louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02033395: A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
Official title: A Correlation Between Hair Cortisol Levels and the Development of Post Traumatic Stress Disorder (PTSD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-10
Enrollment: 60
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: NON_PROBABILITY_SAMPLE
Study population: Men and women, age 18-70, who were examined in the ER following a traumatic event.

Brief summary: This observational study follows subjects who have been exposed to a traumatic event and are at risk of developing PTSD symptoms. Participants are recruited within six hours of a traumatic event, and, starting from the recruitment session, are then examined on six set points of time within a period of thirteen months. The examinations include both biological studies of cortisol in hair, blood and saliva, and psychological examinations and questionaires that assess the development and severity of PTSD symptoms.

The novel method of sampling hair cortisol allows investigators to retroactively estimate the mean levels of blood cortisol during the tree months prior to the sampling.

The study aims at further illuminating the correlation between cortisol levels both prior and following a traumatic event, and the development and severity of PTSD symptoms


Eligibility criteria: Inclusion Criteria:

* Age 18-70.
* Experienced a traumatic and were at risk (or perceived risk) of serious injury to themselves or others in their surroundings.
* Signed an informed consent form.

Exclusion Criteria:

* Age under 18 or over 70.
* Severe or complex physical injury, such as severe head trauma, massive burns or injuries that require surgery under full anesthesia.
* A personal history of Psychotic state or PTSD.
* Pregnancy
* Weight below 45 Kg or over 120 Kg.
* Hair shorter than 1.5 cm.

Primary outcomes:
measure: PTSD diagnosis and symptom severity as measured by Clinician Administered PTSD Scale (CAPS).
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT06830395: Study of CM313 in Subject With IgA Nephropathy
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of CM313 (SC) Injection in Subjects With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled phase II clinical study evaluating the safety and efficacy of CM313 (SC) in subjects with IgA nephropathy


Eligibility criteria: Inclusion Criteria:

1. Able to comprehend the research study and voluntarily signing the informed consent form (ICF).
2. Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.
3. Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
4. Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor \[ACE-I\] or angiotensin receptor blocker \[ARB\]) for 12 weeks prior to screening.

Exclusion Criteria:

1. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
2. Known or suspected hypersensitivity to excipients used in CM313.
3. Rapidly progressive glomerulonephritis (RPGN), defined as a decrease of eGFR by more than 50% within 3 months prior to Baseline Visit and/or formation of crescents in more than 50% of glomeruli in renal paracentesis specimens.
4. Confirmed acute kidney injury (AKI) within 4 weeks prior to Baseline Visit.
5. Receipt of live attenuated vaccine within 30 days prior to the Baseline Visit or plan to receive such a vaccine during the study; receipt of novel coronavirus vaccines within 7 days prior to study drug administration.
6. History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo transplantation during the study.
7. History of severe recurrent or chronic infection.
8. Current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.

Primary outcomes:
measure: Adverse event
timeFrame: Up to Week 24
measure: Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR)
timeFrame: Up to Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Frist Hospital
name: Jicheng Lv
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139395: 68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Official title: 68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Fever of Unknown Origin
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.

Detailed description: The purpose of this research study is to evaluate a PET tracer (68Ga-Citrate) that can localize the origin of patients diagnosed with fever of unknown origin (FUO) using a PET/MRI scanner. We hope to learn if this can detect FUO better than with the present nuclear imaging standard of care (67Ga SPECT).

We propose the following aim:

• To evaluate 68Ga Citrate PET/MRI for detection of origin of fever in patients with fever of unknown origin.

Patients disgnosed with fever of unknown origin are injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45-60 minutes later, a whole body PET/MRI images are obtained.

Eligibility criteria: Inclusion Criteria:

* Patient is \>/=18 years old at the time of the scan.
* Patient with diagnosis of FUO.
* Patient is capable of complying with study procedures.
* Patient can remain still for duration of imaging procedure.
* Able to provide written consent.

Exclusion Criteria:

* Patient is pregnant or nursing.
* Metallic implants (contraindicated for MRI).
* History of renal insufficiency (only for MRI contrast administration).
* Inability to lie still for the entire imaging time.
* Inability to complete the needed investigational and standard of care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.

Primary outcomes:
measure: Uptake detected by investigational imaging agent
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: clinical professor
name: Carina Mari Aparici, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02505295: Selenium and Ischemic Stroke Outcome
Official title: Evaluation of Selenium Supplementation in Ischemic Stroke Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Mazandaran University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a feasibility/pilot study
Primary purpose: TREATMENT

Brief summary: Selenium is a trace element essential to human health.Selenium protection against cellular damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is associated with the generation of oxygen free radicals resulting in a condition of oxidative stress. Supplementing stroke patients with antioxidant nutrients may improve survival.


Eligibility criteria: Inclusion Criteria:

1. Accepted ischemic stroke by brain CT or MRI during last 72 h
2. Ischemic stroke in Middle Cerebral Artery territory
3. Volume of stroke at list one third of MCA territory
4. written informed consent.

Exclusion Criteria:

1. Known allergy to selenium
2. Severe renal failure( cr clearance under 50 ml/min or serum cr upper than 2
3. Severe hepatic failure( total bill upper than 2 or ALT/AST 5 time upper than normal limit)
4. Severe neurodegenerative disease such as severe dementia, alzheimer and Parkinson
5. Pregnancy or lactation

Primary outcomes:
measure: National Institutes of Health Stroke Scale(NIHSS)
timeFrame: up to 3 days
measure: modified Rankin Scale (MRS)
timeFrame: at day 5-8
Secondary outcomes:
measure: Barthel index
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Sari
country: Iran, Islamic Republic of
facility: Athena Sharifi Razavi
state: Mazandaran
Study officials:
affiliation: assistant professor in neurology
name: athena sharifi razavi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02393495: Ultrasound Guided Intra-uterine Device Insertion
Official title: A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 102
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.


Eligibility criteria: Inclusion Criteria:

* Females desiring contraception with the use of IUD

Exclusion Criteria:

* Are pregnant or think they may be pregnant
* Septic pregnancy or abortion
* Have unexplained abnormal vaginal bleeding
* Have untreated cervical cancer
* Have malignant gestational trophoblastic disease
* Have uterine cancer
* Have uterine abnormalities
* Have or may have had a pelvic infection within the past three months
* Have or may have any sexually transmitted disease
* Have pelvic tuberculosis
* Are postpartum between 48 hours and 4 weeks
* Have benign gestational trophoblastic disease
* Have ovarian cancer
* Have AIDS (unless clinically well on anti-retroviral therapy)

Primary outcomes:
measure: Assessment of degree of pain during IUD insertion
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el ainy hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01675895: Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
Official title: Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostate Hyperplasia
Keywords: Hyperbaric Levobupivacaine
İntrathecal
Lidocaine
TUR-P
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.

Detailed description: A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).

Eligibility criteria: Inclusion Criteria:

* elective transurethral resection of the prostate (TUR-P)

Exclusion Criteria:

* patients with contraindications for spinal anesthesia,
* known sensitivity to the study drugs,
* emergency cases, and
* patients who refused spinal anaesthesia were excluded

Primary outcomes:
measure: The duration of the spinal block (S1 regression of the block)
timeFrame: participanta will be followed on the operation day
Secondary outcomes:
measure: postoperative care unit stay
timeFrame: participants will be followed on the operation day
Other outcomes:
measure: maximum block level
timeFrame: participants will be followed on the operation day
Locations:
city: Ankara
country: Turkey
facility: Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Study officials:
affiliation: Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
name: Taylan Akkaya, MD
role: STUDY_DIRECTOR
References:
citation: Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
Clinical trial NCT03120481: Controls for Respiratory Diseases
Official title: The Registry of Controls for Respiratory Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Asthma
Idiopathic Pulmonary Fibrosis
Nontuberculous Mycobacterium Infection
Bronchiectasis
Lung Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 1572
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who visited the hospital for health check-up, and agree to participate in this study.

Brief summary: This is the registry of control participants for patients with various respiratory diseases. We screened healthy volunteers who visited Seoul National Hospital Healthcare System Gangnam Center for routine health check-up, and enrolled patients who agree to participate in the study. The participants undergo baseline questionnaires, provide blood specimen and information of the results of health check-up. We will include participants as controls if they have no significant respiratory symptom and no significant radiographic abnormality. The data from this registry will be compared with those from other registry of various respiratory diseases


Eligibility criteria: Inclusion Criteria:

* 19-90 years old male and female
* underwent health check-up including chest radiography
* obtained informed consent

Exclusion Criteria:

* those who showed a significant abnormal finding of chest radiography
* those who reported a significant respiratory symptoms

Primary outcomes:
measure: Mortality
timeFrame: 20 years
Secondary outcomes:
measure: Hospitalization
timeFrame: 20 years
measure: Respiratory hospitalization
timeFrame: 20 years
measure: Respiratory diseases diagnosis
timeFrame: 20 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Healthcare System Gangnam Center
Study officials:
affiliation: Seoul National University Hospital
name: Chang-Hoon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01603381: The Effect of Family History on Insomnia During Sobriety in Alcoholics
Official title: The Effect of Family History on Insomnia During Sobriety in Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2012-05-22
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators intend to assess the following:

* the efficacy of CBTi in treating insomnia during recovery,
* does a family history of alcoholism moderate the insomnia symptoms,
* does an improvement in insomnia lead to a decrease in impulsivity.

Detailed description: The primary goals of this pilot study are the following:

a) to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,

The secondary goals include the following:

1. to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,
2. to assess for change in psychiatric symptoms of mood and anxiety across the groups,
3. to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,
4. to evaluate for any change in impulsivity-related measure with insomnia treatment.

Eligibility criteria: Inclusion Criteria:

1. Presence of insomnia currently
2. DSM IV diagnosis of alcohol dependence within the past year
3. Not in acute alcohol withdrawal and within a year of sobriety from alcoholism
4. Patients with moderate-severe sleep apnea compliant on their PAP device
5. Can speak, understand and print in English.
6. Is capable of giving written informed consent.

Exclusion Criteria:

1. Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.
2. Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.
3. Unstable or serious medical/neurologic illness
4. Severe cognitive impairment
5. Untreated moderate - severe obstructive sleep apnea

Primary outcomes:
measure: Insomnia Severity Index total score
timeFrame: 8 weeks.
Secondary outcomes:
measure: Time Line Follow Back measure
timeFrame: 8 weeks.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veterans Affairs Medical Center
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Subhajit Chakravorty, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chakravorty S, Morales KH, Arnedt JT, Perlis ML, Oslin DW, Findley JC, Kranzler HR. Cognitive Behavioral Therapy for Insomnia in Alcohol-Dependent Veterans: A Randomized, Controlled Pilot Study. Alcohol Clin Exp Res. 2019 Jun;43(6):1244-1253. doi: 10.1111/acer.14030. Epub 2019 Apr 29.
Clinical trial NCT00372281: Cliavist in Infectious and Degenerative Diseases of the Spine
Official title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spine Infection
Keywords: MRI, CLIAVIST, MACROPHAGE, INFECTION, SPINE
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.


Eligibility criteria: Inclusion Criteria:

* spine infection or spine degenerative disease
* patient agreement obtained

Exclusion Criteria:

* pregnancy
* MRI contra-indications
* cliavist contra-indication
* dextran allergy

Primary outcomes:
measure: First MRI: performed immediately after gadolinium administration
timeFrame: immediately after gadolinium administration
measure: Second MRI: performed 24 hours after cliavist administration
timeFrame: 24 hours after cliavist administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Service de Neuroradiologie - Hôpital Central
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Strasbourg
country: France
facility: Service de Radiologie 2 - Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Service de Rhumatologie - Hôpital de Hautepierre
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jean-Louis Dietemann, MD
role: STUDY_DIRECTOR
References: