louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03188107: Interrater Reliability of Infant Motor Profile
Official title: Interrater and Intrarater Reliability of Infant Motor Profile: Assessing Motor Profiles of Risky Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Infants
Cerebral Palsy
Down Syndrome
Metabolic Disorders
Spina Bifida
Low; Birthweight, Extremely (999 Grams or Less)
Keywords: Risky Infant
Cerebral Palsy
Down Syndrome
Spina Bifida
Infant Motor Profile
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2017-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consists of risky infants (premature infants, low birth weighted infants, infants with spina bifida or down syndrome

Brief summary: The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.

Detailed description: It is very hard to assess risky infants because of many problems like lack of cooperation, crying, discomfort ect. But with "Infant Motor Profile (IMP)" it is possible to assess motor behavior of risky infants in their daily environment. The assessment relays on video recordings so after recording the motor behavior many people can score the same children many times to have a certain idea about the infant. With this tool it could be easier to set a therapy program after determining the basic motor problem. In Turkey there are a lot of risky infants which later have diagnosed with Cerebral Palsy, Metabolic Disorders and other diseases. Also there are a lot of infants with Down Syndrome (DS) and Spina Bifida (SB). It has been known motor development is impaired with different childhood conditions but there is less information in literature about motor development of children with SB, DS and other diseases. With this study motor status of risky infants between 3- 24 months old will be explored, interrater and intrarater reliability of Infant Motor Profile will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Cerebral Palsy
* Clinical Diagnosis of Down Syndrome
* Clinical Diagnosis of Spina Bifida

Exclusion Criteria:

* Uncontrolled Epilepsy
* Severe Congenital Disorders

Primary outcomes:
measure: Infant Motor Profile
timeFrame: Infants will be assessed at baseline and 3 months later from the first assessment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Abant Izzet Baysal University
name: Ayşe NUMANOĞLU AKBAŞ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heineman KR, Bos AF, Hadders-Algra M. Infant Motor Profile and cerebral palsy: promising associations. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:40-5. doi: 10.1111/j.1469-8749.2011.04063.x.
Clinical trial NCT05928507: FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Official title: CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza A
Influenza Type B
SARS CoV 2 Infection
RSV Infection
Lead sponsor: Baebies, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this protocol will consist of samples collected from adult and pediatric individuals with signs and symptoms of respiratory disorders.

Brief summary: The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.

The main question it aims to answer are:

• the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.


Eligibility criteria: Inclusion Criteria:

* Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
* The samples are obtained from individuals exhibiting respiratory signs and symptoms.
* These samples are collected as part of standard differential diagnostic procedures.
* A minimum sample volume of 1.5 mL is required for testing purposes.

Exclusion Criteria:

* de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
* Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
* The sample with a volume is less than 1.5 mL

Primary outcomes:
measure: Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)
timeFrame: within 72 hours of collection of NP swab
Secondary outcomes:
measure: CLIA Waived results and clinical laboratory result
timeFrame: within 72 hours of collection of NP swab
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Wake Med
state: North Carolina
Study officials:
affiliation: Baebies, Inc.
name: Candice Prowse
role: STUDY_DIRECTOR
References:
Clinical trial NCT02722707: Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX
Official title: Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX. A Humanitarian Use Device ( HUD), Which Has Recently Received a Humanitarian Device Exemption (HDE) From the Food and Drug Administration ( FDA)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Fecal Incontinence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal incontinence. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).

Detailed description: The FENIX is surgically placed. This surgery could be an outpatient procedure or at most an overnight stay in the hospital. The design of the device allows it to be effective immediately. The device is similar to the LINX device used for esophageal reflux. It is a circular set of magnets which surrounds the ano-rectal support. The size of the device is determined at the time of surgery so that the ano-rectum is closed. When the patient strains at stool, this pressure separates the magnets and allows passage of stool. The magnets are held together by an independent malleable titanium wire. Once straining at stool stops, the magnets are able to re-connect or close the rectum. We will monitor patients for postoperative complications related to surgery.

Eligibility criteria: Inclusion Criteria:

* non-pregnant female patients
* 18 years of age or older with fecal incontinence
* failed conservative therapy ( pelvic floor physical therapy, medications) and failed trial of interstim.

Exclusion Criteria:

* patients less than 18 years of age,
* pregnant
* previous radiation to pelvis,
* chronic diarrhea or inflammatory bowel disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Paul D Pettit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808807: Factors Influencing Cesarean Section Rate: Does the Audit Still Work?
Official title: Factors Influencing Cesarean Section Rate: Does the Audit Still Work?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Keywords: cesarean section rate
the cesarean section rate audit
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 47
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women who delivered in a medical center will be included retrospectively in this study

Brief summary: To elucidate the audit's effect on caesarean section rate, and also define the factors influencing the caesarean section rate.

From Jan 2007 , pregnant women who delivered in a medical center will be included retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the indications of cesarean section, began from July 2008. Clinical data, indications of cesarean section, and perinatal outcomes were compared between the cases of before and after the audit. Multivariate logistic regression was performed to identify factors affecting cesarean section rate.


Eligibility criteria: Inclusion Criteria:

* All pregnant women who delivered in a medical center will be included retrospectively in this study

Exclusion Criteria:

* All pregnant women who delivered in a medical center will be included retrospectively in this study , no exclusion criteria

Primary outcomes:
measure: the impact of the cesarean section rate audit
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao,
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
Clinical trial NCT02955407: Genetic Predisposition for Chronic Non-specific Low Back Pain
Official title: Genetic Predisposition for Reduced Back Muscle Strength and Back Muscle Endurance in Patients With Chronic Non-specific Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 with chronic low back pain and healthy controls without low back pain.

Brief summary: Patients with inflammatory back pain were shown to differ from healthy controls in genotype of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The aim of this study is to investigate whether genetic reduction of muscle perfusion might be a pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).

Detailed description: The following genes will be investigated:

* Insertions-/deletions-polymorphism of the angiotensin-converting enzyme (ACE-I/D gene polymorphism; 3 genotypes: ACE-II, ACE-ID, ACE-DD).
* Anti-adhesive extracellular matrix protein Tenascin-C: gene polymorphism rs2104772

The goals of this study are to investigate whether these genotypes correlate with 1) endurance of back muscles, 2) comorbidities such as asthma and diabetes and 3) the risk for LBP as assessed by a LBP-classification tool.

Eligibility criteria: Inclusion Criteria:

* 18-65

Exclusion Criteria:

* Spinal surgery
* Spinal fracture
* Inflammation
* Tumour
* Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)

Primary outcomes:
measure: Polymorphism ACE Gene
timeFrame: baseline
measure: Polymorphism Tenascin Gene
timeFrame: baseline
Secondary outcomes:
measure: Back muscle endurance in Sorensen test
timeFrame: baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Martin Flück, Professor
role: STUDY_DIRECTOR
References:
citation: Vaughan D, Huber-Abel FA, Graber F, Hoppeler H, Fluck M. The angiotensin converting enzyme insertion/deletion polymorphism alters the response of muscle energy supply lines to exercise. Eur J Appl Physiol. 2013 Jul;113(7):1719-29. doi: 10.1007/s00421-012-2583-6. Epub 2013 Feb 9.
citation: Shehab DK, Al-Jarallah KF, Al-Awadhi AM, Al-Herz A, Nahar I, Haider MZ. Association of angiotensin-converting enzyme (ACE) gene insertion-deletion polymorphism with spondylarthropathies. J Biomed Sci. 2008 Jan;15(1):61-7. doi: 10.1007/s11373-007-9203-1. Epub 2007 Aug 23.
Clinical trial NCT02856607: Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
Official title: Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infective Endocarditis (IE)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all adults with infective endocarditis episode

Brief summary: Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances.

Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center.

The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center.

For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years.

Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.


Eligibility criteria: Inclusion Criteria:

- adult with infective endocarditis episode according to Duke Criteria

Exclusion Criteria:

* Patients with a new episode of infective endocarditis that led to its prior inclusion in the study

Primary outcomes:
measure: the all-cause one-year mortality according to the group
timeFrame: one year
Secondary outcomes:
measure: the application of European recommendations
timeFrame: one year
measure: antibiotic treatment
timeFrame: one year
measure: surgery
timeFrame: one year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT00510107: Weekly Docetaxel Plus Cisplatin or Oxaliplatin for AGC
Official title: A Randomized Phase II Trial of Weekly Docetaxel/Cisplatin Versus Weekly Docetaxel/Oxaliplatin in Previously Untreated Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasm
Stage IV
Recurrent
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-08-01
Enrollment: 90
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: To evaluate the efficacy and safety of weekly administered combination of docetaxel/cisplatin and docetaxel/oxaliplatin in chemotherapy-naïve patients with advanced gastric cancer. The primary endpoint will be the response rate.

Detailed description: Gastric cancer is the most frequently occurring malignancy in Korea, and is one of the main causes of cancer death. While treatment options for AGC have expanded in recent years to include newer agents such as taxanes, irinotecan and oxaliplatin, myelosuppression remains a problem. Recently, weekly schedule of docetaxel is appealing due to limited incidence of severe myelosuppression compared with standard 3-weekly regimen. This altered toxicity profile suggests a potential for better tolerance and increased dose intensity.

Eligibility criteria: Inclusion Criteria:

* histologically proven gastric cancer
* aged 75 years or less
* performance status 0 to 2
* no prior chemotherapy
* inoperable, recurrent, or metastatic
* normal marrow, hepatic and renal functions

Exclusion Criteria:

* active infections
* severe co-morbidities
* pregnant or lactating women
* active brain metastasis
* neuropathy of grade 2 or higher

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01244607: NI-0801 in Allergic Contact Dermatitis
Official title: A Proof-of-Principle Study Investigating the Effect of Single Doses of NI-0801 on Nickel Induced Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Contact Dermatitis
Lead sponsor: Light Chain Bioscience - Novimmune SA
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: The purpose of the study is to assess the effect of a single dose of NI-0801 on the severity of nickel-induced allergic contact dermatitis.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 and ≤ 70 years
* Either male or a female lacking childbearing potential
* Previously documented nickel allergy

Exclusion Criteria:

* Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial or that would prevent subjects from providing informed consent.
* Known or previous diagnosis of malignancy
* Known current active tuberculosis or a history of active TB within 12 months of screening
* Known infection with HIV, Hepatitis B or C

Primary outcomes:
measure: Effect of NI-0801 administration on the severity of the cutaneous response to Nickel challenge as measured using the score system of the DKG (Deutsche Kontakt-Allergie Gruppe).
Secondary outcomes:
measure: Safety and tolerability of NI-0801 as measured by the incidence and severity of treatment emergent adverse events.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06118307: Shanghai Ovarian Cancer and Family Care Project
Official title: Shanghai Ovarian Cancer and Family Care Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 3546
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending the oncology department; patients with known risk factors for ovarian cancer; healthy individuals who are in good health determined by physical examination.

Brief summary: Ovarian cancer is the most lethal gynaecological malignancy, but its incidence in the general population is low. Due to the lack of effective prevention and successful screening approaches, most cases are diagnosed at advanced stages, leading to poor prognosis. In order to address the research requirements pertaining to ovarian cancer, the Shanghai Ovarian Cancer and Family Care Project was established. This initiative offers hospital-based resources for investigating ovarian cancer and high-risk populations. The project comprises an on-going ovarian cancer cohort, a high-risk population cohort, and a healthy population cohort. By leveraging these comprehensive cohorts, the project provides a unique platform for in-depth studies on the detection, prevention, early diagnosis, treatment, and prognosis of ovarian cancer.


Eligibility criteria: Participant meet the criteria for one of the following conditions:

* Patients attending the oncology department require differential diagnosis of ovarian cancer.
* Patients with known high-risk factors for ovarian cancer, such as history of ovarian cancer or BRCA-associated cancer, etc.
* Patients attending the Physical Examination Center who have normal findings on physical examination and no symptoms.

Exclusion Criteria:

* Individuals with evidence of another active cancer.
* Individuals who have prior bilateral oophorectomy.
* Individuals who are unwilling or unable to sign the informed consent form.

Primary outcomes:
measure: Death due to ovarian cancer
timeFrame: From diagnosis of ovarian cancer until October 31, 2028.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first maternity and infant hospital
state: Shanghai
Study officials:
References: