louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05356052: Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Official title: Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Serious Disease or Conditions Associated With Pulmonary Hypertension
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pulmonary Fibrosis
Pulmonary Hypertension
Keywords: PF
Pulmonary Fibrosis
Pulmonary Hypertension
PH
Inhaled Nitric Oxide
iNO
Long Term Oxygen Therapy
LTOT
Oxygen
INOpulse
pulsed inhaled nitric oxide
fILD
fibrotic interstitial lung disease
portable pulsed inhaled nitric oxide
Lead sponsor: Bellerophon
Sponsor class: INDUSTRY
First posted: 2022-05-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
2. Subjects greater than 18 years of age at the time of consent to study participation.
3. Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
4. Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
5. Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
6. Subjects, in the opinion of the Investigator that would benefit from iNO treatment.

Exclusion Criteria:

1. Subjects who require treatment with riociguat.
2. Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator.
3. Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP).
4. Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bellerophon Therapeutics
name: Ashika Ahmed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01644552: Positive Angle Kappa
Official title: Positive Angle Kappa: a Sign in Aniridia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aniridia
Keywords: aniridia
positive angle kappa
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with aniridia

Brief summary: Patients with aniridia have positive angle kappas.


Eligibility criteria: Inclusion Criteria:

* patients with aniridia only

Exclusion Criteria:

* poor va
* PK,
* K-pro

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Dept of ophthalmlogy
state: Minnesota
Study officials:
References:
Clinical trial NCT06203652: The Pathogenesis and Prognostic Factors of Lymphoma
Official title: The Pathogenesis and Prognostic Factors of Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Hodgkin Lymphoma
Non-hodgkin Lymphoma
Keywords: lymphoma
Hodgkin lymphoma
Non-Hodgkin lymphoma
THRLBCL
DLBCL
MZL
CLL/SLL
MCL
WM
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological diagnosis of lymphoma from 2007 to 2027 according to 2016 WHO classification.

Brief summary: The aim of this study is to describe the clinical and genetic characteristics of Chinese lymphoma patients, and to explore the relationship between those characteristics and phatogenesis.

Detailed description: Lymphoma is a highly common malignant tumor in Asia. This study aims to observe and describe the clinical and genetic charateristics of Chinese lymphoma patients, and to explore the relationship between those charateristics and pathogenesis and prognostic factors in the real-world population. This study is a non-interventional real world, observational study and all registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility criteria: Inclusion Criteria:

* Patients with pathological diagnosis of lymphoma (including Hodgkin lymphoma and non-Hodgkin lyphoma, eg. THRLBCL, DLBCL, MZL, CLL/SLL...) from 2007 to 2027.
* Patients with complete diagnostic, treatment and follow-up records.
* Fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

* Those who refuse to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.
* Severe mental illness.
* Patients deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: OS
timeFrame: Baseline up to data cut-off (Up to approximately 20 years)
Secondary outcomes:
measure: PFS
timeFrame: Baseline up to data cut-off (Up to approximately 20 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital，Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03638752: The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients
Official title: The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comprehensive Education
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 260
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: DIAGNOSTIC

Brief summary: This clinical trial is being conducted to assess whether the comprehensive education before gastroscopy could reduce the adverse reactions, such as nausea, vomiting and improve patient satisfaction.


Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 18 years undergoing routine gastroscopy
2. Informed consent

Exclusion Criteria:

1. Serious coronary heart disease and myocardial injury with serious heart failure
2. Stenosis of the esophagus or cardia obstruction
3. Acute pharyngitis and tonsillitis
4. Acute upper gastrointestinal bleeding
5. Hemodynamically unstable
6. allergy to topical lidocaine
7. Patients did not cooperate or spirit was not normal
8. Pregnancy

Primary outcomes:
measure: Adverse reaction times in gastroscopy
timeFrame: 1 day
Secondary outcomes:
measure: Patients' tolerance scores
timeFrame: 1 day
Other outcomes:
measure: Endoscopists' assessment scores
timeFrame: 1 day
measure: Systolic/diastolic blood pressure (SBP/DBP)
timeFrame: 1 day
measure: Pulse rate (PR)
timeFrame: 1 day
measure: Oxygen saturation by pulse oximetry (SpO2)
timeFrame: 1 day
Locations:
city: Ningbo
country: China
facility: Ningbo NO.1 hospital
state: Zhejiang
Study officials:
affiliation: Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
name: Lei Xu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734352: Patient Experiences on the Stroke Unit
Official title: Patient Experiences of the CVA Care Program on the Stroke Unit
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ischemic Stroke
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke

Brief summary: In this study we want to develop and validate a PREM for patient with ischemic stroke.

Detailed description: Patient Reported Experience Measures (PREMs) assess patient's perception of health care. Currently, there is no suitable PREM tool for patients with ischemic stroke. Therefore, we aim to develop and validate a PREM for this patient population. This PREM will be validated in a multicentre study, in 10 Flemish hospitals. We want to investigate the feasibility of our new questionnaire, as well as the usefulness. In addition we well analyse the results of the questionnaires and use this information to improve the quality of the care program for stroke patients.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* ischemic stroke
* stayed at least one day at the stroke unit

Exclusion Criteria:

* not able to read the questionnaire
* not able to answer question orally
* are not proficient in the dutch language

Primary outcomes:
measure: Validation of a new Patient Reported Experience Measurements (PREMs) for stroke patients
timeFrame: 6-months
Secondary outcomes:
measure: Patient experiences
timeFrame: 6-months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
state: Flemish Brabant
Study officials:
References:
Clinical trial NCT02479932: A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section
Official title: A Comparison of Skin to Delivery Time at Exztraperitoneal vs. Transpirational Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Extra-peritoneal cesarean
Intra-peritoneal cesarean
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.


Eligibility criteria: Inclusion Criteria:

* elective cesarean
* previous cesarean (\<4)
* cesarean for distocia

Exclusion Criteria:

* emergency cesarean ( fetal distress)
* risk of obstetrical bleeding
* maternal coagulation defects
* adnexial mass
* uterin myoma at incision site

Primary outcomes:
measure: Skin-to-delivery time
timeFrame: 1 minute after delivery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 and 48 hour after cesarean
measure: Operation time
timeFrame: Two minutes after surgery
measure: Hemoglobin differences
timeFrame: One hour before cesarean and 48 hours after cesarean
measure: Need for analgesic
timeFrame: 24 and 48 hours after cesarean
measure: Nausea
timeFrame: Two minutes and 48 hours after cesarean
measure: Vomiting
timeFrame: Two minutes and 48 hours after cesarean
measure: Thoracic shoulder pain
timeFrame: 48 hours after cesarean
measure: Urogenital distress measured by Urogenital Distress Inventory
timeFrame: One hour before cesarean and 24 hours after cesarean
measure: Oral intake
timeFrame: 12 and 24 hours postoperatively
measure: Anxiety during surgery
timeFrame: One minute after cesarean
measure: Pain during surgery
timeFrame: One minutes after surgery
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi Araştırma Hastanesi
Study officials:
affiliation: Ataturk University
name: Yunus E TOPDAGI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ataturk University
name: Omer E Yapca, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00219232: An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Official title: An Open-label Extension to Evaluate the Efficacy and Safety of the Rivastigmine Transdermal Patch in Patients With Probable Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Dementia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 868
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to evaluate, in the open-label extension phase, the safety and efficacy of the rivastigmine transdermal patch in patients with probable Alzheimer's Disease


Eligibility criteria: Inclusion Criteria:

* Patients who fulfilled the inclusion and exclusion criteria as listed in the study CENA713D2320 and have completed the double-blind treatment phase on study medication without significant protocol violations.

Primary outcomes:
measure: Safety and tolerability as measured by adverse events, vital signs and skin irritation for up to 28 weeks treatment
Secondary outcomes:
measure: Change in cognition from baseline (week 24 of the double blind phase) at week 52
measure: Clinical global impression of change from baseline at week 52
measure: Change in activities of daily living from baseline at week 52
measure: Change in behavioral symptoms from baseline at week 52
measure: Change in executive function from baseline at week 52
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References:
citation: Grossberg G, Sadowsky C, Frostl H, Frolich L, Nagel J, Tekin S, Zechner S, Ros J, Orgogozo JM. Safety and tolerability of the rivastigmine patch: results of a 28-week open-label extension. Alzheimer Dis Assoc Disord. 2009 Apr-Jun;23(2):158-64. doi: 10.1097/wad.0b013e31818b1c2c.
Clinical trial NCT00368732: Genetic and Nutritional Causes of Heart Birth Defects
Official title: Gene and Nutrient Etiologies of Human Heart Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Defects, Congenital
Keywords: Congenital Heart Defects
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2006-08-25
Enrollment: 1610
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mothers of babies with heart defects and mothers of babies without any malformation.

Brief summary: Each year in the United States, thousands of babies are born with heart defects. Women who take folic acid during pregnancy have a lower risk of giving birth to infants with heart defects, but the reason for this remains unknown. This study will examine the relationship between genes, nutrition, and the occurrence of heart defects in infants.

Detailed description: Congenital heart defects are the most common type of birth defect; each year, more than 30,000 babies in the United States are born with this kind of abnormality. Conotruncal heart defects, considered to be a very serious type of defect, involve a structural abnormality in the chambers of the heart or blood vessels that lead to and from the heart. Infants born with conotruncal defects must undergo complex open heart surgery, and there is a high fatality rate. Folic acid supplementation during pregnancy has been shown to reduce the risk of conotruncal defects. However, some women who take folic acid during pregnancy still give birth to infants with conotruncal defects. Specific genes may influence the way individuals metabolize folic acid, and variations in these genes may make some infants more prone to developing heart defects. This study will examine the relationship between genes, maternal nutritional intake, and conotruncal heart defects. The results from this study may help to determine genetic and nutritional causes of congenital heart defects.

This study will use previously collected data on 550 infants born with conotruncal defects and 1060 infants born without heart defects. There will be no study visits specifically for this study. Infant DNA will be analyzed for genes that may play a role in folate metabolic pathways. Blood previously collected from the mothers during pregnancy will be analyzed for differences in nutrient intake. Specifically, levels of folic acid, choline, vitamin B12, and methionine will be examined.

Eligibility criteria: Inclusion Criteria:

* Conotruncal heart defect

Exclusion Criteria:

* If part of control group, must not have heart defect

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: California Birth Defects Monitoring Program
state: California
Study officials:
affiliation: California Birth Defects Monitoring Program
name: Gary M. Shaw, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084432: Effect of Caffeine on Preterm Infants' Bone Mineral Content
Official title: Assessment of Bone Mineral Content for Preterm Neonates Treated With Caffeine Using Dual Energy X-ray Absorptiometry : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteopenia (Disorder)
Apnea of Prematurity
Keywords: caffeine
bone mineral content
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm neonates

Brief summary: The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture.


Eligibility criteria: Inclusion Criteria:

Preterm infants with gestational age of 34 weeks or less consecutively admitted to the neonatal intensive care unit

Exclusion Criteria:

Renal or endocrinal diseases Congenital anomalies Suspected chromosomal aberrations Receiving diuretics or steroid therapy

Primary outcomes:
measure: effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry
timeFrame: 5-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02823132: Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia
Official title: Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Invasive Fungal Infection
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute leukemia

Brief summary: The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.


Eligibility criteria: Inclusion Criteria :

* persons who have provided written consent
* Patients with national health insurance cover
* Patients with malignant hemopathy who have been treated with chemotherapy able to induce profound neutropenia (PN \< 500 / mm3) lasting more than 10 days.
* Patients with malignant hemopathy who have received an autologous bone marrow graft
* Patients with severe idiopathic medullar aplasia (PN \< 500 / mm3) who need to be hospitalized for at least 10 consecutive days (with or without treatment with immunosuppressants)

Exclusion Criteria:

* Patients who have received an bone marrow PSC allograft (as such patients have a risk of aspergillosis, which appears in most cases after medullar recovery; they will not be included in the study).
* Patients who have received an autologous PSC graf (as the duration of neutropenia is in most cases less than 10 days).
* Patients whose neutropenia, retrospectively assessed, lasted less than 10 days.

Primary outcomes:
measure: serum level of Mannose Binding Lectin (MBL) in patients with acute leukemia
timeFrame: 1st day of the period of aplasia
Secondary outcomes:
measure: Serum levels of MBL during an episode of aplasia for both groups of patients studied
timeFrame: Every day except Saturday and Sunday for roughly 3 weeks
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT05273632: Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)
Official title: Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss, Surgical
Blood Loss, Postoperative
Keywords: blood loss
cesarean section
oxytocin
tranexamic acid
etamsylate
saline
Intra-operative
Postoperative
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2022-03-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.

Detailed description: Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant females admitted for Elective Cesarean Section.
* Gestational age of pregnancy (38 weeks To 40 weeks).
* the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
* Singleton living fetus.
* No medical disorders.
* Informed Oral Consent From The Patient.

Exclusion Criteria:

* Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
* Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
* Acute liver or kidney diseases; blood disorders, such as anaemia.
* Allergy to Tranexamic acid.
* Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
* Ante partum Hemorrhage such placental abruption.

Primary outcomes:
measure: blood loss during and after cesarean delivery
timeFrame: First 2 hours after C-Section
Secondary outcomes:
measure: post operative bleeding
timeFrame: first 24 hours after C-Section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital
Study officials:
References: