louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02384252: Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
Official title: Characterization of Obesity-related Cardiomyopathy Through Exploration of Human Atrial Trabeculae Contraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Heart Failure
Keywords: obese cardiomyopathy
mitochondria
contractile dysfunction
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients undergoing coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation

Brief summary: The investigators aim to explore obese cardiomyopathy by studying contractile twitch force, sarcomere sensitivity to calcium and mitochondrial function in atrial myocardial samples of patients grouped according to their body mass index, i.e. normal weight, overweight and obese.

Detailed description: Obesity is associated with the development of heart failure, regardless of coronary artery disease or other comorbidities.

Right atrial samples obtained from patients undergoing cardiac surgery and presenting no sign of clinical cardiomyopathy will be grouped according to patient's body mass index. Atrial trabeculae will be explored to dissect out the respective contribution of (i) sarcoplasmic reticulum dysfunction (isometric twitch force contraction analysis), (ii) abnormal sarcomere sensitivity to calcium assessed in permeabilized fibers and (iii) mitochondrial dysfunction to intrinsec contractile dysfunction of myocardium in obese patients.

Eligibility criteria: Inclusion Criteria:

* patient schedulled for coronary artery bypass graft surgery or aortic valve replacement surgery with extracorporeal circulation
* must be over 18 years of age
* must be able to read and understand the consent form in French
* must be in sinus rhythm at inclusion time

Exclusion Criteria:

* medical history of type 1 diabetes
* medical history of sustained atrial arrhythmia
* pregnancy
* class III anti-arhythmic drug

Primary outcomes:
measure: Intrinsic myocardial contractile force
timeFrame: the day of cardiac surgery
Secondary outcomes:
measure: sarcomere sensitivity to calcium
timeFrame: the day of cardiac surgery
measure: Mitochondrial function
timeFrame: the day of cardiac surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Cardiologique - EFCV - CHRU
Study officials:
affiliation: University Hospital, Lille
name: David Montaigne, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01509352: Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication
Official title: Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflux
Keywords: fundoplication
gastric reflux
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective trial of the utility of esophageal stitches during fundoplication.

The hypothesis is that recurrence rate may be different with or without the esophageal stitches.

Detailed description: This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.

One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.

Eligibility criteria: Inclusion Criteria:

Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.

Exclusion Criteria:

1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
3. Prior operation for congenital diaphragmatic hernia
4. Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)

Primary outcomes:
measure: hiatal herniation
timeFrame: 4 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital and Clinics
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694352: Trampoline Exercises Children With Developmental Coordination Disorder
Official title: Effects of Trampoline Exercises Children With Developmental Coordination Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Balance
Developmental coordination disorder
Motor Activity
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RCT in which 28 children with developmental coordination disorder (DCD) were enrolled and equally distributed into two groups; Participants in control group were treated with conventional physical therapy while experimental were given conventional physical therapy in addition to trampoline exercises. Assessment was at 0, 4 and 8 week using developmental coordination disorder questionnaire (DCDQ), pediatric balance scale (PBS) and peads quality of life (PQL)


Eligibility criteria: Inclusion Criteria:

* Children with DCD indicated using DCDQ.

Exclusion Criteria:

* No developmental coordination disorder
* declined to participate
* Progressive unstable health condition.

Primary outcomes:
measure: Developmental coordination disorder questionnaire (DCDQ)
timeFrame: 8 weeks
measure: Pediatric balance scale (PBS)
timeFrame: 8 weeks
measure: Peads quality of life (PQL)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Federal Government Polyclinic Hospital
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitsiou M, Giagazoglou P, Sidiropoulou M, Kotsikas G, Tsimaras V, Fotiadou E. Static balance ability in children with developmental coordination disorder. European Journal of Physical Education and Sport. 2016;11:17-23.
citation: de Oliveira IS, da Silva Oliveira D, de Azevedo Guendler J, Rocha BM, Sarinho SW. Effectiveness of motor intervention on children with Developmental Coordination Disorder (DCD): A systematic review. Journal of Physical Education and Sport Management. 2017;8(3):32-40.
Clinical trial NCT00020852: Cryosurgery in Treating Women With Breast Lesions
Official title: Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.

PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.

Detailed description: OBJECTIVES:

* Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
* Determine the safety of this procedure in these patients.

OUTLINE: This is a multicenter study.

Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.

Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy

  * Tumor no greater than 2.0 cm in diameter
* Eligible for lumpectomy or mastectomy
* No superficial breast lesions
* No prior open surgical biopsy
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Any age

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics
* No other surgery that would preclude study participation

Other:

* No other medical treatment that would preclude study participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center, UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Helena R. Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433952: Pharmacokinetics of Oral Thiamine
Official title: Pharmacokinetics of High Dose Oral Thiamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics in Healthy Subjects
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.

The aims of this study are to:

* Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers;
* Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55

Exclusion Criteria:

* Non dietary thiamine supplement within two weeks of the start of the study or during the study
* History of thiamine deficiency
* Anemia (Hgb\<10)
* History of gastrointestinal absorption disorders
* Taking prescription or over-the-counter medication
* Pregnant or breast feeding a child
* Alcohol and or drug abuse
* Smoker

Primary outcomes:
measure: Area Under the Curve (AUC) for whole blood
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
measure: Area Under the Curve (AUC) for plasma
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
Study officials:
affiliation: Baystate Medical Center
name: Howard Smithline, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03283852: Identifying New Genetic Causes to Development Disorders
Official title: Identifying New Genetic Causes to the Disorders of Growth, Puberty and Sex Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disorders of Sex Development
Growth Disorders
Puberty Disorders
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-09-14
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with disorders of growth, puberty and sex development and related subjects.

Brief summary: Disorders of growth, puberty and sex development can have genetic causes. The exome analysis could detect new mutations responsible for these disorders and the frequency of these mutations in these disorders, their association with other malformations.


Eligibility criteria: Inclusion Criteria:

* congenital growth hormone deficiency
* puberty disorder
* gonadal dysgenesis or anorchia
* primary ovarian failure
* disorder of sex development
* subjects related to a patient with one of the above criteria

Exclusion Criteria:

* environmental or auto-immune cause

Primary outcomes:
measure: mutation research
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A de Rothschild
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Raja Brauner, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205452: Quality of Life (QOL) Following Parathyroid Surgery
Official title: Does Quality of Life Improve Following Minimally Invasive Parathyroid Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parathyroidectomy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing parathyroid surgery

Brief summary: The only established treatment for the complete resolution of hyperparathyroidism is the surgical removal of the affected glands. While proven as a means of resolving hyperparathyroidism, there have been no comprehensive preoperative and postoperative assessments to determine quality of life for patients undergoing minimally invasive vs. traditional parathyroid surgery. Quality of life will be assessed in subjects undergoing minimally invasive procedures and traditional procedures using a clinically validated survey. We will gather data one week preoperatively as well as one week and one year postoperatively then compare the survey results from the two study groups to each other. We will also compare the study groups to a control group consisting of patients undergoing thyroid surgery. Our ultimate goal is to clarify if minimally invasive parathyroid surgery techniques contribute to a higher patient quality of life as compared to traditional techniques.


Eligibility criteria: Inclusion Criteria:

* parathyroidectomy

Exclusion Criteria:

* subjects under the age of 18

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Medical School
name: Herbert Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01349452: Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Official title: Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctivitis, Viral
Adenoviridae Infections
Keywords: Conjunctivitis, Viral
Adenoviridae Infections
Ganciclovir
Adenovirus Keratoconjunctivitis
Treatment of viral conjunctivitis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. The majority of adenoviral conjunctivitis will resolve without damaging vision, however, the investigators have no way to determine which cases will progress to ocular complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* onset of symptoms for five days or less
* eighteen years old or more
* not pregnant or breastfeeding
* be able to understand and sign the consent term

Exclusion Criteria:

* use of antibiotic or corticoid 30 days before
* monocular vision
* keratopathy or other ocular diseases

Primary outcomes:
measure: improvement of symptoms of conjunctivitis (pain relief)
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Simone T Yabiku, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yabiku ST, Yabiku MM, Bottos KM, Araujo AL, Freitas Dd, Belfort R Jr. [Ganciclovir 0.15% ophthalmic gel in the treatment of adenovirus keratoconjunctivitis]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):417-21. doi: 10.1590/s0004-27492011000600007. Portuguese.
Clinical trial NCT02165852: Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
Official title: A Prospective Comparative Study of Papillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ampulla of Vater Adenoma
Keywords: ampulla of Vater
adenoma
papillectomy
injection
non-injection
Lead sponsor: Soon Chun Hyang University
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.

Detailed description: While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.

In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.

Eligibility criteria: Inclusion Criteria:

* ampulla of Vater adenoma
* no uncontrolled coagulopathy

Exclusion Criteria:

* adenocarcinoma of ampulla of Vater
* uncontrolled coagulopathy
* refusal to this study

Primary outcomes:
measure: complete resection
timeFrame: one month
Secondary outcomes:
measure: complication
timeFrame: within 24 hours
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Tae Hoon Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hyun JJ, Lee TH, Park JS, Han JH, Jeong S, Park SM, Lee HS, Moon JH, Park SH. A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma. Gastrointest Endosc. 2017 Apr;85(4):746-755. doi: 10.1016/j.gie.2016.08.013. Epub 2016 Aug 24.
Clinical trial NCT04693052: Attitudes Towards Receiving Mental Health Care Using Telehealth During the Coronavirus Disease 2019 (COVID-19) Pandemic
Official title: Attitudes Towards Receiving Mental Health Care Using Telehealth During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Mental Health Disorder
Stress
Adjustment Disorders
Keywords: Telehealth
Telemedicine
Telepsych
Telepsychiatry
Telepsychology
Telemental health
Survey
Attitudes
COVID-19
pandemic
mental health
therapy
psychiatry
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: People receiving mental health care at Northwestern Medicine during the COVID-19 pandemic

Brief summary: The purpose of this study is to collect patients' experiences and feedback to better understand and improve mental health care using telehealth services. This is critically important as telehealth appointments, including both phone and video calls, continue to be offered for regular appointments to reduce in-person interaction as a preventive measure to help control the spread of COVID-19.

Detailed description: Studying patients' perceived benefits and challenges of using telehealth services for mental health care will allow us to prioritize improvements to the telehealth experience and potentially, patient adoption of and comfort with remote appointments. This study's results would also inform policy makers and insurance companies about the potential utility of delivering mental health care through telehealth, even beyond the duration of the COVID-19 pandemic.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 and over who received mental health care through Northwestern prior to telehealth implementation from March 15th 2019 to March 14th 2020, and had at least one mental health care appointment through Northwestern between March 15th 2020 and September 30th 2020.

Exclusion Criteria:

* Adults unable to access study questionnaires via computer or mobile device

Primary outcomes:
measure: Patient Choosing Telehealth as an Option for Future Care
timeFrame: At baseline
measure: Comparison Between In-person and Telehealth
timeFrame: At baseline
measure: Patient Satisfaction With Telehealth
timeFrame: At baseline
measure: Patient Comfort Using Telehealth
timeFrame: At Baseline
measure: Patient Easy of Using Telehealth
timeFrame: At Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jeffrey Rado, MD
role: PRINCIPAL_INVESTIGATOR
References: