louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05223335: Clopidogrel Monotherapy in Patients With High Bleeding Risk
Official title: Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding Complications
Keywords: Antiplatelet medications
Blood thinners
Stent thrombosis
Percutaneous Coronary Intervention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research is to show that a shorter duration of two antiplatelet medications (compared to the standard of care) is safe and effective while reducing the risk of bleeding complications. Bleeding complications can cause significant problems (hospitalizations, need for blood transfusions, and even death) for patients on antiplatelet medications after coronary stents. Researchers hope to show that reducing the time on two antiplatelet agents in patients at high risk for these bleeding complications will reduce the number of bleeding events while not causing any increase in cardiovascular complications (heart attack, stent malfunction, death).


Eligibility criteria: Inclusion Criteria:

* Informed consent in adults
* Successful percutaneous coronary intervention (PCI) \[no non-fatal myocardial infarction (MI)/stroke/repeat target revascularization/bleeding/acute kidney injury\].
* Academic research consortium-high bleeding risk (ARC-HBR) score ≥ 4.

Exclusion Criteria:

* Chronic use of warfarin or direct oral anticoagulant (DOAC).
* Unsuccessful PCI (see above).
* Lesions with angiographic thrombus.
* Prior PCI within 6 months.
* Planned PCI or surgical intervention to treat any cardiac or noncardiac condition within 6 months.
* High risk lesion/stent characteristics (\> 50% unprotected left main disease, bifurcation disease requiring 2 stents technique, rotational atherectomy.
* Vein graft.
* Unprotected left main intervention or history of definite stent thrombosis.
* Women of child-bearing age unless negative pregnancy test is done.
* Life expectancy \< 1 year.
* Known drug/alcohol dependence.
* Assessment that the patient will not be compliant with the study protocol.

Primary outcomes:
measure: Ischemic Risk Post-PCI in High Bleed Risk Patients With Genotype-guided Single Antiplatelet Therapy
timeFrame: Through study completion, approximately 90 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mandeep Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375635: Removal of Protein Bound Uremic Toxins by Modified Plasma Separation and Adsorption Combined With Hemodialysis
Official title: Removal of Protein Bound Uremic Toxins in Chronic Hemodialysis Patients by Modified Plasma Separation and Adsorption Combined With Hemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uremia
Keywords: mFPSA
Uremic toxins
Protein bound toxins
Uremia
Chronic hemodialysis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to examine removal of protein bound uremic substances by mFPSA in chronic hemodialysis patients. mFPSA is an extracorporal blood purification system developed for detoxification in acute liver failure by removal of protein bound as well as water soluble substances.

Detailed description: Measurements of uremic protein bound substances before and after mFPSA and a preceding routine hemodialysis session.

Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Anuria
* Chronic hemodialysis dependence

Exclusion Criteria:

* No present history of bleeding episodes
* Cardiac diseases

Primary outcomes:
measure: Blood pressure
measure: Safety serological parameters
measure: Concentrations of protein bound uremic toxins
Secondary outcomes:
measure: Bleeding episodes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet P2132
name: Mette B Damholt, MD,Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Soren D Ladefoged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683435: The Value of HBA in the Evaluation of Idiopathic Infertility
Official title: The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor

Detailed description: We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate

Eligibility criteria: Inclusion Criteria:

* . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups

  1. Abnormal Semen Analysis (sperm count \<10 million/ml and /or rapid progressive motility \< 50 %, WHO morphology \<30%) normal HSG , normal ovarian reserve testing and ovulation testing
  2. Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH\< 10, AMH\>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
  3. Tubal infertility as assessed by HSG or laparoscopy

Exclusion Criteria:

* women over 40, prior failed IVF

Primary outcomes:
measure: In each of these groups we will assess presence of HBA bound sperm
timeFrame: immediate at time of preforming HBA test
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Continuum Reproductive Center
state: New York
Study officials:
affiliation: Mount Sinai St. Luke's
name: Martin Keltz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05618535: Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy
Official title: Effect of Body Position on Hemodynamics in Patients With Acute Ischemic Stroke Undergoing Ultra-early Reperfusion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the differences in hemodynamics between different positions in patients undergoing ultra-early reperfusion therapy.

Detailed description: Hemodynamic stability can prevent hypoperfusion or hyperperfusion after reperfusion therapy. It has been reported in a large number of literatures that body position has an effect on hemodynamics, but the effect of different body positions on the hemodynamics of patients undergoing ultra-early reperfusion therapy is not clear. In this study, we hypothesized that the hemodynamics of patients undergoing ultra-early reperfusion therapy would differ between different positions.

Eligibility criteria: Inclusion Criteria:

* Age≥18 years, \< 80 years, regardless of sex；
* Patients with clinically confirmed acute ischemic stroke who received intravenous thrombolysis or emergency endovascular treatment;
* Baseline National Institute of Health stroke scale（NIHSS）score ≤25;
* Baseline Glasgow Coma Scale (GCS) ≥8;
* Signed and dated informed consent is obtained

Exclusion Criteria:

* The patient has clear indications or contraindications, such as active vomiting, spinal cord injury；
* Clinicians considered that the assigned body position could not be maintained; Patients unable to cooperate with all noninvasive beat-by-beat continuous BP monitoring;
* Poor temporal window penetration;
* Patients with diseases that seriously affect hemodynamics, such as atrial fibrillation, anemia, and hyperthyroidism;
* Previous history of atrial fibrillation or ECG showing atrial fibrillation or arrhythmia;
* Pregnant or lactating women;
* Poor treatment compliance;
* Complicated with severe systemic diseases, such as heart failure, respiratory failure, renal failure, gastrointestinal bleeding, coagulopathy, malignant tumors.

Primary outcomes:
measure: Differences in blood pressure variability（BPV）between different positions
timeFrame: 0-7 days
measure: Differences in heart rate variability (HRV) between different positions
timeFrame: 0-7 days
Secondary outcomes:
measure: The difference of middle cerebral artery blood flow velocity between different positions.
timeFrame: 0-7 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT06648135: Labial Bone Thickness Around Immediate Implants in the Esthetic Zone Following a Novel Socket Evaluation System
Official title: a Novel Socket Evaluation System and Its Impact on Bone Formed Labial to Bone Immediate Anterior Implants. A 1-year Clinical Trial.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immediate Implant Placement
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The anterior maxilla is a particularly challenging area for immediate implant placement due to its thin buccal bone walls. These walls are more susceptible to resorption after tooth extraction, which can lead to significant bone loss and inadequate support for an implant. However, Different socket dimension may affect the amount of bone formed labial to the implant, regardless of the garfting procedure.

Detailed description: Bone formation labial to the immediate implant is not related to the initial thick- ness of the labial plate of bone, rather than the initial labio-palatal socket dimension. this study aims to evaluate the bone formed labial to the implant following a Novel Socket Evaluation System.

Eligibility criteria: Inclusion Criteria:

* Immedaite implants in anterior maxilla
* thick gingival phenotype
* intact but thin labial plate of bone (≤1mm)
* sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque)

Exclusion Criteria:

* smokers
* pregnant women
* patients with systemic disease
* patients with parafunctional habits such as bruxism or clenching,
* infected socket
* periapical pathosis
* history of radiotherapy or chemotherapy within the past 2 years.

Primary outcomes:
measure: Bone labial to the implant
timeFrame: one year
Secondary outcomes:
measure: Bone area at the Interproximal component
timeFrame: preoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: International Dental Clinic Educational centre
Study officials:
References:
Clinical trial NCT00353535: Total Lymphoid Irradiation (TLI) to Prevent Focal Segmental Glomerulosclerosis (FSGS)Recurrence in the Renal Graft
Official title: Phase 1 Study of TLI Pretransplant to Prevent Recurrence of FSGS in the Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glomerulosclerosis, Focal
Keywords: glomerulosclerosis, focal
pretransplant immunosuppression
total lymphoid irradiation
renal transplant
recurrence
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2006-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose was study the immunosuppression using total lymphoid irradiation plus Csa, MMF and prednisone pretransplant to prevent focal segmental glomerulosclerosis recurrence in the renal graft

Detailed description: Focal and segmental glomerulosclerosis (FSGS) is resistant to treatment with immunosuppressants and after transplant, 40% of such patients have recurrences in renal allograft. The purpose of this trial was to use Total Lymphoid Irradiation (TLI) plus mycophenolate mofetil (MMF), cyclosporine A (CsA) and prednisone (PRED) to prevent recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients (age \> 18 years)
* Biopsy-proven primary FSGS
* End-stage renal failure at presentation or prior allograft loss due to recurrent FSGS.
* Signed the informed consent before entering in the study.

Exclusion Criteria:

* Age \< or equal 18 years
* No biopsy-proven FSGS
* Without living donor to perform the transplant
* No signed the informed consent

Primary outcomes:
measure: Efficacy of immunosuppression using TLI plus CsA, MMF and Pred in prevent recurrence of FSGS after the renal transplant
Secondary outcomes:
measure: Morbidity and mortality ot the treatment
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - Division of Urology and Radiotherapy - University of Sao Paulo
Study officials:
affiliation: Renal Transplant Unity - Hospital das Clinicas - Medicine School - University of Sao Paulo - Brazil
name: Pedro Chocair, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistent doctor and Medical Supervisor of Division of Radiotherapy - Institute of Radiology - Hospital das Clinicas - University of Sao Paulo
name: Rosangela Villar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328635: Post-traumatic Headache Multidisciplinary Study
Official title: The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Traumatic Headache
Post-Concussion Syndrome
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 58
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: All patients with a head trauma as a cause of the headache will be included in the study

Brief summary: The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center

Detailed description: Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year

Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.

Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.

Eligibility criteria: Inclusion Criteria:

Patients with post-traumatic headache

-

Exclusion Criteria:

* Medication-overuse headache

Primary outcomes:
measure: Change in headache days
timeFrame: 1 year
measure: Rivermead post-concussion questionare score
timeFrame: 1 year
measure: HADS-scores
timeFrame: 1 year
measure: Self-perceived health
timeFrame: 1 year
measure: Level of physical activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
Clinical trial NCT02467335: Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Official title: Single-dose Pharmacokinetics of BMS-626529, Administered as BMS-663068, in Subjects With Hepatic Impairment Compared to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2015-06-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A single oral dose study in subjects with hepatic impairment and healthy control subjects. Subjects will stay at the clinical facility where interval blood samplings will be obtained and examined for drug effect.


Eligibility criteria: Inclusion Criteria:

* Males and females, ages 18 to 70 years, inclusive
* BMI: 18.5 to 38 kg/m2
* Body weight great or equal to 45.5 kg
* Subjects with hepatic impairment
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to the first four subjects with hepatic impairment with regard to age, body weight, and sex, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any major surgery within 4 weeks of study drug administration
* Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Subject has required additional medication for hepatic encephalopathy within 12 months (6 months for severe hepatic impairment) prior to dosing
* Presence of severe ascites or edema in subjects, as judged by the PI

Primary outcomes:
measure: The effects of hepatic impairment on the single-dose peak plasma concentration Cmax of BMS-626529 (metabolite).
timeFrame: 5 days
measure: The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (INF) of BMS-626529 (metabolite).
timeFrame: 5 days
measure: The effects of hepatic impairment on the single-dose area under the plasma concentration versus time curve AUC (0-T) of BMS-626529 (metabolite).
timeFrame: 5 days
Secondary outcomes:
measure: The safety and tolerability of a 600-mg single dose of BMS-663068 in subjects with hepatic impairment and in healthy subjects through analysis of adverse events.
timeFrame: 5 days
measure: The relationship between the Child-Pugh classification (including its components) as well as liver function tests and BMS-626529 profile PK parameters.
timeFrame: 5 days
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: GSK Investigational Site
state: New Jersey
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02245035: Dairy Intake and Brain Health in Aging
Official title: Dairy Intake and Brain Health in Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aged Healthy Volunteer
Keywords: Glutathione
Dairy consumption
Brain
Humans
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Dairy Council
First posted: 2014-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy elderly individuals with an age range of 60-85 years.

Brief summary: The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 60-85 years of age.
2. Good general health with no concomitant diseases, which would be expected to interfere with the study
3. BMI range 20-35 kg/m2

Exclusion Criteria:

1. Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) or prior major head trauma with loss of consciousness
2. Presence of an active unstable and life-threatening systemic illness (e.g., cancer)
3. Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score\>6)
4. Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
5. Use of psychoactive and investigational medications
6. Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. All subjects subjects will receive a structural MRI as part of this study. Individuals with evidence of infection, infarction, neoplasm or other lesions will be excluded. Individuals found to have abnormalities in their structural MRI will be referred to their primary physician for further evaluation and management.
7. Pregnancy
8. Special diet regimens such as lactose free or vegan

Primary outcomes:
measure: Cerebral glutathione (GSH) levels measured by magnetic resonance spectroscopy (MRS)
timeFrame: Baseline
measure: Dietary dairy food intake measured using 7-day diet recording
timeFrame: 1 week, prior to MRS scan
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: In-Young Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References: