louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03251794: Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
Official title: Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with threatened preterm labor

Brief summary: Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.

Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at \< 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%


Eligibility criteria: Inclusion Criteria:

1. singleton fetus less than 37 weeks of gestation
2. women diagnosed to having Threatened preterm labor.

   1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
   2. cervical effacement \<80 %
   3. cervical dilatation \<1 cm

Exclusion Criteria:

1. suspected fetal growth restriction,
2. maternal medical complications,
3. presence of fetal heart rate abnormalities at enrollment.
4. Preterm Premature rupture of membranes
5. Placenta previa
6. Lower urinary tract infection or genital infection
7. Fetal congenital anomaly

Primary outcomes:
measure: the volume of adrenal gland
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT04855994: Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block
Official title: Comparison of the Results of Ultrasound-Guided Thoracic Paravertebral Block and Modified Pectoral Nerve Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery; A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Paravertebral Block
Video-assisted Thoracoscopic Surgery
Postoperative Analgesia
Keywords: Thoracic paravertebral block,
pectoralis block,
Video-assisted thoracoscopic surgery,
Postoperative analgesia
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-22
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.

Detailed description: 52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.

Eligibility criteria: Inclusion Criteria:

* Ages of 18-65
* Patients who will undergo VATS
* ASA I-II-III patients

Exclusion Criteria:

* Patients with ASA IV
* Clinically diagnosis of spinal or chest wall deformity or pathology
* Clinically known local anesthetic allergy
* Morbid obesity (body mass index\>40 kg m2)
* Clinically diagnosis of opioid, alcohol and substance dependence
* Clinically diagnosis of psychiatric disease
* Coagulopathy

Primary outcomes:
measure: Postoperative 24-hours total morphine consumption of patients
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Visual Analog Scale values of patients
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
state: Bakirkoy
Study officials:
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
name: Gokhan Sertcakacilar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06798194: Fusing Ultrasound and Magnetic Resonance Imaging to Intelligently Plan Highly Conformal Ablation Thermal Field for Hepatocellular Carcinoma
Official title: Fusing Ultrasound and Magnetic Resonance Imaging to Intelligently Plan Highly Conformal Ablation Thermal Field for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 300
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: HCC patients receiving ablation therapy

Brief summary: Thermal ablation is an important minimally invasive treatment for hepatocellular carcinoma (HCC), but local tumor progression (LTP) after ablation restricts the efficacy and status of ablation technology and seriously threatens patient survival. Insufficient coverage of thermal field is an important factor on the occurrence of LTP. Current thermal field planning relies on tumor contours and doctor experience, and the safety margin is uniform. Therefore, it cannot cope with the problem of insufficient coverage of thermal field caused by the different invasion capabilities of different tumors and different parts of the same tumor. This project intends to integratively analyze gray-scale ultrasound, contrast-enhanced ultrasound, magnetic resonance imaging and clinical information of HCC through deep canonical correlation analysis; summarize the prior knowledge of LTP risk factors in previous studies and perform conjoint analysis individual case data and common conclusions through knowledge graph; interpretatively predict the LTP risk and the high-risk LTP locations through link prediction; accurately predict the ablation safety margin required for different tumor parts through graph neural network, and achieve highly conformal thermal field planning based on different invasion capabilities to minimize the LTP risk of HCC. The project leverages tumor multi-modal imaging and prior knowledge as the entry point, performs highly conformal planning of the ablation thermal field through artificial intelligence technology, and provides a new method for precise ablation.


Eligibility criteria: Inclusion Criteria:

1. Pathologically confirmed primary hepatocellular carcinoma
2. Undergo curative ablation
3. With complete clinical information and pre- and post-operative imaging information

Exclusion Criteria:

1. Undergo palliative ablation
2. Lack of clinical or imaging information
3. Age less than 18 years

Primary outcomes:
measure: Local tumor progression
timeFrame: 2 years
Secondary outcomes:
measure: tumor recurrence
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA Hospital
Study officials:
References:
Clinical trial NCT04189094: Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC
Official title: Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Lung Cancer Limited Stage
Keywords: radiotherapy
chemotherapy
immunotherapy
PD-1 inhibitor
lung cancer
small cell
limited-stage
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Affiliated Hospital of Guangdong Medical University
name: First People's Hospital of Foshan
First posted: 2019-12-06
Enrollment: 140
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 study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.


Eligibility criteria: Inclusion Criteria:

1. Histologically/cytologically confirmed diagnosis of SCLC.
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be ≥ 18 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.

Exclusion Criteria:

1. Histology confirmed the mixed NSCLC components;
2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
7. Received live vaccination within 28 days before the first administration of the study drug;
8. 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials.
9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
10. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Overall response rates
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)
name: Ming Chen, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389294: HSS Covid-19 Antibody Serology Among Surgeons & Anesthesiologists
Official title: Hospital for Special Surgery COVID-19 Antibody Serology Among Anesthesiologists and Surgeons 2020
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 143
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to understand the infectious exposure of SARS-coronavirus 2 (SARS-CoV2) among surgeons and anesthesiologists and to correlate this status with self-reported indices of COVID-19 illness.


Eligibility criteria: Inclusion Criteria:

* Accredited to practice at HSS
* All anesthesiology and surgery faculty
* All anesthesia and orthopedic surgery fellows
* All orthopedic surgery residents

Exclusion Criteria:

• Refusal to participate in either of the interventions at either of the timepoints of interest

Primary outcomes:
measure: Number of Participants With SARS-CoV-2 IgG Antibodies
timeFrame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
Secondary outcomes:
measure: Differences in Sex Between IgG Antibody-positive vs. Negative Participants
timeFrame: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020
measure: Number of Asymptomatic Participants With Positive Antibody Serology
timeFrame: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
measure: Percentage of Antibody-positive Participants Who Subsequently Develop COVID-19
timeFrame: Serology Test #1 (Study Enrollment) and Serology Test #2 (3 months apart)
measure: Differences in Race Between IgG Antibody-positive vs. Negative Participants
timeFrame: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020
measure: Differences in Average Number of Adults in Household Between IgG Antibody-positive vs. Negative Participants
timeFrame: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020
measure: Differences in Comorbidities Between IgG Antibody-positive vs. Negative Participants
timeFrame: Survey completed before or on day of serology testing asking about information from January 1, 2020 to May 5, 2020
Other outcomes:
measure: Participants Who Were Eligible for in Plasma Donation
timeFrame: Serology Test #1 (Study Enrollment) and Test #2 (3 months apart)
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT00788294: Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Official title: Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.


Eligibility criteria: Inclusion Criteria:

* Generally healthy
* BMI of 18-30 kg/m2
* more than 50 kg bodyweight.

Exclusion Criteria:

* Pregnant
* exposure to biologic type drugs within the last 3 months
* history of allergic or anaphylactic reaction to a biologic drug
* use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
* excessive alcohol use.

Primary outcomes:
measure: Subcutaneous bioavailability
timeFrame: 16 weeks
measure: Injection site reactions
timeFrame: 16 weeks
measure: Immunogenicity
timeFrame: 16 weeks
Secondary outcomes:
measure: Nerve growth factor levels
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03375294: Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Official title: Exploring Nitrous Oxide Effects for Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to understand nitrous oxide effects in post traumatic stress disorder (PTSD)

Detailed description: Post traumatic stress disorder (PTSD) is a disabling mental health disorder that impacts the lives of individuals. This study aims to understand nitrous oxide's effects in PTSD.

Eligibility criteria: Inclusion Criteria:

* age 18-80
* Veterans of the United States Uniformed Services
* primary diagnosis of PTSD
* sufficient severity of PTSD symptoms
* fluency in English
* capacity to provide informed consent

Exclusion Criteria:

* psychiatric or medical conditions that make participation unsafe
* pregnant or nursing females
* allergy to nitrous oxide

Primary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Baseline and 1 week post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto
state: California
Study officials:
affiliation: Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varias A, van Roessel P, Parsiani M, Filippou-Frye M, Neylan TC, Nagele P, Yesavage J, Clark JD, Rodriguez CI. Does Nitrous Oxide Help Veterans With Posttraumatic Stress Disorder? A Case Series. J Clin Psychiatry. 2020 Jun 30;81(4):20l13393. doi: 10.4088/JCP.20l13393. No abstract available.
Clinical trial NCT04820894: Perception of Cure Among Patients With Metastatic Cancer
Official title: The Perception of Cure Among Patients With Metastatic Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Metastatic Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-29
Enrollment: 0
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: Patients with metastatic cancer

Brief summary: This study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). This study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy.

SECONDARY OBJECTIVES:

I. To determine if expectations of cure are associated with quality of life and distress.

II. To determine if patients' perceptions differ by gender, age, and ethnicity.

OUTLINE:

Patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed.

Eligibility criteria: Eligibility Criteria:

1. Patients must be aged 18 and over
2. Patients sufficiently fluent in English
3. Patients must have a cytologically or pathologically verified diagnosis of cancer
4. Patients must have measurable metastatic disease
5. Patients must be initiating immunotherapy
6. Patients must be undergoing evaluation and treatment at City of Hope Cancer Center

Primary outcomes:
measure: Percentage of patients
timeFrame: Up to 2 years
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Up to 2 years
measure: Functional Assessment of Cancer Therapy-General (FACT-G)
timeFrame: Up to 2 years
measure: Perceptions of cure
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Sumanta K Pal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342094: DE-111 Against Timolol Ophthalmic Solution 0.5%
Official title: A Double-masked Study of DE-111 Ophthalmic Solution Versus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension - Phase 3, Confirmatory Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Primary open angle glaucoma or ocular hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-04-26
Enrollment: 166
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open angle glaucoma or ocular hypertension
* Provided signed, written informed consent
* 20 years of age and older
* If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* Presence of any abnormality or significant illness that could be expected to interfere with the study

Primary outcomes:
measure: Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study
timeFrame: Week 0(Baseline) and Week 4(End of Study)
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References: