louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03984266: The Pilot Study of High-throughput Sequencing in Neonatal Birth Defects
Official title: The Pre-clinical Study of Genomic Sequencing for Birth Defects in Newborns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Defect
Newborn; Fit
Genetic Diseases
Multiple Malformation
Congenital Malformation
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
name: Maternal and Child Health Hospital of Hubei Province
name: The First Hospital of Jilin University
name: Xuzhou Maternity and Child Health Care Hospital
First posted: 2019-06-12
Enrollment: 3423
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates in one of the study hospitals

Brief summary: In China, birth defects can reach as high as 5.6%, about 900,000 new cases of birth defects are added each year, making it the second cause of death for infants, with a total death rate of 19.1%. At present, China implements the three-level prevention and control system for birth defects, which is performed before marriage, before birth, and during the neonatal period. Newborn screening is the last line of defense against birth defects. Early screening diagnosis and timely intervention are extremely important, especially for diseases which can be preventive and treatable. This study aims to evaluate the clinical application of high-throughput targeting sequencing in newborns, and investigate whether this new technology can significantly shorten the time of examination, improve the diagnosis rate, guide the intervention treatments and promote prognosis for these disease.


Eligibility criteria: Inclusion Criteria:

1. Neonates in one of the study hospitals
2. Abnormal laboratory testing or abnormal response to standard therapy suggestive of a genetic disease

Exclusion Criteria:

1. Any infant whose genome has been shown to have large chromosomal aberration (Trisomy 13, 18, 21 or other)
2. Any infant in which clinical considerations preclude drawing 1.0 ml of peripheral blood
3. Parents refuse consent

Primary outcomes:
measure: Mortality
timeFrame: At corrected age of 18 months
measure: Disability Rate
timeFrame: At corrected age of 18 months
measure: Allele Frequency
timeFrame: In 120 days after receipt of all the patients' sequencing data
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Lin Zou, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00094666: Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 30-Night Polysomnographic Study of MK0928 in Elderly Patients With Primary Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Primary Insomnia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2004-10-22
Enrollment: 465
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.


Eligibility criteria: Inclusion Criteria:

* Elderly patients with a diagnosis of primary insomnia and in good physical and mental health

Primary outcomes:
measure: Amount of time spent awake and time to fall asleep at night after two days
Secondary outcomes:
measure: Amount of time spent awake and time to fall asleep at night after 30 days
measure: Amount of deep sleep after two days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lankford DA, Corser BC, Zheng YP, Li Z, Snavely DB, Lines CR, Deacon S. Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies. Sleep. 2008 Oct;31(10):1359-70.
citation: Svetnik V, Snyder ES, Tao P, Roth T, Lines C, Herring WJ. How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients? Sleep Med. 2020 Mar;67:137-146. doi: 10.1016/j.sleep.2019.08.020. Epub 2019 Sep 11.
Clinical trial NCT06234566: Effect of Different Drilling Techniques on Primary Stability and Marginal Bone Loss of Extra Short Implants
Official title: The Effect of Low Speed Drilling Without Irrigation Versus Conventional Drilling With Irrigation in Extra Short Implants on Primary Stability and Marginal Bone Loss
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Different Surgical Techniques in Dental Implant Surgery
Keywords: Dental Implants
Low speed drill
Extra Short Implants
Primary Stability
Marginal Bone Loss
Osstel
Osseointegration
Lead sponsor: Erzincan University
Sponsor class: OTHER
Collaborators: name: Mode Medical Implant Manufacturer
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim in this study is to compare the effects of low-speed drilling surgery technique without irrigation and conventional implant surgery technique with irrigation on extra short implants. The criteria to be taken into consideration when investigating the effect of these techniques on implants are as follows: evaluation of osseointegration at the end of three months, evaluation of marginal bone loss at the end of three months, initial insertion torque values (maximum insertion torque and final insertion torque), ISQ values obtained with a radiofrequency analyzer (Osstel) at the beginning and at the end of three months.


Eligibility criteria: Inclusion Criteria:

* There must be toothless space in the maxillary and mandibular posterior region (distal part of the canine in each quadrant).
* The edentulous space should not require additional bone grafting.
* Bleeding areas on probing should be less than 10%
* There should be no pathological periodontal pockets
* Patients who do not smoke or smoke less than 10 cigarettes
* There should be no bruxism
* At least 6 months must have passed since the last tooth extracted from the toothless space where the implant is planned.
* There should be no diabetes.

Exclusion Criteria:

* Having psychological problems
* Smoking more than 10 cigarettes
* Alcohol and drug use
* Pregnancy

Primary outcomes:
measure: Evaluation of the status of osseointegration
timeFrame: Three months after the implant is placed in the bone. At the end of three months
measure: Marginal bone lose
timeFrame: Three months after the implant is placed in the bone. At the end of three months
Secondary outcomes:
measure: Insertion Torque value
timeFrame: Surgical stage where the implant is placed
measure: Implant Stability Quotient (ISQ Value)
timeFrame: 1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04803266: Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer
Official title: Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 747
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.

Detailed description: This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Eligibility criteria: Inclusion Criteria:

1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with ≥8 nodes removed.

Exclusion Criteria:

1. Neoadjuvant chemotherapy
2. Bilateral breast cancer
3. Distant metastasis
4. History of other malignancy
5. Involvement of supraclavicular nodes or internal mammary nodes at diagnosis

Primary outcomes:
measure: Disease-free survival
timeFrame: 7 years
Secondary outcomes:
measure: Rates of overall survival
timeFrame: 7 years
measure: breast cancer-specific survival
timeFrame: 7 years
measure: Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3
timeFrame: 7 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Yong Bae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YB, Byun HK, Kim DY, Ahn SJ, Lee HS, Park W, Kim SS, Kim JH, Lee KC, Lee IJ, Kim WT, Shin HS, Kim K, Shin KH, Nam CM, Suh CO. Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):96-105. doi: 10.1001/jamaoncol.2021.6036.
Clinical trial NCT06326866: Otoacoustic Emissions in Different Blood Types
Official title: The Association of Blood Type Differences and Signal-Noise Ratio in TEOAE and DPAOE in Individuals With Normal Hearing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Cochlear
Keywords: otoacoustic emissions
blood type
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals between the ages of 18-26 with known blood type without hearing loss

Brief summary: The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds.

Detailed description: Many factors have a significant impact on otoacoustic emission (OAE) measurement and quality of analysis. Race, age and gender are among the non-pathological factors. To date there is clear data to demonstrate the association of blood types with OAEs. The aim of our research is to investigate the relation of different blood groups (ABO) and Rh factors on transient evoked OAE and distortion product OAE amplitudes and inner ear potentials, differences between ears and to contribute to the limited literature on cochlear hearing loss susceptibility and blood groups with the hypothesis that blood groups may be associated with hearing thresholds.

Eligibility criteria: Inclusion Criteria:

* not having hearing loss
* having a blood group card obtained from health institutions

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: Signal to noise ratios
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Eyyup KARA
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Eyyup Kara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473366: Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
Official title: Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Induction Ventilation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The sequence of standard vs Tao mask will be determined by random number generator. Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication. The duration of the study procedures is variable but would last approximately 30-60 seconds, seldom exceeding 5 minutes additional time to the study patient from what is necessary in a non-study patient. The number of ventilations to achieve adequate ventilation is variable with both the standard mask and the Tao mask. After grading mask ventilation the study intervention is complete and the remainder of surgical and anesthesia care will be based on the clinical needs and decisions of the care team.
Primary purpose: OTHER

Brief summary: The Tao Mask is a new novel facemask for positive pressure ventilation which has recently been demonstrated (MUSC study Pro00047645) to have superior performance to our conventional (standard) positive pressure mask in a random distribution of patients with experiences users. This additional study will extend our investigation of the new masks capabilities by studying it's performance in the morbidly obese - which are more challenging patients to ventilate by mask. Our hypothesis is that the Tao mask will be even more effective in this challenging population than in the random distribution of patients.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years.
2. BMI of \>40.
3. Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.

Exclusion Criteria:

1. Need for awake intubation based on standard preoperative evaluation by the attending anesthesiologist.
2. Increased risk for aspiration of gastric contents due to full stomach, pregnancy, gastro-esophageal reflux disease, and/or hiatal hernia as identified during the pre-operative assessment.
3. Previous tracheostomy procedure.
4. Patient is cognitively incapable of providing their consent for the study.

Primary outcomes:
measure: Tao Scale Score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03176966: Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Official title: Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Cramp
Cirrhosis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.

Detailed description: Muscle cramps are common in liver disease, especially in patients with cirrhosis. Despite the association of muscle cramps with liver disease, there is a paucity of information regarding treatment in these patients. Many treatment options have been reported in the literature but no standard of treatment has been established.

Oral vitamin E replacement has been used successfully in the management of nocturnal muscle cramps in cirrhotic patients. Ropinirole is primarily used for treatment of restless leg syndrome. An off label trial of low dose Ropinirole in clinical practice has shown some success in providing relief of muscle cramps in patients with cirrhosis. This study will compare Ropinirole to vitamin E treatment in a prospective cross-over study.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice
* diagnosis of cirrhosis
* Self report regular muscle cramping

Exclusion Criteria:

* Patients without cirrhosis
* Patients under the age of 18
* Pregnant women

Primary outcomes:
measure: Frequency of Muscle Cramps as Assessed by Patient Survey
timeFrame: 3 months
Secondary outcomes:
measure: Muscle Cramp Severity as Assessed by Patient Survey
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Andrew Scanga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431066: ActiPatch Plantar Fasciitis Clinical Trial
Official title: Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plantar Fasciitis
Plantar Fasciopathy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: BioElectronics Corporation
First posted: 2011-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.

The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.

The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.


Eligibility criteria: Inclusion Criteria:

* All patients with diagnosis of plantar fasciitis agreeing to participate
* Over 18 years old
* Able to wear unit and keep data up-to-date records of use
* Agree to forgo additional treatments during the study period

Exclusion Criteria:

* Patients who have refused, are unable to give or have withdrawn consent
* Patients with heel pain present less than 3 months

Primary outcomes:
measure: Visual Analog Scale (VAS) for pain
timeFrame: 4 Weeks Follow-up
Secondary outcomes:
measure: Visual analog scale for pain
timeFrame: 26 weeks
measure: Foot and ankle disability index
timeFrame: 26 weeks
measure: Tegner activity scale
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Division of Sports Medicine
state: British Columbia
Study officials:
References:
Clinical trial NCT03072966: Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Official title: Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Quality of Life
Keywords: Distress
Exercise
Wearable device
Smartphone
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Stage 0-III breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness

Primary outcomes:
measure: Efficacy of distress screening of wearable device
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
Study officials:
References:
citation: Jung M, Lee S, Kim J, Kim H, Ko B, Son BH, Ahn SH, Park YR, Cho D, Chung H, Park HJ, Lee M, Lee JW, Chung S, Chung IY. A Mobile Technology for Collecting Patient-Reported Physical Activity and Distress Outcomes: Cross-Sectional Cohort Study. JMIR Mhealth Uhealth. 2020 May 4;8(5):e17320. doi: 10.2196/17320.
citation: Chung IY, Jung M, Park YR, Cho D, Chung H, Min YH, Park HJ, Lee M, Lee SB, Chung S, Son BH, Ahn SH, Lee JW. Exercise Promotion and Distress Reduction Using a Mobile App-Based Community in Breast Cancer Survivors. Front Oncol. 2020 Jan 10;9:1505. doi: 10.3389/fonc.2019.01505. eCollection 2019.
citation: Chung IY, Jung M, Lee SB, Lee JW, Park YR, Cho D, Chung H, Youn S, Min YH, Park HJ, Lee M, Chung S, Son BH, Ahn SH. An Assessment of Physical Activity Data Collected via a Smartphone App and a Smart Band in Breast Cancer Survivors: Observational Study. J Med Internet Res. 2019 Sep 6;21(9):13463. doi: 10.2196/13463.