louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05187871: Study for Rapid Diagnosis of Postoperative Abdominal Infection
Official title: Establishment and Research for Rapid Diagnosis of Postoperative Abdominal Infection Based on Metagenomic Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Infection
Abdominal Surgery
Intra-abdominal Infection
Postoperative Fever
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receive abdominal surgery including pancreatic, gastrointestinal, biliary surgery, etc. with routinely placing abdominal drainage in Peking Union Medical College Hospital. They are clinically suspected with postoperative abdominal infection.

Brief summary: This is a prospective and exploratory study, which utilizes non-targeted metagenomic next-generation sequencing (mNGS) detecting drain fluid from patients who are suspected of postoperative abdominal infection. This study aims to explore the clinical value of mNGS in the rapid diagnosis of postoperative abdominal infection, to refine the pathogenic bacteria spectrum, and to establish a novel procedure for postoperative abdominal infection diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Patients who receive abdominal operations with routinely abdominal drainage placement.
2. Abdominal infection is suspected by the clinicians, and one of the following conditions is met:

   1. Temperature ≥38℃;
   2. One of the following laboratory indicators: WBC≥10×10\^9/L, PCT≥0.5ng/ml, hsCRP≥100mg/L.

Exclusion Criteria:

1. Patients who are diagnosed with the abdominal infection before surgery.
2. Evidence of non-abdominal infection is clear and could explain the clinical symptoms.

Primary outcomes:
measure: The pathogenic spectrum of postoperative abdominal infection
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Consistency between mNGS and conventional culture methods
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00363571: The Effect of Glyceryl Trinitate and Diamox on Cerebral Haemodynamics.
Official title: The Effect of Glyceryl Trinitrate (GTN) and Diamox on Cerebral Haemodynamics Judged With the Help of 3-Tesla MRI.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: After infusion / injection of Glyceryl trinitrate and Diamox it is wished to study the effect of drugs on the cerebral haemodynamics such as Cerebral blod flow and cerebral blod volume.

Detailed description: Experimental headache model open a unike opportunity to study the pathophysiological mechanisms behind headache in general and migrane in particular. Previous studies have used various techniques to study the cerebral haemodynamics as a basis for the headache pathophysiology. We wish to use a 3-Tesa MRI so study the cerebral haemodynamics after application of various pharmacological substances.

The most used experimental headache model is the glyceryl trinitrate model (GTN). Where infusion of the NO donor GTN induces headache and changes in the cerebral arteries. On the other hand injection of Diamox (Acetazolamide) apparently causes increase of the cerebral blod flow with out dilation of the arteries. We wish to study the precise effect of GTN and diamox on the cerebral haemodynamics such as Cerebral blod flow (CBF) and Cerebral blod volume (CBV) via a 3-Tesla MRI.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers; men and women age 18-50 years.
* weight 50-100 kg

Exclusion Criteria:

* Tension type headache more then once per month during the last year.
* Other primary headache types.
* Daily use of medication.
* Pregnant or lactating women.
* Headache on the trail day or 24 hours prior to the trial.
* Contraindications to MRI.
* Hypotension og hypertension.
* Other significant medical conditions judged by the doctor in charge.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Neurological Dep. Glostrup hospital
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD,Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00038571: Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Official title: Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, B-Cell
Keywords: Cancer
Relapsed
Refractory
B cell lymphoma
Proteasome Inhibitor
PS-341
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2002-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Detailed description: Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

Eligibility criteria: INCLUSION:

* Relapsed or Refractory B cell lymphoma.
* Zubrod status \</= 3.
* Measurable disease.
* No anti-cancer treatment within past 3 weeks.
* ANC \>= 1500/uL, Plt \>/= 50,000, Bilirubin \<2 mg/dL, SGPT \<2.5xULN, creatinine \<2. Patients with ANC\>/1000, PLT\>/30000 will be eligible if due to massive splenomegaly and/or BM involvement.
* HIV negative.
* No active CNS lymphoma.
* No serious intercurrent illness, active infections or cancer except basal cell carcinoma of the skin or in situ cervical carcinoma.
* Not eligible for treatment of a higher priority. Patients may be entered before BMT.
* No pregnancy \& age bearing females must be practicing adequate contraception.
* Age \> 16.

EXCLUSION:

* Patients with platelets \<30x10(9)/L within 14 days before enrollment.
* Patients with ANC\<1.0 x10(9)/L within 14 days before enrollment.
* Patients with peripheral neuropathy \>/= grade 3 within 14 days before enrollment.

Primary outcomes:
measure: Number of Patients with Response to PS-341
timeFrame: Every two 21-day cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Luis Fayad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
Clinical trial NCT04506671: Percutaneous Cryoablation Versus Partial Nephrectomy for T1b Renal Tumor
Official title: A Prospective, Non-randomized, in Parallel Groups Study Evaluating the Efficacy and Safety of Percutaneous Cryoablation and Partial Nephrectomy in Localized T1b Renal Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Tumor
Keywords: Cryoablation
Renal cancer
Partial nephrectomy
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to assess the long-term oncological and functional outcomes of cryoablation for T1b renal tumors, as well as such important parameters as the patient's quality of life after treatment, and to compare the results with those after partial nephrectomy.


Eligibility criteria: Inclusion Criteria:

•CT-confirmed renal mass \> 4 to 7 cm (T1b)

Exclusion Criteria:

* Multiple renal tumors;
* Recurrence of renal tumor;
* Intolerance to iodine-containing contrast agents;
* Pregnancy;
* Patients with Bosniak 4 cysts
* Presence of other oncological diseases;
* Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system
* Absence of malignant pathology based on prior biopsy.

Primary outcomes:
measure: Local recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Metastatic progression
timeFrame: 5 years
measure: Quality of life assessment: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30)
timeFrame: 5 years
measure: Renal function
timeFrame: 5 years
measure: Rate of adverse events
timeFrame: 3 months
measure: Blood loss
timeFrame: 12 months
measure: Length of hospital stay
timeFrame: 1 month
measure: Pain score
timeFrame: 5 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
References:
Clinical trial NCT05173571: Homecare Integral Support Program for IPF Patients
Official title: Home Comprehensive Therapeutic Support Program in Patients With Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Homecare patient support
Lead sponsor: Institut d'Investigació Biomèdica de Bellvitge
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Minimal intervention study, pre- and post- supportive care effects on quality of life
Primary purpose: SUPPORTIVE_CARE

Brief summary: Homecare patient support program especially designed for covering IPF patient needs, implemented for 12 months, for improving quality of life

Detailed description: The proposed comprehensive IPF home care programme consists of: 1) improving patient's quality of life (autonomy, activity, emotional well-being and symptoms), 2) reducing the number and severity of side effects associated with the anti-fibrotic drug, 3) reducing the number of hospitalisations attributable to the disease, and 4) providing a rapid response to any problem associated with the disease (after diagnosis or progression) that may cause distress or require early action.

Eligibility criteria: Inclusion Criteria:

* IPF patients with FVC \> 50% and DLCO \> 30%, in whom pharmacological treatment with nintedanib was started at least one month before the start of the programme.

Exclusion Criteria:

* Hospitalised patients or those who have been hospitalised in the previous month, due to any kind of respiratory exacerbation or due to any other respiratory cause.
* Patients who are under home care controls (PADES) as this implies an advanced stage of the disease (forced vital capacity \[FVC\] less than 50% and the diffusion capacity of the lungs for carbon monoxide \[DLCO\] less than 30%) or, patients thathave a lack of autonomy due to comorbidities or respiratory failure
* Patients diagnosed in incipient phase who have neither symptoms nor limitation in their usual activities.
* Patients who have suffered any other life-threatening disease in the last 2 years, such as cancer or uncontrolled ischaemic heart disease.
* Inability to understand the information given to the patient, relating to the legal aspects of the informed consent.

Primary outcomes:
measure: Qulity of life
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: IDIBELL. University Hospital of Bellvitge
Study officials:
References:
Clinical trial NCT03709771: Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
Official title: Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Renal Cell Carcinoma
Hypertension
Melanoma
Cancer
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with cancer that will be receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor plus ICI or combination ICI treatment), or not receiving any treatment.

Brief summary: The purpose of this study is to understand the effect of vascular endothelial growth factor tyrosine kinase (VEGF) inhibitor, immune checkpoint-inhibitor (ICI), and combination treatment on blood pressure and blood vessel function.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 40 - 75 years old
* Diagnosis of cancer
* Receiving VEGF inhibitor, ICI, or combination (VEGF inhibitor + ICI or combination ICI) treatment, or not receiving any treatment.
* Normal blood pressure or blood pressure treated to \< 140/90 mm Hg with ≤2 antihypertensive medications

Exclusion Criteria:

* Presence of peripheral artery disease
* History of a heart attack within 1 year
* History of a stroke within 1 year
* Diabetes
* Life expectancy \< 3 months
* Women who are pregnant
* Women who are nursing

Primary outcomes:
measure: Change in Mean Blood Pressure
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Ratio of Post-treatment to Pre-treatment Change in Digital Pulse Amplitude
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Joshua Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760471: Palliative and Oncology Care Intervention: Symptom COACH
Official title: A Collaborative Palliative and Oncology Care Intervention to Improve Symptoms and Coping During Treatment for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Head and Neck
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators propose to conduct the first pilot trial of a collaborative palliative and oncology care intervention for HNC patients receiving CRT to assess the feasibility and acceptability of the intervention. The intervention will incorporate weekly palliative care visits into standard oncology care targeting coping, mood, and symptom management.


Eligibility criteria: Inclusion Criteria:

1. adult patients (≥18 years) with a diagnosis of HNC for which they are undergoing CRT
2. receiving all oncology care at Fox Chase Cancer Center (FCCC)
3. able to speak and read in English or with assistance from an interpreter

Exclusion Criteria:

1. patients with prior history of HNC for which they underwent CRT
2. patients with uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease which the treating clinician believes prohibits informed consent or participation in the study
3. patients enrolled on other supportive care intervention trials

Primary outcomes:
measure: Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04834271: Effects of Blood Flow Restriction Training in Rotator Cuff Related Shoulder Pain
Official title: Effects of Blood Flow Restriction Training on Central Mechanisms of Pain Modulation in Subjects With Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Subacromial Pain Syndrome
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 0
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: TREATMENT

Brief summary: Blood flow restriction training is widespread in sport performance areas, where it has proven to be beneficial in strength and hypertrophy development. However, there are only few studies related to its effects on subjects with pathology, and currently, there is no recent clinical trial evaluating its effects on patients with RCRSP. We are aiming to define the potential benefits, acute and short-term effects of adding blood flow restriction to a low-load exercise training for patients with RCRSP.


Eligibility criteria: Inclusion Criteria:

* Pain around the antero-lateral (deltoid area) region of the proximal shoulder during active movements in abduction and/or external rotation.
* 3/5 positive impingement tests: Neer, Hawkins-Kennedy, empty can, painful arc, and resisted external rotation or abduction.
* Pain at rest less than 3cm in a visual analogue scale (VAS).

Exclusion Criteria:

* Previous shoulder surgery.
* Being treated with physical therapy or pharmacogical therapy for shoulder pain.
* External rotation range of motion less than 45º or 50% compared to the contralateral side.
* Suspected shoulder instability (previous dislocation/subluxation, sulcus sign, anterior drawer test, anterior/posterior aprehension test, relocation test).
* Suspected cervical radiculopathy (distraction, spurling, ULNT1, squeeze test, ipsilateral rotation less than 60º)
* Presence of neck pain.
* Suspected rotator cuff tears (drop arm test, external rotation lag sign, diagnostic imaging).
* Contraindications to blood flow restriction therapy.

Primary outcomes:
measure: Conditioned Pain Modulation (CPM)
timeFrame: Baseline, immediately after the first treatment session, 1 month, and 2 months
Secondary outcomes:
measure: Shoulder pain and disability index (SPADI)
timeFrame: Baseline, 1 month, and 2 months
measure: Pain intensity
timeFrame: Baseline, 1 month, and 2 months
measure: Pain-free isometric strength
timeFrame: Baseline, immediately after the first treatment session, 1 month, and 2 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Ruben Fernandez-Matias
Study officials:
References:
Clinical trial NCT01719471: fMRI of Stress in Smoking Behavior
Official title: fMRI of Stress in Smoking Behavior
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Smoking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 tobacco dependent and 30 matched healthy controls who have never smoked will be recruited for this study

Brief summary: To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions

Detailed description: Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.

Eligibility criteria: Inclusion Criteria:

1. age 18-50 years inclusive;
2. able to read and write English;
3. for women, being in follicular phase of menstrual cycle;

5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.

Exclusion Criteria:

1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview;
2. use of any psychoactive medication within past four weeks;
3. any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
4. IQ\<70 based on past intelligence testing;
5. any metal in body that would pose a risk with MRI; and
6. claustrophobia that would interfere with MRI;
7. alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
8. pregnancy for women.

Primary outcomes:
measure: No outcome measures for this study, this is an imaging study only
timeFrame: Upon study completion
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Marc Potenza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: