louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05409690: Renal Arterial Resistive Index for Differential Diagnosis of Acute Kidney Injury
Official title: Value of Renal Resistive Arterial Index for Differential Diagnosis of Patient With Anticipated Acute Kidney Injury Administered to Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
renal resistive index
doppler ultrasound
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient administering to emergency service with acute kidney injury independent of etiology

Brief summary: early differential diagnosis of anticipated acute kidney injury via ultrasound renal resistive index calculation

Detailed description: acute kidney injury is a common clinical syndrome introducing to emergency services with varying symptoms. acute kidney injury is divided into 3 subgroups: prerenal, renal and postrenal. there is not any certain laboratory or imaging modality for early detection of injury's type. calculation of renal resistive index with doppler ultrasound at emergency setting can be helpful for early detection of etiology of acute kidney injury subgroup.patient will be selected according to clinical status and detailed history and laboratory parameters.renal resistive index will we calculated with doppler ultrasound of arcuate and interlober arteries of kidneys. resistive index values of acute kidney injury patients will be compared depending on further tests and resistive indexes of suggestive etiologies will be compared according to final diagnosis.

Eligibility criteria: Inclusion Criteria:

1. age over 18
2. patient with acute kidney injury diagnosed according to KDIGO, AKIN or RIFLE criteria

Exclusion Criteria:

1. end stage kidney disease
2. patients receiving renal replacement treatment

Primary outcomes:
measure: increased resistive index
timeFrame: time spent at emergency service until renal doppler is done and resisitive index is calculated (6 hours)
Secondary outcomes:
measure: mortality
timeFrame: mortality at 7 days
measure: mortality
timeFrame: mortality at 28 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Research and Training Hospital
Study officials:
References:
Clinical trial NCT00768690: A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics

Detailed description: Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333

Eligibility criteria: Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
* If female, subject is postmenopausal for at least 2 years or surgically sterile.
* If female, subject is not pregnant and is not breast-feeding.
* Male or female between 18 and 55 years old, inclusive.
* If male, subject must be surgically sterile or practicing at least 1 method of birth control.
* Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

* See above for main selection criteria

Primary outcomes:
measure: Analysis of pharmacokinetic results.
timeFrame: Approximately 1 week.
measure: Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
timeFrame: Approximately 1 week.
Secondary outcomes:
measure: Analysis of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics.
timeFrame: Approximately 1 week.
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 12701
state: Illinois
Study officials:
References:
Clinical trial NCT06696690: The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest
Official title: The Safety and Efficacy of Median Nerve Electrical Stimulation for Improving Neurological Function Prognosis in Patients With Cardiac Arrest: A Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Median Nerve
Coma
Post Cardiac Arrest Brain Injury
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Median nerve stimulation (MNS), a non-invasive brain stimulation technique, has been widely adopted in clinical arousal therapies and multiple clinical investigations have attested to the efficacy of this technique; nevertheless, evidence concerning the application of MNS in improving the neurological prognosis of patients with return of spontaneous circulation (ROSC) following cardiac arrest (CA) remains scarce. The current study endeavors to assess the safety and efficacy of MNS treatment in enhancing the neurological prognosis of CA patients after ROSC and it is designed as a multicenter, prospective, randomized controlled trial with an estimated sample size of 400 patients. Eligible patients will be randomly allocated in a 1:1 ratio to either receive MNS treatment or sham stimulation treatment for 8 hours per day for 14 consecutive days and the primary outcome measure is the proportion of patients in each group with a Cerebral Performance Category (CPC) score ranging from 1 to 2, 6 months after randomization, which will help to determine the effectiveness of MNS in providing neuroprotection for patients with ROSC after CA.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old.
2. Hemodynamics remains continuously stable for ≥ 7 days.
3. There is still a lack of purposeful movements after the return of spontaneous circulation following cardiopulmonary resuscitation.
4. Advanced life support is provided within 6 hours after the return of spontaneous circulation (ROSC).

Exclusion Criteria:

1. Patients with hemodynamic instability.
2. Pregnant patients.
3. Those who have abnormal anatomical structures on the median nerve conduction pathway and are unable to receive electrical stimulation.
4. Patients with a confirmed history of epilepsy before admission or during hospitalization.
5. Patients with severe arrhythmia or those who have pacemakers implanted.
6. Patients whose family members do not agree to their enrollment in the study.

Primary outcomes:
measure: The proportion of patients with a CPC score of 1-2
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06697964: High Resolution Anuscopy Study
Official title: High Resolution Anuscopy Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papilloma Virus
Anal Squamous Cell Carcinoma
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent or will undergo High Resolution Anoscopy in UZ Brussel after Informed Consent

Brief summary: The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.

High-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.

HRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.

At UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.


Eligibility criteria: Inclusion Criteria:

* All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel
* 18 years or older
* Understands and able to speak and write in French, Dutch or English

Exclusion Criteria:

* None

Primary outcomes:
measure: comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive Men
timeFrame: Through study completion, on average 5 years
measure: Exploration of associations between abnormal histology and patient characteristics
timeFrame: Through study completion, on average 5 years
measure: comparison of the prevalence of precancerous lesions in different groups
timeFrame: Through study completion, on average 5 years
measure: to delineate unique features associated with HSIL in each risk group by linking patterns or characteristics
timeFrame: Through study completion, on average 5 years
measure: Prevalence of anal cancer among the at-risk populations
timeFrame: Through study completion, on average 5 years
measure: correlation between abnormal histology and abnormal cytology, as well as HPV infection in MSM using PrEP and MSM living with HIV
timeFrame: Through study completion, on average 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT01002664: Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Official title: A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-2 in Treating Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia in Treatment Naïve Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Multi-carotenoids
MCS-2
Lower Urinary Tract Symptoms
International prostate symptom scores
Lead sponsor: Health Ever Bio-Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 272
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of the study is to examine whether MCS-2 is safe and effective in the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia.

Detailed description: Eligible male subjects will be randomized to receive either MCS-2 or placebo for 12 weeks. Subjects are those not currently on any medicines for BPH or LUTS. During and at the end of the 12-week treatment period, randomized subjects will be evaluated for efficacy and safety parameters. All subjects will be advised to maintain a normal diet, similar to what was consumed before joining the study.

Eligibility criteria: Inclusion Criteria:

* Age ≧ 40 years old.
* Not being treated for BPH or LUTS.
* PSA ≦ 4 ng/ml and no pathologically-proven prostate cancer.
* I-PSS ≥ 10
* No known malignancy
* AST/ALT ≦ 3X UNL.
* Creatinine ≦ 3X UNL.
* Subjects who sign the informed consent form.

Exclusion Criteria:

* Subjects' LUTS are not BPH-related
* Have been treated with pelvis irradiation or pelvic surgery.
* Plan to undergo any invasive procedures within the study period.
* Active infection or inflammation.
* Considered ineligible by the investigators.

Primary outcomes:
measure: Changes in total International Prostate Symptom Scores (I-PSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in I-PSS subscores
timeFrame: 12 weeks
measure: Changes in I-PSS quality of life index
timeFrame: 12 weels
measure: Changes in urinary peak flow rate
timeFrame: 12 weeks
measure: Incidence of treatment-emergent adverse events
timeFrame: 12 weeks
measure: Incidence of withdrawals due to treatment-emergent adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeong-Shiau Pu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04052464: The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Official title: The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
IVF
Keywords: gene expression
biomarkers
implantation window
embryo transfer
endometrium
biopsy
lavage
liquid biopsy
Lead sponsor: Prelife Kft
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women participating in the diagnostic evaluation of infertility. The patients are contacted for participation in the study during the diagnostic evaluation of their infertility at specialized infertility or gynaecological clinic.

Brief summary: The objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.

Detailed description: The endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. In this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample.

Endometrium biopsy samples can be used for endometrium phasing. A question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. The advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. In some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample.

A list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. From the endometrium derived samples, RNA will be isolated and gene expression biomarkers will be measured. Expression profiles will be compared to published reference samples.

Eligibility criteria: Inclusion Criteria:

* infertile women participating in the diagnostic evaluation of infertility.

Exclusion Criteria:

* patients who are legally incapable or partially capable
* pregnancy should be excluded before sampling
* bleeding problems
* the active phase of severe psychiatric disorders

Primary outcomes:
measure: gene expression profile
timeFrame: measurements are performed within 3 weeks after samples are shipped to the laboratory
measure: endometrium phase assesment
timeFrame: phase assignment is performed within two weeks after the measurements are performed.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Prelife Kft
name: Balint L. Balint, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04779164: The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
Official title: The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
type 2 diabetes
Lead sponsor: Eskisehir City Hospital
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 126
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both patients with and without diabetes mellitus was evaluated in terms of pain and ultrasonographic femoral cartilage thickness.
Primary purpose: SCREENING

Brief summary: Background:Knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity.

Objectives:The aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life.

Design:A cross-sectional design. Settings:Training and research hospital in Turkey. Patients and Methods:Female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. Later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes.

Main Outcome measures:Clinical parameters were visual analog-scale, gait speed and short form-36. Knee radiographs were evaluated according to Kellgren Lawrance-Scale. And ultrasonography parameters were the measurements of distal femoral cartilage thickness.

Sample size:126


Eligibility criteria: Inclusion Criteria:

* being female
* aged between 40 and 70.

Exclusion Criteria:

* Patients with any concomitant chronic disease
* rheumatoid arthritis
* cardiac diseases (except type 2 diabetes mellitus and hypertension)
* knee surgery
* trauma
* bone mass or cancer
* inflammatory arthritis
* impaired cognitive status
* immobilized patients
* type 1 diabetes mellitus

Primary outcomes:
measure: Femoral cartilage thickness
timeFrame: baseline
Secondary outcomes:
measure: visual analog scale
timeFrame: baseline
measure: radiographic knee osteoarthritis
timeFrame: baseline
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir City Hospital
Study officials:
affiliation: Eskisehir City Hospital
name: Fulya Bakılan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01949064: Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Official title: Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Craniomandibular Dysfunction
Orofacial Pain
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.

Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Age between 18 and 70 years
* Non-chronic painful CMD with/without mandibular movement restriction
* Female

Exclusion Criteria:

* Pregnancy or breastfeeding
* Chronic Pain Status higher than 2
* Known allergic reaction against the gel pads
* Electronic implants (pacemaker, defibrilator, insulin pump)
* Facial pain of dental or neuropathic etiology
* Traumatic injuries of the face / operations
* Dental treatment need
* Problems with swallowing reflex

Primary outcomes:
measure: Worst perceived pain
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Poliklinik für Zahnärztliche Prothetik
Study officials:
affiliation: Poliklinik für Zahnärztliche Prothetik
name: Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc
role: PRINCIPAL_INVESTIGATOR
References: