louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01825473: Study of Erythromycin in GER-Associated Apnea of the Newborn
Official title: Study of Erythromycin in GER-Associated Apnea of the Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Apnea
Bradycardia
Keywords: neonate
apnea
preterm
reflux
gastroesophageal reflux
impedance
erythromycin
desaturation
bradycardia
hypoxia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the relationship of reflux and apnea and to determine whether the administration of erythromycin improves the incidence of GER and GER-associated apnea, bradycardic and/or desaturation events in a prospective randomized controlled trial.

Detailed description: A randomized placebo-controlled trial to determine whether erythromycin, a drug known to enhance gut motility, will improve the incidence of GER and GER-associated apnea, bradycardiac and/or hypoxic events. The investigators have two aims: 1) to examine the relationship between GER and apnea, bradycardia, and/or desaturation (ABD) events by simultaneously employing a unique computer algorithm developed at the University of Virginia to measure ABD events and an Multi-channel Intra-luminal Impedance (MII) pH monitoring to measure GER episodes. 2) In a randomized placebo-controlled trial, the investigators will study whether erythromycin decreases GER and GER-associated apnea, bradycardia and/or hypoxia in premature infants.

Eligibility criteria: Inclusion Criteria:Infants admitted to neonatal intensive care unit who are \<37 weeks at birth and \>14 days of age, non-intubated, on full feeds for 3 days with one of the following:

* Any apnea, bradycardia, or desaturation (ABD) event, or
* Documented symptoms of reflux

Exclusion Criteria:

* major central nervous system, gastrointestinal, or complex cardiac anomalies

Primary outcomes:
measure: Reflux Impedance events (both acidic and non-acidic) as recorded by Multichannel Intraluminal (MII) pH Impedance
timeFrame: during day 6 to 7 of study treatment
Secondary outcomes:
measure: ABD events per Physiologic Monitoring Database
timeFrame: during the entire 7 days of treatment
measure: ABD events recorded by nursing
timeFrame: during the entire 7 days of treatment
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Children's Hospital
state: Virginia
Study officials:
affiliation: University of Virginia
name: Fara Davalian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05772273: PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allo-HSCT
Official title: Efficacy and Safety of PD-1 Inhibitor, Azacitidine and Low-dose DLI in AML Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: PD-1 inhibitor
Azacitidine
low-dose DLI
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2023-03-16
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy and safety of PD-1 inhibitor, Azacitidine, and low-dose DLI in AML relapse After allogeneic hematopoietic stem cell transplantation


Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of AML relapse after allogeneic hematopoietic stem cell transplantation.
2. Adequate organ function.
3. Be able to understand and sign informed consent.
4. Age 18 to 60 years old.
5. Serum pregnancy test for females of childbearing potential that is negative within one week prior to initiation of first dose of treatment. Female patients of childbearing potential and sexually active males must agree to use a highly effective method of contraception throughout the study and for at least 90 days after the last dose of assigned treatment.
6. ECOG performance status ≤ 1.
7. Known HLA-matched donor without contraindications to donate.
8. Life expectancy \> 3 months.

Exclusion Criteria:

1. Diagnosis of anther malignant disease.
2. Suspected or proven acute or chronic GVHD.
3. Proven central nervous system leukemia.
4. Prior treatment with anti-PD-1, anti-PD-L1, or DLI.
5. HLA loss positive.
6. Known active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B (HBV) or C (HCV) or Corona Virus Disease 2019(COVID-19);
7. Uncontrolled systemic fungal, bacterial, or viral infection.
8. Known or suspected hypersensitivity to PD-1 inhibitor or azacytidine.
9. Participation in another clinical study within 3 months.
10. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of study procedures.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: ORR assessment is at day 39 (±2).
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Progression-Free Survival (PFS)
timeFrame: 2 years
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01106573: Associations Between Diabetes, Arterial Stiffness and Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?
Official title: Is There an Association Between the Presence of Diabetes, the Degree of Arterial Stiffness and a New Plasma Marker for Vascular Elasticity, Fibulin-1 in Patients Undergoing Heart- and Vascular Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Arteriosclerosis
Carotid Stenosis
Thrombosis
Aortic Aneurysm, Abdominal
Keywords: Diabetes Mellitus
Arteriosclerosis
Intima media thickness
arterial stiffness
pulsewave velocity
fibulin-1
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be selected from patients undergoing planned heart and vascular surgery at our department.

Brief summary: Diabetes Mellitus (DM) is frequently appearing in patients with cardiovascular disease and these patients, as a consequence herby, has a lesser prognosis. DM is often related to increased arterial stiffness and hypertension. The investigators thesis is that DM and pre-diabetes is prevalent in patients undergoing cardiovascular surgery and to some extend is under-diagnosed. At the same time the investigators imagine that DM is closely related to the degree of arterial stiffness, and that these parameters are closely related to a new biochemical marker, fibulin-1.

The investigators aim to describe the prevalence of type 2 DM and dysmetabolism in patients admitted to the hospital to undergo cardiovascular surgery and besides that to investigate if there is a connection between the degree of the dysmetabolism and arterial disease, by studying arterial stiffness and by measuring a new biochemical marker, fibulin-1, which the investigators newly have identified. The results of this project will give us a measure for the quantity of unknown DM in patients undergoing cardiovascular surgery and furthermore tell us more in terms of the connections between a newly identified plasma arterial marker, arterial stiffness and diabetes.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* undergoing heart- or vascular surgery

Exclusion Criteria:

* Physical or mental disability not enabling participation in the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Biochemnistry and Farmacology, Odense University Hospital
Study officials:
affiliation: Department of Biochemnistry and Farmacology, Odense University Hospital
name: Lars Melholt Rasmussen, Professor, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01470573: Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo
Official title: Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Autologous Cells of Sclerocorneal Limbus Amplified ex Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unilateral Limbic Insufficiency
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 10
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: Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.


Eligibility criteria: principal Inclusion Criteria:

* Serious unilateral limbic insufficiency
* Normal ophthalmological clinical examination in the opposite eye (biopsied eye)

Exclusion Criteria:

* one-eyed
* serious disorders in palpebral dynamics
* bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid
* breastfeeding or pregnancy
* positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum

Primary outcomes:
measure: Visual Acuity
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in appearance of ocular surface
timeFrame: 6 months
measure: lack of scar tissue in ocular surface
timeFrame: 6 months
measure: decrease of preexisting corneal vascularization
timeFrame: 6 months
measure: Improvement of corneal transparency
timeFrame: 6 months
measure: absence or decrease of corneal conjunctivalization
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Instituto Universitario Barraquer
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Ricardo P Casaroli Marano, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02504073: Clinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait
Official title: Clinical Reasoning Process of Physiotherapists When Observing Hemiplegic Gait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Clinical Reasoning
Physiotherapists
Lead sponsor: Technical University of Bern
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physiotherapists working with stroke patients

Brief summary: The goal of this study is to find out what clinical reasoning process physiotherapists undergo when observing hemiplegic patients gait.

Detailed description: Physiotherapists don't usually use any assessments to evaluate gait but observe it without an instrument. The questions in this study are:

* what abnormalities can physiotherapists detect when observing a patient walking?
* what do they consider the main problem that has a negative effect on the patient's walking?
* what hypothesis do they generate?
* how is the inter-rater reliability for the "main problem" and the hypothesis?

Eligibility criteria: Inclusion criteria:

* chartered physiotherapists
* physiotherapists in training
* working with stroke patients

Exclusion criteria:

- other languages than German

Primary outcomes:
measure: Number of Gait Abnormalities Observed
timeFrame: up to 2 months
measure: Number of Main Problems Observed
timeFrame: up to 2 months
measure: Number of Hypotheses Observed
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05618873: Comparison of Flutter and PEP Mask on Chest Clearance, Dyspnea in Elderly Asthmatic Patients
Official title: Comparative Effects of Flutter and Positive Expiratory Pressure on Chest Clearance and Dyspnea in Elderly Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Flutter
PEP Mask
Chest Clearance
Dyspnea
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.

Detailed description: This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. Treatment will be given to all the participants 3 sessionsin a week, or 2 weeks and post treatment evaluation will be done after every week. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis Of Asthma
* Both age above 40-60 years of age
* Both gender
* No previous surgery

Exclusion Criteria:

* Other pulmonary disease
* Neurological problems
* Rib fracture

Primary outcomes:
measure: ST. GEORGE'S RESPIRATORY QUESTINAIR
timeFrame: 2weeks
measure: PULMONARY FUNCTION TEST
timeFrame: 2weeeks
measure: SPUTUM DIARY
timeFrame: 2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Allied hospital
state: Punjab
Study officials:
affiliation: riphah internationl university
name: Madiha younas, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00587873: Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Official title: Sequential Administration of Oral 6-Thioguanine (6-TG) After Methotrexate (MTX) in Patients With Relapsed Hodgkin's Disease (Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Disease
Keywords: Relapsed
Hodgkin's Disease
Methotrexate
6-Thioguanine
94-030
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX).


Eligibility criteria: Inclusion Criteria:

* Patients with histologic proof of HD who are in relapse and have failed \> or = to 2 prior chemotherapy regimens.
* Patients must have a life expectancy of at least 8 weeks.
* All patients must have ECOG performance level rating of \< or = to 2.
* Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study.
* Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of CT.
* Patients must have adequate liver function (bilirubin \< or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine \< or = to 1.5 mg/dl, creatinine clearance \> or = to 60 ml/min/1.73 m2).
* Patients should have a granulocyte count \> or = to 500/gL and a platelet count \> or = to 100,000/uL (unless due to disease involvement of the bone marrow).
* Male and female patients of child-bearing age should use effective methods of contraception, if sexually active.

Exclusion Criteria:

* Patients with active infections or significant medical conditions other than their malignancy shall be excluded.
* Patients with HD who had prior MTX or 6-TG should be excluded.

Primary outcomes:
measure: To determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's Disease (HD) treated with sequential administration of oral 6-Thioguanine (6-TG) after IV Methotrexate (MTX).
timeFrame: Conclusion of the study
Secondary outcomes:
measure: Define Toxicity of this sequential drug combination.
timeFrame: Conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan-Kettering Cancer Center/94-030
name: Tanya Trippett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04706273: GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Official title: GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions in Japan

Brief summary: This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.


Eligibility criteria: Inclusion Criteria:

* Symptomatic peripheral arterial disease in superficial femoral artery lesions

Primary outcomes:
measure: Primary Assisted Patency
timeFrame: 12 and 24 months
measure: Freedom From Target Lesion Revascularization
timeFrame: 1, 12 and 24 months
measure: Number of Participants With One or More Device- or Procedure-related Serious Adverse Events and Deficiencies
timeFrame: Procedure day, 1, 12, 24, 36, 48 and 60 months
measure: Number of Participants With a Stent Fracture
timeFrame: Month 12, 24, 36, 48 and 60
Secondary outcomes:
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Kansai Rousai
state: Hyogo
Study officials:
References:
Clinical trial NCT00438373: LH/HCG Receptor Expression and Retrieval Rates
Official title: Association of LH/HCG Receptor Expression and Retrieval Rates at Oocyte Pick up.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Subfertility
Keywords: Subfertility, Luteinizing hormone, receptor
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2007-02-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infertile patients undergoing assisted reproduction tratment

Brief summary: The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up

Detailed description: The purpose of this study is to evaluate if there is an association between the serum LH receptor expression on the day of hCG or the day of oocyte retrieval and the retrieval rates at oocyte pick up.

For this purpose, m-RNA copy numbers will be assessed in the blood serum of patients undergoing ovarian stimulation for IVF on different days.

Furthermore, detailed ultrasound scans will be perfomed, as well as assesment of hormonal levels during ovarian stimulation.

Eligibility criteria: Inclusion criteria:

* Age \<39 years,
* Body mass index (BMI) between 18 and 29 kg/m2,
* Presence of both ovaries,
* FSH levels \<10 IU/l.

Exclusion criteria:

* Endometriomas,
* Polycystic ovarian syndrome.

Primary outcomes:
measure: LH/hCG receptor expression
timeFrame: at oocyte retrieval
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Human Reproduction, 1st Department of Obstetrics & Gynecology, AUTH, Papageorgiou Hospital
Study officials:
affiliation: Unit of Human Reproduction, 1st Department of Obs & Gyne, Aristotle University of Thessaloniki, Papageorgiou Hospital, Greece
name: Basil C Tarlatzis, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Patsoula E, Loutradis D, Drakakis P, Michalas L, Bletsa R, Michalas S. Messenger RNA expression for the follicle-stimulating hormone receptor and luteinizing hormone receptor in human oocytes and preimplantation-stage embryos. Fertil Steril. 2003 May;79(5):1187-93. doi: 10.1016/s0015-0282(03)00071-2.
citation: Patsoula E, Loutradis D, Drakakis P, Kallianidis K, Bletsa R, Michalas S. Expression of mRNA for the LH and FSH receptors in mouse oocytes and preimplantation embryos. Reproduction. 2001 Mar;121(3):455-61. doi: 10.1530/rep.0.1210455.