louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02990403: The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Official title: The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Recurrent Pregnancy Loss
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

- Woman who had 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experienced severe allergies, trauma history and/or operation history within 3 months.
2. with a history of mental illness and/or family history of mental illness limb disabled.
3. taking medicine within one month.
4. suffering major events or having mood swings.
5. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
6. chromosome aberrations in anyone of the couple.
7. patients who have drugs contraindications

Primary outcomes:
measure: live birth
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: D-dimer
timeFrame: through study completion, an average of 3 year
measure: Uterine artery blood flow
timeFrame: through study completion, an average of 3 year
measure: human chorionic gonadotropin
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first Maternity and Infant health hospital, Tong Ji University
Study officials:
References:
Clinical trial NCT02523703: Excitotoxicity Markers and the Clinical-radiological Progression After a Demyelinating Event: a Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Multiple sclerosis (MS) is an inflammatory disease of the central nervous system, beginning most often in subjects aged 20-40 years. In France, thanks to recent studies reported during general states of MS in 2006, the prevalence is estimated at 65.5 / 100,000 population (96.3 / 100,000 women and 41.9 / 100,000 men) and incidence at 7.91 per 100,000. In Lower Normandy, the incidence of MS is estimated to 4.45 / 100,000 inhabitants or 60 new cases per year.

The primary objective of this pilot study is to assess the levels of glutamate and aspartate (excitotoxicity markers) and their repercussions on the clinical and radiological outcome in 40 patients experiencing an event demyelinating central nervous system.


Eligibility criteria: Inclusion Criteria:

* Man or woman between 18 and 60 years old.
* Patient with one or more type of inflammatory events of Central system suggestive of demyelinating disease (multiple sclerosis, neuromyelitis optical Devic extensive myelitis)
* No treatment with corticosteroids for less than 1 month
* Need for a lumbar puncture performed in the etiologic
* Need a brain MRI performed within the etiologic
* Patient who signed informed consent

Exclusion Criteria:

* Secondary progressive MS
* Any cons-indication for lumbar puncture
* Any contra-indication to MRI
* Minor patient or patient major under guardianship

Primary outcomes:
measure: glutamate concentration (in nM)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01612403: Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
Official title: Study the Effect of Oral Zinc Supplementation on High Molecular Weight Zinc Binding Protein in Semen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthenozoospermia
Keywords: zinc binding protein
Lead sponsor: Babylon University
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 37
Sex: MALE
Minimum age (years): 27
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes 37 subfertile male partners from couples who had consulted the infertility clinic of the Babil hospital of maternity (Hilla city/ IRAQ).

Brief summary: There are several causes leading to male infertility, like oxidative stress, and nutritional deficiency of trace elements like zinc. Zinc in human seminal plasma was divided into three types of ligands which are high (HMW), intermediate (IMW), and low molecular weight ligands (LMW). The present study was conducted to study the effect of Zn supplementation on the quantitative and qualitative characteristics of semen along with Zinc Binding Protein levels in semen of patients with asthenozoospmia.

Detailed description: Elevation of ROS levels lead to an increase the oxidation of HMW-Zn binding proteins in seminal plasma of asthenozoospermic subjects. Zinc supplementation restores HMW-Zn% in seminal plasma of asthenozoospermic subjects to normal value. LMW-Zn% is elevated in seminal plasma of asthenozoospermic patients. It may be because increment the levels of semenogelin in seminal plasma of asthenozoospermic subjects. Zinc supplementation elevates LMW-Zn% in seminal plasma of asthenozoospermic subjects to more than normal value, this may be because of its enhancement of the synthesis of metallothioneins (Low molecular weight zinc binding protein).

Eligibility criteria: Inclusion Criteria:

The inclusion criteria were the presence of asthenozoospermia in the semen sample.

Exclusion Criteria:

* the absence of endocrinopathy,
* varicocele, and
* female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Primary outcomes:
measure: high molecular weight zinc binding protein
timeFrame: at the end of three months
Secondary outcomes:
measure: qualitative semen parameters
timeFrame: at the end of three months
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Babylon university/ college of science
city: Hilla
country: Iraq
facility: Babylon University
Study officials:
affiliation: babylon university / Iraq
name: mahmoud H. hadwan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadwan MH, Almashhedy LA, Alsalman AR. Oral zinc supplementation restores high molecular weight seminal zinc binding protein to normal value in Iraqi infertile men. BMC Urol. 2012 Nov 13;12:32. doi: 10.1186/1471-2490-12-32.
Clinical trial NCT05413603: Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
Official title: Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stone, Kidney
Child, Only
Keywords: pediatric renal stones
ultrasound shock waves
fluoroscope.
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Detailed description: Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.

Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

Eligibility criteria: Inclusion Criteria:

* Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

Exclusion Criteria:

1. Previous percutaneous nephrolithotripsy at the same side.
2. Previous renal exploration for stones at the same side.
3. Positive urinary culture.
4. Calyceal stones

Primary outcomes:
measure: Lithotripsy or nephrolithotripsy by Shock waves
timeFrame: from baseline to 3 months after the Lithotripsy date.
Secondary outcomes:
measure: Complications of shockwave lithotripsy
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Urology department - faculty of medicine, South Valley university
Study officials:
affiliation: Urology department - faculty of medicine, South Valley university.
name: Mahmoud Moubarak, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04946903: A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008
Official title: A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between HCP1902 and RLD2007/RLD2008 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator

Primary outcomes:
measure: AUCt
timeFrame: 0~48 hour
measure: Cmax
timeFrame: 0~48 hour
Secondary outcomes:
measure: AUCinf
timeFrame: 0~48 hour
measure: Tmax
timeFrame: 0~48 hour
measure: t1/2
timeFrame: 0~48 hour
measure: CL/F
timeFrame: 0~48 hour
measure: Vd/F
timeFrame: 0~48 hour
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk University Hospital
name: Mingeul Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04056403: Ultrasound Evaluation of Labor Epidural
Official title: The Use of Ultrasound to Evaluate Precision and Analgesic Efficacy of Labor Epidural Analgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parturient
Keywords: labor epidural
ultrasound
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturient who receive labor epidural

Brief summary: To compare the labor epidural analgesic (EA) profiles between landmark insertion EA levels which are congruent and ingruent to ultrasound confirmation in lateral decubitus position.

Detailed description: Epidural analgesia is the mainstream method for labor analgesia. Landmark identification of L3 to L5 spinous process is most commonly applied for determination of epidural insertion. However, the precision of epidural catheter insertion site was affected by physiological and anatomical variations in pregnant women and positions such as sitting or lateral decubitus. Previous study showed the clinical estimation would be ≥ 1 vertebral level higher than the anatomical position determined by ultrasound at least 40% of the time in sitting position among western pregnant women. For asian parturients, epidural analgesia is commonly performed in lateral decubitus position because of smaller stature. In addition, it remains uncertain whether the landmark epidural insertion level congruent or ingruent is associated with different analgesia profiles such as the dosage requirement and the frequncy of adjustment.

Eligibility criteria: Inclusion:

1. Normal spontaneous delivery parturients receiving labor epidural analgesia in first stage of labor
2. Using patient-controlled epidural analgesia

Exclusion:

1. who has an accidental epidural puncture
2. who receives epidural insertion by ultrasound identification
3. who uses of magnesium sulfate

Primary outcomes:
measure: Accuracy of landmark epidural level
timeFrame: 10 minute
Secondary outcomes:
measure: Labor analgesic dose
timeFrame: one day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chun-Yu Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000203: Buprenorphine Maintenance for Opioid Addicts - 2
Official title: Buprenorphine Maintenance for Opioid Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Withdrawal symptoms
measure: Psychological symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schottenfeld RS, Pakes J, Ziedonis D, Kosten TR. Buprenorphine: dose-related effects on cocaine and opioid use in cocaine-abusing opioid-dependent humans. Biol Psychiatry. 1993 Jul 1-15;34(1-2):66-74. doi: 10.1016/0006-3223(93)90258-f.
Clinical trial NCT05964803: Lower Urinary Tract Symptoms in Males Living With HIV
Official title: Males Living With HIV and LUTS: A Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Lower Urinary Tract Symptoms
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Infectious Diseases Clinic (100 living with HIV, 100 HIV-negative males) will be directed to Urology clinic. The same questionnaires will be given and scores will be compared.

Brief summary: The primary aim of this study is to learn whether the frequency of lower urinary tract symptoms differ between the males with seronegativity for HIV and males living with HIV.


Eligibility criteria: Inclusion Criteria:

* Patients above 18 years old

Exclusion Criteria:

* Non-Turkish speakers
* Previous surgeries or medications for lower urinary tract symptoms

Primary outcomes:
measure: Questionnaire 1
timeFrame: Day 1
measure: Questionnaire 2
timeFrame: Day 1
measure: Questionnaire 3
timeFrame: Day 1
measure: Questionnaire 4
timeFrame: Day 1
measure: Questionnaire 5
timeFrame: Day 1
measure: Questionnaire 6
timeFrame: Day 1
measure: Questionnaire 7
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koc University Hospital
Study officials:
References:
Clinical trial NCT05772403: Contrast Enhanced Ultrasound (CEUS) in Atypical Liver Nodules in Patients With Chronic Liver Disease
Official title: Contrast-enhanced Ultrasound (CEUS) Improves Characterization of Atypical Liver Nodules in Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 100
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: Patients followed for liver cirrhosis or chronic liver disease with increased risk of HCC (HBV-related hepatopathy or fibrosis F3) and diagnosed with liver atypical nodules on contrast-enhanced CT or MRI.

Brief summary: The present study aims to investigate the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS classification.

Detailed description: This retrospective study investigates the role of CEUS in evaluating liver lesions with atypical characteristics on contrast-enhanced CT or MRI. All patients enrolled in the study underwent contrast-enhanced ultrasound. All CEUS exams were performed, recorded, and analyzed by two experienced operators (\>10 years of experience with abdominal US and CEUS). Based on CEUS characteristics, atypical nodules will be categorized according to CEUS LI-RADS (LR) classification. If the analyzed nodule shows a typical hallmark on CEUS (LR-5), that is arterial phase hyperenhancement with late-onset (\>60 s) washout of mild intensity, it is definitively considered HCC and have been treated appropriately. Categories LR-3 and LR-4 comprise nodules with different combinations of arterial and venous phase enhancement features, expected to correspond to an intermediate or high probability of lesions to be HCC. Patients with LR-3 or LR-4 nodules underwent follow-up; in some cases they underwent biopsy.

LR-M is used to classify high-probability malignant lesions but nonspecific for HCC; these nodules underwent biopsy for further characterization.

Eligibility criteria: Inclusion Criteria:

* diagnosis of liver cirrhosis or chronic liver disease with increased risk of HCC
* diagnosis of atypical nodules on contrast-enhanced CT or MRI

Exclusion Criteria:

* less than 18 years of age
* pregnancy
* typical nodules on contrast-enhanced CT or MRI
* non-visualized nodule on B-mode US
* CEUS not performed or performed more than three months after CT or MRI

Primary outcomes:
measure: The role of CEUS in evaluating atypic liver lesions on contrast-enhanced CT or MRI.
timeFrame: Between January 2018 and January 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico A Gemelli Irccs
state: RM
Study officials:
References:
Clinical trial NCT06998303: Imaging Core Aim 2, and Udall Project 2 Aim 2
Official title: Imaging Core Aim 2, and Udall Project 2 Aim 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single arm study in which all participants will receive the same study interventions
Primary purpose: TREATMENT

Brief summary: More than one million people in the United States have Parkinson's disease (PD) and the prevalence is expected to double by 2040. Over 60% of these individuals will develop debilitating postural instability and gait disturbances (PIGD), including freezing of gait (FOG). With disease progression, axial motor symptoms typically become resistant to dopamine replacement therapies (e.g. levodopa) and a primary source of disability and morbidity. While subthalamic (STN) and globus pallidus internus (GPi) deep brain stimulation (DBS) using standard locations and stimulation parameters can be highly effective for the treatment of the cardinalmotorsymptomsof PD, both treatments often fail to control levodopa-resistant motor features of PD such as PIGD. DBS can also impair cognitive function which further exacerbates PIGD, particularly when the task requires attentional resources. Thus, despite considerable improvements in appendicular bradykinesia, rigidity and tremor with conventional DBS, the disease can continue to be dominated by PIGD, leading to increased falls, decreased mobility, and increased rate of hospitalization and morbidity. This is why one of the top NINDS priorities for clinical research in PD is the development of novel therapeutic approaches, such as DBS targeting, to treat levodopa-resistant motor symptoms.

This study will provide crucial information to elucidate the functional properties of the networks involved in Deep Brain Stimulation (DBS) treatment. By refining our understanding of the neural networks involved in stimulation of DBS targets, we will improve our ability to program patients to enhance their clinical outcomes and minimize side effects.


Eligibility criteria: Inclusion Criteria:

* Age 21 and up
* Implanted with MR-compatible DBS device (Medtronic Percept/Percept RC DBS System) for treatment of Parkinson's disease
* English speaking

Exclusion Criteria:

* Unable to consent for themselves
* Implanted with a DBS device that is not MR compatible
* Pregnant
* Extreme claustrophobia
* Any contraindications for MRI

Primary outcomes:
measure: Change in Blood Oxygen-Level Dependent (BOLD) signal in leg region of primary motor cortex
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Noam Harel, PhD
role: PRINCIPAL_INVESTIGATOR
References: