louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01578993: Observational Study of Complications Related to Use of Peripherally Inserted Central Catheters
Official title: A Phase IV, Prospective Clinical Evaluation of Complications Related to the Use of Peripherally Inserted Central Catheters (PICC) - An Observational Baseline Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Patients With Peripherally Inserted Central Catheters
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients necessitating insertion of a PICC for fluid, nutritional, chemotherapy or antibiotic treatment for a minimum of 14 days.

Brief summary: The purpose of this study is to determine the rate and timing of interventions and complications related to the use of peripherally inserted central venous catheters in adult patients.


Eligibility criteria: Inclusion Criteria:

* Male or Female Age \> 18 years requiring central venous access
* Ability to comply with study requirements
* Written Informed Consent

Exclusion Criteria:

* Previous enrollment in study
* Current or recent upper extremity thrombosis, occlusion or stenosis
* Previous axillary lymph node dissection
* Skin inflammatory condition or rashes within 15 cm from insertion site
* Pre-existing history of hypercoagulability unrelated to malignant disease
* Participating in trial involving antithrombotic, anticoagulant or anti- infective drug therapies
* Positive blood culture within 48 hours from planned PICC placement
* Known, renal insufficiency with chronic creatinine levels \> 1.7 mg/dl

Primary outcomes:
measure: Rate of PICC Line Occlusions
timeFrame: Insertion to Removal / maximum 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
References:
Clinical trial NCT04927793: Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
Official title: A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-938 Following a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: AME Study
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2021-06-16
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]EDP-938 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Males of any ethnic origin, between 18 and 55 years of age, inclusive.
* Able to comprehend and willing to sign an Informed Consent Form
* In good health, determined by no clinically significant findings from medical history, physical examination (check-in only), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).

  a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded.
* Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
* A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening

Primary outcomes:
measure: Cmax of EDP-938 in plasma
timeFrame: Up to 11 days
measure: AUC0-tlast of EDP-938 in plasma
timeFrame: Up to 11 days
measure: AUC-inf in plasma
timeFrame: Up to 11 days
measure: Amount excreted in urine (Aeu)
timeFrame: Up to 11 days
measure: Amount excreted in feces (Aef)
timeFrame: Up to 11 days
measure: Cmax of EDP-938 metabolites in plasma
timeFrame: Up to 11 days
Secondary outcomes:
measure: Safety measured by occurrence of adverse events
timeFrame: Up to 11 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00193193: Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma
Official title: A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Detailed description: Upon determination of eligibility, patients will receive:

Paclitaxel + Estramustine + Carboplatin

Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate not curable with local treatment
* Disease progression while receiving hormonal therapy
* Measurable or evaluable disease
* Previous treatment with a maximum of one prior chemotherapy regimen
* ECOG performance status 0, 1, or 2.
* Adequate bone marrow, liver and kidney function
* Able to comprehend the nature of this study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* History of treatment for an invasive malignancy within five years
* Significant heart disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Toxicity
measure: Overall survival
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06044493: MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
Official title: A Multicenter, Randomization, Open-label Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Kidney Transplant
Keywords: Kidney transplant
Mycophenolic acid
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 158
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: The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients

Detailed description: This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety of MYREPTIC-N® or MY-REPT® administration for 24 weeks in renal transplant patients combined Calcineurin inhibitor.

Eligibility criteria: Inclusion Criteria:

1. Over 19 years old
2. Patients who at least 1 year after kidney transplant
3. serum creatinine ≤2.3 mg/dL
4. Patients on immunosuppressive maintenance therapy using combination of Calcineurin Inhibitor and Mycophenolate Mofetil after kidney transplantation

Exclusion Criteria:

1. Patients who had received treatment Acute rejection within 4 weeks
2. Patients who had discontinued corticosteroid within 4 weeks
3. At the time of Screening

   * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/ mm\^3
4. In investigator's judgement

Primary outcomes:
measure: Incidence of composite efficacy failure
timeFrame: Until 24 weeks
Secondary outcomes:
measure: Change in survey evaluation score [Gastrointestinal symptom rating scale(GSRS), EuroQol-5D(EQ-5D)]
timeFrame: Changes in scores from the baseline at week 24
measure: Intra patient variability of mycophenolic acid
timeFrame: Until 24 weeks
measure: Intra patient variability of calcineurin inhibitor
timeFrame: Until 24 weeks
measure: Incidence of Virus infection
timeFrame: Until 24 weeks
measure: Incidence of biopsy-confirmed acute rejection
timeFrame: Until 24 weeks
measure: Incidence of Graft loss
timeFrame: Until 24 weeks
measure: Incidence of Death
timeFrame: Until 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jongwon Ha, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00827593: Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Official title: Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Baruch College City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-01-23
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.


Eligibility criteria: Inclusion Criteria:

* Age between 30-65 years
* BMI between 27-50 kg/m2
* Written approval/consent from primary health care provider

Exclusion Criteria:

* Unable to walk 2 blocks without stopping.
* Currently participating in a weight loss program or taking weight loss medication.
* Participated in a weight loss program in the last year
* Took weight loss medication in the last 6 months.
* Participated in Weight Watchers in last 2 years.
* Lost \>=5% of body weight during 6 months prior to screening.
* Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
* Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
* Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.

Primary outcomes:
measure: weight loss
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Baruch College
state: New York
Study officials:
affiliation: Baruch College
name: Angela M Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinto AM, Fava JL, Hoffmann DA, Wing RR. Combining behavioral weight loss treatment and a commercial program: a randomized clinical trial. Obesity (Silver Spring). 2013 Apr;21(4):673-80. doi: 10.1002/oby.20044.
Clinical trial NCT00678093: Effects of a Mulligan Mobilisation in the Lumbar Flexion Range of Asymptomatic Subjects
Official title: The Effects of the Mulligan Mobilisation Sustained Natural Apophyseal Glide (SNAG) in the Lumbar Flexion Range of Asymptomatic Subjects as Measured by the Zebris CMS20 3-D Motion Analysis System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Manual therapy
Mulligan snag
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Mulligan's mobilisation techniques are believed to increase the range of movement (ROM) in patients with low back pain. The primary aim of this study was to investigate the mechanical effects of Mulligan's "SNAG" technique on lumbar flexion ROM. The secondary aim was to measure the intra- and inter-day reliability of lumbar ROM employing the same procedure, and utilising a 3-D motion analysis system for measuring range of motion (ROM).

Detailed description: The primary aim of this study was to investigate the mechanical effects of Mulligan's "SNAG" technique on lumbar flexion ROM. The secondary aim was to measure the intra- and inter-day reliability of lumbar ROM employing the same procedure. For the interventional component of the study, 49 asymptomatic volunteers participated in it. Subjects were randomly assigned into either a treatment (SNAG) group (n=25), or a placebo (SHAM) group (n=24). The "SNAG" technique was applied on L3 and L4 spinal levels by an experienced manual therapist. SNAGs were performed with active flexion in sitting, 10 times at each level. The placebo-SHAM was similar to the SNAG without however applying the appropriate direction or force. Lumbar ROM was measured by a three dimensional electronic goniometer (Zebris CM20), before and after each technique. For the reliability component, five measurements in two different days (one week apart) were performed in 20 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* asymptomatic
* health individuals

Exclusion Criteria:

* Low back pain
* spinal pathology
* vascular or heart problems
* subjects taking anticoagulants

Primary outcomes:
measure: Range of Movement (ROM)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Centre for Rehabilitation Science
Study officials:
affiliation: University of Manchester
name: Evdokia Billis, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131.
Clinical trial NCT00334711: Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations
Official title: A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Permanent Neonatal Diabetes
Kir6.2
KCNJ11
Infancy onset diabetes
Sulfonylurea
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Hôpital Necker-Enfants Malades
name: Haukeland University Hospital
First posted: 2006-06-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.


Eligibility criteria: Inclusion Criteria:

* Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion Criteria:

* None

Primary outcomes:
measure: HbA1c reduction
Secondary outcomes:
measure: insulin secretory response to intravenous glucose
measure: insulin secretory response to oral glucose
measure: insulin secretory response to mixed meal (sustacal)
measure: Incidence of Hypoglycemia
Other outcomes:
Locations:
Study officials:
affiliation: Peninsula Medical School, Exeter, UK
name: Andrew T Hattersley
role: STUDY_DIRECTOR
affiliation: Peninsula Medical School, Exeter, UK
name: Ewan R Pearson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gloyn AL, Pearson ER, Antcliff JF, Proks P, Bruining GJ, Slingerland AS, Howard N, Srinivasan S, Silva JM, Molnes J, Edghill EL, Frayling TM, Temple IK, Mackay D, Shield JP, Sumnik Z, van Rhijn A, Wales JK, Clark P, Gorman S, Aisenberg J, Ellard S, Njolstad PR, Ashcroft FM, Hattersley AT. Activating mutations in the gene encoding the ATP-sensitive potassium-channel subunit Kir6.2 and permanent neonatal diabetes. N Engl J Med. 2004 Apr 29;350(18):1838-49. doi: 10.1056/NEJMoa032922.
citation: Pearson ER, Flechtner I, Njolstad PR, Malecki MT, Flanagan SE, Larkin B, Ashcroft FM, Klimes I, Codner E, Iotova V, Slingerland AS, Shield J, Robert JJ, Holst JJ, Clark PM, Ellard S, Sovik O, Polak M, Hattersley AT; Neonatal Diabetes International Collaborative Group. Switching from insulin to oral sulfonylureas in patients with diabetes due to Kir6.2 mutations. N Engl J Med. 2006 Aug 3;355(5):467-77. doi: 10.1056/NEJMoa061759.
Clinical trial NCT01097811: Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy
Official title: Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis
Keywords: Hepatic Encephalopathy
Hypertension, Portal
Liver Cirrhosis
Bacterial Overgrowth Syndrome
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Biophisics Department of Biosciences Institute - Unesp
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.


Eligibility criteria: Inclusion Criteria:

* Hepatic cirrhosis or portal hypertension
* Hepatic Encephalopathy

Exclusion Criteria:

* Acute liver failure
* Neuropsychiatric diseases
* Inflammatory bowel diseases
* Intestinal obstruction
* Shock
* Renal insufficiency
* Alcoholic hepatitis
* Alcohol abuse
* Antibiotic premedication

Primary outcomes:
measure: Recovery of hepatic encephalopathy
timeFrame: three years
Secondary outcomes:
measure: length of hospitalization caused by hepatic encephalopathy
timeFrame: three years
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - Universidade Estadual Paulista
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina de Botucatu, Unesp
name: Fernando G Romeiro
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina de Botucatu, Unesp
name: Carlos A Caramori
role: STUDY_CHAIR
References:
Clinical trial NCT01612611: Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China
Official title: A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Coronary Heart Disease
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
First posted: 2012-06-06
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all inpatients used Shenmai injection in 30 selected hospitals in mainland China

Brief summary: The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

Detailed description: Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use shenmai injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yan M Xie
role: PRINCIPAL_INVESTIGATOR
References: