louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00198419: Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase)
Official title: Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase) Open Label, Normal Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Hypersensitivity
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to 10% hypersensitivity response was considered acceptable.


Eligibility criteria: Inclusion Criteria:

* Avoid disallowed meds throughout study

Exclusion Criteria:

* Known hypersensitivity to hyaluronidase and/or bee sting
* Atopic individuals assessed by med history
* Topical/systemic corticosteroids within 30 days
* Concurrent use of antihistamines or anti-inflammatory during study
* Active or chronic disease likely to affect immune function
* History of alcohol/drug abuse within 6 months

Primary outcomes:
measure: Hypersensitivity
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Solano Clinical Research (A Division of Dow Pharmaceutical Sciences)
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Lisa R Grillone, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01341119: Retrospective Analysis of Skin/Soft Tissue Primary NK/T Cell Lymphoma
Official title: Retrospective Analysis of Skin/Soft Tissue Primary NK/T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extranodal NK/T Cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary hospital

Brief summary: To study clinical features, prognostic factors and treatment outcome and to develop a possible prognostic index in skin/soft tissue primary NK/T cell lymphoma patients.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed extranodal NK/T cell lymphoma
* primary site is skin or soft tissue

Exclusion Criteria:

* involvement of upper aerodigestive tract

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05618119: [18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function
Official title: The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gender
Keywords: P-glycoprotein
MC225
[18F]MC225
PET
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of healthy volunteers (5 male, 5 female)
Primary purpose: BASIC_SCIENCE

Brief summary: P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of medication with a known effect on the BBB P-glycoprotein transporter
* Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function

Primary outcomes:
measure: PET kinetic modeling outcome parameters [18F]MC225
timeFrame: 60 minutes after administration [18F]MC225
Secondary outcomes:
measure: PET kinetic modeling outcome parameters [15O]H2O
timeFrame: 10 minutes after administration of [15O]H2O
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00139919: Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Keywords: Decreasing Titration Study
Schizophrenia
Bipolar
Pharmacokinetic
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.


Eligibility criteria: Inclusion Criteria:

* Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
* Age 18 to 55
* Body weight 100-250 lbs
* Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

* Acutely psychotic subjects
* Subjects that are acutely manic
* Subjects with a psych diagnosis other than Bipolar Type I Disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Site 1
state: California
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02967835: Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult
Official title: Pilot to Assess Effectiveness of and Satisfaction With Brief Synchronous Tele-psychiatry Consult
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depression
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 0
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: Will Tele-psychiatry be effective and acceptable to patients.

Detailed description: This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic Florida primary care sites. The primary aim of this study is to assess the impact of brief tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex care management; the secondary aim is to assess patient satisfaction with brief tele-psychiatry consults.

Eligibility criteria: Inclusion Criteria

1. Enrolled in complex care management
2. PHQ9 above 10 or GAD7 above 10.

Exclusion Criteria

1. Not able to provide informed consent
2. Severe cognitive impairments or sensory deficits
3. Not able to understand and speak English

Primary outcomes:
measure: Depression Outcome
timeFrame: 6 month
measure: Anxiety Outcome
timeFrame: 6 month
Secondary outcomes:
measure: Patient satisfaction with tele-psychiatry consult
timeFrame: baseline visit
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Mohit Chauhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05502835: Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Official title: Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Fluid Volume
Hemodynamics
Serum Lactate
Intestinal Edema
Length of the Hospital Stay
First Time to Gastrointestinal Motion
Postoperative Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

Detailed description: All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group):

Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution.

Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
* Patients scheduled for elective open colonic mass resection and anastomosis.

Exclusion Criteria:

* Serious cardiac arrhythmia.
* Peripheral artery disease.
* An ejection fraction below 30%.
* A pulmonary pathology.

Primary outcomes:
measure: Intraoperative fluid volume
timeFrame: calculated immediately after surgery
Secondary outcomes:
measure: intraoperative blood pressure
timeFrame: every ten minutes till the end of the surgery
measure: lactate level
timeFrame: every hour till the end of the surgery
measure: POSTOPERATIVE COMPLICATIONS
timeFrame: till one week after surgery
measure: intestinal oedema
timeFrame: intraoperatively after tumor resection
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References:
Clinical trial NCT01865435: IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE
Official title: IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 40
Sex: ALL
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.


Eligibility criteria: Inclusion Criteria:

* Born weight upper or equal to the 10th percentile and absence of smoking declared by the mother
* Born weight lower than the 10th percentile and absence of smoking declared by the mother
* Born weight upper or equal to the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day
* Born weight lower than the 10th percentile and smoking declared by the mother of at least 5 cigarettes a day

Exclusion Criteria:

* Gestationnel age 37 LIMITED COMPANIES
* Low(Weak) declaratory(declarative) maternal smoking (1 in 4 cigarettes a day)
* Pathologies associated by the newborn child (deformations, foetal suffering, infection maternofœtale, respiratory distress syndrome)

Primary outcomes:
measure: cord blood samples
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT05848635: Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled
Official title: Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Nodule
Ablation
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.

Detailed description: Although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. In view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.

Eligibility criteria: Inclusion Criteria:

* Voluntarily attend and sign the informed consent form in person;
* Patients undergoing selective pulmonary tumor ablation;
* The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less;
* The estimated survival time is more than 3 months;
* Age 18-80, both sexes.

Exclusion Criteria:

* Severe coagulation dysfunction that cannot be corrected;
* History of severe cardio-cerebrovascular and respiratory diseases;
* Patients allergic to test drugs or contrast media;
* Patients with opioid addiction;
* Patients with cognitive dysfunction;
* Participated in other clinical investigators within three months;
* Investigators or their family members directly involved in the trial;
* Those who are deemed unfit to participate in the study by the investigator.

Primary outcomes:
measure: Analgesic efficiency
timeFrame: The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: perioperative period
Other outcomes:
Locations:
Study officials:
affiliation: head of intervention department
name: Xin Ye, graduate
role: STUDY_DIRECTOR
References:
Clinical trial NCT06941935: Etiological Classification-guided Individual Intervention in Primary Hypertension
Official title: Etiological Classification-guided Individual Intervention in Primary Hypertension: An All-comer Registry Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Etiological Classification
Digital Intervention
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years.
* Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
* signed informed consent.

Exclusion Criteria:

* Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation).
* Comorbidities such as diabetes, chronic kidney disease (eGFR \< 30 mL/min/1.73m²), coronary artery disease, heart failure, or serious valvular heart disease.
* History of stroke or myocardial infarction.
* Pregnancy, breastfeeding, or planning to become pregnant.
* Life expectancy \< 1 year.
* Participation in another clinical trial.

Primary outcomes:
measure: Changes in Blood Pressure Recorded in a 1-Week Home Blood Pressure Diary
timeFrame: 3 months following intervention
Secondary outcomes:
measure: Change in 24-hour Ambulatory Blood Pressure Monitoring
timeFrame: 1/2/3 months following intervention
measure: Change in Home Blood Pressure Monitoring
timeFrame: 1/2 months following intervention
measure: Control Rate
timeFrame: 3 months following intervention
measure: Drug adjustment times
timeFrame: 3 months following intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00691535: Genetics of Symptomatology and Treatment Response in Psychotic Major Depression
Official title: Association of BDNF, COMT, MDRI, CRH, CRF, and GC Receptor Genetic Polymorphisms With Symptomatology and Treatment Response in Psychotic Major Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorders
Depressive Disorder
Depressive Disorder, Major
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression.

Detailed description: From the blood sample you donate, the researchers will obtain DNA. This DNA will be used to search for DNA markers related to the underlying biology of psychiatric illness and how this might explain the symptoms of these disorders. Research using DNA is an important way to try to understand human disease and/or the role genes play in disease. In effect, part of your blood sample will be used to attempt to understand how genetic factors contribute to the symptoms of such psychiatric conditions as major depression.

Eligibility criteria: Inclusion Criteria:

1. You are currently experiencing symptoms that are consistent with an episode of major depression without symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
2. You are currently experiencing symptoms that are consistent with an episode of major depression with symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
3. You have been diagnosed with either schizophrenia or schizoaffective disorder, or
4. You are a volunteer without a history of psychiatric illness (a healthy control subject).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alan F Schatzberg, MD
role: PRINCIPAL_INVESTIGATOR
References: