louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05949151: Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
Official title: Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusion
Keywords: implant supported overdenture
muscle activity
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 22
Sex: MALE
Minimum age (years): 55
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Primary purpose: TREATMENT

Brief summary: 22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.

The patients were randomly categorized into two groups according to the final restoration.

Detailed description: Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.

Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.

Eligibility criteria: Inclusion Criteria:

* edentulous mandible with well-developed alveolar ridge
* free from temporomandibular joint disorder
* free from any chronic diseases.

Exclusion Criteria:

* smoker
* patients having systemically immunosuppressive diseases
* patients receiving radiotherapy.

Primary outcomes:
measure: Occlusal equilibrations
timeFrame: Day 1 , one month and 3 month
measure: Muscle activities
timeFrame: Day 1 , one month and 3 month
Secondary outcomes:
measure: oral health-related quality of life (OHRQoL)
timeFrame: Day 1, one month and 3 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: Dokki
Study officials:
affiliation: National Research Centre, Egypt
name: Asmaa Elboraey, Ass.Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01552551: Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
Official title: Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Weakness Distal
Distorted; Balance
Keywords: Falls
exercise
safety
injury
Older adults
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-03-13
Enrollment: 189
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.

Detailed description: This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.

This study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.

Eligibility criteria: Inclusion Criteria:

1. Able to provide informed consent
2. Willing to be randomized
3. Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery
4. Age 50+

Exclusion Criteria:

1. Hospice enrollee or life-threatening illness
2. Active cancer treatment
3. Neurologic disease linked to falls risk, such as Parkinson's
4. Unable to ambulate indoors
5. High likelihood of moving in next 6 months

Primary outcomes:
measure: Falls
timeFrame: 6 months
Secondary outcomes:
measure: Fall-related injuries requiring hospitalization/emergency department care
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Steven M Albert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06102551: A Retrospective Analysis of Incisional Hernia Repair's Postoperative Recurrence
Official title: A Retrospective Study of Factors Associated With Postoperative Recurrence of Incisional Hernia Repair in the Abdominal Wall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Recurrent Hernia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination.

Exclusion Criteria:

* Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.

Brief summary: ABSTRACT Purpose：A retrospective study was conducted among patients with incisional hernia in our hospital to analyse the factors associated with postoperative recurrence of abdominal wall incisional hernia.

Methods：Patients with a diagnosis of incisional hernia obtained from our hospital's electronic medical record system were divided into primary incisional hernia group and recurrent incisional hernia group according to whether or not they had a recurrence after surgery. Baseline information on these patients was recorded and statistically analysed after our review.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: diagnosis of incisional hernia of the abdominal wall and primary; surgical treatment for hernia repair at our hospital; all patients originating from outpatient clinics rather than emergency clinics; age of 18 to 80 years at the time of admission; and those with a well-established preoperative examination.

Exclusion Criteria:

* Exclusion criteria: severe organ dysfunction (ASA score of IV, V, VI); unconsciousness and poor cooperation with various preoperative examinations; correction of other types of abdominal hernia by perfect examination after admission; incomplete necessary information.

Primary outcomes:
measure: Recurrent
timeFrame: 2017.1-2023.8
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: YiMing Lin
state: Shanghai
Study officials:
References:
Clinical trial NCT00660751: The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control
Official title: The Role of Central Serotonergic and Adrenergic Systems in the Effectiveness of DNIC (Diffuse Noxious Inhibitory Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Physiology of Serotonergic and Adrenergic systems
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* age 18-80
* no chronic disease

Exclusion Criteria:

* Subjects who suffer from chronic pain / pain syndrome
* use of anti-depressant or anti-psychotic drugs
* food/ drugs sensitivity
* breast feeding

Primary outcomes:
measure: level of DNIC
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
name: Prof. David Yarnitsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04419051: Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
Official title: Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Anxiety
Stress
Keywords: Owlet
Pregnancy
Digital Health
Wellness
Lead sponsor: Owlet Baby Care, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 8000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women 24 weeks' gestation and later

Brief summary: This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.

Detailed description: The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". The study involves women age 18 and older who are currently pregnant, at least 24 weeks' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.

Eligibility criteria: Inclusion Criteria:

* Must be at least 24 weeks pregnant with a singleton pregnancy
* Must be at least 18 years of age
* Must currently live in the United States
* Must have a compatible smartphone (Apple iOS Version 13 or above)
* Able to read and understand English in order to provide Informed Consent and follow study instructions

Exclusion Criteria:

* NA

Primary outcomes:
measure: Gather information
timeFrame: From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks
measure: Gather information
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Management of anxiety State Trait Anxiety Inventory
timeFrame: Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)
measure: Management of stress (Perceived Stress Scale)
timeFrame: Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)
measure: Participant's experience while using the Owlet Band
timeFrame: Through study completion, up to 16 weeks
measure: Maintenance of standard medical care
timeFrame: Through study completion, up to 16 weeks
Other outcomes:
Locations:
city: Lehi
country: United States
facility: Owlet Baby Care, Inc.
state: Utah
Study officials:
References:
Clinical trial NCT06816251: A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-obstructive Hypertrophic Cardiomyopathy
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

1. Age 18\~85 years old (including boundary value), male or female.
2. Body mass index \< 35 kg/m2.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
4. Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
5. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.

Exclusion Criteria:

1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 14 weeks.
measure: The incidence of left ventricular ejection fraction (LVEF) < 50%
timeFrame: Up to 14 weeks.
Secondary outcomes:
measure: Peak oxygen uptake (pVO2) value
timeFrame: About 12 weeks.
measure: The cardiac troponin value
timeFrame: About 12 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03345251: Physical Endometrial Manipulation and Its Effect on ICSI
Official title: Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: ICSI - physical - Manipulation - scratching
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 640
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 640 were enrolled but 608 were analyzed
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .

Detailed description: Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate

Eligibility criteria: Inclusion Criteria:

* Infertile female age 20-35 years
* Previous Failed one ICSI trial
* normal basal hormonal profile \[FSH, LH\] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
* patent tubes
* normal Husband semen analysis

Exclusion Criteria:

* Ovarian factor of infertility
* Tubal factor of infertility
* Endometrial factor of infertility
* Male factor of infertility

Primary outcomes:
measure: The number of participants who achieved clinical pregnancy
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: The number of participants who achieved ongoing pregnancy and live birth
timeFrame: 9 months after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt )
name: Mahmoud Alalfy, master
role: STUDY_CHAIR
References:
Clinical trial NCT05904951: The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
Official title: Balloon Dilatation Catheter for the Dilation of Stenotic Atherosclerotic Lesions in Coronary Artery or Bypass Grafts: Evaluation of Safety and Performance in Everyday Clinical Practice. The INVADER™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Post Market Clinical Follow-up (PMCF) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Vascular Diseases
Lead sponsor: Alvimedica
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of all consecutive patients treated with the INVADER™ PTCA at the study sites: all patients who met the inclusion/exclusion criteria were enrolled

Brief summary: The aim of the present observational study is to collect clinical data on the non-implantable medical device INVADER™ PTCA in the daily use in an unselected population.


Eligibility criteria: Inclusion Criteria:

* To be a Turkish citizen,
* To be \>18 years of age,
* Lesion must be successfully crossed with a guidewire without complication,
* INVADER™ PTCA is used in the primary lesion treated during the procedure,
* Patient has signed and dated the informed consent.

Exclusion Criteria:

* Patients who have a known allergic reaction to any of the composition of INVADER™ PTCA Balloon Dilatation Catheter.
* Device use not consistent with Instructions for Use (IFU).
* Patients concurrently participating in another medical device or pharmaceutical clinical trial.

Primary outcomes:
measure: Device success
timeFrame: 48 hours after index procedure
Secondary outcomes:
measure: Rate of individual components of device success
timeFrame: 48 hours after index procedure
measure: Procedural success:
timeFrame: 48 hours after index procedure
measure: Rate of Target Lesion Failure (TLF)
timeFrame: 48 hours after index procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Alvimedica
Study officials:
References:
Clinical trial NCT05572151: Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer
Official title: Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer: a Population Study of the US Database and a Chinese Multi-institutional Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: The Second Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 7694
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Information about patients (age, sex and year of diagnosis), tumor (TNM stages, histology, size and differentiation), treatments (resection type, chemotherapy), and outcome variables (follow-up time and survival status) were obtained in SEER database and China registry

Brief summary: A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China

Detailed description: A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)

Eligibility criteria: Inclusion Criteria:

* Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible

Exclusion Criteria:

* Patients with missing values on lymph node count and clinical features were excluded

Primary outcomes:
measure: lymph node number
timeFrame: during the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Del Paggio JC, Peng Y, Wei X, Nanji S, MacDonald PH, Krishnan Nair C, Booth CM. Population-based study to re-evaluate optimal lymph node yield in colonic cancer. Br J Surg. 2017 Jul;104(8):1087-1096. doi: 10.1002/bjs.10540. Epub 2017 May 24.
Clinical trial NCT00533351: Safety and Efficacy of AGN201781 in Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuralgia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
* Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia

Exclusion Criteria:

* Women of child-bearing potential
* Any other uncontrolled diseases

Primary outcomes:
measure: Change From Baseline in Daily Pain Score at Week 2
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Change From Baseline in Subject Global Impression of Change Score at Week 2
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: St. Leonards
country: Australia
state: New South Wales
city: Kiel
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: