louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01066065: Metabolic Safety of Raltegravir Versus Darunavir in HIV Naive Patients
Official title: Metabolic Profile and Cardiovascular Biomarker Pattern Compared in naíve Patients Initiating HAART With TDF-FTC and Raltegravir 400mg BID Vs Darunavir 800 mg Plus Ritonavir 100 mg QD; a One Year Follow-up Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
HIV Infections
Keywords: cardiovascular disease
HIV
metabolic disorder
HIV naive patients initiating HAART with Raltegravir or boosted Darunavir
Lead sponsor: Hospital Carlos III, Madrid
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive naïve patients regularly attended at a referral outclinic. 1:1 Randomization in two arms by a local electronic process.

Brief summary: The advent of new antiretroviral drugs improved the management of HIV naive patients in terms of efficacy. However, the long term metabolic profile of this drugs has not yet been compared and associations between new antiretrovirals and cardiovascular events remains controversial.

Moreover, the better tolerability and easy dosage of this new drugs might hypothetically influence adherence and QOL of HIV patients.


Eligibility criteria: Inclusion Criteria:

* VIH-1

Exclusion Criteria:

* pregnancy
* previous Antiretroviral exposure

Primary outcomes:
measure: lipid profile defined as a clinically significant increment (delta) in Total cholesterol LDL, HDL y non-LDL cholesterol.
timeFrame: baseline and week 12, 24, 36 and 48
measure: Insulin resistance defined by HOMA index.
timeFrame: baseline and week 12, 24, 36 and 48
measure: Cardiovascular biomarkers: ICAM, VICAM, IL-6, PCR hs...
timeFrame: baseline and week 12, 24, 36 and 48
Secondary outcomes:
measure: Antiretroviral adherence and quality of life items.
timeFrame: baseline and week 12,24,36,48
measure: Efficacy defined as viral suppression and CD4 count recovery
timeFrame: baseline and week 12,24,36,48
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Carlos III
Study officials:
References:
Clinical trial NCT02492139: Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
Official title: ESP II Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set in Home Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall purpose of this study is to evaluate the reliability and usability of the reusable BrownieForSymphony pump set in home use.

The primary objectives of this study is to asses and compare the System Usability Scale (SUS) score of the BrownieForSymphony pump set and the current used Symphony pump set.

Secondary Objectives

The secondary objectives of this study are:

to evaluate the rate of usability problems with the BrownieForSymphony pump set

* to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set
* to evaluate perceived comfort during pumping with the BrownieForSymphony pump set Prospective Cohort Study (quasi Cross over design)


Eligibility criteria: Inclusion Criteria:

* Lactating woman \>18 years who

  * Have been pumping for at least 7 days with the Symphony pump and pump set prior to study participation
  * Have been pumping at least 10 times in the week prior to study participation
  * Consistently pump 10 ml of milk or more per breast, per pumping session prior to study participation
  * Currently use a breast shield size of 24 mm
  * Participant has agreed to pump at least 10 times a week over the next three weeks

Exclusion Criteria:

* o Woman has a medical condition of the breast (eg. Mastitis)

Primary outcomes:
measure: Usability Scale (SUS) Symphony Pumpset usability
timeFrame: after 7 days
measure: Usability Scale (SUS) BrownieForSymphony Pumpset usability
timeFrame: after 14 days
Secondary outcomes:
measure: User experience questionnaire (UEQ)
timeFrame: after 7 days, 14 days, 3 week
Other outcomes:
Locations:
city: Baar
country: Switzerland
facility: Medela AG
state: Zug
Study officials:
affiliation: Medela AG
name: Nicole Steinfelder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04677439: Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
Official title: Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Flumatinib
Chronic Myeloid Leukemia, Chronic Phase
Imatinib
Keywords: Flumatinib, CML-CP with Ph+
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
Collaborators: name: Hainan General Hospital
name: Sanya Central Hospital
name: First Affiliated Hospital of Shantou University Medical College
name: Peking University Shenzhen Hospital
name: Dongguan People's Hospital
First posted: 2020-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

Detailed description: A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Diagnosis of CML-CP with Ph+.
* ECOG performance of 0-2.
* Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
* Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%.
* Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

* Previously documented T315I mutation.
* History of TKI treatments except of imatinib.
* History of undergone major surgery within 4 weeks.
* Patients unwilling or unable to comply with the protocol.
* Pregnant or breast-feeding patients.
* patients with other malignant tumor.

Primary outcomes:
measure: Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
timeFrame: 3, 6, 9, 12 months.
measure: Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
timeFrame: 3, 6, 9, 12 months.
measure: Proportion of patients with MMR at 3, 6, 9 months.
timeFrame: 3, 6, 9 months
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.
timeFrame: 24 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Xin Du, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04630639: Sparkle Respiratory Effort Validation
Official title: Validation of the Sparkle Respiratory Effort Signal Against Esophageal Pressure in Healthy Participants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea, Central
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Pulmonary Critical Care Associates of Baltimore
First posted: 2020-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study has been developed in order to demonstrate the validity of the Sparkle respiratory effort signal.

Detailed description: The rationale for undertaking this study is to demonstrate that the agreement between the Sparkle respiratory effort signal amplitude and esophageal manometry is non-inferior to the agreement between the thoracic belt respiratory effort signal amplitude and esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the Sparkle device, respiratory belts, and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years;
* Fluent in English;
* Able to provide informed consent.

Exclusion Criteria:

* Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
* History of allergic reactions to medical adhesives;
* Known allergy to lidocaine;
* Known seizure disorder;
* Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
* Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms;
* At risk for excessive bleeding including use of anticoagulants;
* An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
* An employee, or spouse of an employee, of Pulmonary and Critical Care Associates of Baltimore.

Primary outcomes:
measure: Breath amplitude correlation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
Study officials:
affiliation: Pulmonary and Critical Care Associates of Baltimore
name: Alan Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348439: Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
Official title: A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vitreoretinal Traction Syndrome
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 29
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: Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.


Eligibility criteria: Inclusion Criteria:

* Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.

Exclusion Criteria:

* Presence of a posterior vitreous detachment in the study eye
* History of vitrectomy in the study eye
* Proliferative diabetic retinopathy in the study eye
* Presence of media opacity that precludes quality examination of the vitreous and fundus.

Primary outcomes:
measure: Presence of a Grade A Posterior Vitreous Detachment (PVD)
timeFrame: 14 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT04768439: Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
Official title: Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteopenia of Prematurity
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.

Detailed description: The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).

Eligibility criteria: Inclusion Criteria:

* Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.

Exclusion Criteria:

* Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics)
* Being NPO (nothing per oral) for more than 2 wks
* Gestational age more than 32 weeks
* Birth weight more than 1500 grams

Primary outcomes:
measure: Calcium level and activity
timeFrame: six weeks
measure: Phosphorus level and activity
timeFrame: six weeks
measure: Alkaline phosphatase level and activity
timeFrame: six weeks
measure: 25-Hydroxy Vitamin D
timeFrame: six weeks
measure: Bone fracture
timeFrame: six weeks
measure: Intracortical resorption
timeFrame: six weeks
measure: Losing the sharp bone border (fraying)
timeFrame: six weeks
measure: Cupping of metaphyseal edge of bone
timeFrame: six weeks
measure: Widening of the distal end of the metaphysis of bone
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
Study officials:
affiliation: Faculty of Medicine, Alexandria University, Egypt
name: Marwa M Farrag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04976439: Patogenic Mutation in 5 Genes
Official title: Genomic Landscape of APC, KRAS, TP53, PIK3CA, and MLH1 in Colorectal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
APC Gene Mutation
TP53 Gene Mutation
PIK3CA Gene Mutation
KRAS Mutation-Related Tumors
MLH1 Gene Mutation
Keywords: next-generation sequencing
colorectal cancer
indonesia population
co-occurring mutation
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a descriptive study in patients with colorectal malignancies who underwent surgery and/or chemoradiation and/or chemotherapy at RSCM, RSKJ, and MRCCC in 2017-2018 whose tumor tissue specimens were still properly stored in the form of formalin-fixed paraffin-embedded (FFPE). .

Brief summary: This is a pathogenic mutation profile of colorectal patients specifically in 5 genes, i.e. APC, TP53, PIK3CA, KRAS, and MLH1. Single nucleotide variants identified were synchronized with patients' characteristics.


Eligibility criteria: Inclusion Criteria:

* FFPE samples fullfilling purity criterion and pass quality control

Exclusion Criteria:

* none

Primary outcomes:
measure: Description of clinical characteristics
timeFrame: January 2017 - June 2021
measure: Description of tumor nature
timeFrame: January 2017 - June 2021
measure: Description of survival
timeFrame: January 2017 - June 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Vania Myralda Giamour Marbun
state: ALL
Study officials:
References:
Clinical trial NCT02047539: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
Official title: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Clinical High Risk for Psychosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.

Detailed description: Patients will be randomly assigned to either active treatment (aspirin) or placebo.

Eligibility criteria: Inclusion Criteria:

* Age 19 - 35
* Must have a SIPS interview
* CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS
* Must demonstrate adequate decisional capacity

Exclusion Criteria:

* Under age of 19
* Have pre-existing gastrointestinal disease, heart disease
* Have kidney disease
* Taking non-steroidal anti-inflammatory medications
* Hypersensitive to NSAID (non-steroidal anti-inflammatory medications)
* Have coexisting unstable major medical illness
* Are pregnant or breastfeeding
* Consume more than 2 drinks of alcohol per day
* Have a blood clotting disorder
* Are taking ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, oral hypoglycemic or uricosuric agents
* Have a history of substance abuse in past three moths or dependence in past 6 months

Primary outcomes:
measure: Scale of Prodromal Symptoms (SOPS)
timeFrame: 2 weeks
measure: Scale of Prodromal Symptoms (SOPS)
timeFrame: 4 weeks
measure: Scale of Prodromal Symptoms (SOPS)
timeFrame: 8 weeks
measure: Scale of Prodromal Symptoms (SOPS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: PRIME Research Clinic
state: Connecticut
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558539: Tibial Nerve Stimulation for Post-BPH Overactive Bladder
Official title: Study on the Efficacy of Wearable Transcutaneous Tibial Nerve Stimulation for Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Persistent Overactive Bladder Symptoms Post Benign Prostatic Hyperplasia Surgery
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 90
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-center, randomized, parallel-controlled design. Approximately 90 cases of persistent overactive bladder symptoms post benign prostatic hyperplasia surgery are expected to be enrolled. The study participants will be randomly assigned to three groups, with 30 participants in each group.


Eligibility criteria: Inclusion Criteria:

* 1. Patients with overactive bladder before benign prostatic hyperplasia 2.Overactive bladder still exists 1 month after the operation of benign prostatic hyperplasia; 3.50 ≤ age ≤80 , male 4.72-hour urination diary showed an average of ≥8 urination times every 24 hours at baseline

Exclusion Criteria:

-

Primary outcomes:
measure: Average Daily Urination Frequency Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
Secondary outcomes:
measure: Average Urinary Urgency Score
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: Average Daily Nocturia Frequency Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: Average Voided Volume per Urination Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: Average Daily Incontinence Episodes
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: OABSS Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: PPBC-S Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: AUA-SI-QOL Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: SAS Compared to Baseline
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: Participant Satisfaction
timeFrame: treatment during 12 weeks : assessments at weeks 4, 8, and 12.
measure: Potential Adverse Events Related by TTNS
timeFrame: Entire Study
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00370539: Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Photodynamic therapy,
Bevacizumab,
Triamcinolone,
Age-related macular degeneration,
Choroidal neovascular membrane
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and intravitreal triamcinolone for neovascular AMD.


Eligibility criteria: Inclusion Criteria:

* Cases of active neovascular AMD with visual acuity of 20/400- 20/40

Exclusion Criteria:

* History of glaucoma or ocular hypertension
* Disciform scar

Primary outcomes:
measure: Visual acuity
Secondary outcomes:
measure: Central macular thickness
measure: Leakage in fluorescein angiography
measure: Intraocular pressure
measure: Anterior chamber reaction
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References: