louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04028947: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty
Official title: Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty: a Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Pain Chronic
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Researchers are trying to determine if knee pain can be reduced by proactively protecting the free end of the saphenous nerve versus leaving it in the standard position during total knee arthroplasty.

Detailed description: Subjects scheduled for total knee arthroplasty will be randomized to two arms. One arm will have the standard saphenous nerve neurectomy during their surgery. The other arm will have the same neurectomy procedure with the free end of the nerve tucked into soft tissue to protect the nerve ending.

Eligibility criteria: Inclusion Criteria:

* Primary unilateral total knee arthroplasty candidate

Exclusion Criteria:

* Body Mass Index (BMI) \>40
* Inflammatory arthritis
* Unable to follow up visits (long distance from Mayo Clinic)
* Poor compliance risk
* Health condition deemed by physician to preclude patient's ability to participate in the trial

Primary outcomes:
measure: Pain after surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Glenn G Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191347: A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
Official title: A Phase II Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 30
Sex: FEMALE
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 study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine regimen when given to patients with metastatic breast cancer. Each agent has well demonstrated antitumor activity in patients with locally advanced or metastatic breast cancer. In addition, in the phase I combination trial of the two agents, a durable tumor response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al. 2000). Therefore, it is reasonable to expect that the combination of pemetrexed and gemcitabine administered may be associated with considerably more anti-tumor activity than either agent alone. If such activity is seen in this study, randomized studies comparing this combination with other active agents or combinations of active agents will be considered.


Eligibility criteria: INCLUSION:

1. Have a performance status of 0 to 2 on the ECOG performance status schedule.
2. Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
3. Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
4. Have adequate organ function including the following

EXCLUSION:

1. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.

Primary outcomes:
measure: To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)
Secondary outcomes:
measure: To measure time-to-event efficacy variables including: time to objective tumor response for responding patients, duration of response for responding pts, time to treatment failure, time to progressive disease, progression free survival, overall survival
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Ontario
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours,EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06389747: Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness
Official title: Effect of Blood Flow Restriction Technique on Pain, Muscle Tone and Strength in Delayed Muscle Soreness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain Intensity
Keywords: pain
muscle strength
muscle tonus
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.

Detailed description: All participants will be taken into the DOMS creation protocol. Participants will then be divided into 80% intensity BFR and 20% intensity Blood Flow Restriction technique (BFR) groups and will be included in an exercise protocol accompanied by BFR application.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months)

Exclusion Criteria:

* Having a previous musculoskeletal system injury
* Having a condition that prevents resistance exercise
* Having cardiovascular disease
* Using medication for blood pressure control

Primary outcomes:
measure: Visual analog scale
timeFrame: 2 months
measure: myoton
timeFrame: 2 months
measure: dynamometer
timeFrame: 2 months
measure: dolorimeter
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gamze Aydın
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
References:
Clinical trial NCT00737347: Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Official title: Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Obesity
Keywords: type 2 diabetes
obesity
weight gain
thiazolidinediones
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2008-08-19
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

Detailed description: The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

Exclusion Criteria:

* insulin treated

Primary outcomes:
measure: change in body weight
timeFrame: 24 weeks
Secondary outcomes:
measure: change in body composition
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital Wellness Institute
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert F Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03382847: HCV Positive Heart Donors
Official title: A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.


Eligibility criteria: Inclusion Criteria:

* Listed for an isolated heart transplant at NYU Langone Health
* Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
* No active illicit substance abuse
* Weight at least 50kg
* Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
* Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
* Able and willing to provide informed consent

Exclusion Criteria:

* HIV positive
* HCV RNA positive or history of previously treated HCV
* Hepatitis B surface antigen positive or on active antiviral treatment for HBV
* Pregnant or nursing (lactating) women
* Use of strong CYP3A inducers

Primary outcomes:
measure: Sustained Virologic Response After Treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Transplant Institute
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alex Reyentovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784847: A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Official title: A Pilot Trial of Triheptanoin for the Preventive Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Migraine
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A pilot trial of triheptanoin, a natural compound able to promote anaplerotic mitochondrial metabolism, for the preventative treatment of migraine.

Detailed description: To test the ability of a daily 3-month treatment with triheptanoin to prevent migraine attacks in 10 migraine patients.

This is an open, non-randomized pilot trial that might justify a placebo-controlled trial, if there are at least 50% of patients with ≥50% reduction in attack frequency.

Eligibility criteria: Inclusion Criteria:

* Females aged 18-65 years old having an effective contraception or being menopaused
* Diagnosis of migraine without aura (ICHD3beta 1.1) since at least 2 years
* 4-10 migraine days per month during the last 3 months
* No preventive anti-migraine therapy during the last month

Exclusion Criteria:

* \> 4 tension-type headache episodes per month
* Medication overuse headache or other headache types
* Resistance to \>3 previous preventive anti-migraine drug treatments
* Any serious medical or psychiatric condition
* On-going or previous bowel disorder

Primary outcomes:
measure: Change in monthly migraine days
timeFrame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Secondary outcomes:
measure: Change in mean attack severity
timeFrame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
measure: Change in mean attack duration
timeFrame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
measure: Number of patients who have at least a 50% reduction in monthly migraine days
timeFrame: Between the 1-month baseline and the 3rd month of triheptanoin treatment
Other outcomes:
measure: Tolerance and gastrointestinal adverse effects
timeFrame: During the 3 months of triheptanoin treatment
Locations:
Study officials:
affiliation: University Hospital Liège
name: Jean Schoenen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04890847: A Platform for Multidisciplinary Medical Artificial Intelligence Development
Official title: A Platform for Multidisciplinary Medical Artificial Intelligence Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medical Artificial Intelligence
Medical Imaging
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: medical imaging for multiple disciplines including ophthalmology, pathology, radiography, blood cells, and endoscopy

Brief summary: Biomedical deep learning (DL) often relies heavily on generating reliable labels for large-scale data and highly technical requirements for model training. To efficiently develop DL models, we established an integrated platform to introduce automation to both annotation and model training-the primary process of DL model development. Based on this platform, we quantitively validated and compared the annotation strategy and AI model development with the pure manual annotation method performed on medical image datasets from multiple disciplines.


Eligibility criteria: Inclusion Criteria:

* have medical imaging record (including ophthalmology, pathology, radiography, blood cells, and endoscopy)

Exclusion Criteria:

* unqualified medical imaging

Primary outcomes:
measure: annotation accuracy
timeFrame: baseline
Secondary outcomes:
measure: accuracy of model performance
timeFrame: baseline
measure: AUC of model performance
timeFrame: baseline
measure: annotation time cost
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Haotian Lin, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01532947: Randomized Controlled Trial of Fiber Post Restorations
Official title: Survival of Endodontically Treated and Restored Premolars: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restoration Survival
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This in vivo study examined the contribution of remaining coronal dentin and placement of a prefabricated or customized fiber post to the six-year survival of endodontically treated premolars. A sample of 345 patients provided 6 groups of 60 premolars in need of endodontic treatment. Groups were classified according to the number of remaining coronal walls before abutment build-up. Within each group, teeth were allocated to three subgroups: A) no post-retention; B) LP; C) ES (N=20). All teeth were protected with a crown. Cox regression analysis was applied to assess whether the amount of residual coronal dentin and the type of endocanalar retention had a significant influence on failure risk of the restored teeth.


Eligibility criteria: Inclusion Criteria:

* endodontically treated premolars with symptom-free root canal filling and a minimum apical seal of 4 mm, in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.

Exclusion Criteria:

* periapical lesion on the X-ray.

Primary outcomes:
measure: survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ferrari M, Sorrentino R, Juloski J, Grandini S, Carrabba M, Discepoli N, Ferrari Cagidiaco E. Post-Retained Single Crowns versus Fixed Dental Prostheses: A 7-Year Prospective Clinical Study. J Dent Res. 2017 Dec;96(13):1490-1497. doi: 10.1177/0022034517724146. Epub 2017 Aug 3.
citation: Juloski J, Fadda GM, Monticelli F, Fajo-Pascual M, Goracci C, Ferrari M. Four-year Survival of Endodontically Treated Premolars Restored with Fiber Posts. J Dent Res. 2014 Jul;93(7 Suppl):52S-58S. doi: 10.1177/0022034514527970. Epub 2014 Mar 19.
citation: Ferrari M, Vichi A, Fadda GM, Cagidiaco MC, Tay FR, Breschi L, Polimeni A, Goracci C. A randomized controlled trial of endodontically treated and restored premolars. J Dent Res. 2012 Jul;91(7 Suppl):72S-78S. doi: 10.1177/0022034512447949.
Clinical trial NCT06469047: Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia
Official title: Relationship Between Serum N/OFQ and Acute Myeloid Cell Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: AML
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Second Hospital of Shanxi Medical University from June 2022 to November 2023

Brief summary: Patients diagnosed with acute myeloid leukemia in the Second Hospital of Shanxi Medical University were selected and divided into the newly diagnosed group, the relapsed group, the complete remission group as the experimental group, and the healthy physical examination subjects as the control group. The relationship between IL-1β, catecholamine and norkephalin in peripheral blood of the experimental group and the control group was observed. According to the literature, the experimental group was significantly higher than the control group. In the experimental group, the newly diagnosed group was higher than the relapse group, and the relapse group was higher than the complete remission group, and the correlation was positive, and the difference was statistically significant.


Eligibility criteria: Inclusion Criteria:

* In accordance with adult acute myeloid leukemia (non-acute promyelocytic leukemia)The diagnostic criteria for AML in the Chinese Diagnosis and Treatment Guidelines (2017 edition); ②Leukocyte count ≤ 25×109/L;

  * No treatment has been received in the past 6 months.

    * None of the candidates are related and known this study, and sign the informed consent.

Exclusion Criteria:

* Patients who are allergic to the drugs used in this study;

  * People with mental illness or cognitive impairment;

    * Patients with infectious diseases; ④Patients with severe heart, liver, kidney and other organ function lesions; ⑤ Combined with other malignant swelling. The tumor.

Primary outcomes:
measure: N/OFQ
timeFrame: 24 hours
measure: IL-1β
timeFrame: 24 hours
measure: NE
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT06432777: Recurrent Campylobacter Bacteraemia in Immunocompromised Patients
Official title: Recurrent Campylobacter Bacteraemia in Immunocompromised Patients: a Retrospective Nationwide Study in France, 2000-2025
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Campylobacter Infections
Keywords: primary immunodeficiency
Campylobacter
Relapsing bacteraemia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 30
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French hospitals

Brief summary: Some rare cases of recurrent Campylobacter bacteraemia (RCB) exist with relapses months to years after an effective treatment and a negativation of all bacterial samples.

As of today, only around 20 cases have been described in the international literature for the last 30 years. The cases are likely highly underreported.

No study describes those recurrent Campylobacter bacteraemias at the scale of a country.

The aim of this multicentre, nationwide, retrospective study is to describe their precise epidemiology in France for the last 25 years, the immune profile of the patients, the specificities of the bacteria involved, the treatments received and the evolution of these infections.

The perspective is to propose a standardization of the medical care of those patients mainly by describing the effective treatments and the explorations of the immune system which should be considered.


Eligibility criteria: Inclusion Criteria:

* 2 episodes or more of Campylobacter bacteraemia separated by at least 60 days
* AND immunodeficiency condition
* followed by a French hospital

Exclusion Criteria:

-Opposition of the patient

Primary outcomes:
measure: Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
timeFrame: Baseline
measure: Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
timeFrame: Baseline
measure: Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
timeFrame: Baseline
measure: Description of the characteristics of the patients presenting with recurrent Campylobacter bacteraemia
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Infectious diseases department, Hospital de la Croix Rousse,
Study officials:
References: