louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03857204: Fetus Weight Estimation by Ultrasound Data Collection
Official title: Fetus Weight Estimation by Ultrasound Data Collection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Weight
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-02-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research aims to allow deployment \& optimization of SAMPL plain wave algorithm so as to make required advancement towards a light-weight portable US platform or wireless probe - thus elevating clinician's care level and patient treatment by allowing more scan availability and flexibility.


Eligibility criteria: Inclusion Criteria:

1. Women between 24+0 weeks and 41+6 weeks gestation.
2. Women with a singleton viable pregnancy.

Exclusion Criteria:

None

Primary outcomes:
measure: US scans for fetal weight assessment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Alon Shrim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05899504: The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration
Official title: The Use of Novel Over-The-Scope-Clip to Prevent Esophageal Stent Migration- Randomized Controlled Trial- A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migration of Implant
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
Collaborators: name: Ovesco Endoscopy AG
First posted: 2023-06-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A new endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration
Primary purpose: PREVENTION

Brief summary: New endoscopic clipping device called the over-the-scope-clip (OTSC) system (Ovesco Endoscopy, Tübingen, Germany) has become available for the closure of perforations, anastomotic leaks, and fistulas. The OTSC system has a stronger closing force than the through-the-scope hemostatic clip. Therefore, some researchers have reported esophageal SEMS fixation with an OTSC to prevent migration.

Detailed description: Participants requiring esophageal SEMS placement for various indications such as stricture (benign, malignant), leaks All participants who require esophageal SEMS placement. Esophago-gastroscopy will be done to assess the feasibility of SEMS placement.

Participants are randomized into two arms- one arm (interventional) use of OTSC stent fix after esophageal SEMS placement or the other arm (non-interventional) esophageal SEMS is placed.

Participants are followed up for 1 year to observe stent migration rate in both the groups.

Eligibility criteria: Inclusion Criteria:

* All adults (18+ years)
* Have benign, malignant non-stricture esophageal lesions (i.e. fistulae, perforation, leaks) warranting esophageal stent placement as an inpatient or outpatient
* Ability to consent to stent fixation.

Exclusion Criteria:

* Patients aged under 18 years of age
* Unable to provide informed consent
* Inherited or acquired coagulopathy likely to affect the risk of bleeding
* Receiving anticoagulant therapy that could not be stopped or bridged prior to procedure
* Breast feeding, pregnant and lactating women's.

Primary outcomes:
measure: Esophageal SEMS migration rate at 4 weeks follow up.
timeFrame: 4 weeks
Secondary outcomes:
measure: Procedural time in minutes
timeFrame: immediately after procedure
measure: Migration of stent in both groups
timeFrame: 6 months
measure: Adverse events in both groups apart from stent migration
timeFrame: 6 months
measure: Improvement in dysphagia score
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04274504: Osteopontin in Metastatic Breast Cancer Patients
Official title: Osteopontin Level and Promoter Polymorphism in Egyptian Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival, Prosthesis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 119
Sex: FEMALE
Minimum age (years): 31
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Denovo Metastatic breast

Brief summary: OPN plays an important role in various aspects of malignancy, particularly those involved in tissue invasion and metastasis, and OPN levels have been associated with aggressive¬ness in several cancer types, including breast cancer. Tumor response to treatment is a predictor of prognosis and overall survival for cancer patient population the investigators assigned osteopontin as potential contributors in breast cancer.

Detailed description: Analysis of polymorphisms in the OPN regulatory region:

The PCR amplification of the promoter regulatory region from the extracted DNA by using the following primers -3 (forward primer 5" -CAA GCT ACT GCA TAC TCG AAA TCA CA-3" ; reverse primer 5" - ACA ACC AAG CCC TCC CAG AAT TTA-3" ). PCR was performed using 50 ng DNA as a template under the following conditions: 95°C for 10 min, then 36 cycles of 94°C for 30 s, an annealing temperature for 60 s, and 72°C for 60 s, with a final extension at 72°C for 15 min. After affinity membrane purification using the QIAquick Gel Extraction kit (Qiagen, Carlsbad, CA, USA), the PCR products were subjected to cycle sequencing with the respective forward and reverse primer using an automated ABI 310 DNA sequencer.

Measurement of serum level of osteopontin:

OPN level were measured using Enzyme linked immnosorbent (ELISA) Kit supplied by IBL (Immuno-Biological laboratories Co. Ltd., Japan). 30 normal females were conducted with matched age with a median osteopontine serum level of 15 so, this level was assigned as a cut off value.

Pretreatment serum level and polymorphism of oteopontine was correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.

Eligibility criteria: Inclusion Criteria:

* de novo metastatic breast cancer patients recruited from Oncology center Mansoura University and clinical oncology department, Mansoura University Hospital All included patients were presented with disseminated visceral +/- bone metastasis (visceral crisis)

Exclusion Criteria:

* brain metastasis was excluded

Primary outcomes:
measure: Both pretreatment serum level of oteopontin and gene mutation were correlated with different clinicopathological criteria of the patients, response to the treatment, PFS and OS.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Oncology Center
state: Daqahliyah
Study officials:
affiliation: Mansoura university Oncology Center
name: Mohamed A Elbaiomy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03952104: Strength Training and Quality of Life in Elderly
Official title: Effects of Different Strength Training Programs on Quality of Life in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.

Detailed description: Background: Physical activity in the elderly has benefits which improve psychological wellbeing. However, the majority of older adults perform less physical activity with advancing age.

Aim: To evaluate the impact of three different 32-week strength training programs (low, moderate and high intensity) on psychological wellbeing of elderly.

Design: Randomized Controlled Trial.

Eligibility criteria: Inclusion Criteria:

* age ≥60 years;
* having the ability to speak and write in Spanish;
* having the ability to complete the questionnaires independently.

Exclusion Criteria:

-the presence of any medical problem or pathology that could hinder physical activity practice

Primary outcomes:
measure: Quality of life, assessed through the Short Form 36 health survey questionnaire.
timeFrame: 32 weeks
Secondary outcomes:
measure: Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.
timeFrame: 32 weeks
measure: Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JF Lisón, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01540604: CRD007 for the Treatment of Duchenne Muscular Dystrophy, Becker Muscular Dystrophy and Symptomatic Carriers
Official title: An Open-label, Un-controlled, Single-centre Trial Investigating the Efficacy and Safety of CRD007 in Children With Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (BMD) or Children Being Symptomatic Carriers for DMD or BMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Keywords: DMD
BMD
symptomatic carriers
Lead sponsor: RSPR Pharma AB
Sponsor class: INDUSTRY
First posted: 2012-02-29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD

Brief summary: This is an investigation of the efficacy and safety of CRD007 in Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD) and symptomatic carriers.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dystrophinopathy

Exclusion Criteria:

* Severe functional impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
Study officials:
affiliation: Karolinska University Hospital
name: T Sejersen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04261504: Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention
Official title: Brain Mechanisms of Reducing Polysubstance Use Following a Novel Body-mind Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Drug Use
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2020-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) on alcohol, tobacco, and cannabis (ATC) reduction.

Detailed description: The R61 phase of the proposed study will examine brain mechanisms of a brief mindfulness intervention - integrative body-mind training (IBMT) that targets at self-control networks in the brain, and test IBMT effects on alcohol, tobacco, and cannabis (ATC) reduction.

Eligibility criteria: Inclusion Criteria:

* (1) at least 18 years old;
* (2) free of any psychiatric diagnoses or medication (besides a substance use disorder to alcohol, tobacco, or cannabis);
* (3) in the past month, at least 4 episode of heavy episodic drinking; at least 3 occasion of cannabis use; and daily cigarette use for at least the past month;
* (4) normal or corrected-to-normal vision;
* (5) written informed consent;
* (6) no previous meditation or neurofeedback (NF) experiences.

Exclusion Criteria:

* (1) any psychiatric diagnoses other than a substance use disorder;
* (2) medical disorder(s) that may affect the central nervous system; medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females);
* (3) excluding cannabis, evidence of recent (past month) illicit drug use.

Primary outcomes:
measure: Brain Changes in Functional Activity
timeFrame: The outcome measure is assessed at baseline and post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTU/UT
state: Texas
Study officials:
affiliation: Texas Tech University
name: Yi-Yuan Tang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03096704: Vitamine d Dosage and Constipation
Official title: Vitamine D Deficiency in Slow Transit Time Constipation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamine d Dosage in Slow Transit Time Constipation
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: observational prospective study

Brief summary: Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function.

It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.

Detailed description: Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.

Eligibility criteria: Inclusion Criteria:

* slow transit time constipation

Exclusion Criteria:

* drugs assumption comorbidity

Primary outcomes:
measure: dosage of vitamine D
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Noci
country: Italy
facility: Alba Panarese
state: Puglia
Study officials:
References:
Clinical trial NCT05679804: Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire
Official title: Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder, Recovery
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar Affective Disorder

Brief summary: In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. However, as far as we know, there is no scale that evaluates subjective improvement for a disorder such as bipolar disorder that progresses in episodes and has a heterogeneous appearance of loss of functionality. In this study, we aimed to conduct a validity and reliability study of the recovery questionnaire for BDD.


Eligibility criteria: Inclusion Criteria:

* Being between 18-65 ages
* Be diagnosed with bipolar affective disorder
* Be at least primary school graduate

Exclusion Criteria:

* having a physical disability (blindness, etc.) that might prevent filling in the scales,
* having an additional neurological disease that prevented filling out the scale items.

Primary outcomes:
measure: validity and reability of scale
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Seyh Edebali University Faculty of Medicine
Study officials:
References:
Clinical trial NCT00790504: Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation
Official title: Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Pregnancy
Keywords: Pelvic floor
Transperineal ultrasound
Multiple pregnancy
Singleton pregnancy
Female pelvic floor
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-11-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with multiple gestations recruited from the prenatal care or high risk pregnancy units

Brief summary: This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.

Detailed description: This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.

Eligibility criteria: Inclusion Criteria:

* Women with multiple gestations
* Women with singleton gestation
* Able to understand the consent form

Exclusion Criteria:

* None specified

Primary outcomes:
measure: Multiple gestation affects the pelvic floor more than singleton gestation
timeFrame: Until recruitment completion
Secondary outcomes:
measure: The mode of delivery affects pelvic floor outcome
timeFrame: As above
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Vered H Eisenberg, MD MHA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03069404: INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI
Official title: INSTrUCT-SCI: INdependent Observational STUdy of Cell Transplantation in SCI, an Investigator Initiated Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Foundation Wings For Life
First posted: 2017-03-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal cord injured patients T2-T11

Brief summary: The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for 5 years post-transplantation of the Phase I/II investigation CL-N02-SC.


Eligibility criteria: Inclusion Criteria:

* Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
* Must be able to provide written informed consent prior to any study related procedures
* Must agree to comply in good faith with all conditions of the study and to attend all required study visits
* Female subjects who are pregnant remain eligible for enrollment, but the MRI examination will not be performed during the pregnancy. Female subjects of child-bearing potential must have a negative urine pregnancy test prior to the MRI examination

Exclusion Criteria:

* Subjects have received or are receiving off-protocol immunosuppressive medications
* Subjects who after completion of CL-N02-SC have entered, or are about to enter any other interventional study

Primary outcomes:
measure: American Spinal Injury Association (ASIA) Impairment Scale Improvement
timeFrame: 36 months after transplantation of HuCNS-SC®
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
affiliation: Universitätsklinik Balgrist
name: Armin Curt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598804: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Official title: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Physical Activity
Education
Self-management
Exercise
Keywords: Physical activity level
Knee osteoarthritis
Randomized controlled trials
Alternate month design study
Self-management
Self-care
Education and exercise in knee osteoarthritis
Education
Non pharmacological treatment
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Clermont Communauté
name: Innovatherm
First posted: 2015-11-06
Enrollment: 172
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

Detailed description: The aim of this study is to prove the effectiveness of an educational intervention in thermal environment on physical activity level with knee osteoarthritis patients.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, aged 50 to 75 years.
* Patients with knee osteoarthritis clinical criteria of the American College of Rheumatology (ACR)
* Patient affiliated to a social security scheme (beneficiary entitled)
* Patient registered spa
* Patient has given its consent in writing to

Exclusion Criteria:

-

Primary outcomes:
measure: Level of physical activity at 3 month, with score on IPAQ Short form
timeFrame: at 3 months
Secondary outcomes:
measure: Self efficacy at 3 months with score on ASES
timeFrame: at 3 months
measure: Functional status at 3 months with score on WOMAC
timeFrame: at 3 months
measure: Fears and beliefs at 3 months with score on KOFBeQ
timeFrame: at 3 months
measure: Pain at 3 months with score on EVA
timeFrame: at 3 months
measure: Sarcopenia at 18 days
timeFrame: at 18 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References:
citation: Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.