louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03509922: A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity
Official title: A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Artery Disease, PAD
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with PAD\* (\*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
2. tODI \< 3 at randomization
3. Aged ≥ 19 years
4. Written informed consent

Exclusion Criteria:

1. Patients requiring acute or two or more antiplatelet agents
2. Patients requiring anticoagulant therapy
3. Patients requiring surgical procedure due to vascular occlusion
4. Patients whose results are confirmed at the screening as follows:

   * hemoglobin (Hb) test value: male \< 13 g/dL, female \< 12 g/dL
   * platelet count \< 60,000/µL
   * severe renal disease (eGFR \< 30 mL/min/1.73 m2)
5. Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months
6. Contraindications stated in the SPC of sarpogrelate
7. Patients who are pregnant or planning to become pregnant
8. Those participating in other clinical trials with administration of investigational products at the screening
9. Those who are deemed to be ineligible to participate in the trial by investigator

Primary outcomes:
measure: Change from baseline to week 24 in tissue oxygen delivery index (tODI)
timeFrame: baseline, week 24
Secondary outcomes:
measure: Change from baseline to week 12 in tODI
timeFrame: baseline, week 12
measure: Proportion of subjects with tODI elevated by 20% or more
timeFrame: baseline, week 12, week 24
measure: Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)
timeFrame: baseline, week 24
Other outcomes:
Locations:
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
state: Gyeonggido
Study officials:
References:
Clinical trial NCT00477022: The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer
Vacuum compression therapy
Stereology
Ulcer Area
Vasotrain
Random Controlled Trial.
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.

Detailed description: Diabetic foot ulcers are common and serious complications of chronic diabetes mellitus. The prevalence of foot ulcers among patients with diabetes is 15%. The length of hospital stay is approximately 60% longer among patients with foot ulcers, as compared with those without ulcers. Diabetic foot ulcers accounts for \>50% of all nontraumatic lower-leg amputations.Although, current preventive methods and treatment modalities have been effective in healing foot ulcers, statistics show high incidence of foot ulcers and amputations in individuals with diabetes.On the other hand, only a few studies were performed on the effects of Vasotrain in healing diabetic foot ulcers. The use of the machine enhances the delivery of oxygen and nutrients to the area, which in turn, facilitate wound healing

Eligibility criteria: Inclusion Criteria:

* A diabetic foot ulcer corresponding to grade 2
* No history of deep venous thrombosis and no hemorrhage in ulcer

Exclusion Criteria:

* Significant loss of protective sensation
* Hemorrhage during treatment
* Vertigo
* No completion of treatment

Primary outcomes:
measure: Foot ulcer surface area was estimated stereologically, based on Cavalieri's principle before and after intervention, at pre treatment and post treatment
timeFrame: Baseline, 3 Weeks,
Secondary outcomes:
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Dept. of physiotherapy, Zahedan university of medical scinces
state: Sistan & Bladchestan
Study officials:
affiliation: Deputy of research, Zahedan university of medical scinces
name: Asghar Akbari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCulloch JM Jr, Kemper CC. Vacuum-compression therapy for the treatment of an ischemic ulcer. Phys Ther. 1993 Mar;73(3):165-9. doi: 10.1093/ptj/73.3.165.
citation: Akbari A, Moodi H, Ghiasi F, Sagheb HM, Rashidi H. Effects of vacuum-compression therapy on healing of diabetic foot ulcers: randomized controlled trial. J Rehabil Res Dev. 2007;44(5):631-6. doi: 10.1682/jrrd.2007.01.0002.
Clinical trial NCT00581139: Psychological Influences on Postoperative Recovery
Official title: Psychological Influences on Postoperative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Care, Postoperative
Pain, Postoperative
Surgical Procedures, Operative
Otorhinolaryngologic Surgical Procedures
Tonsillectomy
Adenoidectomy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2007-12-27
Enrollment: 241
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* Outpatient tonsillectomy or tonsils/adenoids
* ASA I, II

Exclusion Criteria:

* Developmental delay
* ASA III-IV
* Psychotropic medication
* Meds which interfere with metabolism of midazolam
* 36 weeks gestation

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale
timeFrame: Day of surgery
measure: Percentage of Children Not Exhibiting Negative Behaviors, Fear, or Anxiety (Perfect Induction, 0)
timeFrame: Induction, up to 10 minutes
measure: Percent of Children Crying During Induction
timeFrame: Induction, up to 10 minutes
measure: Percentage of Children Arriving to PACU Awake
timeFrame: Arrival at PACU, after surgery up to 20 minutes
measure: Percentage of Children Arriving to PACU in Deep Sleep
timeFrame: Arrival at PACU, after surgery up to 20 minutes
measure: Post Anesthesia Care Unit (PACU) IV Fluid
timeFrame: Post Anesthesia Care Unit up to 2 hours
measure: Visual Analogue Pain Scale (VAS) 24 Hour After Surgery
timeFrame: 24 Hours after surgery
measure: Heart Rate in the General Clinical Research Unit (GCRC)
timeFrame: Hour 0-6 after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Department of Anesthesiology
state: Connecticut
Study officials:
affiliation: Yale University Department of Anesthesiology
name: Zeev N Kain, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366339: Tolerance and Pharmacokinetics Study of MNTX Tablets
Official title: A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Healthy Volunteers
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.


Eligibility criteria: Inclusion Criteria:

1. Weight between 55 and 85 kg
2. In good health with no evidence of a clinically significant chronic medical condition
3. Non-Smokers.

Exclusion Criteria:

1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
2. Known or suspected hypersensitivity to opioids or opioid antagonists
3. History or suspicion of alcohol or drug abuse.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax) of oral doses of MNTX
timeFrame: 7 days
Secondary outcomes:
measure: Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX
timeFrame: 7 days
measure: Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX
timeFrame: 7 days
measure: Half-life of oral doses of MNTX
timeFrame: 7 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01272739: Randomized Study to Evaluate the Effect of an Investigational Product on Weight Loss and Body Composition
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of IHBG-10 on Weight Loss and Body Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
weight loss
weight management
overweight
nutriceutical
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 10
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: This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight loss, and changes in body composition.

Detailed description: Subjects will be randomized to one of two groups: one group will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; the other group will take placebo 15 minutes prior to the three main meals of the day. Subjects will be on the investigational product or placebo for 12 weeks. Participation in this study involves four study visits.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Body mass index of 30 or greater
* Agree to keep diet, exercise and all current health habits stable during participation in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning to become pregnant
* Prior bariatric surgery
* Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
* Obesity as a result of a clinically diagnosed endocrine problem
* Currently taking an anti-psychotic medication
* History of peptic ulcer disease

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Edward Zawada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04702139: Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
Official title: Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Osteoarthritis
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint


Eligibility criteria: Inclusion Criteria:

1. First-line reverse prosthesis
2. Without prosthetic history
3. Patient who has given his consent to participate in the observational study after being informed by the surgeon
4. Patient living in France and able to answer the questionnaire alone.
5. Subject affiliated to a social security scheme or beneficiary of such a scheme
6. Lack of participation in another clinical study

Exclusion Criteria:

1. Minor patient
2. Major subject protected by law, under curatorship or tutorship
3. Anterior prosthesis
4. Infection
5. Parkinson's, degenerative neurological disease
6. Pregnant or breastfeeding woman

Primary outcomes:
measure: the level of postoperative pain following the installation of the Game Ready
timeFrame: 9 months
Secondary outcomes:
measure: risk of stiffness
timeFrame: up to 9 months
measure: occurrence of hematoma, edema
timeFrame: up to 9 months
measure: length of hospitalization
timeFrame: up to 24 hours
measure: evolution of mobility
timeFrame: up to 9 months
measure: the time limit for returning to a possible professional activity
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bizet Clinic
Study officials:
affiliation: Clinique Bizet
name: philippe VALENTI, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05136339: Healthy Immigrant Community: Mobilizing the Power of Social Networks
Official title: Healthy Immigrant Community: Mobilizing the Power of Social Networks
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Weight Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-11-29
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.


Eligibility criteria: Inclusion Criteria:

* Self-identification as Hispanic or Somali.
* Member of a social network identified in the social network analysis.
* Willingness to participate in all aspects of the study.
* Provision of informed consent.

Exclusion Criteria:

* Pregnancy at the time of enrollment.
* Serious medical conditions or disabilities that would make physical activity difficult.
* To avoid stigmatization, a normal weight (BMI\<25) will not exclude individuals from participating in the intervention, but they will be excluded from the measurements and analyses.

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in waist circumference
timeFrame: Baseline, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Change in "Life's Simple 7" Composite Score
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in blood pressure (systolic and diastolic)
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in fasting glucose level
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in low-density lipoprotein (LDL)
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in Dietary Quality
timeFrame: Baseline, 6 months, 12 months, 24 months
measure: Change in physical activity
timeFrame: Baseline, 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Wieland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808439: Endovascular Repair of AAA
Official title: Endovascular Abdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: On Abdominal Aortic Aneurysms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patient older than 18 years

Brief summary: We study differen t endovascular techniques as an alternative to surgical reconstruction to repair AAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates


Eligibility criteria: Inclusion Criteria:

* Older than 18

Exclusion Criteria:

* inflammatory or mycotic AAA

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit
state: Assuit
city: Assuit
country: Egypt
facility: Assuit
Study officials:
References:
Clinical trial NCT04412239: To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic
Official title: To Assess the Efficiency and Satisfaction of Pharmacist Giving Patient-centred Advice on Telephone Consultation in TB Patients: Experience of the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TB - Tuberculosis
Patient Satisfaction
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Pakistan Institute of Medical Sciences Islamabad Pakistan
name: District Headquarter Hospital Bannu Pakistan
First posted: 2020-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The COVID-19 pandemic might be an opportunity to review and refine our practices in anti TB treatment. For the follow-up of selected patients, telephone consultations may be efficient and cost-effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the pharmacist and the TB patient. The study was conducted in tertiary care hospital TB control centres patients.

Detailed description: Tuberculosis (TB) is the world's biggest killer among infectious diseases, claiming more than 4000 lives each day. The unprecedented coronavirus pandemic seriously impacts people with pre-existing health conditions. People who have TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are at a higher risk of developing complications from COVID-19. Certain populations are at greater risk of TB, because of where they live, where they work or because of other socio-economic factors which result in them experiencing barriers to accessing health services.

Eligibility criteria: Inclusion Criteria:

New, smear-positive drug-susceptible TB who have been on treatment for less than two weeks Access to a mobile phone (self-reported)

Exclusion Criteria:

Patients who do not have regular access to a mobile phone Patients who have previously received TB treatment Patients who have another member in their household who is already a part of the study

Primary outcomes:
measure: Efficiency of the telephone consultation,
timeFrame: 2 Months
measure: Patient satisfaction
timeFrame: 2 Month
Secondary outcomes:
measure: Adherence Rate
timeFrame: 2 Months
Other outcomes:
Locations:
city: Bannu
country: Pakistan
facility: Dhq Bannu Kpk
state: KPK
city: Bannu
country: Pakistan
facility: District Bannu TB Control Center
state: KPK
Study officials:
References:
Clinical trial NCT05055739: Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
Official title: Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung
Lung Transplant
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 40
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: This will be a prospective, randomized clinical trial, comparing the sternal alignment between the fixation with rigid plate X steel wires. Patients over 18 years of age, belonging to the lung transplant line in the State of São Paulo, who will undergo bilateral lung transplantation will be studied.


Eligibility criteria: Inclusion Criteria:

1. Above 18 years of age;
2. Belonging to the transplant queue of InCor;
3. Eligible for sequential bilateral lung transplantation submitted to clamshell incision;

Exclusion Criteria:

1. Patients undergoing a new surgical procedure after lung transplantation with the need to manipulate the steel wires or the sternal fixation plate other than for osteomyelitis;
2. Intraoperative death;
3. Patients who have undergone unilateral lung transplantation or have not undergone a clamshell incision.

Primary outcomes:
measure: Sternal Alignment
timeFrame: 1 month
measure: Sternal Alignment
timeFrame: 3 months
measure: Sternal Alignment
timeFrame: 6 months
Secondary outcomes:
measure: Bone healing
timeFrame: 1 month
measure: Bone healing
timeFrame: 3 months
measure: Bone healing
timeFrame: 6 months
measure: Pain
timeFrame: 1 month
measure: Pain
timeFrame: 3 months
measure: Pain
timeFrame: 6 months
measure: Time to close the Rib cage
timeFrame: 1 month
measure: Time to close the Rib cage
timeFrame: 3 months
measure: Time to close the Rib cage
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HCFMUSP
state: SP
Study officials:
References: