louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00548535: Is Self-Reported Quality Assessment in Surgery Reliable?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients of Visceral- and Transplantation Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-10-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Aim of the study is to evaluate the reliability of self-reported surgical outcome by residents

* prospective assessment of postoperative complications done by residents using a validated five-scale complication classification
* simultanously, complications will be prospectively assessed in the same manner by an external clinical nurse
* Trial with surgical intervention


Eligibility criteria: Inclusion criteria:

* All patients undergoing elective surgery

Exclusion criteria:

* Patients not undergoing surgery
* Patient in outpatient setting

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Daniel Dindo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06026735: Non-small Cell Lung Cancer With Central Nervous System Metastasis
Official title: Comprehensive Profiling of Promising Biomarkers in Exosomes From Non-small Cell Lung Cancer With Central Nervous System Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer With Central Nervous System Metastasis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients with brain metastases or meningeal metastases.

Brief summary: Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.


Eligibility criteria: Inclusion Criteria:

- A. Non-small cell lung cancer patients diagnosed with brain metastases or meningeal metastases on brain computed tomography (CT) or magnetic resonance (MRI) images.

B. Patients with non-small cell lung cancer who are about to undergo surgical brain surgery, such as brain tumor resection, lumbar abdominal drainage, Euclidean storage, or ventriculoperitoneal drainage.

Exclusion Criteria:

- A. Non-small cell lung cancer patients without brain metastases or meningeal metastases.

B. Physical condition does not allow surgical removal of the tumor.

Primary outcomes:
measure: predict lung cancer metastasis and Bioindicators of treatment effect
timeFrame: follow 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03184935: Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
Official title: Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
mesenchymal stem cells
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.

Detailed description: This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including

* diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;
* routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;
* stem cell-based medicinal products usage, dosage, time, and course of treatment.

Then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.

Eligibility criteria: Inclusion Criteria:

* MDS patients with international prostate symptom score is moderate or severe symptoms

Exclusion Criteria:

* with serious renal function impaired
* with other organ function abnormal: acute hepatitis B, ejection fraction \< 40%, serum bilirubin \> 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease
* bad physical condition (Karmofsky \< 60%)
* without signing informed consent form
* under other therapy that possibly influence MSC security or efficacy
* HIV or other serious disease infection
* Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
* Donor/ participants: alcoholism, drug addicted, mental disease

Primary outcomes:
measure: Treatment related-adverse events counting
timeFrame: 16 weeks
Secondary outcomes:
measure: Improvement in clinical function
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
Study officials:
affiliation: Inner Mongolia International Mongolian Hospital
name: Shana Chen
role: STUDY_DIRECTOR
affiliation: China-Japan Union Hospital, Jilin University
name: Lei Guo
role: STUDY_CHAIR
References:
Clinical trial NCT00950235: Weight Management for Improved Pregnancy Outcomes
Official title: Weight Management for Improved Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Pregnancy
Keywords: obese
pregnant
large for gestational age
large for gestational age baby
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2009-07-31
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the safety and effectiveness of a dietary intervention in pregnant women. Women who are obese will be invited to participate. The control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. The intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. The goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Eligibility criteria: Inclusion Criteria:

* BMI 30 or more
* Less than 20 weeks gestation
* member of Kaiser Permanente Northwest (NW)
* receive pre-natal care at Kaiser Permanente NW
* speaks English

Exclusion Criteria:

* no current treatment for cancer
* no bariatric surgery
* no current renal disease
* no multiple birth anticipated
* no hyperemesis requiring hospitalization
* no diabetes (type 1 or 2)

Primary outcomes:
measure: Maternal Weight Change
timeFrame: baseline to 2 weeks post partum
Secondary outcomes:
measure: Pregnancy Weight Change
timeFrame: baseline to 34 weeks gestation
measure: Large for Gestational Age (LGA)
timeFrame: At birth
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Victor J Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vesco KK, Karanja N, King JC, Gillman MW, Leo MC, Perrin N, McEvoy CT, Eckhardt CL, Smith KS, Stevens VJ. Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial. Obesity (Silver Spring). 2014 Sep;22(9):1989-96. doi: 10.1002/oby.20831.
citation: Vesco KK, Karanja N, King JC, Gillman MW, Perrin N, McEvoy C, Eckhardt C, Smith KS, Stevens VJ. Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale. Contemp Clin Trials. 2012 Jul;33(4):777-85. doi: 10.1016/j.cct.2012.03.006. Epub 2012 Mar 20.
Clinical trial NCT02836535: The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
Official title: The Patient-Perspective of Complications After Colon and Rectum Surgery: A Qualitative Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: complications
surgery
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at MSK

Brief summary: The purpose of this study is to understand the patient experience with an adverse event after surgery. An adverse event is an undesirable experience or complication associated with your surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Patients who had elective surgery for a primary colorectal cancer within the last 90 days.
* Patients who either:

  * Develop an eligible complication (Appendix 1) within 30 days of surgery (n = 25 - 30)
  * Do not develop any complication after surgery (n = 25 - 30)

Exclusion Criteria:

* Multivisceral resections
* Metastatic or locally-recurrent disease
* Physical impairment that may prevent participation in an interview or survey setting
* Active psychiatric illness, cognitive or sensory impairment
* Inability to speak or understand English
* Refusal to participate in an audio-recorded interview
* Inability to participate in an audio-recorded interview for reasons not otherwise specified
* Any second surgical procedure unrelated to the complication within the 90-day period

Primary outcomes:
measure: Number of complications
timeFrame: within 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Larissa Temple, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04689035: A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144
Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenously Administered AVLX-144
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Tolerance
Lead sponsor: Avilex Pharma
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.


Eligibility criteria: Inclusion Criteria:

- Healthy male and female subjects, body mass index (BMI) 18-28 kg/m2, body weight from 50 kg (females) or 60 kg (males) up to 100 kg, good general health.

Exclusion Criteria:

- History or evidence of current clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, haematological, metabolic-endocrine, neurological, urogenital or psychiatric disorder. Febrile convulsions in childhood do not necessarily exclude a subject, but subjects with any type of generalized seizure in adulthood must be excluded. Personal or first-degree family history of congenital long QT syndrome or sudden death of a first-degree relative suspected to be due to long QT syndrome will also exclude the subject.

Primary outcomes:
measure: Safety and tolerability of AVLX-144
timeFrame: From randomisation to end of study participation
Secondary outcomes:
measure: Pharmacokinetics parameter
timeFrame: From dosing until 48 hours after dosing
measure: Pharmacokinetics parameter
timeFrame: 24 hrs
measure: Pharmacokinetics parameter AUC
timeFrame: From start to end of assessment
measure: Pharmacokinetics parameter elimination
timeFrame: From start to end of assessment
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku / CRST Oy
Study officials:
affiliation: Clinical Research Services Turku - CRST Oy
name: Mika Scheinin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592735: Effects of Medical and Surgical Weight Loss on Metabolism
Official title: The Role of Adipocyte-derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Obesity
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: morbidly obese subjects with type 2 diabetes or metabolic syndrome

Brief summary: This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.


Eligibility criteria: Inclusion Criteria:

* morbidly obese subjects with type 2 diabetes or metabolic syndrome
* age \<70

Exclusion Criteria:

* contra-indications to bariatric surgery

Primary outcomes:
measure: weight loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
Study officials:
References:
Clinical trial NCT00881335: Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Official title: Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Keywords: geriatric
pulmonary disease
flutter
sputum
physical therapy techniques
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2009-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.

Detailed description: Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.

Eligibility criteria: Inclusion Criteria:

* available to perform the device, the elders in geracomium
* male and female
* aging 85 years or more

Exclusion Criteria:

* not available to perform the procedure
* untreated pneumothorax
* diffusion interstitial lung disease
* acute coronary syndrome
* third stage hypertension
* advanced cancer
* severe heart, liver, renal, blood system and endocrine system dysfunction
* noninvasive mechanical ventilation
* active hemoptysis

Primary outcomes:
measure: Number of Cases With Fever (Body Temperature Reach 38 Degree Celsius or Higher)
timeFrame: up to 28 days
measure: MPEF,Mean Peak Expiratory Flow
timeFrame: up to 28 days
measure: FEV1, Forced Expiratory Volume at First Second
timeFrame: up to 28 days
measure: FVC, Forced Vital Capacity
timeFrame: up to 28 days
measure: FEV1/FVC%, the Ratio of FEV1 to FVC
timeFrame: up to 28 days
Secondary outcomes:
measure: Number of Cases With Antibiotics Therapy
timeFrame: up to 28 days
measure: Number of Cases With Hospital Visit
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Tebth People's Hospital
name: Zhang Xiangyu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang QX, Zhang XY, Li Q. Effects of a flutter mucus-clearance device on pulmonary function test results in healthy people 85 years and older in China. Respir Care. 2010 Nov;55(11):1449-52.
Clinical trial NCT00618735: Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
Official title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of BIIB021 Administered Once or Twice Daily to Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 68
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: The purpose of the study is to see if daily and twice daily administration of BIIB021 is tolerated in patients with advanced solid tumors.

Detailed description: Heat shock protein 90 (HSP90) inhibitors are anticipated to have clinical activity in solid tumors because Hsp90 is required for the folding, activation, and assembly of many proteins involved in cancer cell survival, proliferation, and metastasis. The maximum tolerated dose (MTX) for BIIB021 administered twice weekly in a phase I study in subjects with advanced solid tumors have been defined at 600mg. It is now reasonable from a safety perspective and desirable from a pharmacokinetic perspective to evaluate more frequent dosing intervals in solid tumors with the goal of providing more sustained and completed inhibition of Hsp90.

Eligibility criteria: Inclusion Criteria:

Subjects with histologically or cytologically confirmed solid tumor who have failed or refused standard therapies or for which no approved therapy is available.

Age greater than or equal to 18 years at the time of informed consent. ECOG performance status of less than or equal to 2. Lab values consistent with adequate renal, hepatic, and bone marrow functions.

Exclusion Criteria:

Prior antitumor therapies, including prior experimental agents or approved antitumor small molecules and biologics within 28 days and all associated toxicities resolved to eligibility levels.

Subjects with known brain metastases. Concurrent severe or uncontrolled medical disease. Must utilize effective contraception.

Primary outcomes:
measure: Safety and tolerability of BIIB021
timeFrame: As specified in protocol
Secondary outcomes:
measure: PK and PD of BIIB021
timeFrame: As specified in protocol
measure: Antitumor activity
timeFrame: As specified in protocol
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
References:
citation: Saif MW, Takimoto C, Mita M, Banerji U, Lamanna N, Castro J, O'Brien S, Stogard C, Von Hoff D. A phase 1, dose-escalation, pharmacokinetic and pharmacodynamic study of BIIB021 administered orally in patients with advanced solid tumors. Clin Cancer Res. 2014 Jan 15;20(2):445-55. doi: 10.1158/1078-0432.CCR-13-1257. Epub 2013 Oct 4.
Clinical trial NCT02453035: DESolve® X-Pand Global Post Market Registry
Official title: X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree Of Selection Criteria
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Stenosis
Keywords: bioresorbable scaffold
CAD
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2015-05-25
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have received implants of one or more DESolve scaffold(s)

Brief summary: The X-Pand Registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with DESolve in patients with CAD.

Detailed description: The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.

The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \& internal hospital guidelines.

Eligibility criteria: Inclusion Criteria:

1. Minimal age 18 years
2. Patient is willing/able to cooperate with study procedures and required follow up visits. Patient or legal representative has been informed \& agrees by signing EC approved written consent. Consent can occur before implantation of the DESolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure).
3. Planned or unplanned DESolve scaffold implantation

Exclusion Criteria:

None

Primary outcomes:
measure: TLF (Target Lesion Failure)
timeFrame: 12 months
measure: Death
timeFrame: 12 months
measure: MI
timeFrame: 12 months
measure: CABG
timeFrame: 12 months
measure: CD-TVR
timeFrame: 12 months
Secondary outcomes:
measure: Thrombosis
timeFrame: 12 months
measure: Device Success
timeFrame: day of treatment procedure
measure: Procedure Success
timeFrame: 30 days
measure: MACE
timeFrame: 3 years
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Rüsselsheim
country: Germany
facility: GPR Klinikum Rüsselsheim
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
Study officials:
affiliation: University Hospital of Toulouse
name: Jean Fajadet, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Giessen und Marburg
name: Holger Nef, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
References: