louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02502630: Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
Official title: CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Detailed description: From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* Unresectable pulmonary metastases from colorectal cancer.
* diagnosis by CT, and confirmed by percutaneous puncture biopsy.
* Age range 18-70 years old.
* Eastern Cooperative Oncology Group performance status 0-1.
* Life expectancy of more than 3 months.
* Adequate organ function.

Exclusion Criteria:

* Resectable lung metastases.
* Life expectancy less than 3 months
* Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
* Coagulopathy with platelet count less than 50000.
* Active infectious disease.
* Age below 18 years.
* Pregnancy of breastfeeding.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: one year
Secondary outcomes:
measure: Treatment related adverse events
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: The First People's Hospital of Changzhou
name: Jingting Jiang, PD
role: STUDY_DIRECTOR
References:
citation: Cheng G, Shi L, Qiang W, Wu J, Ji M, Lu Q, Li X, Xu B, Jiang J, Wu C. The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. Int J Hyperthermia. 2018 Jun;34(4):486-491. doi: 10.1080/02656736.2017.1366553. Epub 2017 Nov 16.
Clinical trial NCT00195130: Prognostic Measures in Ambulatory Care Settings
Official title: Prognostic Measures in Ambulatory Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Internal Medicine Patients
Keywords: prognosis
risk of death
morbidity
mortality
quality of life
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective of this prospective study is to develop a new method of classifying the prognosis of ambulatory patients according to their risk of long term mortality, institutionalization, morbidity (including the deterioration of pre-existing conditions or development of new problems) and functional deterioration.

Detailed description: Specifically, from a random sample of 2000 patients taken from a cohort of established patients followed for at least three years in a general medicine practice, the objectives are:

1. to identify the demographic, clinical, and functional status variable that predict the risk of death, morbid events (e.g., the development of new complications or deterioration of existing conditions), or the deterioration in functional status using a half of the cohort chosen at random;
2. to combine these findings into a prognostic scale that can be employed in routine clinical practice; and
3. to validate the performance of this scale in the second half of the cohort.

There are no interventions in this study. Patients already under medical care by Cornell physicians will be enrolled. The only requirements for patients are to complete the questionnaires on an annual basis.

Eligibility criteria: Inclusion Criteria:

1. Patients who are currently under the care of Physicians at Cornell Internal Medicine Associates.

Exclusion Criteria:

1. Patients who do not wish to participate in the study.
2. Patients who are not able to provide informed written consent.

Primary outcomes:
measure: To develop a new method of classifying the prognosis of ambulatory patients according to their risk of long term mortality, institutionalization, morbidity and functional deterioration.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College at Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00672230: Dietary Lutein and the Retinopathy of Prematurity
Official title: The Placental and Mammary Transfer of Lutein and Zeaxanthin Into the Fetus and the Breast-fed Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Keywords: Lactation
Breast milk
Lutein
Lutein supplement
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 212
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

Detailed description: About one-fourth of preterm infants who weight less than 2 3/4 pounds at birth develop an eye problem. This problem occurs in the retina (back of the eye) and may result in blindness. This eye problem is called the retinopathy of prematurity(ROP). There are two yellow pigments in the retina called lutein and zeaxanthin. These pigments may protect the retina from being damaged by light. They may also protect the retina from being damaged by oxygen. These pigments are transferred from the mother to the baby. Most of this takes place during the last trimester of pregnancy. The situation could be worse if the baby receives formula. Most baby formulas do not contain lutein and zeaxanthin; breast milk does. Another worry is that breast milk may not have enough lutein and zeaxanthin if the mother does not eat enough vegetables and fruits. The purpose of this study is to measure the transfer of lutein and zeaxanthin from the mother to the baby, to measure the amount of lutein and zeaxanthin in breast milk, to find out if taking a lutein supplement will increase the amount of lutein in breast milk and to find out if dietary lutein and zeaxanthin are involved in the development of the retinopathy of prematurity (ROP).

Eligibility criteria: Inclusion Criteria:

* Planning to breast feed for at least 12 weeks
* Willing to be randomized to take the lutein supplement

Exclusion Criteria:

* Insufficient quantity of breast milk

Primary outcomes:
measure: Breast milk lutein, mcg/dL
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma Lutein, mcg/dL
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: William E Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04574830: Study to Evaluate Biomarkers and Clinical Manifestations in Individuals With Glycogen Storage Disease Type III (GSD III)
Official title: Clinical Survey Study to Evaluate Biomarkers and Clinical Manifestations in Individuals With Glycogen Storage Disease Type III (GSD III)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glycogen Storage Disease Type III
Lead sponsor: Ultragenyx Pharmaceutical Inc
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a confirmed diagnosis of GSD III

Brief summary: The primary objective of this study is to evaluate potential biomarkers of GSD III.


Eligibility criteria: Inclusion Criteria:

* Confirmed historical diagnosis of GSD III based on pathogenic mutations in the AGL gene on both alleles or GDE deficiency based on biopsy of liver, muscle, or fibroblasts
* Willing to comply with all study procedures
* Willing and able to provide written informed consent. If a minor, willing and able to provide written assent and have a legally authorized representative willing and able to provide written informed consent

Exclusion Criteria:

* Presence or history of any condition that, in the view of the Investigator, places the subject at high risk of poor study compliance, interferes with study participation, or interferes with the subject's ability to safely or reliably complete the study assessments
* Use of any IP within 30 days prior to informed consent/assent or at the time of enrollment

Primary outcomes:
measure: Urine hexose tetrasaccharide (Hex4): mean and variance
timeFrame: Up to Day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California
state: California
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Aurora
country: United States
facility: Colorado Children's Hospital
state: Colorado
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
Study officials:
affiliation: Ultragenyx Pharmaceutical Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03155230: Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)
Official title: Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Chronic Pain
Keywords: Inguinal hernia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 209
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish males, age\>18 years undergoing elective, bilateral TAPP due to inguinal hernia (medial, lateral, and combined hernias) within the study period from July 1, 2012 to June 30 2013

Brief summary: Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.

Detailed description: The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).

Eligibility criteria: Inclusion Criteria:

* Danish males,
* Age\>18 years
* Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013

Exclusion Criteria:

* age \<18 years
* miss-classified surgical code
* non-Danish speaking
* psychiatric anamneses
* regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair
* femoral hernia repair

Primary outcomes:
measure: Activities Assessment Scale Questionnaire
timeFrame: Within one week
Secondary outcomes:
measure: Questionnaire about sexual impairment
timeFrame: Within three months
measure: Questionnaire about sleep impairment
timeFrame: Within three months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gastrounit, Surgical Division, Hvidovre Hospital, Denmark
state: Danmark
Study officials:
affiliation: HvidovreUT
name: Thue Bisgaard, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05627830: Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial
Official title: Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMJ Disc Disorder
Ultrasound Therapy; Complications
TMJ
Prolotherapy
Internal Derangement
Clicking Tinnitus
Injection Site
Pain, Chronic
Anterior Disc Displacement
Myofascial Pain Syndrome
Masticatory Muscle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.

Rationale for conducting the research:

The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.


Eligibility criteria: Inclusion Criteria:

1. Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
2. Muscles spasm causing TMDs.
3. Patients who failed to improve on conservative measures or highly hyperactivity patients.
4. Female and male patients age range from 20 to 60 years old.

Exclusion Criteria:

1. Patients who refused to be included in the research.
2. Patients with a systemically diseases or inflammation whether local or generalized.
3. Patients with bleeding disorders.
4. Patients with unknown dextrose allergy.

Primary outcomes:
measure: visual analogue scale
timeFrame: Change from Baseline VAS at 4 weeks ( lower score means better outcome)
measure: visual analogue scale
timeFrame: VAS change at 2 months ( lower score means better outcome )
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: CairoU
state: Al Manial, Old Cairo
Study officials:
References:
Clinical trial NCT03615430: Serratus Plane Block in Preventing Postoperative Pain of Mastectomy
Official title: The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serratus Plane Block
Chronic Pain
Breast Cancer
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.


Eligibility criteria: Inclusion Criteria:

* women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
* between the ages of 18 and 85 yr
* with an American Society of Anesthesiology (ASA) physical status I or II
* without any significant cardiopulmonary, renal and hepatic dysfunction

Exclusion Criteria:

* Patients with any previous cancer other than breast cancer
* occurrence of allergy to local anesthetics
* occurrence of opioid-tolerant subjects
* occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery

Primary outcomes:
measure: Numerical Rating Scale (NRS) of chronic pain
timeFrame: 3 months after surgery
Secondary outcomes:
measure: the change trend of Numerical Rating Scale (NRS) after surgery
timeFrame: 0-24 hours after operation
measure: Morphine consumption
timeFrame: 0-24 hours after operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xia Feng, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamiya Y, Hasegawa M, Yoshida T, Takamatsu M, Koyama Y. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):215-223. doi: 10.1097/EJA.0000000000000762.
Clinical trial NCT00924430: Interaction Study SLV337/Simvastatin
Official title: A Drug Interaction Study to Investigate the Effects of SLV337 on the Pharmacokinetics of Simvastatin and Simvastatin Acid in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Interaction SLV337 and simvastatin
Type 2 diabetes mellitus
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Volunteers with Body Mass Index 18.0-28.0 kg/m2

Exclusion Criteria:

* Clinically relevant medical history

Primary outcomes:
measure: Simvastatin and simvastatin acid: Cmax, tmax, AUC0-t, AUC, lz, and t1/2, as well as CL/F and Vz/F for simvastatin only
timeFrame: 20 days
Secondary outcomes:
measure: SLV337 and its acylglucuronide metabolite: Cmax, tmax, AUC0-24, AUC0-t, CL/F (SLV337 only) on Days 1 and 13, as well as AUC, lz, t1/2 and Vz/F (SLV337 only) on Day 1
timeFrame: 20 days
measure: Safety and tolerability assessments including adverse events, clinical laboratory tests, electrocardiogram (ECG) and vital signs
timeFrame: During the duration of study participation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT00802230: Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure
Official title: Beta-Receptor SELECTivity of Carvedilol and Metoprolol Succinnate in Patients With Heart Failure: A Randomized Dose Ranging Trial (SELECT Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-12-04
Enrollment: 25
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: Metoprolol succinate is a beta1-selective beta-blocker, becoming non-selective at higher doses, while carvedilol is non-selective. We examined whether metoprolol remained beta1-selective compared to carvedilol during dose up-titration in Class C heart failure (HF) Beta-blocker naïve patients.

METHODS: Twenty-five NYHA FC II-III HF patients were randomized to carvedilol or metoprolol. Patients were studied at baseline and after 2 weeks of up-titration (metoprolol at 25, 50, 100, and 200 mg daily; carvedilol IR at 3.125, 6.25, 12.5, 25 mg and 50mg twice daily). Beta2- blockade was determined by an infusion of terbutaline at 6 mg/kg over 1 hour. Glucose and potassium levels were serially measured at baseline, every 15 minutes for the 1st hour and 30 minutes for 2nd hour post-infusion. The median area under the curve (AUC) for glucose and potassium changes were calculated.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for the study had objective evidence of systolic dysfunction (ejection fraction ≤40%), were \>18 years of age, and were on stable optimal medical heart failure therapy excluding the use of beta-blockers within the previous 30 days.

Exclusion Criteria:

* . Patients were excluded for active viral myocarditis; hemodynamically significant valvular heart disease; hypertrophic cardiomyopathy, peripartum cardiomyopathy; contra-indications to beta-blockers (asthma or obstructive airway disease requiring scheduled bronchodilators or inhaled steroids), resting heart rate \<55; supine blood pressure \<85/50; second or third degree heart block); concomitant use of beta-agonists, beta-antagonists, or anti-arrhythmics; unstable angina; myocardial infarction or bypass surgery within 3 months; or significant renal insufficiency (creatinine \>2.5 mg/dL), liver disease (transaminase levels \> 3 fold above laboratory normal), or anemia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT01320930: Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)
Official title: Early Detection and Rehabilitation of Subjects With COPD - Rehabilitation in Moderate COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Effect of Pulmonary rehabilitation.
Exercise capacity
Quality of life
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
name: Danish Lung Association
name: Sygekassernes Helsefond
First posted: 2011-03-23
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of moderate COPD.
2. Motivation for Pulmonary rehabilitation.

Exclusion Criteria:

1. Comorbidity contraindicating rehabilitation.
2. Participation in pulmonary rehabilitation within the last year.
3. Cognitive disorders limiting the ability to participate in physical training and education sessions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: