louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05800938: The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
Official title: The Effect of Oral Isosorbide Mononitrate Therapy on Umbilical Artery Doppler Resistance Index in Pregnancies With Intrauterine Growth Restriction: Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrauterine Growth Restriction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 46
Sex: FEMALE
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: Will follow up umblical artery Doppler indices for pregnancies with iugr taking placebo and oral isosorbide mononitrate to study its efficacy on the intrauterine growth restricted fetuses

Detailed description: Patients meeting these criteria are to be randomized into one of the following two groups:

* Group A (n=23): The Isosorbide Mononitrate group: will receive (IMDUR®, 30 mg, tablet, AstraZeneca, Egypt) (Isosorbide-5-mononitrate Biphasic) twice daily for 4-6 weeks (according to xPharm: The Comprehensive Pharmacology Reference, 2007, Pages 1-4).
* Group B (n=23): The placebo group will receive (Osteocare®, tab, VITABIOTICS, Egypt) twice daily for 4-6 weeks Justification: Using PASS 11 program for sample size calculation, setting power at 80% and alpha error at 0.05 and according to "Trapani et al., 2015", the expected change in UTA-PI in isosorbide mononitrate group=21% compared to no change in placebo group. Sample size of 23 women per group will be needed to detect difference between two groups.

The study is to be double-blinded, where neither the researcher, nor the participants will know what type of medication each participant will receive, as a nurse will give each patient a closed envelope containing 21 tablets of one of the above two medications in a randomized fashion.

Eligibility criteria: Inclusion Criteria:

* age : 18-34 BMI: 18-30 Singleton pregnancy Gestational age between 28-30 Criteria of IUGR

Exclusion Criteria:

Had known or suspected chromosomal or structural anomaly Had a condition which will require delivery Multiple pregnancy

-

Primary outcomes:
measure: Reduction in umbilical artery Doppler indices
timeFrame: 4 weeks after initiation of treatment
Secondary outcomes:
measure: Enhancement of fetal growth as measured by the increase in estimated fetal weight and abdominal circumference
timeFrame: 4 weeks after initiation of treatment
measure: Development of fetal complications
timeFrame: 4 weeks after initiation of treatment
measure: Interval to delivery
timeFrame: 37 weeks
measure: Maternal side effects
timeFrame: 4 weeks after initiation of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT03694938: Detection of Brain Metastasis by MRI in Metastatic Colorectal Cancer Patients
Official title: Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Colon Cancer
Keywords: Brain metastasis
Magnetic resonance imaging
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven colorectal adenocarcinoma
* Metastases from colorectal cancer diagnosed since less than 6 months
* Indication of an oncologic treatment

Exclusion Criteria:

* Patient with contraindication for MRI
* Diagnosis of cancer other than colorectal cancer in the last three years, except in situ cancers, basal-cell skin cancer or squamous-cell skin cancer, and other cancer with low risk of brain dissemination according to the investigator
* Pregnant or breastfeeding women, women of childbearing potential without effective contraception

Primary outcomes:
measure: Prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients with annual MRI.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: C.H.U. d'Amiens
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Poitiers
country: France
facility: C.H.U. de Poitiers
city: Tours
country: France
facility: C.H.U. de Tours
Study officials:
References:
Clinical trial NCT06246838: 68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study
Official title: 68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Ventilation Perfusion Mismatch
Keywords: Ga-68-MAA
Galligas
Tc-99m-MAA
Technegas
PET/CT
SPECT/CT
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 20
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: Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. In last two decades after the introduction of pulmonary CTA, general PE detection has shifted towards CTA and V/Q SPECT/CT has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). V/Q SPECT/CT acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. A potential alternative is the nowadays broadly available. 68Ga as a positron emitter allows PET/CT imaging. Replacing 99mTc with 68Ga in both MAA and aerosol suspension is easy and requires no modifications. However, 68Ga-V/Q with PET/CT will resolve many of the disadvantages of V/Q SPECT/CT. International studies have proven safety and feasibility of replacing 99mTc with 68Ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. However, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. The aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of V/Q PET/CT, and confirm preliminary non-inferiority of this new technique over the current clinical standard (V/Q SPECT/CT).


Eligibility criteria: Inclusion Criteria:

* Adult ≥18 years and declared competent
* Provided written informed consent
* Referred to the Nuclear Medicine Department for a conventional V/Q-SPECT/CT
* Indication for conventional V/Q-SPECT/CT includes known or suspected pulmonary embolism

Exclusion Criteria:

- Pregnancy

Primary outcomes:
measure: Qualitative assessment of V/Q-PET/CT
timeFrame: Study participation is maximum 1 week.
measure: Quantitative assessment of V/Q PET/CT
timeFrame: Study participation is maximum 1 week.
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References:
Clinical trial NCT06181838: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
Official title: Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Quality of Life
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

Detailed description: The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed as moderate acne vulgaris
* Able to read and speak in Indonesia
* Indonesian Citizen
* Sign the consent form

Exclusion Criteria:

* Pregnant of breastfeeding women
* Acne vulgaris lesion located only outside of face
* Experiencing COVID-19 symptoms
* Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks
* Consume any oral antibiotics in the last 1 month
* Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks
* Having laser or chemical peeling in the last 1 month

Primary outcomes:
measure: Quality of Life Score
timeFrame: Every 4 weeks, measured until 8 weeks
Secondary outcomes:
measure: Acne Grading
timeFrame: Every 4 weeks, measured until 8 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT01335438: Total Knee Arthroplasty Comparing Cementless to Cemented Fixation
Official title: Total Knee Arthroplasty Comparing Cementless to Cemented Fixation, A Prospective Comparison of Long Term Outcomes Using and Identical Design of Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
cemented
cementless
fixation
posterior stabilized
cruciate retaining
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 96
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are any clinical or radiographic differences in cemented and cementless fixation in total knee replacement.

Detailed description: Out comes measures were to determine:

1. whether the knee and function scores and the radiographic results of the knees with a Nexgen cemented knee prosthesis would be better than those with an Nexgen cementless prosthesis.
2. whether the patients with a Nexgen cemented knee prosthesis would have a better range of knee motion than those with an Nexgen cementless prosthesis.
3. whether patient satisfaction and preference would be better in the patients having a Nexgen cemented knee prosthesis than those of patients having an Nexgen cementless knee prosthesis
4. whether complication rate would be less in the knees with a Nexgen cemented knee prosthesis than in the knees with an Nexgen cementless prosthesis.

Eligibility criteria: Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery

Primary outcomes:
measure: Improvement in Knee Society Knee Score
timeFrame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Secondary outcomes:
measure: Improvement in the Range of Motion
timeFrame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hosptial
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Jang Won Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706338: Transcranial Magnetic Stimulation in the Rehabilitation of Postoperative Motor Dysfunction.
Official title: A Study of Transcranial Magnetic Stimulation in the Rehabilitation of Glioma Patients With Postoperative Motor Dysfunction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Postoperative Motor Deficit
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients with postoperative motor deficits, especially for patients with SMA syndrome.
Primary purpose: TREATMENT

Brief summary: This study focused on glioma patients with postoperative motor deficits, especially for patients with supplementary motor area syndrome. The investigators want to investigate whether the recovery of motor function will be accelerated by using transcranial magnetic stimulation to stimulate primary motor area and supplementary motor area on the lesional hemisphere.


Eligibility criteria: Inclusion Criteria:

1. patient underwent awake craniotomy and motor functional identification during tumor resection;
2. patients with postoperative motor deficit (muscle strength of limbs is weaker than preoperative status)

Exclusion Criteria:

1. patients with contraindication of transcranial magnetic stimulation;
2. patients without data of the pre- and postoperative resting state MRI and diffusion tensor image.

Primary outcomes:
measure: Accelerate motor functional recovery
timeFrame: From the day of tumor resection to 3 months after tumor resection.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Neurosurgical Institute
name: Jiang Tao
role: STUDY_CHAIR
References:
citation: Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.
citation: Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
Clinical trial NCT04369638: Fabrication of Naso-alveolar Molding (NAM) Appliance in Cleft Lip and Palate (CLP) From Digital Magnetic Resonance Imaging (MRI) Face Scan
Official title: Fabrication of NAM Appliance in CLP From Digital MRI Face Scan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: nasoalveloar molding
3D printing
MRI
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to fabricate a nasoalveolar molding (NAM) appliance that is digitally fabricated and 3 dimensionally printed utilizing an MRI face scan and to assess the fit of the NAM in new borns with cleft lip and palate.


Eligibility criteria: Inclusion Criteria:

* new born babies with cleft lip and/or palate
* will undergo treatment with UT Pediatric Dental Clinic with a NAM appliance

Exclusion Criteria:

* Patients without cleft lip and/or palate
* patients that cannot tolerate an intraoral appliance
* patients that are not able to be discharged from the hospital 2-3 days after birth.

Primary outcomes:
measure: Fit as measured by number of adjustments to the device
timeFrame: One month after MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Chelsea Wehr, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05404438: Mouth Breathing Habits Improvement Intervention
Official title: Improvement of Mouth Breathing Habits During Sleep in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: mouth breathing
mouth puffing
sleep apnea
oral appliance
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study intends to investigate the improvement in patients with OSA through objective measurement, including oxygen desaturation index (ODI) and the percentage reduction in intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. A total of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. A suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six weeks.


Eligibility criteria: Inclusion Criteria:

* (1) aged 20-60 years old,
* (2) having symptoms of OSA including snoring, daytime sleepiness, etc.
* (3) AHI \& ODI \>=5 events/hour,

Exclusion Criteria:

* (1) taken sleep medication within the last two months or were on long-term use,
* (2) reported tobacco, alcohol, caffeine or drug addiction,
* (3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.

Primary outcomes:
measure: Differences in OSA-related variables before and after the six weeks oral device intervention
timeFrame: baseline, six weeks after intervention
measure: Differences in percentage of mouth puffing before and after the six weeks oral device intervention
timeFrame: baseline, six weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Faculty of Medicine, and Institute of Brain Science, National Yang-Ming Chiao-Tung University
Study officials:
affiliation: Institute of Brain Science ,National Yang-Ming University, Taipei City, Taiwan
name: Cheryl CH Yang, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00000438: Naltrexone Treatment for Alcoholism
Official title: Naltrexone Treatment for Alcoholism: Predicting Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 192
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Committed to alcohol abstinence as a treatment goal.
* Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.

Exclusion Criteria:

* Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
* Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
* Females who are pregnant, lactating, or not using a reliable method of contraception.
* Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
* Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
* Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
* Vocabulary below the 5th grade reading level.
* Abnormal MRI scan.
* HIV infection due to the neurological sequelae.
* Significant central nervous system diseases.
* Seizure disorder or history of closed head trauma.
* Neuroendocrine disorders.
* Treatment with opiates within the last six months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References: