louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05042193: A Prospective Virtual Study to Evaluate the Longevity of IgG Antibodies in Individuals Exposed to COVID-19
Official title: A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Everly Health
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 1883
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have tested positive for SARS-CoV-2 by either RT-PCR or Antigen test for COVID-19 or have received one of the commercially available SARS-CoV-2 vaccines.

Brief summary: The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.

Detailed description: This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Willing to provide informed consent prior to participation.
* Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
* Cohort 2 (Arm 2) - Received the COVID-19 vaccine

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy

Primary outcomes:
measure: To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
timeFrame: Up to 9 months
Secondary outcomes:
measure: To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load
timeFrame: Up to 9 months
measure: To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Everlywell, Inc
state: Texas
Study officials:
affiliation: Everly Health
name: Timothy Bauer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715893: Ostomy Belt Use Associated Quality of Life
Official title: Ostomy Belt Use Associated Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Stoma Colostomy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.


Eligibility criteria: Inclusion Criteria:

* Current patients at University of Miami Hospital with stoma willing to trial an ostomy belt
* 18 - 70 years old
* Willing and able to sign informed consent

Exclusion Criteria:

* Patients without stoma or unwilling to wear ostomy belt.
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Primary outcomes:
measure: Change in quality of life as measured by SQOLS
timeFrame: Baseline to 4 weeks, baseline to 8 weeks post ostomy belt use
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Vanessa Hui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139893: A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
Official title: A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Gastroparesis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each dosing. Exclusion criteria include serum glucose \>300 mg/dL, Hb1Ac \>10%, and concurrent illness interfering with gastrointestinal motility. Subjects will stay in the clinic overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve (AUC) from time zero to 8 hr will be compared for the 2 formulations.

Detailed description: See approved Package Insert for Adverse Event information.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis

Exclusion Criteria:

* Serum glucose \>300 mg/dL, HbA1C \>10%, and concurrent illness interfering with gastrointestinal motility

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: Patricia Witt
role: STUDY_DIRECTOR
References:
Clinical trial NCT05718193: Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
Official title: Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence
Colonoscopy
Quality Control
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Loudi Central Hospital
First posted: 2023-02-08
Enrollment: 2868
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.


Eligibility criteria: Inclusion Criteria:

Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.

Exclusion Criteria:

History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.

Primary outcomes:
measure: adenoma detection rate
timeFrame: up to 9 months
measure: adenomas per colonoscopy
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Loudi
country: China
facility: Loudi Central Hospital
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: xiaowei liu, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03998293: Direct Measurement of Proinsulin Clearance in Humans
Official title: Direct Measurement of Proinsulin Clearance in Humans
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers are trying to determine how quickly proinsulin is cleared from the circulation.

Detailed description: proinsulin clearance is necessary to determine the rate of secretion into the circulation

Eligibility criteria: Inclusion Criteria:

* Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester

Exclusion Criteria:

* Age \< 25 or \> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).
* HbA1c ≥ 6.5%
* Use of glucose-lowering agents.
* For female subjects: positive pregnancy test at the time of enrollment or study
* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
* Hormone replacement therapy \>0.625 mg premarin daily

Primary outcomes:
measure: Proinsulin Clearance
timeFrame: through study completion, each study will take an average of 8 hours
measure: Proinsulin Distribution
timeFrame: through study completion, each study will take an average of 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376193: Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
Official title: Drug Use Investigation for AMERGE (Naratriptan Hydrochloride) Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects with migraine headache

Brief summary: The study is designed to investigate the information on safety and efficacy of naratriptan tablets on Japanese subjects with migraine headache during Japanese post-marketing surveillance period.


Eligibility criteria: Inclusion Criteria:

* Subjects with migraine headache
* Must use naratriptan tablets for the first time

Exclusion Criteria:

* Subjects with hypersensitivity to naratriptan
* Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
* Subjects with history of peripheral vascular disorder
* Subjects with history of cerebrovascular disorder or transient ischemic attacks
* Subjects with uncontrolled high-blood pressure
* Subjects with severe hepatic function disorder or renal function disorder
* Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist

Primary outcomes:
measure: The number of incidence of adverse events in subjects with migraine headache
timeFrame: 2 months
Secondary outcomes:
measure: Occurrence of cardiovascular-related adverse events
timeFrame: 2 months
measure: Occurrence of cerebrovascular disorder
timeFrame: 2 months
measure: Occurrence of serotonin syndrome
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Takao Takeshima, Atsuko Ishida, Terufumi Hara. Drug Use Investigation on Naratriptan Tablets (Amerge®) in Patients with Migraine. [Prog Med]. 2012;32(8):95-105.
Clinical trial NCT06329193: Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance
Official title: Effects of Mid-Season Camp Period Loading on Sports Injury Anxiety and Physical Performance of Professional Male Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Exercise
Athletic Performance
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 34
Sex: MALE
Minimum age (years): 19
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players.

Detailed description: According to the periodization theory, the seasonal training process of soccer players is divided into four periods such as pre-season, early competition, late competition, and transition. In general, these periods aim to prepare soccer players for the competitive season, improve their fitness and physical performance, and reduce the risk of sports injuries. Therefore, the loading applied to soccer players during these camp periods are the key determinants of physical performance enhancement and the control of sports injury risks. In particular, the mid-season camp period loading is an important requirement to maintain the gains obtained in the pre-season training programs throughout the season. In this context, sports clubs prefer regions with different physical conditions (sea level, high altitude etc.) for the camp periods and allocate serious budgets for this periods.

Previous studies largely focused on effects of the pre-season camp period on psychological state and physical performance in soccer players. However, few studies in the current literature focused on the mid-season camp period. To the best of authors knowledge, sports injury anxiety and physical performance responses to the mid-season camp period loading in professional soccer players has not been very well discussed. Therefore the aim of this study is to investigate the effects of 3-week mid-season camp period loading on sports injury anxiety level and physical performances of professional male soccer players.

Eligibility criteria: Inclusion Criteria:

* volunteering to participate in study
* not have any musculoskeletal disease

Exclusion Criteria:

* using any drugs or supplements
* with a history of moderate to major injury within last 6 months
* having any systemic disease

Primary outcomes:
measure: Sports Injury Anxiety
timeFrame: Three week
Secondary outcomes:
measure: Muscle strength
timeFrame: Three week
measure: Flexibility
timeFrame: Three week
measure: Dynamic balance
timeFrame: Three week
measure: Single-leg jump
timeFrame: Three week
measure: Agility
timeFrame: Three week
measure: Sprint
timeFrame: Three week
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Erhan Seçer
Study officials:
References:
Clinical trial NCT02828293: Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Official title: Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty
Replacement, Knee
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 8-10 subjects with Medacta GMK Sphere TKA, 8-10 subjects with GMK PS Fixed Bearing TKA and 8-10 subjects with a GMK UC Fixed Bearing TKA will be involved in this project.

The subject recruitment will be based on the clinical reports of the follow-up examination including the standard clinical assessed parameters alignment, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the visual analog scale (VAS)

Brief summary: The objective of this research project is to perform a comparative study on the in vivo kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed Bearing TKA and the GMK UC Fixed Bearing TKA.


Eligibility criteria: Inclusion Criteria:

* subjects bearing a TKA with one of the studied prosthesis
* male and female older than 18 years old
* patients who are willing and able to sign an informed consent form

Exclusion Criteria:

* any case not described in the inclusion criteria

Primary outcomes:
measure: 2D/3D videofluoroscopy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Institute for Biomechanics ETH Zurich
city: Zurich
country: Switzerland
facility: Institute for Biomechanics ETH Zurich
Study officials:
References:
Clinical trial NCT06804993: Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
Official title: Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Obstructed Defaecation Syndrome
Anterior Rectocele
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 60
Sex: FEMALE
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: This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome


Eligibility criteria: Inclusion Criteria: all required

* female patients
* symptomatic rectocele
* failed conservative treatments for at least 3 months
* anterior rectocele larger than 3 cm in size in defecogram.
* retention of the contrast in the rectocele on defecography
* obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia

Exclusion Criteria:

* significant urinary manifestations due to anterior vaginal wall prolapse
* recurrent rectocele
* previous anal surgery
* slow-transit constipation
* faecal incontinence (FI)
* abnormal thyroid functions
* patients under systemic steroid treatment
* patients with connective tissue disease
* ASA classification \>3

Primary outcomes:
measure: Recurrence rate
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
References:
Clinical trial NCT01472393: Creatine on Bone Mass in Postmenopausal Women
Official title: A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Women
Keywords: creatine supplementation
bone mass
postmenopausal women
muscle function
bone markers
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: AlzChem AG
First posted: 2011-11-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* healthy postmenopausal women
* T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

Exclusion Criteria:

* drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
* low BMI (\< 18.5 Kg/m2).

Primary outcomes:
measure: bone mineral density (BMD)
timeFrame: 12 and 24 months
Secondary outcomes:
measure: bone markers
timeFrame: 12 and 24 months
measure: history of falls
timeFrame: 24 months
measure: bone microarchitecture
timeFrame: 12 and 24 months
measure: muscle function
timeFrame: 12 and 24 months
measure: lean mass
timeFrame: 12 and 24 months
measure: laboratory parameters
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - School of Medicine
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Rosa M Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.
citation: Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17.
citation: Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.
Clinical trial NCT03179293: Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
Official title: Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emergence Agitation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoﬂurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.


Eligibility criteria: Inclusion Criteria:

1. Children Aged 3 - 8 years
2. ASA (I - II)
3. Genito-urinary Surgeries: hernia, varicocele, etc.

Exclusion Criteria:

1. Patients or parental refusal
2. Allergy to Propofol or egg products; or a family history of malignant hyperthermia
3. Operating time more than 60 minutes
4. Performance of any other procedure under the same anaesthetic
5. Presence of co-morbidities or congenital anomalies
6. mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Primary outcomes:
measure: Emergence Agitation
timeFrame: 30 min after emergence
measure: Emergence Agitation
timeFrame: 30 min after emergence
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
References: