louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00236223: The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery
Official title: The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Primary hip replacement
Gabapentin
Dexamethasone
Ketamine
Multimodal postoperative analgesia.
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.

Detailed description: The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for primary total hip replacement,
* Between 55 and 85 years of age,
* ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

* Unable to cooperate
* Does not speak Danish
* Has allergy for drugs used in the trial
* Drug or alcohol abuse
* Epilepsy
* Medically treated diabetes
* Known kidney disease
* Daily use of analgetics
* Apart from NSAID
* Paracetamol or COX2 inhibitors
* Are treated with a antidepressive.

Primary outcomes:
measure: The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
timeFrame: 0-24h
Secondary outcomes:
measure: Pain score (VAS)= at rest and at mobilisation.
timeFrame: 0-24h
measure: Postoperative Nausea and vomiting.
timeFrame: 0-24h
measure: Dizziness
timeFrame: 0-24h
measure: Sedation
timeFrame: 0-24h
measure: Nightmare and hallucinations.
timeFrame: 0-24h
measure: All measurements are taken at 2,4 and 24 h postoperatively.
timeFrame: 0-24h
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Operations og Anæstesiologisk afd. Y, KAS Glostrup
city: Herning
country: Denmark
facility: Anæstesiafdelingen, Herning Centralsygehus
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
name: Ole Mathiesen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04513223: A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
Official title: Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Gastric Cancer
Colorectal Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-14
Enrollment: 101
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: This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
* At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
* Has an ECOG PS 0-1.
* Has a life expectancy of ≥ 3 months.
* Has adequate organ function

Exclusion Criteria:

* Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
* Has received HER2 antibody drug conjugates,.
* Central nervous system metastasis or meningeal metastasis with clinical symptoms
* Has active infection requiring systemic treatment.

Primary outcomes:
measure: DLT and the recommended Phase 2 dose (RP2D)
timeFrame: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00306423: Rehabilitation Post Lumbar Microdiscectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Disorder
Keywords: exercise
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2006-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a rehabilitation program following lumbar microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in quality of life, activity and endurance.

Detailed description: Exercise

Eligibility criteria: Inclusion Criteria:

* 18-60 years old
* Single level lumbar microdiscectomy

Exclusion Criteria:

* Potential subjects will be excluded is they exhibit symptoms suggestive of facet arthrosis or neurogenic claudication, or if their plain radiographs showed more than 50 percent loss of disc height at the relevant level.
* Patients in whom the protrusion occupied more than 50 percent of the sagittal diameter of the spinal canal or in whom sequestrated fragments were seen on MRI will also be excluded.

Other exclusion criteria will include:

* Previous back surgeries
* Presence of any other concurrent foot pathology besides leg and low back pain and associated single level disc injury
* Nervous system problems (e.g., stroke, dementia, seizures)
* Cognitive dysfunction (e.g. TBI, CVA, Alzheimer's)
* Uncontrolled cardiovascular disease
* Evidence of cord compression
* Uncontrolled hypertension
* Infection
* Severe respiratory disease
* Pregnancy
* Rheumatic joint disease
* Peripheral vascular disease with sensory loss of the foot
* Any condition that the subject identifies that might limit participation in physical activity

Primary outcomes:
measure: ODI
timeFrame: pre and post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Kornelia Kulig, PhD, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT05678023: Study About Contrast Media
Official title: Multicentre Randomized Trial on the Timing and Effect of Contrast Media on Patients with Adhesive Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Bowel Obstruction
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: North Estonia Medical Centre
First posted: 2023-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients hospitalized with adhesive small bowel obstruction (SBO) are randomized to 2 study groups at admission after signing an informed consent form. Water-soluble contrast media (CM) will be administered after 4 or after 24 hours of nasogastric- tube decompression.

Detailed description: Patients presenting with symptoms of small bowel obstruction (SBO) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice.

If immediate surgery is needed- it will not be delayed If patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (CM) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression.

Contrast media challenge acquires radiographs (X-rays) to be taken after an interval (common practice) decided by the surgeon.

If at any point patient needs surgery- it will not be delayed. The results are compared. The hypothesis is, that if CM is administered sooner- it will help SBO resolution

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older
* Adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation
* No peritonitis present, no need for an emergent surgery
* Patients sign an informed consent

Exclusion Criteria:

* Patients younger than 18 yeas
* Patients with mechanical small bowel obstruction caused by incarcerated hernias
* Patients with mechanical small bowel obstruction caused by carcinomatosis
* Patients with paralytic small bowel obstruction
* Patients who have undergone surgery within 6 weeks
* Patients who do not want to be enrolled in the study

Primary outcomes:
measure: SBO resolution
timeFrame: Period of hospitalization- approximately 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: University of Tartu
name: Liis Jaanimäe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03232723: Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG
Official title: Imaging Non-brain Electromagnetic Activity in Healthy Adults Using MEG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Magnetoencephalography
Whole-cortex MEG System (with optional EEG)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The primary purpose of this study is to determine the effectiveness of the Magnetoencephalography (MEG) instrument to record electrical activity from parts of the body other than the brain. This study will examine if electrical activity from parts of the body, other than the brain, can be imaged by the MEG instrument. Finding will contribute to studies of pain, since abnormal electrical activity in skeletal muscle is the basis of pain, which can be severe, yet there is no non-invasive way to image this abnormal activity. This is particularly relevant to deep muscle pain and back pain.


Eligibility criteria: Inclusion Criteria:

* Healthy adults who are willing and able to provide informed consent.

Exclusion Criteria:

* Subjects with characteristics incompatible with MEG recordings as listed on the MEG Safety checklist (Appendix A),
* Involuntary, uncontrolled tremor,
* chronic pain.
* pregnant women (based on self-report).

Primary outcomes:
measure: Determination of optimal position to obtain safe and effective imaging of structures other than the brain.
timeFrame: 2 Weeks
measure: Evoked activity to obtain safe and effective imaging of structures other than the brain
timeFrame: 2 Weeks
Secondary outcomes:
measure: Dominant frequency of non-brain electrical activity in healthy adults.
timeFrame: 2 Weeks
measure: Location of non-brain of activity in healthy adults.
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Rodolfo Llinas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064423: Clinical Trials Outreach & Education
Official title: Clinical Trials Outreach & Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-10-01
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to provide education and information about clinical trials and clinical trials participation. Investigators also aim to see if education makes a difference in increasing knowledge of clinical trials and clinical trials participation.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Able to provide informed consent
* Reside in the Tampa Bay Area (Hillsborough, Pinellas, Polk or Pasco county)

Primary outcomes:
measure: Change in Participants Clinical Trials Knowledge
timeFrame: Change from baseline to immediately after receiving intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Clement K Gwede, PhD, MPH, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787523: Rectrospect - a Retrospective Study of Treatment Response
Official title: Rectrospect - a Study on the Immun Cell Infiltrate in a Retrospective Rectal Cancer Cohort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with neoadjuvant treatment between 2007-2019

Brief summary: Biopisies from patients diagnosed with rectal cancer between 2007-2019 will be cut into 4-6 micrometer thin sections for morphology and immunostaining. Every section will be numbered with a code that is connected to the patients personal identification number and the code list will be kept separately from the biopsies in a password protected file on the Sahlgrenska University Hospital server.

Patient data and outcome regarding response to treatment will be collected from patient charts and the Swedish ColoRectal Cancer Registry, but all data will be numbered with the same code number and all results will be kept away from the code list. In order to achieve the stated aims, that is, to study how the molecular and cellular characteristics of the tumour and its surrounding microenvironment as well as the interaction of tumour cells and immune cells affect treatment response, several molecular and cellular techniques and assays may be applied.


Eligibility criteria: Inclusion Criteria:

* Rectal cancer and treatment between 2007 and 2019

Exclusion Criteria:

* No rectal cancer or no neoadjuvant treatment

Primary outcomes:
measure: Immun cell infiltrate in pathology sections from the tumour
timeFrame: Biopsies taken preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT02643823: Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Official title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Rheumatoid Arthritis
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Futian People's Hospital
First posted: 2015-12-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.

To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-80 Rheumatoid Arthritis patient;
* Patients must consent in writing to participate in the study by signing and dating an informed consent document;
* Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
* Stage I and II according to X-ray.

Exclusion Criteria:

* History of neurological disease, head injury or psychiatric disorder;
* Pregnant women;
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
* Progressive apoplexy;
* With malignant tumors;
* Patients who had participated in other clinical trials within three months prior to this study.

Primary outcomes:
measure: Severity of adverse events
timeFrame: 12 months
Secondary outcomes:
measure: RA Serology
timeFrame: 1, 3 ,6 and 12 months
measure: Disease Activity Score (DAS 28) Index
timeFrame: 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Fourth People's Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: Futian People's Hospital
name: Zhong Z Ye, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390023: Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples
Official title: Finding Opportunities for Clinical Care and Trial Participation Among Underrepresented Samples: An Administrative Supplement to the ADORE Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: Prenatal Care
Barriers
Clinical Trials
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Focus group participants will be identified both from community health fairs, community events and from local obstetrics and gynecology clinics.

Brief summary: Focus groups for Hispanic women who are pregnant and their close family members to assess attitudes, barriers and cultural beliefs involved in participation in clinical trials

Detailed description: This is a qualitative study conducted with Hispanic pregnant women and their families. Focus groups for Hispanic pregnant women will run concurrent to groups for their close family member, but in separate rooms. Each focus group session of approximately 8-10 participants is expected to last 60-90 minutes and will be led by an experienced moderator who is fluent in Spanish. All discussions will be audio taped and will be kept confidential. Information learned will be used to refine clinical trial procedures and ensure our model of recruitment and retention in the parent ADORE Trial (NCT02626299) is culturally and linguistically acceptable and feasible.

Eligibility criteria: Inclusion Criteria:

* Hispanic women between the ages of 18.0-49.99 yrs old who have been pregnant within the past 5 years OR a close family member
* Speak and understand Spanish

Exclusion Criteria:

-

Primary outcomes:
measure: Exploratory results from focus groups: access to and attitudes towards prenatal care
timeFrame: 1 year
measure: Exploratory results from focus groups: access to and attitudes towards clinical trials
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Susan Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References: