 3. People who have chronic pain symptoms in other parts of the body other than the knee joint;
* 4. Patients with a history of multiple operations on the knee joint, or patients with abnormal anatomical structures;
* 5. Patients who cannot perform early functional exercise after unconventional knee replacement or other systemic diseases;
* 6. Cannot communicate with researchers normally.

Primary outcomes:
measure: Change of the pain score before and after surgery
timeFrame: pre-operation, 6hours after surgery, 24hours after surgery, 48 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Orthopedics, Xijing Hospital, The Air Force Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT04346030: Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome
Official title: Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.

Detailed description: This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).

Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function

-

Primary outcomes:
measure: change from baseline in the scores on Boston Carpal tunnel Questionnaire (BQ)
timeFrame: 0, 6, 12 weeks.
Secondary outcomes:
measure: change from baseline in self reported pain intensity
timeFrame: 0, 6, 12 weeks
measure: change from baseline in median nerve distal motor latency
timeFrame: 0, 6, 12 weeks
measure: Change from Baseline in sensory nerve conduction velocity
timeFrame: 0, 6, 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei veteran general hospital
Study officials:
References:
Clinical trial NCT05376930: Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.
Official title: A Multi-center, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

1. Participated in the prior phase 3 study (Protocol No: DW_DWP16001301) for meeting the inclusion criteria and completed the study
2. Voluntarily decided to participate in the extension study and provided a written consent on the consent form

Exclusion Criteria:

1. Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
2. Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following

   * Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
   * A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
   * Use of male condom combined with either cervical cap or diaphragm
3. In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)

Primary outcomes:
measure: Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary outcomes:
measure: Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
measure: Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
measure: Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References: