louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00232453: Preoperative Combined Radiation and Chemotherapy - Rectal Cancer
Official title: A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-10-04
Enrollment: 34
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: There is no established standard preoperative treatment in rectal cancer. Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies. This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy. The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2. An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity. It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum
* Performance status \<2 (ECOG, appendix II)
* Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis

Exclusion Criteria:

* Prior pelvic irradiation
* Inflammatory bowel disease
* Evidence of distant metastasis
* Performance status \>2

Primary outcomes:
measure: Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: James Brierley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02580253: Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation
Official title: Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 0
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: This study is a randomized, open-label, controlled study that will explore the efficacy of individualized adjuvant chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay for patients with hepatocellular carcinoma after liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients who had experienced liver transplantation with histologically confirmed advanced hepatocellular carcinoma with more one risk factor (tumour burden \>8 cm, AFP\>400 ng/mL,poorly differentiated,vessels invasion )
* No extrahepatic metastasis confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
* Additional inclusion criteria were age 18 years or older
* Karnofsky performance status (KPS) of at least 70%
* Adequate renal function, defined as creatinine clearance greater than 30 mL/min)
* Adequate hepatic function, defined as ALT and AST less than 5× upper limit of normal
* Adequate bone marrow function, defined as platelets greater than 100×10E9/L and WBC greater than 3.5×10E9/L.

Exclusion Criteria:

* The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
* Hypersensitivity to study drugs
* Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
* National Cancer Institute CommonToxicity Criteria (NCI-CTC) grade 3 or 4 sensory or motor neuropathy
* Prior or concurrent malignancy (other than pancreatic cancer)
* Female, pregnancy or breastfeeding.

Primary outcomes:
measure: Desease free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
References:
citation: Lin HS, Wan RH, Gao LH, Li JF, Shan RF, Shi J. Adjuvant chemotherapy after liver transplantation for hepatocellular carcinoma: a systematic review and a meta-analysis. Hepatobiliary Pancreat Dis Int. 2015 Jun;14(3):236-45. doi: 10.1016/s1499-3872(15)60373-3.
Clinical trial NCT04448353: Carotid Risk Prediction (CRISP) Consortium
Official title: Carotid Risk Prediction (CRISP) Consortium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Atherosclerosis
Lead sponsor: Elucid Bioimaging Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland, College Park
First posted: 2020-06-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All-comers, design, adjusted for demographic factors

Brief summary: Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.

Detailed description: Develop adverse event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as information on events and interventions.

Eligibility criteria: Inclusion Criteria:

* Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
* Atherosclerotic plaque must be visualized within the carotid artery.

Exclusion Criteria:

* Subjects without visible plaque within the carotid artery
* Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)

Primary outcomes:
measure: Adverse outcome model performance
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: New York
country: United States
facility: Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital)
state: New York
city: Cleveland
country: United States
facility: University Hospital Harrington (Affiliated with Case Western Reserve University)
state: Ohio
Study officials:
affiliation: University of Maryland, College Park
name: Brajesh K. Lal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lal BK, Khan AA, Kashyap VS, Chrencik MT, Gupta A, King AH, Patel JB, Martinez-Delcid J, Uceda D, Desikan S, Sikdar S, Sorkin JD, Buckler A. Computed tomography angiographic biomarkers help identify vulnerable carotid artery plaque. J Vasc Surg. 2022 Apr;75(4):1311-1322.e3. doi: 10.1016/j.jvs.2021.10.056. Epub 2021 Nov 15.
Clinical trial NCT00824551: The Effects of Hyperbaric Oxygen Therapy (HBOT) on Acute Thermal Burns
Official title: The Effects of Hyperbaric Oxygen Therapy on Acute Thermal Burns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Thermal Burns
Keywords: Acute Thermal Burns
Hyperbaric Oxygen Therapy
Burns conversion
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2009-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The blinded RCTstudy aims to:

* Determine the effects of HBOT on burns conversion for patients who have fresh thermal burns injury using the LDI.
* Objectively determine the proportion of burns conversion in areas of partial thickness burns for early thermal burns injury in both arms of the RCT.
* Study the effects of HBOT on immunological markers IL-1, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α and TGF-β ( comparison between both arms and 2 assessment points).
* Study the effect of HBOT on haematological markers including procalcitonin ,albumin, lymphocyte counts, neutrophil count, and macrophage count.
* Study the effects of HBOT on histology specimens in quantifying P53 protein, leukocyte and macrophage infiltration, burns depth assessment and vascular endothelial growth factor (VEGF) and inducible nitric oxide synthase (iNOS) .
* Study the effects of HBOT on bacteriology of tissue culture in areas of deep dermal burns.


Eligibility criteria: Inclusion Criteria:

* Thermal burns injury less than 40% with areas of deep dermal/ full thickness burns.
* Less than 24 hours from time of injury.
* No inhalational injury (Nasoendoscopy and bronchoscopic diagnosis by burns centre medical team/ department of emergency medicine in SGH).
* Age 21 years old and above and less than 60 years old.
* Not intubated and not on inotropic support.
* Understands and agrees to informed consent (approved by IRB SGH).

Exclusion Criteria:

* Untreated pneumothorax
* Medications: Bleomycin, Cis-platin, Doxorubicin, Disulfiram (Chemotherapy)
* Acute uncontrolled medical condition or significant medical condition (eg. Cerebrovascular accident, diabetic ketoacidosis, severe hypertensive 180/ 110 mmHg, end stage renal failure, chest pain, bleeding gastrointestinal tract, coma and acute asthma attack)
* Other surgical emergencies (eg. open fractures, compartment syndrome and acute abdomen)

Primary outcomes:
measure: Burns conversion
timeFrame: 2 years
Secondary outcomes:
measure: Bacteriology culture and immunology markers
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT05977751: Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Official title: FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Keywords: Permanent Birth Control
Permanent Contraception
Permanent Sterilization
Lead sponsor: Femasys Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 573
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Detailed description: Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Eligibility criteria: Inclusion Criteria:

* Female, 21 - 50 years of age desiring permanent birth control.
* Sexually active with male partner.
* Regular menstrual cycle for last 3 months or on hormonal contraceptives.

Exclusion Criteria:

* Uncertainty about the desire to end fertility.
* Known or suspected pregnancy.
* Prior tubal surgery, including sterilization attempt.
* Presence, suspicion, or previous history of gynecologic malignancy.
* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
* Abnormal uterine bleeding requiring evaluation or treatment.

Primary outcomes:
measure: Pregnancy Rate
timeFrame: one (1) year
Secondary outcomes:
measure: Reliance Rate
timeFrame: ninety (90) days post treatment
measure: Long term Pregnancy Rate
timeFrame: Five (5) years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Columbus
country: United States
facility: Midtown OB GYN North
state: Georgia
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Cincinnati
country: United States
facility: Seven Hills Women's Health Centers
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Medical Affairs and Clinical Development
name: Study Sponsor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01785251: Neuromuscular Electrical Stimulation Following Total Hip Arthroplasty
Official title: Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery From Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Total Hip Arthroplasty
Keywords: Neuromuscular electrical stimulation
NMES
Deep vein thrombosis
DVT
total hip arthroplasty
lower limb hemodynamics
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Irish Research Council
name: Mid Western Regional Hospital, Ireland
First posted: 2013-02-07
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients post total hip arthroplasty (THA) remain at high risk of developing Deep Vein Thrombosis (DVT) during the recovery period following surgery despite the availability of effective pharmacological and mechanical prophylactic methods. The use of calf muscle neuromuscular electrical stimulation (NMES) during the hospitalised recovery period on this patient group may be effective at preventing DVT. However, the haemodynamic effectiveness and comfort characteristics of NMES in post-THA patients immediately following surgery have yet to be established.

The main objectives are:

1. To establish if patients in the early post-operative period have tolerance for NMES.
2. To determine if applying NMES to patients immediately post-THA increases venous outflow from the lower limb over resting conditions.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent total hip arthroplasty the previous day

Exclusion Criteria:

* Patients with Diabetes Mellitus
* Patients with Peripheral Vascular Disease
* Patients currently involved in another trial
* Previous diagnosis of DVT

Primary outcomes:
measure: Lower limb haemodynamic performance
timeFrame: 4 hours
Secondary outcomes:
measure: Patient comfort during application of NMES
timeFrame: 4 hours
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: Mid-Western Regional Orthoapedic Hospital Croom
Study officials:
affiliation: National University of Ireland, Galway
name: Gearóid ÓLaighin, BEng, MEng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broderick BJ, Breathnach O, Condon F, Masterson E, Olaighin G. Haemodynamic performance of neuromuscular electrical stimulation (NMES) during recovery from total hip arthroplasty. J Orthop Surg Res. 2013 Mar 5;8:3. doi: 10.1186/1749-799X-8-3.
Clinical trial NCT00581451: Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects
Official title: A 3-Part, Randomized, Multiple-Dose, Sequential Design Study of Bifeprunox in Healthy Subjects in Order to Establish a Titration Regimen With an Improved Tolerability Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Safety and tolerability study in healthy volunteers


Eligibility criteria: Inclusion criteria:

* Healthy male 18-50 years
* Nonlactating female 18-50 years

Primary outcomes:
measure: Tolerability
timeFrame: 28 days
Secondary outcomes:
measure: Safety
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02105051: A Population-based Investigation of Related Factors of Birth Weight in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Risk Factors
Birth Weight
Lead sponsor: Chinese Neonatal Network
Sponsor class: OTHER
First posted: 2014-04-07
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We continuously collected the information of live births in participating hospitals of Chinese neonatal network during the study period

Brief summary: The purpose of this study is to establish Chinese neonatal network to investigate current situation of neonatal birth weight and related factors. We investigated the risk factors such as sex, gestational age, region, nation, altitude, place of residence, maternal occupation, education level of mother, maternal age, maternal pregnancy diseases and multiple births.


Eligibility criteria: Inclusion Criteria:

* live births
* Gestational age between 24 weeks and 43 weeks

Exclusion Criteria:

* Major malformation
* Physical deformity
* Fetal edema
* Body mass diagnosed in prenatal ultrasound
* Acute blood loss during delivery

Primary outcomes:
measure: birth weight
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan University
Study officials:
References:
Clinical trial NCT02860351: The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein.
Official title: The Effect of Head Positioning on the Cross-sectional Area of the Subclavian Vein
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Volunteers
Keywords: subclavian vein
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults ≥ 20 yr

Brief summary: In the present study, the cross-sectional area of subclavian vein, the distances of subclavian vein \~ subclavian artery and subclavian vein \~ pleura are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) in spontaneous breathing adults.


Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Medication affecting vascular elasticity
* History of central venous catheterization or clavicle fracture
* History of lung surgery, operation of chest cage

Primary outcomes:
measure: Cross-sectional area of subclavian vein
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: depth of subclavian vein from skin
timeFrame: through study completion, an average of 1 year
measure: Distance of subclavian vein ~ subclavian artery
timeFrame: through study completion, an average of 1 year
measure: Distance of subclavian vein ~ pleura
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
citation: Kim H, Chang JE, Lee JM, Han SH, Ryu JH, Hwang JY. The Effect of Head Position on the Cross-Sectional Area of the Subclavian Vein. Anesth Analg. 2018 Jun;126(6):1946-1948. doi: 10.1213/ANE.0000000000002446.
Clinical trial NCT02716051: Wholebody MRI In Lung Cancer StagiNg
Official title: Initial Staging of Bronchopulmonary Neoplasia: Whole-body MRI Versus Pet Scanner
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Magnetic Resonnace Imaging (MRI) and Positron Emission Tomography (PET) can be both used in detection of nodes in patients with cell lung cancer (NSCLC).

However, the cardiorespiratory synchronization in the MRI, allowing acquisition of synchronous images with breathing and heart movements should increase the sensitivity of detection of pathologic mediastinal lymph nodes.

Given its high sensitivity, whole-body MRI with diffusion could possibly be at least as informative as PET, while being less expensive, not radiant.

The purpose of this study is to evaluate the performance of whole-body MRI with diffusion with cardiorespiratory synchronization, on the detection of mediastinal nodes (which are known to be less well detected by MRI) compared to PET.


Eligibility criteria: Inclusion Criteria:

* At least 18 years,
* Neoplasia bronchopulmonary (SCLC and NSCLC) newly diagnosed,
* Patient potentially eligible for curative treatment, but no no treatment started,
* Patients for whom a PET scan and MRI are planned

Non Inclusion Criteria:

* claustrophobia,
* Implantable Medical Device
* not compatible pacemaker type or heart valve, metal splinters eye)
* Pregnant or lactating women,

Primary outcomes:
measure: Th consistency of the locations of mediastinal lesions
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU Limoges
Study officials:
References: