louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01546324: Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing
Official title: Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Following IVF With PGS/PGD
Keywords: Maternal Blood
PGD
PGS
Natera
Gene Security Network
Non-invasive prenatal diagnosis
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women 18 years of age or older who used Natera (formerly Gene Security Network)'s Preimplantation Genetic testing (PGS/PGD) to achieve their current pregnancy.

Brief summary: The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy screening (with or without single gene gene testing). These samples will be used for test development of non-invasive prenatal diagnostic testing.

Detailed description: Eligible subjects will sign a consent form and have blood drawn at approximately 8-17 weeks gestation. Subjects will received $200 reimbursement for providing this blood sample. The collected samples will be used to help develop non-invasive prenatal diagnostic testing using Natera's Parental Support technology which is already commercialized for genetic diagnosis of in-vitro embryos. In this study, the technology will be tested for it's ability to analyze fetal-specific pieces of DNA isolated from the mother's blood. No results of the maternal blood testing will be reported to the subject or to their physicians.

Eligibility criteria: Inclusion Criteria:

* Pregnant women willing to donate a blood sample during the first or second trimester of their pregnancy (approximately 8-17 weeks gestation)
* Use of Natera (formerly Gene Security Network)'s commercial preimplantation genetic testing (PGS/PGD)to achieve the current pregnancy

Exclusion Criteria:

* Pregnant women who did not use Natera (formerly Gene Security Network)'s PGS/PGD testing to achieve their current pregnancy

Primary outcomes:
measure: Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Natera, Inc
state: California
Study officials:
affiliation: CEO, Natera, Inc
name: Matthew Rabinowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954624: Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid
Official title: A Open-Label, Two-sequence Phase I Drug-drug Interaction Clinical Study to Investigate the Pharmacokinetics of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-07-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The drug-drug interaction study had been designed to investigate the effect of ZSP1273 on the pharmacokinetics of digoxin, Rosuvastatin and the effect of Itraconazole and Probenecid on the pharmacokinetics of ZSP1273


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg(male) or \>45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
2. Ability to understand and willingness to sign a written informed consent form;
3. Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

Exclusion Criteria:

1. Participants with a history of hypersensitivity to study drug(ZSP1273,Digoxin, Rosuvastatin,Itraconazole ) or any component of study medication;
2. Participants had taken prescription, over-the-counter, herbal, or vitamin products within 28 days prior to screening；
3. Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
4. Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
5. Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
6. Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
7. Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
8. Females who are pregnant, lactating, or likely to become pregnant during the study.
9. History of dysphagia or any gastrointestinal disorder that affect absorption

Primary outcomes:
measure: Pharmacokinetic - Cmax
timeFrame: 0-168 hours
measure: Pharmacokinetic -Area under the curve（AUC）
timeFrame: 0-168 hours
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Day1 to Day30
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese medicine
Study officials:
References:
Clinical trial NCT02787824: Periodic Versus Continuous IV Iron Supplementation in HD Patients
Official title: Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia of Chronic Kidney Disease
Keywords: iron deficiency
hemodialysis
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose \[continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)\] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Constant rHu-EPO and iron dose for at least 2 months before starting the study
* Hemoglobin ≥ 8,5g/dl and \<12,5 g/dl
* Ferritin \< 1000 mg/dl
* TSAT \< 50%
* CRP \< 5 mg/dl

Exclusion Criteria:

* Malignant tumor disease
* Oral iron supplementation
* Active bleeding issues
* Surgical intervention within the last 8 weeks before study inclusion

Primary outcomes:
measure: Change of serum hemoglobin level (g/dl)
timeFrame: Month 0, 1, 2, 3, 4
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
References:
Clinical trial NCT01308424: Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection
Official title: A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of BTL-TML-HSV for the Treatment of Recurrent Symptomatic Oral Herpes Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Oral Herpes Simplex
Keywords: Herpes Labialis
Herpes Simplex
Herpes
Lead sponsor: Beech Tree Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Norwich Clinical Research Associates Ltd.
First posted: 2011-03-04
Enrollment: 171
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: The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.


Eligibility criteria: Inclusion Criteria:

* Clinical history of recurrent cold sores averaging 2 or more episodes per year
* Experiences prodromal symptoms (tingling, burning, itching) of cold sores
* Herpes Simplex Virus seropositive (by blood test)

Exclusion Criteria:

* Immuno-suppressed or taking immunosuppressant medication
* Use of antiviral therapy directly prior and during the study

Primary outcomes:
measure: Proportion of Subjects Who Experience a New Cold Sore Outbreak That Proceeds to the Lesion Stage. Of Those Subjects That Take Study Medication (Experience a New Emerging Cold Sore) Those That Proceed to Lesion Stage (Cold Sore Stage - 3 Vesicle or Above).
timeFrame: 7-14 days (depending on time of lesion outbreak - subjects had 7 days to experience a new emerging cold sore)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky College of Dentistry/Center for Oral Health Research
state: Kentucky
city: Buffalo
country: United States
facility: School of Dental Medicine, University at Buffalo
state: New York
city: Norwich
country: United States
facility: Family Dentistry
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Dental Medicine
state: Pennsylvania
Study officials:
References:
citation: Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.
Clinical trial NCT00893724: Supplemental Adjuvants for Intracellular Nutrition and Treatment
Official title: The Effect of Supplemental Adjuvants for Intracellular Nutrition and Treatment on Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Keywords: DME
NAMD
Oxidative damage
Nutritional supplements/vitamins
DNA repair
NAMD/wet AMD
Lead sponsor: Mid-Atlantic Retina Consultations, Inc.
Sponsor class: OTHER
Collaborators: name: West Virginia University
First posted: 2009-05-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nutritional supplements have an augmentative effect on the outcomes of standard treatment of diabetic macular edema (DME) and Neovascular Age-Related Macular Degeneration (NAMD).

Detailed description: It has been shown that in chronic diseases, oxidative stress results from Nitric acid reacting with oxygen to form toxins that damage both somatic and mitochondrial DNA. The potential for protecting the DNA and promoting repair by using nutritional supplements will be tested by augmenting standard treatments for DME and NAMD with such supplements. The patients will be randomized to treatment group and placebo group and followed up for a year in a double masked fashion. Anatomic and visual outcomes, as well as side effects will be assessed and analyzed. If the results are promising, this pilot study can be used to design alternative (cheaper, better and longer lasting) treatments for DME, NAMD and perhaps other chronic illnesses.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of NAMD
* Clinical Diagnosis of DME

Exclusion Criteria:

* Pregnant Women
* Known allergy to any component used in the treatment combinations

Primary outcomes:
measure: Degree of regression (Optical Coherence Tomography)
timeFrame: Monthly
measure: Duration of regression (Optical Coherence Tomography)
timeFrame: Monthly
measure: Visual change (ETDRS)
timeFrame: Monthly
Secondary outcomes:
measure: Effect on HbA1C
timeFrame: Monthly
measure: Effect on Blood pressure
timeFrame: Monthly
measure: Effect on serum uric acid
timeFrame: Monthly
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mid-Atlantic Retina Consultations, Inc.
state: West Virginia
Study officials:
affiliation: M.A.R.C.
name: Nabil M Jabbour, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05802524: Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
Official title: Neurophysiological Approach for the Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consciousness Disorder
Cognitive Impairment
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Departments of Serious Acquired Brain Injuries

Brief summary: Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness.

Identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.


Eligibility criteria: Inclusion Criteria:

* Glasgow Coma Scale (GCS) \> 8;

Level of Cognitive Scale (LCF) = 1-3;

Signature of the consent from the family member and/or guardian.

Exclusion Criteria:

* Failure to sign the consent of the family member and/or legal guardian;

Patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.;

Patients with absence of neurophysiological responses in visual evoked potentials (VEP) and with absence of peripheral waves (I-II wave) to acoustic potentials (PEA).

Primary outcomes:
measure: Event-related evoked potentials(ERPs)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
References:
Clinical trial NCT05272124: Effects of Hip Abductors Strengthening In Knee Osteoarthritis
Official title: Comparison of Hip Abductors and Quadriceps Strengthening With Quadriceps Strengthening Alone in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Knees Both
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups are formed. Control group and Experimental group.
Primary purpose: TREATMENT

Brief summary: The aim of my study is to determine the effects of hip abductors strengthening and quadriceps strengthening in comparison with quadriceps strengthening alone in patients with knee osteoarthritis.

Detailed description: As the quadriceps strengthening is a keystone of exercise therapy for knee osteoarthritis. Thus is the hip abductors strengthening along with quadriceps strengthening would be added to the treatment protocol of osteoarthritis it might give more positive results, decrease pain and increase the recovery rate as well as helpful to improve the functional outcomes.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of single or both knees
* Kellgren Lawrence scale between 2-4

Exclusion Criteria:

* Knee valgus or varus deformity
* Hip or knee joint replacement
* Tibial osteotomy
* Any other surgery of hip or knee joint

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 weeks
Secondary outcomes:
measure: Five Times Sit to Stand Test (FTSST)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mansehra
country: Pakistan
facility: Khattak Physiotherapy and Rehabilitation Center
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Riphah International University
name: Muhammad Affan Iqbal, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05632224: Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
Official title: Retrospective Comparison of the Effects of Granisetron and Aprepitant in the Prevention of Postoperative Nausea and Vomiting in Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Nausea
Vomiting
Keywords: postoperative nausea and vomiting
laparoscopic surgery
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group 1:patient who receive aprepitant group 2: patient who receive granisetron
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare frequency with postoperative nausea and vomiting in ASA( American Society of Anesthesiologists) I, II patients undergoing laparoscopic surgery.

The main question\[s\] it aims to answer are:

* Primary Outcome is the incidence of nausea and vomiting between 0-6 and 6-24 hours postoperatively and the need for additional antiemetics
* Secondary outcome is detection of additional analgesic needs and complications between 0-6 and 6-24 hours postoperatively.

Participants will receive aprepitant or granisetron for prevention of postoperative nausea and vomiting.

Detailed description: The aim of this study is to investigate the effectiveness of drugs used for postoperative nausea and vomiting in laparoscopic surgeries.

In the research; During the operation, the patient's vitals will be recorded intraoperative forms. Vitals are; heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide levels; according to the pain level after awakening from the patient follow-up forms in the service.

The doses and times of analgesics will be screened, the frequencies of postoperative nausea, retching, vomiting, and additional antiemetic doses will be screened, respiratory depression, complications of anesthesia, arrhythmia, laryngospasm, hypo-hypertension, headache, dizziness, allergic reactions anxiety symptoms will be screened too.

we will try to emphasize which antiemetic is more effective than the other and which one has few side effects

Eligibility criteria: Inclusion Criteria:

* ASA I, II patients patients undergoing laparoscopic surgery

Exclusion Criteria:

* ASA III and above patients who refused to participate in the study

Primary outcomes:
measure: incidence of nausea
timeFrame: postoperative 24 hours
measure: the need for additional antiemetics
timeFrame: postoperative 24 hours
measure: incidence of vomiting
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: additional analgesic need
timeFrame: postoperative 24 hours
measure: detection of complications
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
References:
Clinical trial NCT06713824: Neoadjuvant Radiotherapy Before Surgery for Rectal Cancer, Surgical and Oncological Outcome Analysis, Retrospective Case Control Study in a Single Institute.
Official title: Neoadjuvant Radiotherapy Before Surgery for Rectal Cancer, Surgical and Oncological Outcome Analysis, Retrospective Case Control Study in a Single Institute.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: General Surgery
Radiology
Keywords: neo-adjuvant
rectal cancer
radiotherapy
concurrent chemo-radiation therapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study collected clinical stage 3 rectal cancer patients who underwent radical resection without neoadjuvant radiotherapy at Taichung Veterans General Hospital from January 1, 2017 to October 1, 2024.

Brief summary: Pre-operative radiotherapy for clinical stage 3 rectal cancer outcome analysis, retrospective case-control study.

Detailed description: For clinical T3 rectal cancer, neo-adjuvant radiotherapy was proved to reduce local recurrent rate in the clinical trials. In this study, we analysis surgical and oncological outcomes of neo-adjuvant radiotherapy for stage 3 rectal cancer in the real world in a single institute and do further subgroups analysis as references for treatment plans.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer, clinical stage T3 or higher, with no distant metastasis.
* Age \> =20 years, ASA class I-III.
* Underwent surgery.
* Complete medical records.

Exclusion Criteria:

* Non-rectal cancer.
* Clinical stage T1-T2.
* Stage IV with distant metastasis.
* Age \< 20 years, ASA class IV-V.
* Incomplete medical records.
* HIV-positive patients (Human Immunodeficiency Virus).
* Patients who completed treatment after October 1, 2024.

Primary outcomes:
measure: Recurrence rate
timeFrame: 5-year postoperative period
measure: survival rate
timeFrame: 5-year postoperative period
Secondary outcomes:
measure: Complication rate
timeFrame: 30 days after surgery
measure: Complications of radiation and chemotherapy
timeFrame: 30 days after radiation and chemotherapy
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: