louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782416: Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation
Official title: A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplantation
Keywords: Renal
Latent
Tuberculosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 800
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Detailed description: Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Eligibility criteria: Inclusion Criteria:

1. Age between 20-65 and match one of below
2. Waiting renal transplant or status post renal transplant
3. Receiving long term dialysis

Exclusion Criteria:

1. Not agree to be enrolled
2. Suspected active TB
3. HIV patients
4. Viral hepatitis
5. Using immunosuppressants within 3 months before enrollment
6. Receiving lymphokine therapy
7. Hemoglobin \< 8 g/dL
8. Serum bilirubin \> 2.5 mg/dL
9. AST or ALT \> 2 times of upper normal limit
10. Lactation or pregnancy

Primary outcomes:
measure: percentage of active TB
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Chung Shu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990816: Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
Official title: Natural Course of Homocysteine After Uneventful Total Joint Arthroplasty
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Joint Prosthesis; Complications, Infection or Inflammation
Keywords: periprosthetic joint infection
diagnosis
natural course
total joint arthroplasty.
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healty volunteers who have undergone uneventful primary total joint arthroplasty

Brief summary: The goal of this observational study is to asses the natural course of blood homocysteine levels in patients who underwent primary total joint arthroplasty surgery. The main question\[s\] it aims to answer are:

* İs homocysteine a good marker for determining periprosthetic joint infection ?
* İs homocysteine more sensitive marker for periprosthetic joint infections ?


Eligibility criteria: Inclusion Criteria:

* People who have undergone Total Knee Arthroplasty operation
* People who have undergone Total Hip Arthroplasty operation

Exclusion Criteria:

* People who have undergone total knee arthroplasty operation and developed a periprosthetic joint infection
* People who have undergone total hip arthroplasty operation and developed a periprosthetic joint infection

Primary outcomes:
measure: Homocysteine
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
citation: Mouravas H, Verettas D, Kazakos K, Xarhas K, Panagiotou N, Ellinas P. Homocysteine and its relationship to deep venous thrombosis in patients undergoing total knee or hip arthroplasty. Hippokratia. 2010 Jul;14(3):185-8.
citation: Watanabe N, Ogawa T, Takada R, Amano Y, Jinno T, Koga H, Yoshii T, Okawa A, Miyatake K. Association of osteoporosis and high serum homocysteine levels with intraoperative periprosthetic fracture during total hip arthroplasty: a propensity-score matching analysis. Arch Orthop Trauma Surg. 2023 Dec;143(12):7219-7227. doi: 10.1007/s00402-023-04989-6. Epub 2023 Jul 19.
citation: Azboy I, Catal B, Basarir K, Mutlu M, Bilgen OF, Parvizi J. The Natural Course of Serum D-Dimer, C-Reactive Protein, and Erythrocyte Sedimentation Rate Levels After Uneventful Primary Total Joint Arthroplasty. J Arthroplasty. 2021 Sep;36(9):3118-3122. doi: 10.1016/j.arth.2021.04.031. Epub 2021 Apr 30.
Clinical trial NCT03593616: Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery
Official title: Auditing of Poor Visual Outcomes After Un-eventual Cataract Surgery: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients for cataract surgery received a comprehensive ophthalmic examination. The standard pre-operative examination included a detailed history, measurements of presenting visual acuity

Brief summary: Globally, cataract is the major cause of blindness accounting for 51% of total blindness and there are regional variations in it. Today, cataract surgery is a highly successful and cost-effective procedure, which enhances both the vision and quality of life of patients.

Visual acuity alone should not be used as a criterion for planning cataract surgery, since visual acuity and function do not necessarily correlate. Therefore, there is a need to review our criteria for management.

Based on recent studies, at least 90% of the patients undergoing cataract surgery obtain a postoperative visual acuity of 6/12 or better in the absence of coexisting ocular pathology.

A number of previous studies have looked at the effect of risk factors on visual outcomes following cataract surgery. Risk factors commonly associated with worse visual outcomes include: age-related macular degeneration, diabetic retinopathy, corneal opacity/pathology, older age, female sex, previous vitrectomy, previous retinal detachment surgery, alpha-blockers, complex surgery, intraoperative complications and refractive surprise.


Eligibility criteria: Inclusion Criteria:

* Patients with any type of cataract.

Exclusion Criteria:

* Patients with diabetic retinopathy.
* Patients with previous ocular surgeries or pathologies.
* Patients with pre-operative visual acuity (no perception of light)

Primary outcomes:
measure: The visual acuity of patients after cataract surgery
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02904616: Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers.
Official title: Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.

This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.


Eligibility criteria: Inclusion Criteria:

* Man and woman over 18 yers old
* Women of childbearing age under contraceptive
* Healthy volunteers able and willing to follow all procedures of the agreement with the study protocol.
* Healthy volunteers affiliated to the social security
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation

Exclusion Criteria:

* Healthy volunteers with scars or open wounds on the palms
* Healthy volunteers with warts on their hands
* Healthy volunteers with blister on their hands
* Healthy volunteers involved in another clinical trial
* Pregnant or breastfeeding women
* People in emergencies
* Deprived of liberty or under supervision

Primary outcomes:
measure: Intraindividual reproducibility of measuring the natural and basal skin fluorescence
timeFrame: 1 day
Secondary outcomes:
measure: Demographic parameter
timeFrame: 1 day
measure: Concomitant treatments
timeFrame: 1 day
measure: Dominant hand
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: Guillemin François, MD, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00633516: A Pilot Study to Evaluate Optical Spectroscopy of Pigmented Skin Lesions
Official title: A Pilot Study to Evaluate the Correlation Between Modified Two Layer Diffuse Optical Spectroscopy With the Clinical and Histological Examinations of Pigmented Skin Lesions Based on Physiological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Cancer
Keywords: moles
melanoma
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-03-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The incidence of malignant melanoma has increased dramatically in recent decades. In 1930, the lifetime risk of an individual in the United States developing melanoma was 1 in 1,500. This has been exponentially increasing over the years with the risk estimated to be 1 in 75 in 2000 . According to the American Cancer Society, approximately 59,580 new cases of melanoma will be diagnosed in the United States in 2005 and about 7,770 people are expected to die of the disease.

Detailed description: The researcher ucan use special imaging devices to obtain information about a typical mole and melanoma and use this information to determine the different between malignant and benign melanized lesions. The imaging devices are, Modified Two Layer Diffuse Optical Spectroscopy,multi-spectral imaging, and Spatially Modulated Quantitative Spectroscopy can use to measure atypical moles and melanoma and correlate the results of the biopsy tissue histology.

The imaging devices can quantify melanin, oxy and deoxy hemoglobin concentration, water, lipid and reduced scattering coefficients and can compare results to histopathologic. Atypical moles and melanoma have a different optical profile based on physiological parameters compared to benign nevus.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Have atypical mole/s and melanoma

Exclusion Criteria:

* Age less than 18 years old.
* have NO atypical mole/s and melanoma

Primary outcomes:
measure: Measure atypical moles and melanoma
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Medical clinic, UCI
state: California
city: Orange
country: United States
facility: UCIMC
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: David JB Hsiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute University of California Irvine
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05817916: Comparison of Erector Spina Plane Block and Lumbar Plexus Block in Femoral Fracture Surgery
Official title: Comparison of Erector Spina Plane Block and Lumbar Plexus Block for Postoperative Analgesia in Femoral Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Erector Spinae
Lumbar Plexus
Ultrasound Guide
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 64
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: The patients in the first group (ESP Group) will be applied ultrasound guided ESP block at the lateral position at the end of the surgery. ESP will be performed with a posterior approach, under ultrasound guidance, by imaging the muscles and the needle.

Group 2: At the end of the surgery, patients in the second group (LP Group) will have an appropriate level of LP block with ultrasound guidance and, if necessary, using a neurostimulator.
Primary purpose: TREATMENT

Brief summary: The aim is to clinical trials compare the lumbar plexus block method with the erector spinae plan block method in terms of analgesic efficacy and possible complications. İn patients for femur fracture surgery. The main questions it aims to answer are: 1. is erector spinae plane block as effective as lumbar plexus block for postoperative analgesia in femur fractures? 2. Is erector spinae plane block effective for reducing opioid consumption compared to lumbar plexus block?


Eligibility criteria: Inclusion Criteria:

* Proximal femoral surgery
* All patients who can respond to pain assessment questions

Exclusion Criteria:

* Regional block contraindications,
* Severe cardiac and respiratory disease,
* Severe coagulopathy,
* Body mass index greater than 35

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Hospital
Study officials:
References:
citation: Badiola I, Liu J, Huang S, Kelly JD 4th, Elkassabany N. A comparison of the fascia iliaca block to the lumbar plexus block in providing analgesia following arthroscopic hip surgery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:26-29. doi: 10.1016/j.jclinane.2018.05.012. Epub 2018 Jun 1.
citation: Tulgar S, Selvi O, Senturk O, Ermis MN, Cubuk R, Ozer Z. Clinical experiences of ultrasound-guided lumbar erector spinae plane block for hip joint and proximal femur surgeries. J Clin Anesth. 2018 Jun;47:5-6. doi: 10.1016/j.jclinane.2018.02.014. Epub 2018 Mar 6. No abstract available.
Clinical trial NCT04360616: The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the US vs Mammography: a Clinical Noninferiority Trial.
Official title: The Diagnosis and Prognosis of Nonpalpable Breast Cancer Detected by the Ultrasound vs Mammography: a Clinical Noninferiority Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: The First Affiliated Hospital of the Fourth Military Medical University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 1277
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients over 18 years old from China

Brief summary: To evaluate and compare the sensitivity, specificity, AUC, pathology results of core needle biopsy and surgical pathology results coincidence rate, tumor staging, and DFS (disease-free survival) of US-detected nonpalpable breast cancer vs mammography-detected nonpalpable breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Women aged 18 years and over with full capacity for civil conduct;
2. Breast imaging examination (including mammography and breast ultrasound) found that patients with BI-RADS 4 or nonpalpable lesion need to have breast biopsy (refer to the classification of BI-RADS, which is consistent with the indications for biopsy), including some patients with BI-RADS 3 nonpalpable breast lesions who are willing to have biopsy;
3. Voluntarily participate in and sign the informed consent form, and be willing to accept the inspection designated by this test;
4. The results of blood examination, coagulation examination, preoperative infection examination, and 12 lead ECG examination within 2 weeks before biopsy met the biopsy requirements;
5. It conforms to the biopsy standard (refer to the image-guided breast histology biopsy guide in the breast cancer diagnosis and treatment guide and specification of China Anti Cancer Association (2019 version)).

Exclusion Criteria:

1. Women are participating in another clinical trial of drug or medical device;
2. Women with neuropsychiatric disorders;
3. Women with severe systemic diseases and serious bleeding diseases that can not cooperate with the examination, or the researchers think it is not suitable to participate in this clinical trial;
4. Other subjects not suitable for X-ray examination

Primary outcomes:
measure: Sensitive
timeFrame: 3 days
measure: Specificity
timeFrame: 3 days
measure: Area under curve
timeFrame: 3 days
measure: Disease-free survival (DFS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing hospital of The fourth military medical university
name: Hongping Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02153216: Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load
Official title: Formative Phase of Reducing Hazardous Alcohol Use & HIV Viral Load: An RCT in ART Clinics in Vietnam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Drinking
Alcohol Use Norms
Alcohol Use Among ART Clients
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ART clients with hazardous alcohol use; PWID in general population with hazardous alcohol use

Brief summary: This study is the Formative Phase of a larger study; once this phase is completed, enrollment into the randomized controlled trial (RCT Phase) will begin. The primary objective of the Formative Phase is to gain a better understanding of the context in which drinking alcohol among ART client in Vietnam occurs, in order to culturally tailor the intervention to be tested in the RCT Phase. Formative Phase activities will consist of up to 40 in-depth interviews with hazardous drinkers who are either: a) ART clients in one of the ART clinics in Thai Nguyen, or b) who are people who inject drugs (PWID) that are not recruited from the ART clinics (whom we will refer to as general population PWID).


Eligibility criteria: Inclusion Criteria:

* being 18-49 years of age;
* having an AUDIT score ≥ 8 (hazardous alcohol use);
* being a current ART client at one of the Thai Nguyen ART clinics or a general population PWID;
* being capable of providing voluntary informed consent.

Exclusion Criteria:

* being unable to participate in study activities due to psychological disturbance, cognitive impairment or threatening behavior;
* currently participating in other HIV, drug use or alcohol studies.

Primary outcomes:
measure: Frequency of heavy drinking episodes
timeFrame: during interviews
Secondary outcomes:
Other outcomes:
Locations:
city: Thai Nguyen
country: Vietnam
facility: Thai Nguyen Center for Preventive Medicine
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Vivian F Go, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856516: Glycemic Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Official title: Plasma Glucose and Insulin Response to Three Oral Nutrition Supplements in Persons With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a randomized, cross-over design. Subjects will be randomized to one of three interventions on three separate study days, 1 week apart.

Detailed description: Following consent, subjects will be randomized to one of three arms. After an overnight fast an intravenous line will be placed for blood withdrawal. The subject will then consume the randomly assigned intervention. Blood samples for glucose and insulin levels will be drawn at specified intervals after the product has been consumed.

Eligibility criteria: Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide (Glucotrol/Glucotrol XL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patients who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.

Primary outcomes:
measure: Area under the blood glucose curve (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Secondary outcomes:
measure: Area under the insulin curves (AUC 0-240)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: Insulinogenic index (Ins30/(Glu30)
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
measure: AUC (0-30min) for insulin
timeFrame: Baseline, 10, 20, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
Study officials:
affiliation: Orange County Research Center
name: Joel Neutel, MD
role: PRINCIPAL_INVESTIGATOR
References: