louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03795545: Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value
Official title: Ultraslow Full-power SWL Versus Slow SWL in Stones With High Attenuation Value
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteric Stone
Keywords: ureteric stone
SWL
High density stones
Ultraslow SWL
Slow SWL
Ramping
Pause
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2019-01-07
Enrollment: 101
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: Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high attenuation value

Detailed description: To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL

Eligibility criteria: Inclusion Criteria:

* single upper ureteric stone less than or equal to 2 cm
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization

Primary outcomes:
measure: stone free rate
timeFrame: 3 months following last session of SWL
Secondary outcomes:
measure: Complications rate
timeFrame: 3 months following last session of SWL
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef Hospitals
state: Outside U.S./Canada
Study officials:
affiliation: Beni-Suef University
name: Ahmad Aref Al-Dessoukey, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01121445: The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea
CPAP
Saline irrigation
Lead sponsor: Bridgeport Hospital
Sponsor class: OTHER
Collaborators: name: NeilMed Pharmaceuticals
First posted: 2010-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Apnea/hypopnea index ≥ 10
* A documented successful CPAP titration

Exclusion Criteria:

* Conditions that in the judgment of the investigator would interfere with subject participation in the study
* History of sinus or nasal surgery
* History of psychiatric illness
* Use of sleep aids, sedatives or narcotics
* Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
* Bilevel or other nocturnal ventilation other than CPAP
* Use of supplemental oxygen
* Pregnancy or lactating
* Inability or unwillingness to provide informed consent
* Inability to perform baseline measurements
* Inability to be contacted by phone

Primary outcomes:
measure: RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
timeFrame: 4 weeks
Secondary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: 4 weeks
measure: SF-36
timeFrame: 4 weeks
measure: CPAP compliance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
Study officials:
affiliation: Bridgeport Hospital
name: Jeff S Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06168045: Bloodpressure and NIRS During the Immediate Transition
Official title: Arterial Blood Pressure and Cerebral Tissue Oxygenation During Immediate Transition After Birth in Term and Preterm Neonates - a Prospective Pilot Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Cerebral Tissue Oxygenation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term and preterm neonates observed routinely at the resuscitation desk at the Division of Neonatology, Department of Pediatrics, Medical University of Graz will be eligible for the study.

Brief summary: Blood pressure will be measured in min. 5/10/15 after birth. Cerebral tissue oxygenation (crSO2) monitoring with NIRS in addition to routine arterial oxygen saturation (SpO2) monitoring with pulse oximetry will be performed continuously during the first 15 minutes after birth


Eligibility criteria: Inclusion Criteria:

Term and preterm neonates observed routinely immediately after birth at the resuscitation desk

* Decision to conduct full life support
* Written informed consent

Exclusion Criteria:

No decision to conduct full life support

* No written informed consent
* Congenital malformation

Primary outcomes:
measure: Blood pressure
timeFrame: 5, 10 and 15 minutes after birth
measure: Cerebral oxygenation
timeFrame: 5, 10 and 15 minutes after birth
Secondary outcomes:
measure: Cardiac output
timeFrame: 5, 10 and 15 minutes after birth
Other outcomes:
Locations:
city: Graz
country: Austria
facility: medical university of Graz
Study officials:
affiliation: Medical University of Graz
name: Gerhard Pichler, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pichler G, Cheung PY, Aziz K, Urlesberger B, Schmolzer GM. How to monitor the brain during immediate neonatal transition and resuscitation? A systematic qualitative review of the literature. Neonatology. 2014;105(3):205-10. doi: 10.1159/000357162. Epub 2014 Jan 25.
citation: Hooper SB, Te Pas AB, Lang J, van Vonderen JJ, Roehr CC, Kluckow M, Gill AW, Wallace EM, Polglase GR. Cardiovascular transition at birth: a physiological sequence. Pediatr Res. 2015 May;77(5):608-14. doi: 10.1038/pr.2015.21. Epub 2015 Feb 4.
citation: Baik N, Urlesberger B, Schwaberger B, Avian A, Mileder L, Schmolzer GM, Pichler G. Blood Pressure during the Immediate Neonatal Transition: Is the Mean Arterial Blood Pressure Relevant for the Cerebral Regional Oxygenation? Neonatology. 2017;112(2):97-102. doi: 10.1159/000455965. Epub 2017 Apr 21.
Clinical trial NCT00713245: A Long Term Follow up Study in Late-onset Pompe Disease
Official title: A Long Term Follow up Study in Late-onset Pompe Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pompe Disease
Keywords: Pompe disease
late onset
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 70
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: individuals with acid alpha glucosidase deficiency but without obvious symptoms

Brief summary: This study is to observe the progression of disease in late-onset Pompe disease


Eligibility criteria: Inclusion Criteria:

* individuals with acid alpha glucosidase deficiency without obvious symptoms
* parents signed inform consent

Exclusion Criteria:

* individuals with acid alpha glucosidase deficiency presenting symptoms

Primary outcomes:
measure: all muscle function
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Whu-Liang Hwu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053845: Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain
Official title: Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Patients Suffering of Peripheral Neuropathic Pain
Keywords: Neuropathic pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Grünenthal GmbH
First posted: 2010-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy.

The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain.

Detailed description: Prospective study with comparison groups

Eligibility criteria: Inclusion Criteria:

* neuropathic patients group

  * Patient suffering of peripheral neuropathic pain
  * 18 years old women or men at least

Exclusion Criteria:

* • Healthy volunteers

  * 18 years old women or men at least

Primary outcomes:
measure: Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain.
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569945: Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 371
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?


Eligibility criteria: Inclusion Criteria:

* women younger than 42 years old
* infertility of at least one year
* normal tubal, pelvic and uterine anatomy
* semen with total motility count of at least 5 million (at least one sample)

Exclusion Criteria:

* premature ovarian failure
* medical history of tubal or ovarian surgery
* tubal or pelvic adhesions

Primary outcomes:
measure: pregnancy rate
timeFrame: on average 30 days if not pregnant and 12 weeks if pregnant
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Leuven University Fertility Center
state: Vlaams Brabant
Study officials:
affiliation: University Hospital, Gasthuisberg
name: Thomas D'Hooghe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peeraer K, Debrock S, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Mol BW, Spiessens C, De Neubourg D, D'Hooghe TM. Low-dose human menopausal gonadotrophin versus clomiphene citrate in subfertile couples treated with intrauterine insemination: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1079-88. doi: 10.1093/humrep/dev062. Epub 2015 Mar 18.
Clinical trial NCT01987245: Plethysmographic Waveform for Monitoring the Quality of Cardiopulmonary Resuscitation
Official title: The Application Research of Plethysmographic Waveform in Quality Control Feedback System During Cardiopulmonary Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Arrest
Cardiopulmonary Resuscitation
Return of Spontaneous Circulation
Pulse Oximeter Plethysmographic Waveform
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: emergency room sample of multi-centers

Brief summary: Cardiopulmonary resuscitation(CPR) is the key to success for high-quality early cardiopulmonary resuscitation, and its success in the restoration of spontaneous circulation (ROSC), therefore, monitoring the quality of cardiopulmonary resuscitation and early identification ROSC is very important. Now there is no an easy, non-invasive and real-time method to monitor the quality of CPR. In this study the investigators hypothesis the pulse oximeter waveform can real-time monitor the quality of CPR ,and feedback the quality of CPR to the physicians.


Eligibility criteria: Inclusion Criteria:

* cardiopulmonary arrest, without do-not-resuscitation(DNR) patients
* After cardiac arrest, there is no more than 10 minutes until basic life support.
* must be carried out advanced life support (tracheal intubation and end-tidal carbon dioxide monitoring)
* comply with ethical requirements and signed informed consent

Exclusion Criteria:

* DNR patients
* rib fractures
* hemorrhagic shock caused cardiac arrest
* severe anemia, hemoglobin less than 7g/dl
* tension pneumothorax without closed drainage
* pulmonary embolism or pericardial tamponade caused cardiac arrest
* onychomycosis
* people who paint fingernails
* clearly influential peripheral oximetry underlying diseases (such as Raynaud's phenomenon, vasculitis)
* The study physicians believe there is any case is not suitable for inclusion.

Primary outcomes:
measure: survival rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PUMCH
Study officials:
References:
citation: Hu Y, Xu J, Zhu H, Zhang G, Sun F, Zhang Y, Yu X. [Profile and outcome of cardiopulmonary resuscitation after sudden cardiac arrests in the emergency department: a multicenter prospective observational study]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2018 Mar;30(3):234-239. doi: 10.3760/cma.j.issn.2095-4352.2018.03.009. Chinese.
Clinical trial NCT05583045: Prediabetes Intervention With Tea
Official title: PREVENT - Prediabetes Intervention With Olive Leaf Tea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Pre Diabetes
Keywords: Olive leaves
Diabetes
Glycaemic control
Insulin resistance
Lead sponsor: Instituto Politécnico de Bragança
Sponsor class: OTHER
Collaborators: name: Unidade Local de Saúde do Nordeste
name: European Social Fund
First posted: 2022-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be divided into two groups (A or B):

A: Olive leaf tea + Lifestyle behavior change program B: Placebo tea + Lifestyle behavior change program
Primary purpose: PREVENTION

Brief summary: The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.

Detailed description: This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment

Eligibility criteria: Inclusion Criteria:

At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:

* Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
* Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
* Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).

Exclusion Criteria:

* Current use of medication for lowering blood cholesterol, glucose or hypertension;
* History of chronic or severe diseases that may affect study outcomes or limit study participation;
* Pregnancy and breastfeeding

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Fasting Plasma Glicose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
measure: Cholesterol Total, c-HDL, c-LDL and triglycerides
timeFrame: 12 weeks
measure: Aspartate transaminase (AST) and Alanine transaminase (ALT)
timeFrame: 12 weeks
measure: Alkaline Phosphatase
timeFrame: 12 weeks
measure: Bilirubin
timeFrame: 12 weeks
measure: Creatinine
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bragança
country: Portugal
facility: Instituto Politécnico de Bragança
Study officials:
affiliation: Instituto Politécnico de Bragança
name: Manuela Meireles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02596945: Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis
Official title: Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Impairment
Renal Anemia of Chronic Kidney Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 223
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: Participants on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor

Brief summary: This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.


Eligibility criteria: Inclusion Criteria:

* Participants on peritoneal dialysis
* Need for Erythropoiesis Stimulating Agent (ESA) therapy
* Prescription of methoxy polyethylene glycol epoetin beta by the doctor

Exclusion Criteria:

N/A

Primary outcomes:
measure: Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
timeFrame: Month 7 to Month 9
Secondary outcomes:
measure: Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
timeFrame: Month 7 to Month 9
measure: Average Duration in Days Mircera Was Administered at a Stable Dose
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Mettmann
country: Germany
facility: Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02712645: A Multicenter Breast Cancer Biospecimen Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Luminist, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-18
Enrollment: 700
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women scheduled for a breast biopsy.

Brief summary: This study is being performed to collect blood for the development of noninvasive tests that can screen for or diagnose cancer. Blood samples will be collected from women who are scheduled to have breast biopsies.


Eligibility criteria: Inclusion Criteria:

1. Females of all racial and ethnic groups who are 40 years or older.
2. Women must:

   1. have suspected neoplasm of the breast (BIRADS 4 or 5) based on the results of any breast screening or diagnostic imaging, such as mammogram, and
   2. be selected or scheduled for a breast biopsy which has not yet been conducted at the time of enrollment.

Exclusion Criteria:

1. Inability to sign informed consent.
2. More than one radiological finding.
3. Any current or prior cancer (with the exception of non-melanoma skin cancer or a suspected breast malignancy targeted for biopsy).
4. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days.
5. Any surgery, hospitalization, or institutionalization (such as in a nursing home) during the previous 3 months.
6. Received any experimental therapeutic treatment during the previous 3 months.
7. Received any blood product transfusion within the previous 3 months.
8. Use of illegal drugs during the previous 3 months.
9. Pregnant or nursing at the time of enrollment or in the preceding 12 months.

Primary outcomes:
measure: Number of patients with untreated newly diagnosed breast cancer.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Redding
country: United States
state: California
city: Dallas
country: United States
state: Texas
Study officials:
References: