louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05311072: Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
Official title: A Chinese Real-world Study to Investigate the Management Pattern and Outcomes of Chronic Thromboembolic Pulmonary Hypertension (CHANGE Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic Thromboembolic Pulmonary Hypertension
epidemiology
diagnosis
treatment
prognosis
balloon pulmonary angioplasty
pulmonary endarterectomy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients dianosed with CTEPH according to the contemporary guidelines

Brief summary: The Change Database is a prospective, observational multi-center disease registry, which will collect data on patients with chronic thromboembolic pulmonary hypertension (CTEPH) in China. It aims to illustrate the epidemiology, management and long-term outcomes of CTEPH.

Detailed description: 18 CTEPH centers will be enrolled in the study. The epidemiology, diagnosis，treatments (pulmonary endarterectomy (PEA), balloon pulmonary angioplasty (BPA) and targeted medical therapy), and long-term prognosis of CTEPH will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Patients must be diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH)
2. Patients must be willing to provide informed consent
3. Patients must meet the following criteria for CTEPH:

a mean pulmonary artery pressures (mPAP) ≥20 mmHg combined with a pulmonary vascular resistance (PVR) ≥ 3 WU and pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg documented at right heart catheterization with radiographic evidence of organized thrombi involving the pulmonary arteries after 3 months of effective anticoagulation.

Exclusion Criteria:

1. Main cause of PH other than CTEPH
2. Participation in a therapeutic clinical trial with an unknown drug;
3. Withdrawal or lack of informed consent.

Primary outcomes:
measure: death
timeFrame: 3 years
measure: The change in mean pulmonary artery pressure (mPAP) in millimetre of mercury (mmHg), pulmonary vascular resistance (PVR) in Wood units, cardiac output (CO) in liter per minute (L/min) or cardiac index (CI) in liter per minute (L/min).
timeFrame: 3 years
measure: The change in 6-minute walk distance in meter, in BNP or NT-proBNP in picograms per milliliter（pg/ml), or WHO-functional class.
timeFrame: 3 years
Secondary outcomes:
measure: lung or heart and lung transplantation
timeFrame: 3 years
measure: changes of health related quality of life
timeFrame: 3 years
Other outcomes:
measure: bleeding
timeFrame: up to 3 years
measure: symptomatic recurrence of DVT or PE
timeFrame: up to 3 years
measure: complication of treatment interventions (PEA or BPA)
timeFrame: up to 3 years
Locations:
city: Beijing
country: China
facility: China-Japan Frendship hospital
Study officials:
References:
Clinical trial NCT04308772: Web-Based Physiotherapy Following Knee Arthroscopy
Official title: Web-Based Physiotherapy Following Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroscopy
Physical Therapy
Keywords: knee
arthroscopy
physiotherapy
web-based
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: NHS Greater Glasgow and Clyde
First posted: 2020-03-16
Enrollment: 33
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: Web-based physiotherapy might improve care following knee arthroscopy. For this study half of the participants will receive usual care (printed leaflet) and half will receive 6 weeks of web-based physiotherapy.

Detailed description: Despite its minimally invasive nature, studies have shown that patients undergoing arthroscopic meniscectomy have pain, effusion, loss of range of motion, functional, neuromuscular and biomechanical changes, loss of quadriceps muscle strength, and a reduced quality of life (Durand et al.,1993;Goodwin and Morrissey,2003; Glatthorn et al.,2010). With changes in service delivery patients following arthroscopy only receive a printed leaflet. Web-based physiotherapy may offer offer cost effective support to patients. Therefore, the aim of this study is to undertake a single blind, randomised controlled pilot study examining the effectiveness of a six week web-based physiotherapy programme compared to usual care alone, for people following knee arthroscopy and to gather essential information for the planning of a definitive trial.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone Knee Arthroscopy surgery.
* Access to a personal computer/tablet or smart phone with an email address and internet connection
* Be able to understand English.

Exclusion Criteria:

* Infection or other post-operative complications
* Other significant co-morbidities for which exercise is contra-indicated
* Unwilling to be randomised to intervention/control group
* Taking part in another research project

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS).
timeFrame: Baseline to 6 weeks.
Secondary outcomes:
measure: Change in Cincinnati Sports Activity Scale (CSAS)
timeFrame: Baseline to 6 weeks.
measure: Adherence to exercise programme
timeFrame: Weekly for 6 weeks
measure: Health Resource Form
timeFrame: Week 6
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: Glasgow Caledonian University
name: Spiros Nikologiannis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360372: Effect of Methylnaltrexone (Relistor) on Digestion and Tolerance to Tube Feeding in Patients Treated With Opiates
Official title: The Effect Of Methylnaltrexone (Relistor™) on Gut Motility and Tolerance to Tube Feeding in Patients Treated With Opiate Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Tube Feeding
Keywords: Hydrogen breath test value and gastric residual volume measurements
Tube feeding tolerance while taking a stable dose of opiate
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2011-05-25
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: It is hypothesized that using methylnaltrexone in addition to pain killer narcotics (opiates) in patients will result in increased tube feeding rates with more frequent nutrition at goal calorie rate.

Detailed description: Tube feeding rates and tube feeding residual volumes will be measured and followed blinded to the treatment arm (methylnaltrexone vs. placebo) to evaluate if patients (who prior to study entry did not tolerate goal rates tube feeds) can get closer to tube feeding goal with the treatment arm.

Eligibility criteria: Inclusion Criteria:

* Inadequate tube feeding rate of greater than equal to 40% below goal rate.
* Prescribed opiate therapy for pain or sedation, stable dose for minimum 48 hours
* Stable dose or no dose laxative for minimum 72 hours

Exclusion Criteria:

* Unstable Hemodynamics (eg. vasopressor medication)
* Pregnancy
* End stage Renal Disease on Dialysis
* Plan to wean opiates in next 48 hours
* Known or suspected mechanical gastrointestinal obstruction
* Initial expired hydrogen breath level greater than 20

Primary outcomes:
measure: Hydrogen breath test measure of bowel transit
timeFrame: 2 days
Secondary outcomes:
measure: Gastric residual volume measurement
timeFrame: 3 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Center of America
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01010672: Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)
Official title: A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Ariad Pharmaceuticals
First posted: 2009-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.


Eligibility criteria: Inclusion Criteria:

* Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization
* Adequate organ and bone marrow function

Exclusion Criteria:

* Presence of brain or central nervous system (CNS) metastases, unless successfully treated
* Prior therapy with rapamycin or rapamycin analogs
* Ongoing toxicity associated with prior anticancer therapy
* History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient

Primary outcomes:
measure: Progression free rate (PFR) at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03818672: Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects
Official title: Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Severe Hepatic Impairment
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to characterize the steady state plasma

Detailed description: The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD \>25), as well as healthy subjects with normal hepatic function.

Eligibility criteria: Inclusion Criteria:

* Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically impaired subjects will have a MELD score of \>25.

Exclusion Criteria:

* Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients and/or vehicles used in the formulation, or any other clinically significant allergies.
* Subject has participated in an investigational drug or device study within 30 days prior to Day 1 (Baseline).
* Subject has any concurrent illness (other than liver cirrhosis), disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the investigator.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 7 days
measure: Time of the Maximum Concentration (Tmax)
timeFrame: 7 days
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Valeant Site 01
state: Texas
Study officials:
affiliation: Bausch Health Companies
name: Varsha Bhatt
role: STUDY_DIRECTOR
References:
Clinical trial NCT05054972: Left Renal Vein Division for Juxtarenal Aortic Exposure
Official title: Left Renal Vein Division for Juxtarenal Aortic Exposure: Renal Function and Role of the Communicating Lumbar Vein
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm
Juxtarenal Aortic Aneurysm
Renal Function Disorder
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were treated surgically for a juxtrarenal aortic aneurysm with an open operation.

Brief summary: Retrospective study on the outcome of the renal function in patients operated because of juxtarenal aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

Only patients who went for a planned operation because of a juxtarenal aortic aneurysm were included in this retrospective analysis.

Exclusion Criteria:

Emergency surgery Rupture Pending rupture

Primary outcomes:
measure: Renal function after surgery.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Vascular Surgery, Medical University of Vienna
Study officials:
References:
Clinical trial NCT00745472: Auditory Evoked Potentials and Experimental Pain
Official title: The Amplitude of Auditory Evoked Potentials and the Intensity of Experimental Pain Stimulation in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: AEP
experimental pain
healthy volunteers
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

Brief summary: Monitoring of auditory evoked potentials (AEP) in patients during general anaesthesia is commonly used to ensure a sufficient hypnotic level during surgery. The amplitude of AEP (AEPa) has in clinical settings been found to correlate to pain. The aim of the study was to test, if AEPa could detect increasing experimental pain stimulations in healthy volunteers. Electric nerve stimulation, cold and heat pain were used as pain models.

Detailed description: During the AEP monitoring, healthy volunteers were exposed to experimental pain. At study day 1: Firstly, single electric nerve stimulation and repetitive electric nerve stimulations causing temporal pain summation. The stimulations were given at 50, 75 and 100% of the thresholds for pain tolerance and temporal pain summation. Secondly, the volunteers were exposed to cold pain by use of two different Cold Pressor Tests (CPT) with water temperatures at 8 and 1 Celsius. All measurements were repeated after an hour to test reproducibility.

At study day 2: Brief Thermal Stimulation were used with two different temperatures and duration.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Age 20 - 40 years old

Primary outcomes:
measure: VAS and amplitude of AEP
timeFrame: before, during and after experimental pain
Secondary outcomes:
measure: reproducibility
timeFrame: after an hour
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Thomas P Enggaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462472: Effect of Lower Leg Heating and Transcutaneous Electrical Nerve Stimulation on Exercise Capacity in Patients With PAD
Official title: The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Salisbury University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).


Eligibility criteria: Inclusion Criteria:

* Intermittent claudication (Fontaine Stage II)
* Resting ankle-brachial index (ABI) \< 0.90
* Ability to walk \> 60 meters in six minutes

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg/m2
* Severe exercise limitations (more than PAD) due to co-morbidity
* Taking illegal/recreational drugs
* Uncontrolled hypertension (\>180/100 mmHg)
* Severe peripheral neuropathy
* Foot ulcers
* Gangrene
* Pregnant or breast feeding

Primary outcomes:
measure: Distance walked during six-minute walk test
timeFrame: 35 minutes post-intervention/control
Secondary outcomes:
measure: Popliteal artery blood flow
timeFrame: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
measure: Time/distance to claudication during six-minute walk
timeFrame: 35 minutes following each intervention and control period
measure: Ankle brachial index (ABI)
timeFrame: Pre-intervention baseline and 20 minutes post-intervention/control
measure: Toe oxygen saturation
timeFrame: Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control
Other outcomes:
Locations:
city: Salisbury
country: United States
facility: Salisbury University
state: Maryland
Study officials:
affiliation: Salisbury University
name: Thomas K. Pellinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971672: Incidence of Iron Deficiency Anemia in Toddlers
Official title: Incidence of Iron Deficiency Anemia in Toddlers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Infants
Keywords: Infants
Iron Deficiency
Anemia
Healthy infants that attend the pediatric community clinics
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.

Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.

Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.

Brief summary: The frequency of iron deficiency anemia was extensively studied in infants on the first year of life. There is not enough information about the frequency of iron deficiency during the second and third years of life. In a previous study performed in Israel and published in Pediatrics 2006 the incidence of anemia does not decrease towards age 18 months. Then there is reasonable to study the iron deficiency frequency beyond this age.

Detailed description: The purpose of this study is to analyze the frequency of Iron deficiency anemia in a group of 400 toddles from age 18 months to 36 months.

Two groups of children will be included, 200 children from Jewish origin and 200 from non Jewish origin, mostly Arabs.

A questionnaire that included demographic characteristics, nutrition and iron supplementation in the first year, growth status, and laboratory results will be filled for each patient.

The laboratory analysis will include complete blood count and serum ferritin analysis.

Children that were previously diagnosed suffering from iron deficiency, children suffering from chronic diseases or were born premature will not be included in the study.

Eligibility criteria: Inclusion Criteria:

* Healthy children that attend the pediatric community clinics.

Exclusion Criteria:

* Children that were previously diagnosed suffering from iron deficiency.
* Children suffering from chronic diseases or were born premature will not be included in the study.

Primary outcomes:
measure: Frequency of anemia (Hemoglobin below normal for age) and Iron deficiency (Low ferritin value)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086072: Survival Trends in Myocardial Infarction 1994 - 2010
Official title: Survival Trends in Myocardial Infarction 1994 - 2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2010-03-12
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Myocardial Infarction in Tayside 1994 - 2010

Brief summary: Practice in management of myocardial ischemia and infarction has changed significantly over the past 20 years, both in terms of immediate management and secondary prevention.

The aim of this observational study is to utilize the established record linkage data available in Tayside to investigate the trends in survivors of myocardial infarction in Tayside since 1994.


Eligibility criteria: Inclusion Criteria:

* Myocardial Infarction

Exclusion Criteria:

* Nil

Primary outcomes:
measure: Cardiovascular Mortality
timeFrame: 20 years
Secondary outcomes:
measure: Cardiovascular hospitalisation
timeFrame: 20 years
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Douglas Elder
Study officials:
References: