louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01165008: Anakinra in Myositis
Official title: Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polymyositis
Dermatomyositis
Inclusion Body Myositis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-07-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.

Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed


Eligibility criteria: Inclusion Criteria:

Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) \[45-47\] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.

-

Exclusion Criteria:

serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT03492008: Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation
Official title: Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation in Anesthetised Intubated Patients: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Keywords: nasogastric tube
general anesthesia
head position
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares two modified techniques(contralateral cricothyroid pressure and ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and intubated patients with the conventional technique.

Detailed description: The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious patients may be difficult, with a reported failure rate of nearly 50% on the first attempt, with the head in neutral position there are many different maneuvers to facilitate the insertion of nasogastric tube published.

Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for nasogastric tube insertion will be able to avoid the difficulty.

Therefore we are going to compare this technique with the conventional technique (head in neutral position) with lateral head turning group and contralateral cricothyroid pressure group We hope that the contralateral cricothyroid pressure will increase the success rate, as this will be helpful in intubated patients with neck pathology.

Eligibility criteria: Inclusion Criteria:

* patient who is scheduled for elective surgery under general anaesthesia requiring NGT insertion
* aged 20 to 70 years old
* with normal airway (Commack Lehane 1 or 2) and neck movements.

Exclusion Criteria:

* Patient who has nasal stenosis, nasal septal deviation, upper airway deformity, base of skull fracture, oesophageal disorders, coagulopathy, and pregnant.

Primary outcomes:
measure: Overall success rate
timeFrame: At induction of general anesthesia
Secondary outcomes:
measure: First attempt success rate
timeFrame: At induction of general anesthesia
measure: Time taken to successful nasogastric tube placement
timeFrame: At induction of general anesthesia
Other outcomes:
Locations:
Study officials:
affiliation: University of Malaya
name: Sook Hui Chaw, M.Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06543108: Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer
Official title: Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer

Brief summary: This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age over 18 years old;
2. Diagnosed as a patient with gastric cancer;
3. Receive FAPI PET/CT and FDG PET/CT imaging within one week;
4. Perform serum tumor marker testing one week before and after scanning

Exclusion Criteria:

1. History of other malignant tumors;
2. Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;
3. Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;
4. Patients with unorganized pathology or incomplete clinical data

Primary outcomes:
measure: 18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate
timeFrame: 2 years
Secondary outcomes:
measure: Detection rate of peritoneal metastasis in gastric cancer
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References:
Clinical trial NCT04399408: Instinct™ Ultrasound Device Safety, Efficacy and Usability
Official title: Mobile, Self-Operated, Home Ultrasound in Pregnancy - Safety, Efficacy and Usability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography, Prenatal
Lead sponsor: PulseNmore
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 100
Sex: FEMALE
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: Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.

Detailed description: Study includes women carrying a singleton fetus at 14 to 40 gestational weeks. Women with multiple gestations, non-viable fetus at recruitment and those with a major fetal anatomical malformation or genetic syndrome are excluded. Each participant receives the device for a self-use period of 7-14 days, instructed to preform 1-3 scans a day. Each participant completes a self-assessment questionnaire which aims to evaluate satisfactory and usability (user experience and satisfaction). Each scan will be evaluated for the possibility to properly view fetal heart activity, amniotic fluid volume, fetal tone, fetal body and breathing movements.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18.
* Pregnancy week - 14-40.
* Fetus - single, no known genetic or anatomic defects.
* Able to understand and give informed consent.

Exclusion Criteria:

* Multiple pregnancy.
* Known genetic or anatomic defect to the fetus.
* Inability to understand how to operate the device or give informed

Primary outcomes:
measure: Safety - Device related SAE's
timeFrame: Through study completion until all subject gave birth, an average of 1 year
Secondary outcomes:
measure: User experience level
timeFrame: Through study completion, an average of 1 year
measure: Usability rating
timeFrame: Through study completion, an average of 1 year
measure: Device Sensitivity level
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Eran Hadar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06513208: Ketorolac Effects on Post-operative Pain and Lumbar Fusion
Official title: Ketorolac Effects on Post-operative Pain and Lumbar Fusion: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spinal Fusion
Lead sponsor: University of Maryland St. Joseph Medical Center
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A double blind prospective randomized trial of IV Ketorolac vs. placebo in management of patients undergoing lumbar one or two level spinal fusions.

Primary objective

- To demonstrate Ketorolac results in decreased postoperative opioid use following posterior spinal fusions during the first 48 hours.

Secondary objectives

* To demonstrate that the use of Ketorolac does not decrease spinal fusion in one or two level instrumented spinal fusions.
* To demonstrate the use of Ketorolac decreases the average length of stay following spinal fusions.


Eligibility criteria: Inclusion Criteria:

* 18-85 years of age
* Elective posterior lumbar instrumented fusion
* One- or two-level fusion
* Consent to participate in study, and willing to adhere to study follow up

Exclusion Criteria:

* - - Under age of 18 y/o or over age 85.
* History of renal failure, dialysis or creatinine over 1.50mg/dl
* Active smoker or history of within the last 6 months
* Revision surgery
* Auto/worker compensation
* Active cancer or history of chemotherapy in last 6 months
* Active narcotic use within 3 months of surgery date.
* Infection at operative levels
* Any allergies to NSAIDs or Opioids

Primary outcomes:
measure: Ketorolac results in decreased post-op opioid use when administered in the first 48 hours, measured by calculating the total amount of MME utilized during the patient's inpatient stay and comparing the control and experimental groups.
timeFrame: 6 months
Secondary outcomes:
measure: Ketorolac use does not decrease spinal fusion rates in one to two level fusion. Fusion failure is measured by > than 2 degrees motion on standardized flexion/extension x-rays when compared to pre-op imaging analyzed by spinecamp software at the 6 months.
timeFrame: 6 months'
measure: Ketorolac use decreases average length of hospital stay. Length of stay for both the control group and the experimental group will be counted, and a statistical average for each group will be calculated and compared.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01960608: The Analysis of Correlation About the Spot Urine Sodium and the Blood Pressure in General Population According to the Income Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-10-10
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: general population

Brief summary: Increasing sodium intake raises blood pressure. And high salt intake could hinder the management of chronic disease. Much previous research has confirmed that dietary habits are affected by economic status. So we compared sodium intake with economic status. We investigated the prevalence, extent and management, and the relevance of sodium intake with income level.


Eligibility criteria: Inclusion Criteria:

* all the patient who participated in the national survey

Exclusion Criteria:

* no pregnancy
* malignancy

Primary outcomes:
measure: sodium intake and the degree of control of blood pressure in general population according to the income level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
Study officials:
References:
Clinical trial NCT06693908: A Study to Evaluate the Activity, and Safety of Vixarelimab in Participants With Moderate to Severe Active Ulcerative Colitis
Official title: A Phase Ic Open-label Study to Evaluate the Pharmacodynamic Effects, Pharmacokinetics, and Safety of Vixarelimab in Patients With Moderate to Severe Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Moderate to Severe Ulcerative Colitis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the pharmacodynamic (PD) effects of vixarelimab in the gut of participants with active moderate to severe ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of UC established at least 3 months
* Moderately to severely active UC
* Participants must meet criteria for either advanced therapy failure or conventional therapy failure

Exclusion Criteria:

* Diagnosis of Crohn's disease or indeterminate colitis
* Suspicion of ischemic colitis, radiation colitis, microscopic colitis or infectious colitis
* Prior colectomy
* Prior treatment with systemic janus kinase (JAK) inhibitors

Primary outcomes:
measure: Change From Baseline in Fibroblast Products From Colonic Tissue
timeFrame: Baseline up to approximately 3 months
Secondary outcomes:
measure: Serum Concentration of Vixarelimab
timeFrame: Up to approximately 3 months
measure: Number of Participants with Anti-drug Antibodies (ADA) to Vixarelimab
timeFrame: Up to approximately 3 months
measure: Number of Participants With Adverse Events (AEs), With Severity Determined According to Division of AIDS (DAIDS) Toxicity Grading Scale
timeFrame: Up to approximately 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01309308: Sweeping the Membranes, Cervical Length and Duration of Labor
Official title: The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Amniotic Cavity and/or Membrane
Keywords: cervical length
sweeping the membranes
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2011-03-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.

Detailed description: Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.

Eligibility criteria: Inclusion Criteria:

* The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.

Exclusion Criteria:

* Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.

Primary outcomes:
measure: Cervical Shortening
timeFrame: 2days
Secondary outcomes:
measure: The Duration of Latency Until Labor
timeFrame: 15 days
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi
Study officials:
affiliation: Baskent University
name: Huriye A Parlakgumus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parlakgumus HA, Yalcinkaya C, Haydardedeoglu B, Tarim E. The impact of sweeping the membranes on cervical length and labor: a randomized clinical trial. Ginekol Pol. 2014 Sep;85(9):682-7.
Clinical trial NCT00002308: A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs
Official title: A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Stavudine
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV positivity with CD4 count \< 300 cells/mm3.
* Intolerance to or failure on approved antiretroviral therapy.
* Ability to provide informed consent (of parent or guardian if appropriate).

NOTE:

* Incarcerated persons may be eligible to participate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Grade 2 or worse disease-related peripheral neuropathy.
* Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
* Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
* Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).

Strongly discouraged:

* AZT, ddI, ddC, and other antiretroviral agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol - Myers Squibb Co
state: New Jersey
Study officials:
References:
Clinical trial NCT02917408: Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Official title: Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangitis
Liver Cirrhosis, Biliary
Cholestasis
Liver Diseases
Liver Cirrhosis
Bile Duct Diseases
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 769
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.

Brief summary: Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.

Exclusion Criteria:

* Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.

Primary outcomes:
measure: Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.
timeFrame: Up to 16 years.
Secondary outcomes:
measure: Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.
timeFrame: Up to 16 years.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital,Chengdu, Sichuan, China
name: Li Yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04963608: RWS of Inetetamab HER2 Positive Advanced Breast Cancer
Official title: Real World Study of Inetetamab HER2 Positive Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Advanced Breast Cancer
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2+ advanced breast cancer patients whose treatment decision with Inetetamab has been made by their physician and who meet the eligibility criteria will be invited to participate in the study

Brief summary: This non-Interventional study will describe and analyze the clinical use of Inetetamab in clinical practice in the treatment of HER2 positive advanced breast cancer in the real world.


Eligibility criteria: Inclusion Criteria:

1. Patients with stage IV breast cancer
2. Patients with HER2 positive status
3. Patients that received Inetetamab
4. Patients that began Inetetamab therapy prior to June 30, 2021.

Exclusion Criteria:

Patients treated with an investigational anticancer agent Inetetamab

Primary outcomes:
measure: Progression Free Survival(PFS)
timeFrame: 12 months
measure: Incidences of adverse events and toxicities
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: