louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01969812: Tolerability and Satisfaction With Evie
Official title: Patient Satisfaction and Tolerability With the Evie® Slow-Release Insemination Device: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Intrauterine Insemination
Slow-release Insemination
Evie
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine patient satisfaction and tolerability of the Evie® slow-release insemination device for US population. Additionally, to assess cramping with the device and to determine pregnancy rates using the slow insemination device compared to standard IUI.


Eligibility criteria: The inclusion criteria:

* Infertile women age ≤39 undergoing first IUI cycle for relatively unexplained infertility
* IRB approval and informed consent signed

Exclusion criteria:

* Women \<18 or ≥40 years old
* Women with abnormalities of the uterine cavity
* Women with tubal occlusion
* History of documented pelvic adhesions or endometriosis
* Uncorrected ovulatory dysfunction
* Uncorrected thyroid function
* AMH \<1 ng/mL
* \<5 million total motile sperm expected for insemination in prior analyses or on the day of sperm preparation for insemination

Primary outcomes:
measure: Patient Tolerability and Satisfaction SF36
timeFrame: 1 month
Secondary outcomes:
measure: Cramping
timeFrame: 1 month
measure: Pregnancy Rates
timeFrame: 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Women's Institute at Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brad Hurst, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muharib NS, Abdel Gadir A, Shaw RW. Slow release intrauterine insemination versus the bolus technique in the treatment of women with cervical mucus hostility. Hum Reprod. 1992 Feb;7(2):227-9. doi: 10.1093/oxfordjournals.humrep.a137622.
citation: Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL, Alper MM, Goldman MB. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertil Steril. 2010 Aug;94(3):888-99. doi: 10.1016/j.fertnstert.2009.04.022. Epub 2009 Jun 16.
citation: Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
citation: Short Form-36. Available at www.sf-36.org. Accessed on September 24, 2013.
Clinical trial NCT02409212: Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
Official title: Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer: the PANTERA Trial (Prostate cAncer Novel ThERApy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
name: University of Sheffield
name: Queen Mary University of London
name: University College London Hospitals
name: Institute of Cancer Research, United Kingdom
First posted: 2015-04-06
Enrollment: 50
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.


Eligibility criteria: Inclusion Criteria:

In accordance with NICE active surveillance guidelines, men:

* Who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months
* With histologically confirmed low or intermediate risk prostate cancer, Gleason score ≤7 (3+4, not 4+3)
* With up to T2a clinical stage tumours
* With pre-treatment PSA ≤20 ng/mL
* Who are willing to participate in optimal active surveillance and provide written informed consent
* With life expectancy of ≥10 years

Exclusion Criteria:

Men:

* With unstable angina
* With uncontrolled hypertension
* With recent myocardial infarction (within the past 6 months)
* With pacemakers
* Already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded
* With any other physical or mental limitation preventing participation in trial assessments
* Participating in other clinical trials which might bias the evaluation of the primary objectives of the present study

Primary outcomes:
measure: Feasibility as measured by rate of recruitment
timeFrame: 36 months
Secondary outcomes:
measure: Feasibility as measured by Intervention adherence
timeFrame: 36 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Trust
state: South Yorkshire
Study officials:
affiliation: University of Sheffield / Sheffield Teaching Hospitals
name: Derek Rosario, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707612: VDR SNPs & 25OHD Correlated With Dyslipidemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemias
Single Nucleotide Polymorphism
Keywords: gene polymorphism
vitamin D receptor
vitamin D
lipid
dyslipidemia
Lead sponsor: Shenzhen Center for Chronic Disease Control
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2021-01-13
Enrollment: 1987
Sex: ALL
Minimum age (years): 20
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult volunteers visiting a health examination center in Shenzhen city of Guangdong province, China were recruited.

A total of 1,987 adults were included in the analysis, aged from 20 to 81 years old. Among them, there were 1,124 females aged 39 (31 - 49) years old and 863 males aged 36 (30 - 44) years old.

Brief summary: The project was aimed to explore the associations of single nucleotide polymorphisms (SNPs) of vitamin D receptor gene with specific circulating lipids in adult Chinese. The circulating 25-hydroxyvitamin D concentration was also tested to explore its interactions with SNPs in the associations.


Eligibility criteria: Inclusion Criteria:

* 1) ≥ 20 years old Han Chinese;
* 2) living in Shenzhen for \> 2 years;
* 3) free of liver diseases, renal diseases, and any cancers in the past 6 months; and
* 4) not in pregnancy for women.

Exclusion Criteria:

* 1) had severe organic diseases,
* 2) had acute infection symptoms, allergic diseases, and malignant tumors,
* 3) had a family history of genetic diseases,
* 4) took VD supplements in the past 6 months,
* 5) took medicines to control lipid levels within 12 hours, or
* 6) took diuretics, did strenuous exercise, or overate within 24 hours before the test.

Primary outcomes:
measure: SNPs of VDR
timeFrame: 6 months
measure: lipid profiles
timeFrame: 6 months
measure: 25OHD
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Center for Chronic Disease Control
state: Guangdong
Study officials:
References:
Clinical trial NCT03067012: Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients
Official title: Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery (Long Limb Uncut Roux-en Y Gastrojejunostomy) for Obese Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Metabolic Disease
Gastric Cancer
Keywords: Oncometabolic surgery
Long limb uncut Roux-en-Y gastrojejunostomy
Obesity
Diabetes
Early gastric cancer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early gastric cancer patients has been revealed in a few pilot studies. However, the nutritional safety has not been dealt with in previous literatures. This is a prospective pilot study for evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese early gastric cancer patients.

Detailed description: We performed long limb uncut Roux-en Y gastrojejunostomy (uRYGJ) in 20 patients with clinical T1N0 stage and preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities between September 2015 and July 2016.

The primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin B12) at postoperative 1 year and secondary endpoints were anemia incidence, BMI change and remission rates of co-morbidities.

Eligibility criteria: Inclusion Criteria:

* Lesion located on distal or mid stomach Lesion confined to submucosa (cT1b) : Early gastric cancer No evidence of metastatic enlarged lymph nodes Preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities

Exclusion Criteria:

* Being unable to understand the risks, benefits and compliance requirements of this trial Non- Korean speaker American society of anesthesiology (ASA) class IV or higher Other malignancy within 5 years.

Primary outcomes:
measure: micronutrients' deficiency (iron, folate, vitamin B12)
timeFrame: postoperative 1-year
Secondary outcomes:
measure: anemia incidence
timeFrame: postoperative 1-year
measure: Body mass index (BMI) change
timeFrame: postoperative 1-year
measure: Remission rates of co-morbidities
timeFrame: postoperative 1-year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02991612: Rifaximin in Patients With Gastroesophageal Variceal Bleeding
Official title: Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 80
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: The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Detailed description: Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.

However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

Eligibility criteria: Inclusion Criteria:

* 18 y.o. ≤age≤75 y.o.;
* Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).

Exclusion Criteria:

* age \<18 y.o. or age \> 75 y.o.;
* Never had the variceal bleeding episode before;
* Do not have endoscopic treatment;
* Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
* Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
* Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
* Acute variceal bleeding within 5 days.
* Refuse to participate

Primary outcomes:
measure: Incidence of all clinical adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of portal vein thrombosis
timeFrame: 2 months
measure: Changes of intestinal flora
timeFrame: 2 months
measure: The changes of serum level of cytokines
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai
name: Shiyao CHEN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918112: Development of a Face Valid Executive Functioning Task
Official title: Development of a Face Valid Executive Functioning Task
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Parkinson's Disease Association, Inc
First posted: 2009-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruit participants through Volunteer for Health, word of mouth, and from a clinical population at the Washington University in St Louis School of Medicine's Neurological Clinical Research Unit (NCRU).

Brief summary: The purpose of this study is to develop a task to measure executive thinking skills that can be performed in a laboratory setting, but has clear parallels to the thinking demands of real life situations, and can be administered to patients such as those with Parkinson's who have difficulty moving.


Eligibility criteria: Brief Inclusion Criteria Parkinson's Disease (PD) group:

* Must have definite PD
* have clear benefit from levodopa

Brief Exclusion Criteria PD Group and Control:

* Hx of stroke
* Head injury
* Visual loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tamara G Hershey, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763212: Reverse Walking With And Without Whole Body Vibration in Children With Cerebral Palsy
Official title: Effects Of Reverse Walking With And Without Whole Body Vibration On Postural Balance And Quality Of Life In Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: postural balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of reverse walking with and without Whole-body vibration on postural balance in children with cerebral palsy.

Detailed description: Current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. However (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. Whereas both techniques were equally effective in improving forward reach in cerebral palsy children.

Eligibility criteria: Inclusion Criteria:

Aged 6-12 years

* Confirm diagnosis of Cerebral Palsy
* GMFCS level I \& II
* Both genders (28)

Exclusion Criteria:

* o Visual impairment

  * Patients who can't follow command
  * Hearing impairment
  * Malignancy
  * Infection (such as Osteomyelitis)
  * Inflammatory arthritis
  * Lower extremity bones fracture
  * Cardiovascular disease
  * Traumatic cases

Primary outcomes:
measure: Pediatric Balance Scale;
timeFrame: 12th week
measure: Pediatric Reach Test (PRT) / Functional Reach Test (FRT)
timeFrame: 12th week
Secondary outcomes:
measure: CP QOL-Child
timeFrame: 12th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Hussain memorial hospital lahore
state: Punjab
Study officials:
affiliation: Riphah international university pakistan
name: fareeha kausar, pp-Dpt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590512: Dietary Salt Intake and Vascular Function
Official title: Dietary Salt Intake and Vascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: dietary salt
sodium
blood vessels
vascular function
endothelial function
heart disease risk
cardiovascular disease risk
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 133
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Detailed description: Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.

Eligibility criteria: Inclusion Criteria:

1. Healthy male, African-American volunteers
2. 18-35 years of age,
3. No personal or first degree relative with hypertension or diabetes,
4. Blood pressure \<130/85 mmHg and \> 90/60 at the screening visit,
5. Body mass index \<30 kg/m2,
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).

Exclusion Criteria:

1. Alcohol intake \>2 beverage/night,
2. Smoking,
3. Recreational drug use,
4. Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
5. Prescription or herbal medication use,
6. Ischemic changes on resting electrocardiogram,
7. Known hypersensitivity to any of the study drugs,
8. Other active medical problems detected by examination or laboratory testing.

Primary outcomes:
measure: endothelial function
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rhonda Bentley-Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06445712: Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
Official title: Examining the Role of Pain in the Link Between Early Childhood Adversity and Psychopathology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Keywords: Pain
Early Life Adversity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to investigate the role of physical pain in the link between childhood adversity and later psychopathology. Children who are participating in a larger longitudinal study will be asked to submerge their hand in cold water and hold it in the cold water as long as possible. Participants will do this twice, once alone and once holding the hand of their parent, to examine the role of parental support in pain development. The study will examine self-report of pain and salivary cortisol response to pain. It is hypothesized that children who have been exposed to more adversity will experience increased pain response and increased psychopathology symptoms. It is expected that higher social support in the family will decrease this relationship.

Detailed description: This study will initiate a program of prospective research, linking early life adversity to both pain and psychopathology symptoms in the pre-adolescent period. This study will examine these links using an existing longitudinal sample of 6.5-9.5 year-old children experiencing familial stress. The project will examine the relationship between dysregulation and pain sensitivity from the behavioral perspective, but also through HPA axis dysregulation. Finally, the project will probe parental support as a moderator on the relationship between dysregulation and pain and psychopathology symptoms. The project will use a novel adaptation of the cold pressor test to examine experimental pain sensitivity as a function of parental support by including a condition in which the child holds the hand of their parent during the task. The project will also examine the neural basis of social support through parent-child brain synchronization. Support for the proposed model may indicate that interventions that increase parental support might decrease both pain and psychopathology.

Eligibility criteria: Inclusion Criteria:

* Subjects who have been enrolled in our ongoing CARE study

Exclusion Criteria:

* Subjects who have not participated in the CARE study

Primary outcomes:
measure: Pain Tolerance
timeFrame: 0-120 seconds
measure: Pain Sensitivity
timeFrame: 0-60 seconds after experiencing stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Laboratory for Child Brain Development
state: Missouri
Study officials:
References: