louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03801291: Transvaginal Versus Transperineal Repair of Rectocele
Official title: Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months


Eligibility criteria: Inclusion Criteria:

* Adult female patients with anterior rectocele

Exclusion Criteria:

* Male patients.
* Combined rectocele with internal rectal prolapse.
* Anismus.
* Associated anorectal condition such as hemorrhoids and anal fissure.
* Pregnancy.
* Unwilling to participate in the trial

Primary outcomes:
measure: Improvement in constipation
timeFrame: 6 and 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595.
Clinical trial NCT00110591: Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
Official title: A Phase I, Randomized, Double Blind, Placebo Controlled, Single-Dose, Rising Dose Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO 140 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
First posted: 2005-05-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.

Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Detailed description: PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.

Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

Eligibility criteria: Inclusion Criteria:

* Not more than 20% below or 20% above ideal weight for height and estimated frame size
* Good health, with no clinically significant abnormal findings on the physical examination, medical history, or laboratory tests

Exclusion Criteria:

* History of clinically significant disease
* History of clinically significant allergies, including drug allergy
* Participated in another clinical trial within the 3 months prior to study entry
* HIV infected
* Hepatitis B or C virus infected
* Active significant infection
* Prior exposure, allergy, or known hypersensitivity to PRO 140

Primary outcomes:
measure: Safety and Tolerability of PRO 140
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: Vice President, Clinical Research, Progenics Pharmaceuticals, Inc.
name: William Olson, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05656391: Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis
Official title: Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis in Remission
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 31
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: The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
* Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
* Subjects aged over 18 years
* Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) \> 175.

Exclusion Criteria:

* Presence of flare-up of UC
* Coeliac disease, colectomy, or intestinal resection
* Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
* Any malignancy, pregnancy, or breastfeeding
* Intake of medication potentially influencing gastrointestinal function
* Disability to give informed consent

Primary outcomes:
measure: Changes in IBS-like symptomatology
timeFrame: Measurements were assessed at baseline (T0) and eight weeks (T1)
Secondary outcomes:
measure: Changes in the abundance of bacterial markers
timeFrame: Measurements were assessed at baseline (T0) and eight weeks (T1)
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Doctor Josep Trueta
state: Catalonia
Study officials:
affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)
name: Xavier Aldeguer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858791: MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension
Official title: MIF- Thyroxine Interactions in the Pathogenesis of Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are either a healthy volunteer, or patietns who have confirmed pulmonary hypertension and interstitial lung disease

Brief summary: The investigators will investigate the interrelationship of macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH.

Detailed description: The investigators will test our hypothesis and accomplish our objectives by pursuing three Specific Aims:

To investigate the interrelationship between macrophage migration inhibitory factor (MIF) and free T4 in patients with PAH with a working hypothesis that an increased release of MIF into the pulmonary vasculature during cardiopulmonary exercise changes the normal balance between plasma MIF and T4.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age and have confirmed pulmonary hypertension (PH) and interstitial lung disease (ILD).
* ILD was identified on high resolution computed tomography along with a total lung capacity (TLC) \<70% of predicted value on pulmonary function tests (PFTs) with no evidence of pulmonary hypertension on echocardiogram.
* PAH group patients were defined as patients with a mean pulmonary artery pressure \>25 mmHg at rest and a wedge pressure of \<15 mmHg (millimeters of mercury), measured by right heart catheterization (WHO group I PAH).
* PH+ILD group, subjects with evidence of ILD on high resolution CT Scan and mean pulmonary artery pressure \>25 mmHg on right heart catheterization.
* Patient with evidence of Chronic thromboembolic disease on CT angiogram and mean pulmonary artery pressure \>25mmHg on right heart catheterization. (WHO group IV)
* Patient with Pulmonary Hypertension due to other conditions, such as Sarcoidosis, Gauchers disease, Hemolytic Anemia and Myeloproliferative disorders.
* Normal control group: Subjects without cardiopulmonary disease, with a normal PFT and ECG.

Exclusion Criteria:

* Failure to obtain informed consent;
* Pregnancy
* Subjects with cardiopulmonary disease other than PH and ILD;
* Unexplained abnormal PFT, ECG, Routine blood/chemistries test
* History or existing other sever organ/system diseases
* Defined Acute pulmonary embolism
* Age \< 18 years

Primary outcomes:
measure: To examine the MIF-T4 relationship in patients before/after a standardized exercise challenge
timeFrame: up to 30 mins
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
Study officials:
References:
Clinical trial NCT04659291: Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)
Official title: Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: cognitive function
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients are recruited from the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. The Respiratory Clinic receives referral from hospital specialists and general practitioners. The clinical evaluation procedure includes an interview by a respiratory specialist followed by either an inpatient polysomnography or home polygraphic study according to the patients' clinical characteristics and preference in concordance of the guidelines from the American Academy of Sleep Medicine (AASM). Sleep records will be scored based on standardized criteria of AASM.

Brief summary: Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.


Eligibility criteria: Inclusion Criteria:

* suspected obstructive sleep apnea syndrome
* aged 18 or above
* must be able to speak, read and understand Chinese or English
* possess the ability to respond to questions and follow instructions.

Exclusion Criteria:

* already treated sleep apnea,
* a limited life expectancy due to illness unrelated to sleep apnea
* human immunodeficiency virus (HIV),
* advanced renal disease,
* uncontrolled malignancies
* documented alcohol or drug abuse up to 1 year prior to inclusion in the study.

Primary outcomes:
measure: incidence of Cardiovascular disease
timeFrame: 5 years
Secondary outcomes:
measure: Change of Montreal Cognitive Assessment score (MoCA)
timeFrame: 5 years
measure: Change of Epworth Sleepiness Score
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong
state: Please Select
Study officials:
References:
Clinical trial NCT00638391: Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer
Official title: Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Primary early MCa
Arimidex
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 1600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with early hormone receptor positive breast cancer/no metastasis

Exclusion Criteria:

* None

Primary outcomes:
measure: evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions
timeFrame: 12 months
Secondary outcomes:
measure: description of population treated with anastrozole
timeFrame: 12 months
measure: further information about the change of specific laboratory parameters
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca Germany
name: H Brasch
role: STUDY_DIRECTOR
References:
Clinical trial NCT00479791: Lipid, Glycemic, and Insulin Responses to Meals Rich in Different Fatty Acids
Official title: Lipid, Glycemic, and Insulin Responses to Meals Rich in Saturated, Cis-Monounsaturated, and Polyunsaturated Fatty (n-3 and n-6)Acids in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Fatty acids
Postprandial response
Insulin
Glucose
Triglycerides
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-05-28
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A meal rich in very-long chain omega-3 fatty acids or oleic acid may lower postprandial insulin levels in comparison to a meal rich in linoleic acid or palmitic acid. A meal rich in very long-chain omega-3 fatty acids may lower postprandial triglyceride levels compared to other fatty acids.

Detailed description: Research Design and Methods: Test meals rich in palmitic acid, linoleic acid, oleic acid, and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and containing 1,000 kcal each were administered in a randomized cross-over design every 3 to 4 days to 11 patients with T2DM. Serum insulin, glucose, and triglycerides concentrations were measured for 360 minutes. All subjects received an isoenergic diet of constant composition throughout the study.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus not on insulin therapy

Exclusion Criteria:

* Thyroid, renal, or hepatic disease, uncontrolled hypertension, anemia, history of ketosis

Primary outcomes:
measure: Insulin, and glucose
timeFrame: 15 days
Secondary outcomes:
measure: Triglycerides
timeFrame: 15 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Abhimanyu Garg, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00306891: Effect of Food Upon Pharmacokinetics of Single Oral Dose of Cediranib (AZD2171, Recentin™)
Official title: Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: Advanced solid tumours
Advanced cancer
tumor
tumour
RECENTIN
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of advanced solid tumour.
* Ability to eat a high fat breakfast

Exclusion Criteria:

* Poorly controlled high blood pressure.
* History of significant gastrointestinal problems

Primary outcomes:
measure: Part A: Area Under Plasma Concentration-time Curve (AUC)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
measure: Part A: Maximum Plasma (Peak) Concentration (Cmax)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
Secondary outcomes:
measure: Part A: AUC (0-t)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
measure: Part A: Time to Peak or Maximum Concentration (Tmax)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
measure: Part A: Terminal Phase Half-life (t1/2λz)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
measure: Part A: Apparent Total Body Clearance (CL/F)
timeFrame: Measurements were collected up to 168 hours (following single dosing).
measure: Part B: Best Overall Response Rate (ORR)
timeFrame: Baseline, week 8, week 16 and every 8 weeks thereafter until discontinuation.
measure: Part B: Progression-free Survival (PFS)
timeFrame: Number of days from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Research Site
city: Headington
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AZD2171 Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04361591: COVID-19 in Liver Transplant Recipients
Official title: COVID-19 in Liver Transplant Recipients in Spain: a Nationwide Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
COVID19
Respiratory Failure
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Trasplante Hepático
First posted: 2020-04-24
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Liver Transplantation

Brief summary: Prospective observational study aimed at analyzing the incidence, clinical characteristics and outcomes of COVID-19 in LT in Spain.

Detailed description: Coronavirus Disease 2019 (COVID-19) is a novel viral disease caused by the SARS-Cov-2 infection with a particular predominance of upper and lower respiratory tract symptoms. First diagnosed in China in late 2019, the virus has progressed to a state of pandemia, involving Spain with a important outbreak.

While the outcomes of viral infections in solid organ transplant (SOT) recipients tend to be worse than those from the general population due to chronic immunosuppression, there is little information on the incidence and outcomes of COVID-19 in liver transplant (LT) recipients. LT recipients are usually under less immunosuppression than other SOT and the clinical expression and outcomes of COVID-19 may be different to the reported outcomes in other SOT.

The Spanish Society of Liver Transplantation, which includes 25 LT programs, has promoted a nationwide registry for LT with COVID-19 to help ascertain the incidence and outcomes and help evidence-based management .

Eligibility criteria: Inclusion Criteria:

* Liver Transplant recipient
* Confirmed (PCR positive) SARS-Cov-2 infection
* Informed Consent

Primary outcomes:
measure: Incidence of COVID19 in LT recipients
timeFrame: 12 months
measure: Clinical characteristics of COVID19 in LT recipients
timeFrame: 12 months
measure: Survival and Mechanical ventilation / respiratory support
timeFrame: 3 months
measure: Observed treatments and immunosuppression management
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: SETH-affiliated Liver Transplant Programs in Spain
Study officials:
affiliation: Sociedad Española de Trasplante Hepático
name: Jordi Colmenero
role: PRINCIPAL_INVESTIGATOR
References: