louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03700541: Influence of Opioid Analgesia on Circulating Tumor Cells in Laparoscopic Colorectal Cancer Surgery
Official title: Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Circulating Tumor Cell
Keywords: Perioperative analgesia
Colorectal Cancer
Circulating Tumor Cell
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
Collaborators: name: General University Hospital, Prague
name: Tomas Bata Hospital, Czech Republic
name: University Hospital Ostrava
name: Hospital Novy Jicin
First posted: 2018-10-09
Enrollment: 71
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: To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.


Eligibility criteria: Inclusion Criteria:

* patients undergoing open radical surgery for colorectal cancer
* age over 18 years
* signed informed consent

Exclusion Criteria:

* intolerance of the study drugs
* history of CRC surgery
* neoadjuvant therapy
* other malignancy not in permanent remission
* chronic opioid medication or opioid administration within 7 days preoperatively
* immunosuppressive or corticosteroid therapy
* surgery within 30 days preoperatively (except minor)
* chronic or acute infection

Primary outcomes:
measure: Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
timeFrame: 1 - 3 days before surgery to 4 weeks after surgery
Secondary outcomes:
measure: Pain assessment
timeFrame: Time Frame: 3 days postoperatively
Other outcomes:
Locations:
city: Zlin
country: Czechia
facility: T. Bata Regional Hospital Zlin
state: Jihomoravsky Kraj
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: General University Hospital
Study officials:
affiliation: Institute of Molecular and Translational Medicine, Palacky University, Olomouc
name: Marian Hajduch, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735241: FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
Official title: Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Carcinoma
Liver Metastases
Keywords: colon cancer
colorectal cancer
liver metastases
SIR-Spheres Microspheres
yttrium-90
FOLFOX
Bevacizumab
chemo-radiation
Lead sponsor: Sirtex Medical
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 0
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: This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum.
* Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
* ECOG performance status 0 - 1.
* Adequate hematological, renal and hepatic function.

Exclusion Criteria:

* Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
* Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
* Previous radiotherapy delivered to the upper abdomen.
* Peripheral neuropathy \> grade 1 (NCI-CTCv3).

Primary outcomes:
measure: Toxicity and safety
timeFrame: from study entry until 28 days after last cycle of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
Study officials:
affiliation: Rocky Mountain Cancer Center
name: Dennis Carter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skye Ridge Medical Center
name: Charlie Nutting, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05187741: Effect of a Mobile Health Intervention on Treatment Adherence
Official title: Effect of an Mobile Health Intervention on Adherence to Antiretroviral Treatment in Adult Patients Living With HIV Compared to Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV I Infection
Keywords: electronic health
adherence
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized clinical trial across the whole of the patients who attend the HIV Unit of the Hospital Civil Viejo, a sample calculated in 43 patients for each group (intervention and control). Patients who have HIV infection and are starting antiretroviral treatment (ART), who are between 18 and 50 years old and have a mobile device, will be included in the study. The messages will consist of medical appointment reminders and adherence and motivational messages for a period of six months.


Eligibility criteria: Inclusion Criteria:

* Recently diagnosed with HIV infection

  . starting with antiretroviral therapy and haven't taken ART before
* Patients with the status of "lost to follow up" who return to re-initiate ART

Exclusion Criteria:

* Patients who are participating in other study
* patients above 18 years old
* Patients who does not have signal phone at their residency
* Those who refuses to participate in the study

Primary outcomes:
measure: antiretroviral treatment adherence
timeFrame: 6 months
Secondary outcomes:
measure: care retention
timeFrame: 6 months
measure: HIV viral loal
timeFrame: 6 months
measure: TCD4+ count in blood
timeFrame: 6 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"
state: Jalisco
Study officials:
References:
Clinical trial NCT02802241: Effects of Open-label vs Double-blind Treatment in IBS
Official title: Effects of Open-label vs Double-blind Treatment in IBS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Placebo Effect
Placebos
Peppermint Oil
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-06-16
Enrollment: 340
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: The purpose of this study is to investigate placebo effects and peppermint oil in Irritable Bowel Syndrome.


Eligibility criteria: Inclusion Criteria:

* Meet Rome IV diagnostic criteria for IBS

Primary outcomes:
measure: Change in Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS) From Baseline to Six Weeks.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: Lembo A, Kelley JM, Nee J, Ballou S, Iturrino J, Cheng V, Rangan V, Katon J, Hirsch W, Kirsch I, Hall K, Davis RB, Kaptchuk TJ. Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial. Pain. 2021 Sep 1;162(9):2428-2435. doi: 10.1097/j.pain.0000000000002234.
citation: Ballou S, Kaptchuk TJ, Hirsch W, Nee J, Iturrino J, Hall KT, Kelley JM, Cheng V, Kirsch I, Jacobson E, Conboy L, Lembo A, Davis RB. Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial. Trials. 2017 May 25;18(1):234. doi: 10.1186/s13063-017-1964-x.
Clinical trial NCT04875741: Comparative Effects of Neural Mobilization and Muscle Energy Technique in Sciatic Patients
Official title: Comparative Effects of Neural Mobilization and Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Sciatica:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Sciatica
Pain
Keywords: Neural mobilization
Muscle energy technique
Sciatica
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 72
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, investigator will see the effects of neural mobilization in comparison to the muscle energy technique in the patients suffering from sciatica. Impact of the these two interventional techniques , there out come measures i.e pain, range of motion and functional disability.

Detailed description: This study is aimed in comparison among two interventional techniques i.e neural mobilization and muscle energy technique patients with sciatica. This study will be a randomized controlled trial with double blinded protocol, patients will be randomly allocated in to the two groups. one is the neural mobilization technique group and other is the muscle energy technique group. both of the groups have the conventional physical therapy in addition to these two interventions. data will be collect from the patients.30 minutes session twice a week will be given to the patients in each group. assessment will be done by using visual analog scale, Goniometer, Modified Oswestry Disability Index. Data will be entered and analyzed by using SPSS.

Eligibility criteria: Inclusion Criteria:

* • Both genders

  * Between the ages group of 35-60 years
  * Patients with diagnosis of Sciatica.
  * Straight Leg Raise\< 45°.
  * Having symptoms from past one month.

Exclusion Criteria:

* Inflammatory or other specific disorders of the spine such as ankylosing spondylitis, vertebral collapse, rheumatoid arthritis, stenosis, spondylolysthesis and osteoporosis.

  * History of any previous spinal surgical intervention
  * Symptomatic bilateral radiculopathy
  * Presence of any of red flags related to spinal column
  * History of involvement in any exercise program for lower extremity in recent time

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6 weeks
measure: Goniometry
timeFrame: 6 weeks
measure: Modified Oswestry Disability Index
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Safi Hospital
state: Punjab
Study officials:
affiliation: The University of Lahore
name: AHMAD Wassi, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174641: Test of Trans-cranial Magnetic Stimulation (TMS) Intervention on Unilateral Neglect
Official title: A Randomised Double-blind Test of TMS Intervention on Unilateral Neglect
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: unilateral neglect
TMS intervention
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: The Stroke Association, United Kingdom
First posted: 2010-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Problems in attention can affect around 40% of stroke survivors and are associated with poor recovery of function. This project will provide the largest scale and most detailed examination to date of whether problems in attention after stroke can be remediated through direct brain stimulation. In Part 1 of the project the investigators will use two forms of direct brain stimulation (neural inhibition) to try and balance activity across the two sides of the brain following a stroke to one side. The investigators will assess whether each form of stimulation leads to an improvement in attentional functions, as well as to wider improvements in other cognitive abilities and to activities of everyday living. Performance will be tested immediately post remediation and on longer-term follow-up, and performance of the two intervention groups will be assessed against data the investigators have collected from a large-scale screen of cognitive impairments and recovery of function under standard treatment conditions. In Part 2 of the project the investigators will take the most promising intervention from Part 1 and the investigators will use magnetic resonance imaging (MRI) to determine the brain changes that are linked to the recovery of attentional functions. The investigators will test whether recovery is linked to a change in the balance of activation within the two hemispheres of the brain, and whether there are associated structural changes in cortical tissue and fibre tracts. The project will evaluate whether neural inhibition can improve attentional functions in particular, and cognitive abilities and everyday activities more generally, in stroke survivors. It will also provide novel information on how recovery of function comes about within the brain.


Eligibility criteria: Inclusion Criteria:

* presence of left unilateral neglect after right hemisphere stroke

Exclusion Criteria:

* presence of epilepsy/family history of epilepsy
* insufficient comprehension to follow instructions

Primary outcomes:
measure: Standardised measure of visual neglect
timeFrame: 9 months
Secondary outcomes:
measure: measure of working memory
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
state: West Midlands
Study officials:
affiliation: University of Birmingham
name: Glyn Humphreys, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00061841: Medical College of Georgia FitKid Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-06-06
Enrollment: 685
Sex: ALL
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will determine whether exposing youths to a "fitogenic" after-school environment that emphasizes vigorous exercise and healthy snacks will have a favorable effect on body composition (i.e., less fat tissue and more lean tissue), cardiovascular fitness and cardiovascular disease risk profile. The environmental intervention will be provided in nine schools in Augusta, Georgia, with another nine schools serving as non-intervention comparison schools. Children in the 3rd grade will be recruited to participate. They will be followed for 3 years, through the 5th grade. Measurements will be made at the beginning and end of each school year. The 2-hour after-school intervention will be offered every school day. It will consist of three components: (1) homework assistance; (2) a healthy snack; and (3) exercise designed to improve skills and fitness.


Eligibility criteria: 3rd graders in schools chosen to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
Study officials:
References:
citation: Yin Z, Moore JB, Johnson MH, Vernon MM, Gutin B. The impact of a 3-year after-school obesity prevention program in elementary school children. Child Obes. 2012 Feb;8(1):60-70. doi: 10.1089/chi.2011.0085.
Clinical trial NCT01428141: A Phase I Study of E7050 in Subjects With Solid Tumors
Official title: A Phase I Study of E7050 in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Gastric Cancer
Keywords: Cancer
Gastrointestinal Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: 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 the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.


Eligibility criteria: Inclusion Criteria

1. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
2. Histological or cytological diagnosis of solid tumors.
3. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
4. Adequate organ function.
5. Subjects who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
6. Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
7. Expected to survive for 3 months or longer after starting administration of the investigational drug.

Exclusion Criteria

1. Females who are pregnant or breastfeeding.
2. Brain metastases with clinical symptoms or which requires treatment.
3. Serious complications or disease history.
4. Subjects who cannot take oral medication.
5. Using antiplatelet/anticoagulant drugs.
6. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
7. Scheduled for surgery during the study period.
8. Known to be HIV, HBV or HCV positive.
9. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years.
10. History of drug or alcohol dependency or abuse within 2 years.
11. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
12. Received any other investigational product or device within 4 weeks before administration.

Primary outcomes:
measure: Determination of the maximum tolerated dose (MTD)
timeFrame: During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Sunto
country: Japan
state: Shizuoka
Study officials:
affiliation: Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
name: Hiroshi Obaishi
role: STUDY_DIRECTOR
References:
Clinical trial NCT05018741: Prognostic Factors After Liver Transplantation
Official title: Prognostic Factors After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Liver Transplant; Complications
Keywords: liver transplantation
chronic liver disease
viral hepatitis
alcoholic liver disease
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute liver failure or chronic liver disease due to different etiologies received liver transplantation

Brief summary: The study retrospectively reviewed the medical records of patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019. We collected their personal data about liver disease, laboratory data about liver function, pre-transplant evaluation and post-transplant outcome. We investigate what prognostic factors may contribute a good survival outcome, and improve our clinical practice.


Eligibility criteria: Inclusion Criteria:

* patients who received adult liver transplantation in Changhua Christian hospital from 2002 to 2019

Exclusion Criteria:

* patients who did not have suitable donor for liver transplantation

Primary outcomes:
measure: number of participants with morbidity and mortality after surgery
timeFrame: upto one month after surgery
Secondary outcomes:
measure: long-term survival rate
timeFrame: upto 5 years after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of General Surgery, Changhua Christian Hospital, Changhua, Taiwan
name: Yao-Li Chen
role: STUDY_CHAIR
References:
citation: Lee SG, Hwang S, Moon DB, Ahn CS, Kim KH, Sung KB, Ko GY, Park KM, Ha TY, Song GW. Expanded indication criteria of living donor liver transplantation for hepatocellular carcinoma at one large-volume center. Liver Transpl. 2008 Jul;14(7):935-45. doi: 10.1002/lt.21445.
citation: Chang Y, Cho Y, Lee JH, Lee YB, Cho EJ, Yu SJ, Sinn DH, Kim BH, Kim SH, Yi NJ, Lee KW, Kim JM, Park JW, Kim YJ, Yoon JH, Joh JW, Suh KS. Comparison of Models for Tumor Recurrence after Liver Transplantation for the Patients with Hepatocellular Carcinoma: A Multicenter Long-Term Follow-Up Study. Cancers (Basel). 2019 Sep 3;11(9):1295. doi: 10.3390/cancers11091295.
citation: Mazzaferro V, Llovet JM, Miceli R, Bhoori S, Schiavo M, Mariani L, Camerini T, Roayaie S, Schwartz ME, Grazi GL, Adam R, Neuhaus P, Salizzoni M, Bruix J, Forner A, De Carlis L, Cillo U, Burroughs AK, Troisi R, Rossi M, Gerunda GE, Lerut J, Belghiti J, Boin I, Gugenheim J, Rochling F, Van Hoek B, Majno P; Metroticket Investigator Study Group. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis. Lancet Oncol. 2009 Jan;10(1):35-43. doi: 10.1016/S1470-2045(08)70284-5. Epub 2008 Dec 4.