louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04303546: VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Validation Study
Official title: VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Protocol for Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Risk Factor
Cardiovascular Diseases
Atherosclerosis of Artery
Keywords: arterial stiffnes
pulse wave velocity
VOPITB
validation
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size has been calculated in order to provide that a difference between the CAVI values obtained from measurement of both devices, VOPITB and VaSera, shall be up to of 0.8 points in comparison with the CAVI reference values for Spanish adults population \[21\]. the base parameters used to calculate the sample size were as follows: standard deviation (sd) of CAVI measured by VaSera VS-1500 and VOPITB (1.44), mean difference between CAVI measurements (0.8), confidence level (95%), and power (80%). Thus, the estimated sample size was found as 102 patients. In addition, for compensating possible incomplete data sets from patients who could withdraw or fail to complete the study, 20% were added. Finally, a total of 120 subjects (a minimum of 40% of subjects for each gender group) will be evaluated according to the following criteria:

* \< 30 years (40 subjects)
* 30 - 60 years (40 subjects)
* \> 60 years (40 subjects)

Brief summary: Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria.

Exclusion Criteria:

* History of CVD (ischaemic heart disease, stroke or peripheral arterial disease)
* Atrial fibrillation or other cardiac rhythm disorders
* Pacemaker-dependent
* Impalpable arterial pulse at site of measurement
* Pregnancy
* Terminal condition
* Age under 18 years

Primary outcomes:
measure: cardio-ankle vascular index (CAVI) validation
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rico Martin S, Vassilenko V, de Nicolas Jimenez JM, Rey Sanchez P, Serrano A, Martinez Alvarez M, Calderon Garcia JF, Sanchez Munoz-Torrero JF. Cardio-ankle vascular index (CAVI) measured by a new device: protocol for a validation study. BMJ Open. 2020 Oct 20;10(10):e038581. doi: 10.1136/bmjopen-2020-038581.
Clinical trial NCT04631146: Efficacy and Safety of Camrelizumab in Real-World Study
Official title: Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Retrospective, Observational, Multicenter Real-World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 450 patients who have received camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.

Brief summary: This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

Detailed description: Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC.

This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Histopathological diagnosed confirmed non-small cell lung cancer;
3. Have received at least one camrelizumab injection between August 1, 2019 and December 31, 2020;
4. Traceable cases.

Exclusion Criteria:

1. Patients who have received other immunotherapy at the same time;
2. Patients who were participating in other intervention studies;
3. Patients with other malignant tumors;
4. The researcher believes that the patient is not suitable to participate in this study with any other conditions .

Primary outcomes:
measure: pCR
timeFrame: From August 1, 2019 to June 31, 2021
measure: R0 resection rate.
timeFrame: From August 1, 2019 to June 31, 2021
measure: ORR
timeFrame: From August 1, 2019 to June 31, 2021
measure: 6-month PFS%
timeFrame: From August 1, 2019 to June 31, 2021
Secondary outcomes:
measure: MPR
timeFrame: From August 1, 2019 to June 31, 2021
measure: operative rate
timeFrame: From August 1, 2019 to June 31, 2021
measure: perioperative mortality
timeFrame: From August 1, 2019 to June 31, 2021
measure: incidence of major postoperative complications
timeFrame: From August 1, 2019 to June 31, 2021
measure: iORR
timeFrame: From August 1, 2019 to June 31, 2021
measure: iPFS
timeFrame: From August 1, 2019 to June 31, 2021
measure: AE
timeFrame: From August 1, 2019 to June 31, 2021
measure: SAE
timeFrame: From August 1, 2019 to June 31, 2021
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
state: Guangdong
Study officials:
affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
name: Wu Yilong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529446: Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women
Official title: Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Specific Knee Osteoarthritis Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to investigate the efficacy of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

Detailed description: Osteoarthritis (OA) is the most common musculoskeletal condition affecting the quality of life of older adults. The prevalence of OA is very high 45% in females in comparison to males, especially after menopause due to the hormonal changes. In the physical therapy practice, therapeutic ultrasound (US) is one of the most frequently applied electrotherapeutic modalities in orthopedics physiotherapy. Simultaneous application of two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US \& Transcutaneous neuromuscular electrical stimulation (TENS )where this approach was effective in pain modulation .The use of combination therapy is highly preferable because of the advantageous effect both electro-therapy and ultrasound provide simultaneously. There are no current studies on using combination therapy in the treatment of pain in mild to moderate knee osteoarthritis in post-menopausal women and we don't know the proper treatment dose.The study is designed as a prospective, randomized, pre-posttest, controlled trial.where we have two groups Intervention group and control. the intervention group will recieve strengthening exercises in addition to combination therapy 10 minutes for each session, 3 times per week, for 3 weeks.The Control group will recieve the same strengthening exercises as intervention group and sham combination therapy 10 minutes for each session, 3 times per week, for 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Forty women who suffer pain out of mild to moderate knee osteoarthritis
* Their age will range from 55 to 65
* At least one year after last menstruation.
* Their BMI will be ranged from 25 to 35 kg/m2

Exclusion Criteria:

* Neurological disorders.
* Cardiovascular disorders.
* Severe knee osteoarthritis
* Areas of the body where cancerous lesions exist.
* Any skin impairment at site of application as inflammation, lesion, wounds, infection and swelling.
* Pacemaker and any metallic implants.

Primary outcomes:
measure: Knee Range Of Motion
timeFrame: up to four weeks
Secondary outcomes:
measure: activity of daily living
timeFrame: up to four weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Madonna Noshi Welson Aiad
Study officials:
References:
Clinical trial NCT02990546: Midodrine in the Recovery Phase of Septic Shock
Official title: Midodrine Use in the Recovery Phase of Septic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Septic Shock
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 0
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: The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.

Detailed description: The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.

The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.

Eligibility criteria: Inclusion Criteria:

* • Patients aged 18-99 years old

  * Admitted to UVA medical ICU with diagnosis of septic shock.

Exclusion Criteria:

* Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent
* Patients \< 18 years
* Prisoners
* Patients already taking midodrine
* Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score \> 9)_
* Patients with Increased intraocular pressure and glaucoma
* Patients with allergy to midodrine
* Non-English speaking patients
* Patients without enteral access
* Patients where the attending physician does not feel MAP goal of \> 65 mmHg is physiologically acceptable.

Primary outcomes:
measure: ICU free days
timeFrame: 28 days
Secondary outcomes:
measure: Central venous catheter free days
timeFrame: 28 days
measure: IV vasopressor free days
timeFrame: 28 days
measure: Hospital length of stay
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Robert M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04593446: Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery
Official title: Difference of Surgical Site Infection Between Using Sodium Picosulfate Solution(PicosolutionⓇ) and Oral Sulfate Tablet(ORA·FANGⓇ) in Colorectal Cancer Surgery : Phase II. Prospective, Randomised, Multicenter, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: sodium picosulfate solution
oral sulfate tablet
surgical site infection
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
name: Daehang Hospital
First posted: 2020-10-20
Enrollment: 414
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study to evaluate the difference in the rate of surgical site infection between the patients who used Sodium Picosulfate solution(PicosolutionⓇ) and tablet Oral Sulphate Solution(ORA·FANGⓇ) for bowel preparation before colorectal cancer surgery .

Detailed description: It has been reported that tablet oral sulphate solution(ORA·FANGⓇ) showed a successful bowel cleansing rate of 95.5%, which is similar to compared to sodium picosulfate solution(PicosolutionⓇ).

In terms of the rate of surgical site infection(SSI), sodium picosulfate solution(PicosolutionⓇ) showed 8% of SSI rate. However there is no report for the SSI rate of tablet oral sulphate solution(ORA·FANGⓇ). We aimed to compare the SSI rates between these two group.

Eligibility criteria: Inclusion Criteria:

1. Patients who are scheduled for an elective minimally invasive surgery for colorectal cancer
2. ASA score, 2 or less

Exclusion Criteria:

1. Bowel obstruction
2. FAP or IBD patients
3. Emergency operation
4. Pregnancy
5. Breast feeding
6. Severe medical condition such as severe cardiac,hepatic, or renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
7. Allergy to drug and refusal to participate in the study

Primary outcomes:
measure: The rate of surgical site infection
timeFrame: 30 days
Secondary outcomes:
measure: The quality of the bowel preparation
timeFrame: during surgery
measure: The patient's tolerability for bowel preparation
timeFrame: 1 day after bowel preparation
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Hyoung-Chul Park, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478646: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV
Official title: The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy on Dyspnoea and Activity in Patients With COPD III-IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: breathing therapy
reflective breathing therapy
COPD
chronic obstructive pulmonary disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: University of Osnabrueck
First posted: 2011-11-23
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
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 determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity.

Detailed description: In the treatment of COPD-Patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet.

Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system.

Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity.

The purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.

Eligibility criteria: Inclusion Criteria:

* inpatient rehabilitation
* COPD (Gold stage III and IV)

Exclusion Criteria:

* severe exacerbation in the last four weeks
* acute infections
* fever
* neuritides
* severe osteoporosis
* skin disease
* manic depression

Primary outcomes:
measure: Change in BORG-Scale
timeFrame: Change from pre (minute o) in BORG-scale at directly post intervention (minute 60)
Secondary outcomes:
measure: Change in residual volume
timeFrame: change from pre (minute 0) in residual volume at post (minute 60) intervention
Other outcomes:
Locations:
city: Schönau
country: Germany
facility: Schön Klinik Berchtesgadener Land
state: Bayern
Study officials:
affiliation: Schön Klinik Berchtesgadener Land
name: Klaus Kenn, Dr. med.
role: STUDY_CHAIR
affiliation: University of Osnabrueck
name: Stella Seeberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373046: Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets
Official title: A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* Adult subjects ≥18 to ≤55 years of age
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211
* History of renal disease, or significantly abnormal kidney function test at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality

Primary outcomes:
measure: AUC
timeFrame: Days 1 to 5, Days 9 to 13
measure: Urinary Glucose Excretion (UGE)
timeFrame: Day 1, Day 9
Secondary outcomes:
measure: # of Adverse Events
timeFrame: Day 1-Day 14
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Lexicon Investigational Site
state: Texas
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Suman Wason, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04235946: Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission
Official title: Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Related Fatigue
Breast Cancer
Keywords: cancer related fatigue
adapted physical activity
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Laboratoire Management Sport Cancer EA 4670
First posted: 2020-01-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.
Primary purpose: PREVENTION

Brief summary: The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).

Detailed description: Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Woman aged 18 to 65, with a good understanding and good practice of the French language.
2. Having been diagnosed with breast cancer: any type of cancer, any type of treatment. Inclusion from 3 weeks to 3 months after the end of treatment (excluding hormone therapy and immunotherapy) Patients who have undergone surgery may be included from 6 weeks post-operative.
3. Signed consent to participate.
4. Affiliation to a social security scheme or beneficiary of such a scheme.
5. Live within a maximum radius of 40 km around Marseille.
6. Swimming skills (basic level).

Exclusion Criteria:

1. Being undergoing chemotherapy treatment
2. Unacquired healing
3. Metastatic cancers
4. Proven psychological pathology proven according to diagnostic criteria (DSM-V)
5. Pregnant or lactating woman

Primary outcomes:
measure: rate of maintenance of a high level of adherence to the program of physical activities
timeFrame: 20 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Cercle des nageurs de Marseille
Study officials:
affiliation: Institut Paoli-Calmettes
name: Monique COHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: