louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00235846: Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Official title: Endoscopic Vessel Harvesting During Coronary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Keywords: Endoscopic vein harvesting
Saphenous vein
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 132
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: Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.

Detailed description: Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.

Preoperative demographic as well ass peri- and postoperative data are collected prospectively at 5-7 days and 1 month postoperatively. Wound complications are registered as well as post operative pain in the wound is evaluated using af visual analogue scale. Patients are evaluating the cosmetic results after wound healing.

Eligibility criteria: Inclusion Criteria:

* Elective coronary artery bypass surgery

Exclusion Criteria:

* Leg wounds
* Acute surgery
* Previous vascular surgery
* Combined surgery (valve + coronary)
* Arterial revascularization

Primary outcomes:
measure: Rate of wound complications
timeFrame: 30 days
measure: Patient satisfaction
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
Study officials:
affiliation: Department of Cardiothoracic Surgery, Aalborg hospital, Hobrovej, postboks 365, DK-9100 Aalborg, Denmark
name: Jan J Andreasen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreasen JJ, Nekrasas V, Dethlefsen C. Endoscopic vs open saphenous vein harvest for coronary artery bypass grafting: a prospective randomized trial. Eur J Cardiothorac Surg. 2008 Aug;34(2):384-9. doi: 10.1016/j.ejcts.2008.04.028. Epub 2008 May 27.
Clinical trial NCT01206946: Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants
Official title: Effect of Antenatal Steroids for Women at Risk of Late Preterm Delivery on Neonatal Respiratory Morbidity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Respiratory Distress Syndrome, Newborn
Transient Tachypnea of the Newborn
Keywords: Respiratory distress
Antenatal steroids
late preterm
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.


Eligibility criteria: Inclusion Criteria:

* Women between 34 0/7- 36 6/7 weeks of gestation
* High risk of preterm birth

Exclusion Criteria:

* Multiple births
* Fetal congenital malformations
* A course of steroids within 2 weeks of randomization
* Multiple courses of steroids
* Chorioamnionitis
* Non reassuring fetal heart rate
* Obstetrical indication of delivery
* Active bleeding
* Pregnancy related hypertensive disorders
* Uncontrolled diabetes

Primary outcomes:
measure: Respiratory Distress Syndrome (RDS)or Transient Tachypnea of the Newborn(TTN)
timeFrame: First three days of life
Secondary outcomes:
measure: Admission to NICU
timeFrame: First three days of life
measure: Hospital stay
timeFrame: Neonatal period (28 days of life)
measure: Days on oxygen
timeFrame: Neonatal period (28 days of life)
measure: Intubations
timeFrame: First three days of life
measure: Surfactant treatment
timeFrame: First three days of life
measure: Pneumothorax
timeFrame: First three days of life
measure: Persistent Pulmonary Hypertension of the Newborn(PPHN)
timeFrame: First three days of life
measure: Days on ventilation
timeFrame: Neonatal period (28 days of life)
measure: Necrotizing enterocolitis (NEC)
timeFrame: Neonatal period (28 days of life)
measure: Clinical sepsis
timeFrame: Neonatal period (28 days of life)
measure: Intraventricular Hemorrhage (IVH)
timeFrame: First week after birth
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Bahman Hospital
city: Beirut
country: Lebanon
facility: Hotel Dieu de France
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Beirut
country: Lebanon
facility: St Georges Hospital- University Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Khalid Yunis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05078346: Immune Fitness Prediction
Official title: Observational Study to Determine the Association Between Self-rated, Perceived Immune Fitness (Using Questionnaire) With Biological Assessment of Immune Fitness (Immune Signatures in the Blood).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood).


Eligibility criteria: Inclusion Criteria:

1. Ability to understand and sign the informed consent
2. Healthy adult men and/or women, 35-65 years old
3. BMI \>18 and \<30 kg/m2

Exclusion Criteria:

1. Volunteer who cannot be expected to comply with the protocol
2. Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study,
3. Individuals with an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition,
4. Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland

Primary outcomes:
measure: Percentage of different immune cell types in whole blood
timeFrame: 6 - 12 months after the start of the trial
measure: Relative quantification of immune protein in plasma
timeFrame: 6 - 12 months after the start of the trial
measure: Amount of cytokines expressed by peripheral blood mononuclear cells
timeFrame: 6 - 12 months after the start of the trial
measure: Amount of analytes in serum
timeFrame: 6 - 12 months after the start of the trial
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Clinical Research Unit
state: Vaud
Study officials:
References:
Clinical trial NCT07025746: Acute Effects of Gastrocnemius Myofascial Release on Cervical Flexion and Extension Range of Motion in Healthy Adults: A Randomized Controlled Trial
Official title: Acute Effects of Gastrocnemius Myofascial Release on Cervical Flexion and Extension Range of Motion in Healthy Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to verify the immediate effects of gastrocnemius myofascial release on the active cervical flexion and extension range of motion.

Detailed description: After completing the questionnaire, 91 healthy participants will be randomly divided into two groups: the Intervention Group (IG) (n=46) and the Control Group (CG) (n=45). In the first assessment (M0), the range of motion of cervical flexion and extension will be measured using a smartphone (Galaxy S21 FE 5G, Android) and the Clinometer application. The myofascial release technique (foam roller) will be applied to the gastrocnemius of the dominant lower limb for 4 minutes (3 sets of 1 minute with 30 seconds of rest). Participants in the control group will remain at complete rest for a period of 4 minutes, lying in the supine position, without performing any type of active or passive intervention. Immediately after the intervention/control, all groups will be reassessed (M1).

Eligibility criteria: Inclusion Criteria:

* Healthy participants of both sexes aged 18-40 years.

Exclusion Criteria:

* Deformities in the lower quadrant region of the body;
* Complaints in this region in the last 6 months;
* Surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies;
* Limb length discrepancy greater than 1.5 cm;
* Pregnant women;
* Ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.

Primary outcomes:
measure: Change of active cervical range of motion in flexion and extension.
timeFrame: Change from Baseline (M0) to Immediately after intervention or control (M1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00702546: Follow-up Protocol on the Outcome of Frozen-thawed Embryo Transfer Cycles From Clinical Trial P05690 (P05711)
Official title: Follow-up Protocol to Collect the Outcome of Frozen-thawed Embryo Transfer Cycles After Cryopreservation of Embryos in Clinical Trial 107012
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Vitro Fertilization
Keywords: In-vitro fertilization
Controlled Ovarian Stimulation
Cumulative pregnancy data
Follow-up
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women from whom embryos have been cryopreserved in base study P05690

Brief summary: Clinical trial objective is to collect the outcome of Frozen-Thawed Embryo Transfer (FTET) cycles performed after the embryos are cryopreserved in the base study P05690 in order to estimate the cumulative pregnancy rate for each treatment group.

Detailed description: This is a follow-up protocol to collect the outcome of FTET cycles, performed after the embryos are cryopreserved in base study P05690 (NCT00702845), to enable estimation of the cumulative pregnancy rate for each treatment group.

Eligibility criteria: Inclusion Criteria:

* Participants from whom embryos have been cryopreserved in base study P05690, of which at least one embryo is thawed for use in a subsequent FTET cycle;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate)
timeFrame: Up to 1 year after embryo transfer in base trial P05690 (NCT00702845), and FTET cycles in follow up study P05711
Secondary outcomes:
measure: Percentage of Participants in Follow up Study With a Miscarriage Per Clinical Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Study With a Miscarriage Per Vital Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Study With an Ecotopic Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Study With a Clinical Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants in Follow up Study With a Vital Pregnancy
timeFrame: After one or more FTET cycles, assessed at least 10 weeks after embryo transfer (up to 1 year)
measure: Percentage of Participants With an Ongoing Pregnancy
timeFrame: After one or more FTET, assessed at least 10 weeks after embryo transfer or at live birth (up to 1 year)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00649246: Prospective Assessment in Newborns for Diabetes Autoimmunity
Official title: 1. Prospective Studies in Infants of the Immunopathogenesis of Type 1 Diabetes 2. Consortium for Identification of Environmental Triggers of Type 1 Diabetes: MCG/UF Clinical Center 3. Identification of Serum Protein Markers for Type 1 Diabetes Using Mass-Spectrometry Techniques 4. Validation of Microarray-Based Biomarkers for Type 1 Diabetes 5. Development of Microarray-Based Biomarkers for Type 1 Diabetes 6. Proteomic Changes/Progression of Human Type 1 Diabetes 7. Identification and Validation of Serum Biomarkers for T1D
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Autoimmunity
Keywords: genetics
type 1 diabetes
biomarkers
autoimmunity
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Florida
name: Emory University
name: Medical University of South Carolina
name: University of South Carolina
First posted: 2008-04-01
Enrollment: 25055
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns, young children, adults with or without type 1 diabetes

Brief summary: This is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.

Detailed description: This study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.

Eligibility criteria: Inclusion Criteria: all are welcome -

Exclusion Criteria:

-

Primary outcomes:
measure: autoantibodies against the pancreas and type 1 diabetes
timeFrame: 50 years
Secondary outcomes:
measure: Risk factors for type 1 diabetes
timeFrame: 50 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: Augusta University
name: Jin Xiong She, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03363646: Italian National Study on the Critically Ill Liver Transplant Patient With an Infection
Official title: Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Infection
Sepsis
Intensive Care Unit
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: liver transplant recipients

Brief summary: Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern

Detailed description: The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs

Eligibility criteria: Inclusion criteria

1. Age\> 18 aa
2. Sex: Both
3. written consent to participate in the study
4. having been undergone to OLT in the 10 years prior to enrollment
5. Infection diagnosis (any type, any localization, any agent)
6. Being admitted in the ICU

Exclusion criteria 1. Death within 72 hours of admission 2. Withdrawal of consent

-

Primary outcomes:
measure: Clinical
timeFrame: 18 months
measure: microbiological
timeFrame: 18 months
Secondary outcomes:
measure: Resistance
timeFrame: 18 months
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: U.O. Anestesia e Rianimazione Trapianti
Study officials:
References:
Clinical trial NCT00775346: A Multi-Center Study to Assess the Performance of Saturation Patterns.
Official title: A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep-Disordered Breathing
Obstructive Sleep Apnea
Sleep Apnea
Central Sleep Apnea
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2008-10-20
Enrollment: 92
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: Subjects who are undergoing a standard sleep lab study/evaluation will have their data analyzed for this clinical trial.

Brief summary: A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.

Detailed description: The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.

Eligibility criteria: Inclusion Criteria:

* Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
* Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
* Subject is able to and willingly signs the informed consent form.

Exclusion Criteria:

* Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
* Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.

Primary outcomes:
measure: Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
timeFrame: 9 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Broomfield
country: United States
facility: SleepFit
state: Colorado
city: Maplewood
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: West Seneca
country: United States
facility: Sleep Medicine Centers
state: New York
Study officials:
affiliation: Medtronic - MITG
name: Roger S Mecca, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01310946: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology
Official title: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphocytic Leukemia
Keywords: Acute Lymphocytic Leukemia
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 203
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Lymphocytic Leukemia Database

Brief summary: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Detailed description: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed Acute Lymphocytic Leukemia

Exclusion Criteria:

* Patients with diagnosis other than Acute Lymphocytic Leukemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: N Chaudhri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: