louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01620346: Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
Official title: Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) Benefits in the Presence of Advanced Maternal Age: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Infertility
Keywords: advanced maternal age
infertility
IMSI
ICSI
implantation
Lead sponsor: Sapientiae Institute
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 66
Sex: FEMALE
Minimum age (years): 37
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI).

This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.


Eligibility criteria: Inclusion Criteria:

* Good physical and mental health
* Advanced maternal age (≥ 37 years old)
* Regular menstrual cycles of 25-35 days
* Normal basal FSH and LH levels
* Body mass index less than 30 kg/m2
* Presence of both ovaries
* Intact uterus
* No hormone therapy for at least 60 days preceding the study

Exclusion Criteria:

* Polycystic ovaries
* Endometriosis
* Gynaecological/medical disorders
* Positive result in a screening for sexually transmitted diseases

Primary outcomes:
measure: Implantation rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Fertility - Assisted Fertilization Center
Study officials:
affiliation: Fertility - Assisted Fertilization Center and Sapientiae Institute - Educational and Research Center in Assisted Reproduction
name: Edson Borges Jr., MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00728546: NAT2 in Re-challenge of INH in Patients With Hepatitis
Official title: The Application of the N-acetyltransferase 2 (NAT2) Genotyping in Re-challenge Protocol of Isoniazid (INH) Titration in Patients With Anti-TB Medications-induced Hepatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tuberculosis
Hepatotoxicity
Keywords: tuberculosis
isoniazid
Arylamine N-acetyl transferase
genotyping
hepatotoxicity
pharmacogenetics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2008-08-06
Enrollment: 100
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: Apply the information of NAT2 genotyping into the re-challenge protocol of INH titration in patients with anti-TB medication induced hepatitis.

Detailed description: adjusting INH dose according to NAT2 genotyping and serum concentration of INH.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years-old
* Taken INH for more than 1 week
* Abnormal liver function

Exclusion criteria:

* Rule out the INH induced liver abnormality
* Existing reasons to cause liver abnormality other than TB-medication
* Taking drugs which interact with INH

Primary outcomes:
measure: Decrease the events of hepatotoxicity when patients are re-challenged with INH
timeFrame: 6-12 months
Secondary outcomes:
measure: economics evaluation of performing pharmacogenetics screening in practice
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Li-Jiuan Shen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03771846: HAIC Versus Systemic Chemotherapy for Unresectable ICC
Official title: Hepatic Arterial Infusion Chemotherapy of Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: intrahepatic cholangiocarcinoma
systemic chemotherapy
hepatic artery infusion chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of ICC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* Without distant metastasis, but intrahepatic lymph node metastasis is allowed
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
measure: Progression free survival
timeFrame: 12 months
measure: Time to progression
timeFrame: 12 months
measure: Number of adverse events.
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Ming Shi
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03844646: Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
Official title: Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weight Loss
PreDiabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-02-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.

Detailed description: Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese (BMI 25-40 kg/m2)
* Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)

Exclusion Criteria:

* On glucose-lowering medications (e.g., metformin)
* On weight-loss medications

Primary outcomes:
measure: Amount of Weight Lost (kg)
timeFrame: Baseline to end of study (3 months)
Secondary outcomes:
measure: Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
timeFrame: Baseline to end of study (3 months)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Sun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361646: Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of LC350189
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperuricemia
Gout
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 129
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a dose block-randomized, double-blind, active and placebo controlled, single and multiple dosing, dose-escalation study to evaluate tolerability, safety and pharmacokinetic / pharmacodynamic characteristics. Adverse events, physical examinations, vital signs, ECG and laboratory tests will be conducted for safety/tolerability evaluation and serial blood samples and urine collections for pharmacokinetic and pharmacodynamic evaluations will be conducted at specified time points.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects between the ages of 20 and 50 years at screening
2. Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). ☞ BMI (kg/m2) = body weight (kg)/ {height (m)}2.
3. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
4. Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests

Primary outcomes:
measure: Adverse events of LC350189
timeFrame: 7 days(plus or minus 1 day)
Secondary outcomes:
measure: Cmax
timeFrame: 3 days
measure: AUC
timeFrame: 3days
measure: Tmax
timeFrame: 3days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415646: The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Official title: The Effect of Double Injection Erector Spinae Plane Block on Postoperative Pain Following Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Cancer
Keywords: erector spinae plane block
breast surgery
postoperative pain
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.


Eligibility criteria: Inclusion Criteria:

* 25-70 years of age
* ASA I-II
* Undergoing elective breast cancer surgery

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs.

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hour postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
References:
Clinical trial NCT03956446: Tick-borne Encephalitis and Borrelial Antibodies in Serum
Official title: Antibiotic Therapy for Patients With Tick-borne Encephalitis and Borrelial Antibodies in Serum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tick Borne Encephalitis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2019-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Slovenia, tick-borne encephalitis and Lyme borreliosis are both endemic diseases with high incidence rates and they are both transmitted by a bite of infected Ixodes ricinus tick. In clinical practice, tick-borne encephalitis is confirmed by demonstration of tick-borne encephalitis antibodies in serum of a patient with compatible clinical presentation and cerebrospinal pleocytosis. Patients with Lyme meningitis or meningoradiculitis also have cerebrospinal pleocytosis, however the presence of borrelial antibodies in serum does not attest Lyme neuroborreliosis. Patients with tick-borne encephalitis and positive borrelial antibodies in serum, but not fulfilling criteria for Lyme neuroborreliosis, are often being treated with antibiotics in several European countries due to the possibility of double infection. The investigators hypothesise that such patients do not benefit from antibiotics. Such an approach may appear safe regarding the possibility of borrelial infection, however it can also be associated with detrimental consequences such as antibiotic related adverse reactions, negative epidemiological impact on bacterial resistance, and intravenous catheter related complications.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* clinical picture compatible with tick-borne encephalitis,
* clear cerebrospinal fluid,
* cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid \>5 x 106/)L,
* positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus,
* positive serum IgG antibodies against Lyme borreliae.

Exclusion Criteria:

* isolation of B.burgdorferi sensu lato from cerebrospinal fluid,
* positive intrathecal borrelial antibody production index,
* seroconversion of borrelial IgG antibodies,
* presence of erythema migrans and/or borrelial lymphocytoma in the last month,
* Bannwarth syndrome.

Primary outcomes:
measure: Number of patients with objective manifestations of Lyme borreliosis
timeFrame: one year
measure: Frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729546: Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus
Official title: Evaluating System Accuracy of Blood Glucose Monitoring Systems for Self-testing in Managing Diabetes Mellitus [Following EN ISO 15197:2003 - 7.3 System Accuracy Evaluation] Part 40 of Study IDT-2010
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: SMBG (self-monitoring of blood glucose)
POCT
System Accuracy
Lead sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-11-20
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: In this clinical trial an evaluation of a blood glucose monitoring system (BGStar) and several POCT (point-of-care testing) devices against two laboratory methods will be performed. This evaluation will be performed according to ISO (International Organization for Standardization) 15197 System Accuracy.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* People with diabetes Typ 1 or Typ 2 and people without diabetes
* for BG adjustment people with diabetes Typ 1 or Typ 2
* informed consent

Exclusion Criteria:

* pregnancy or lactation period
* severe acute diseases
* severe chronic diseases

Primary outcomes:
measure: Evaluation of System Accuracy according to ISO 15197
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study officials:
References:
citation: Freckmann G, Schmid C, Pleus S, Baumstark A, Link M, Stolberg E, Haug C, Sieber J. System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems. Clin Chem Lab Med. 2014 Jul;52(7):1079-86. doi: 10.1515/cclm-2013-0976.
Clinical trial NCT06483646: Evaluation of the Stability of Sulfur Volatile Compounds From Exhaled Air for Halitosis Diagnosis
Official title: Evaluation of the Stability of Volatile Sulfur Compounds in Gas Samples for Halitosis Diagnosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Halitosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Halitosis or bad breath is a problem affecting 30% of the world's population. There are many causes, and oral pathologies, including periodontitis, are the main etiology. In order to make a diagnosis, a clinical interview is necessary to distinguish true halitosis from psychological halitosis. In addition, a measurement of volatile sulfur compounds (VSC), the main molecules involved in bad breath, is necessary. This is done during the consultation by measuring the concentration of VSCs in exhaled air. However, few private practices or hospitals have the necessary equipment to measure VSC. As a result, patients are often obliged to travel long distances to obtain a consultation including this specific VSC analysis. The aim of this study is to evaluate the stability of VSC values obtained in gaseous samples up to 7 days after sampling, in order to assess the clinical relevance of analyzing samples at a distance from sampling. The clinical aim is to determine whether self-sampling by the patient at home and extemporaneous analysis could be considered in the diagnosis of halitosis.


Eligibility criteria: Inclusion Criteria:

* Adult, male or female
* Subject affiliated with a social health insurance plan
* Able to understand the objectives and risks of the research and to give dated and signed informed consent
* Subject presenting for consultation for diagnosis and treatment of periodontal pathology

Exclusion Criteria:

* Subject under safeguard of justice
* Subject under guardianship or curatorship
* Pregnancy or breast-feeding
* Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject, etc.)
* Subject currently included in another clinical research protocol or in an exclusion period

Primary outcomes:
measure: H2S measurement
timeFrame: Analysis will be made at Day 0 and Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06907446: Comparison of New SUREcore Biopsy of Needle to Standard of Care During Transperineal Prostate Biopsies
Official title: Comparison of BARD Max Core 18g Needle With Uro1 SUREcore 18g Needle in Targeted Prostate Biopsies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To study a novel biopsy needle system for performing transperineal prostate biopsy. Prostate biopsy remains the standard approach for prostate cancer detection. While pre-biopsy MRI allows for targeting of visible lesions, systemic or 'off target' samples are recommended due to the well-recognized risk of undegrading and under sampling with current commercially available needles. The SureCore plus single-use biopsy needle produces a more intact tissue core with a same caliber 18g needle with \~21% more tissue per core in pre-clinical studies. This research study will determine if a new biopsy needle designed to produce more robust tissue cores per sample can improve detection and characterization of prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Patient older than age of 18 undergoing prostate biopsy

Exclusion Criteria:

* Unable to consent
* Any comorbidity that, in the opinion of the investigator, could compromise protocol objectives
* Prisoners

Primary outcomes:
measure: Number of patients diagnosed with prostate cancer and histological grade of cancer detected
timeFrame: From prostate biopsy procedure through study completion up to 1 year
Secondary outcomes:
measure: Quality of Biopsy Specimen Obtained at Time of Prostate Biopsy
timeFrame: From prostate biopsy procedure through study completion up to 1 year
measure: Length of time necessary to diagnose the tissue sample
timeFrame: Diagnosis within 10 days of the biopsy
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Departments of Urologic Oncology
state: California
Study officials:
References: