louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04815629: Outcome of Radiation Therapy in Urinary Bladder Squampus Cell Carcinoma
Official title: Outcome of Radical Radiation Therapy in Squampus Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder Squamous Cell Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with urinary bladder squamous cell carcinoma recieved radiotherapy .

Brief summary: Detection of distribution of clinico-pathological features of squamous cell carcinoma of urinary bladder and their relation to treatment outcome.


Eligibility criteria: Inclusion Criteria:

1. age 18-70 .
2. histologically proved urinary bladder squamous cell carcinoma.
3. non-metastatic disease.
4. all patients who underwent radical treatment or bladder preserving approach.
5. patient with isolated urinary bladder carcinoma (no other or previous primary).

Exclusion Criteria:

1. age \< 18 , \> 70.
2. patient not documented having bladder squamous cell carcinoma by biopsy (cystoscopic or operative).
3. metastatic disease.
4. patient with synchronous or metachronous double primary

Primary outcomes:
measure: Disease free survival
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 1. Messing EM. Urothelial tumours of the bladder. In: Wein AJ, Kavoussi LR, Novick AC, Partn AW, Peters CA (editors). Campbell-Walsh Urology. 9th(3). Philadelphia: Saunders Elsevier 2007: pp.2407-2446. 2. Christopher Ho Chee Kong, Praveen Singam, Goh Eng Hong, Lee Boon Cheok, Muhammad Azrif, Azmi Mohd Tamil et.al (2010). Clinicopathological features of bladder tumours in a single insttuton in Malaysia. Asian Pasifc J cancer Prev. 2010; 11: 149-152. 3. Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ (2009). Cancer statstcs. CA Cancer J Clin. 2009 ; 59: 529-533. 4.Zarzour AH , Selim M, Abd -Elsayed A et al., muscle invasive bladder cancer in uppr Egypt : the shift in risk factors and tumor characteristics, license Bio Med central BMC Cancer doi.:10.1186 / 1471-2407-8-250-,2008. 5.Amal S. Ibrahim, Nabiel N Mikhail et al . Egypt National Cancer Registry Damietta profile - 2009: publication number RR2 July, 2011. 6.M.Nabil El- Bolkiny , M.Akram Nouh , Tarek N.El-Bolkiny et al.topographic pathology of cancer , the national cancer institute, Cairo University , 2008. 7.Jason A.Efstathiou, Anthony L.Zietman, Jhon J. Coen, clinical Radiation Oncology , bladder cancer ;3rd edition : p1216-1241, 2012.
Clinical trial NCT00004329: Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipodystrophy
Keywords: endocrine disorders
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic receptor in 6 patients with regional lipoatrophy and in 6 controls.

II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic DNA from peripheral blood leukocytes.

Detailed description: PROTOCOL OUTLINE: Antihypertensives are held, beginning 3 days before the first study day.

An oral challenge is administered as follows: clonidine on day 1, yohimbine on day 2. The order of administration is reversed in alternate subjects.

Timed measurements of norepinephrine, glycerol, and free fatty acids follow each challenge. Structural gene sequencing is evaluated for each participant.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinical diagnosis of regional lipoatrophy Control subjects: Women aged 18 to 65 Weight 90% to 150% of ideal No significant acute or chronic illness --Patient Characteristics-- Negative pregnancy test required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Fannie Smith
role: STUDY_CHAIR
References:
Clinical trial NCT05847829: Phase Locked TRanscranial Electrical EXcitation
Official title: T-REEX: Phase Locked TRanscranial Electrical EXcitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Novel Method for Transcranial Brain Stimulation
Keywords: Brain stimulation
Closed-loop
Brain activity
Lead sponsor: Stichting IMEC-NL
Sponsor class: OTHER
Collaborators: name: Stichting Kempenhaeghe
First posted: 2023-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Transcranial current stimulation (tCS) has been extensively studied due to its potential of selectively stimulate brain regions in a non-invasive way. However, classic stimulation paradigms are often applied in an open loop configuration, without considering the effects on the underlying brain activity.

Recent studies suggest that when alternating current are used, it would be beneficial to phase lock the stimulation to the target brain wave of interest to achieve selective temporal stimulation, allowing for better control over the stimulation effects.

This study aims at demonstrating a novel setup that allows for precise stimulation targeted in space and time. To achieve that, a combination of tCS and (EEG phased locked) closed-loop modality are used to obtain the required selectivity.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age between 18 and 64

Exclusion Criteria:

* Wounded or particular sensitive skin at areas of investigation. For example, skinrash, discoloration, scars, or open wounds
* Allergies to adhesive or dry electrodes or silver chloride
* Pregnant or lactating
* Any of the following symptoms (fever, tiredness, dry cough, aches and pains, nasal congestion, runny nose, sore throat, diarrhoea)
* Known neurological disorders
* Previous epileptic episodes
* Active implants such as pacemakers or brain stimulators
* Intracranial metal implants

Primary outcomes:
measure: The phase difference (error) between the estimated phase of EEG activity and the phase of the delivered stimulation at the target locationor EEG readout and tCS stimulation
timeFrame: 2 hours
Secondary outcomes:
measure: the amount of phase and/or amplitude change in the brain wave of interest (e.g., 10 Hz alpha activity) resulting from different tCS modalities and stimulation parameters used
timeFrame: 2 hours
Other outcomes:
Locations:
city: Heeze
country: Netherlands
facility: Stichting Kempenhaeghe
state: Noord Brabant
Study officials:
affiliation: Stichting Kempenhaeghe
name: Raf van Hoof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06545929: Study of Sunobinop on Craving in Alcohol Use Disorder
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Alcohol craving
Moderate to severe alcohol use disorder
Lead sponsor: Imbrium Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Purdue Pharma LP
First posted: 2024-08-09
Enrollment: 40
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 purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.


Eligibility criteria: Key Inclusion Criteria include:

* Male and female age ≥18 years.
* Diagnosis of moderate or severe alcohol use disorder.
* Currently seeking treatment for alcohol use disorder.
* Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.

Key Exclusion Criteria include:

* Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.

Other protocol-specific inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Alcohol Urge Questionnaire (AUQ)
timeFrame: Day 14
Secondary outcomes:
measure: Desire for Alcohol Visual Analog Scale (DFA-VAS)
timeFrame: Day 14
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio Clinical Trials
state: Ohio
Study officials:
References:
Clinical trial NCT05174429: The Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Official title: Risk-Targeted Behavioral Activation for the Management of Work-Disability Associated With Co-Morbid Pain and Depression: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: l'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
First posted: 2021-12-30
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm.
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to conduct a preliminary evaluation the feasibility and impact of a risk-targeted behavioral activation intervention for work-disabled individuals with co-morbid pain and depression.

Detailed description: The design of the study was a single arm non-randomized trial. The sample consisted of 66 work-disabled individuals with co-morbid pain and depression. The treatment program consisted of a 10-week standardized behavioral activation intervention supplemented by techniques to target two psychosocial risk-factors for delayed recovery, namely, catastrophic thinking and perceptions of injustice.

Eligibility criteria: Inclusion Criteria:

* 1) work-disability greater than 4 weeks associated with a musculoskeletal injury to the back or neck, 2) a score above clinical threshold on a self-report measure of depression, and 3) between 25 and 55 years of age.

Exclusion Criteria:

* 1) Clinical evidence of vertebral fracture, disk herniation, infectious disease, or rheumatoid arthritis: 2) Evidence of chronic pain pre-dating the current injury: 3) Evidence of loss of consciousness at the time of injury: 4) Previous musculoskeletal injury sustained within the past 12 months: 5) Evidence of any medical condition that might contraindicate participation in physical activity: 6) Illiteracy or severe cognitive impairment.

Primary outcomes:
measure: Return to work
timeFrame: Assessed 6 months following termination of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: McGill University
name: Michael Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560429: Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain
Official title: Efficacy of Patient Controlled Epidural Anesthesia (PCEA) Versus Continuous Epidural Analgesia (CEA) for Post-thoracotomy Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Post-thoracotomy Pain
Keywords: anesthesia and analgesia
Epidural Anesthesia
administration schedules, drug
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 52
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: Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural anesthesia (PCEA) is more effective but little research has compared the two methods following thoracotomy. The current randomized, prospective clinical investigation did just this. Following institutional ethics approval 52 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively all patients were titrated on continuous epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined randomization (either remained on continuous epidural infusion or they were switched to receive 2/3 of the stabilized background dose via continuous epidural infusion with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).


Eligibility criteria: Inclusion Criteria:

* 18-75 years of age
* American Society of Anesthesiologist's (ASA) Physical Status I-III
* Body Mass Index (BMI) \< 40
* Able to use a PCEA device

Exclusion Criteria:

* Intolerance/hypersensitivity to agents used in the study
* Contraindication to epidural placement
* Current alcohol/substance abuse
* Chronic pain condition requiring chronic analgesic
* BMI ≥ 40 or body weight less than 50kg.

Primary outcomes:
measure: Local Anesthetic Consumption
timeFrame: 48 hours postoperatively
measure: Anesthetic Consumption (mg)
timeFrame: 4,8,12, 24 and 48 hours postoperatively
Secondary outcomes:
measure: Worst Pain Scores
timeFrame: 48 hours postoperatively
measure: Worst Pain While Coughing
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University & Kingston General Hospital
name: Vidur Shyam, MBBS, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04881929: Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Official title: Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in Patients With Early-stage or Locally Advanced HER2-positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 30
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: This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.

Detailed description: KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.

Eligibility criteria: Inclusion Criteria:

* Male or female subject \>= 18 years;
* Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
* Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
* Adequate organ function assessed within 7 days prior to first trial treatment;
* ECOG score 0 or 1;
* Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;

Exclusion Criteria:

* Stage IV (metastatic) breast cancer;
* Inflammatory breast cancer;
* Previous anti-cancer therapy or radiotherapy for any malignancy;
* Major surgery for any reason within 28 days;
* History of uncontrolled intercurrent illness;
* Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;

Primary outcomes:
measure: tp CR as assessed by local pathologist
timeFrame: up to 12 weeks
Secondary outcomes:
measure: bp CR as assessed by local pathologist
timeFrame: up to 12 weeks
measure: ORR as assessed by the investigator according to RECIST 1.1
timeFrame: up to 12 weeks
measure: safety as assessed by the investigator according to RECIST 1.1
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jiong Wu, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00123929: Genetic Expression and Prediction of Response to Neoadjuvant Docetaxel or Doxorubicin in Locally Advanced Breast Cancer
Official title: Patterns of Genetic Expression Associated to Sensibility to Doxorubicin Versus Docetaxel as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant chemotherapy
genetic signature
doxorubicin
docetaxel
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
Collaborators: name: UNC Lineberger Comprehensive Cancer Center
First posted: 2005-07-26
Enrollment: 250
Sex: FEMALE
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: After a core biopsy of the tumor is obtained, patients with locally advanced breast cancer are randomized to receive 4 cycles of full dose doxorubicin (75 mg/m2 e3w) or docetaxel (100 mg/m2 e3w). After the fourth cycle, patients are submitted to surgery to ascertain pathological response. They then receive the opposite drug, hormones, Herceptin, and radiation as indicated.

Detailed description: The aim of the study is to define the genetic signature which predicts the response to single drug doxorubicin versus docetaxel. 250 patients will be included. cDNA microarrays will be produced and the genetic pattern will be correlated with the response to doxorubicin and docetaxel. Secondary aim is the prediction of response by means of IHC determinations (her2, ER, PgR, Ki67, protein TAU), FISH (topoisomerase II alpha, her2) and PCR (topoisomerase II alpha).

Eligibility criteria: Inclusion Criteria:

* Locally advanced, inoperable breast carcinoma or stage II not amenable to breast preserving surgery (amendment introduced on november 2006)
* Signed informed consent

Exclusion Criteria:

* Age \>75
* Cardiac disease; LEFT \<50%
* Hyperbilirubinemia

Primary outcomes:
measure: correlation of genetic tumoral pattern with response to docetaxel versus doxorubicin
timeFrame: 2005-2009
Secondary outcomes:
measure: response rate to doxorubicin versus docetaxel
timeFrame: 2005-2013
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Oncologia Medica, Hospital Clinico San Carlos
Study officials:
affiliation: Servicio de Oncologia Medica, Hospital Universitario San Carlos, Madrid, Spain
name: Eduardo Diaz-Rubio, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital San Carlos, Madrid, Spain
name: Martin Miguel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Pinto S, Martin M, Pita G, Caronia D, de la Torre-Montero JC, Moreno LT, Moreno F, Garcia-Saenz JA, Benitez J, Gonzalez-Neira A. Pharmacogenetic variants and response to neoadjuvant single-agent doxorubicin or docetaxel: a study in locally advanced breast cancer patients participating in the NCT00123929 phase 2 randomized trial. Pharmacogenet Genomics. 2018 Nov;28(11):245-250. doi: 10.1097/FPC.0000000000000354.
Clinical trial NCT00320229: Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Disease
Myocardial Infarction
Keywords: angioplasty
stent
abciximab
Platelet Glycoprotein GPIIb-IIIa Complex
myocardial infarction
Lead sponsor: Azienda Sanitaria Ospedaliera
Sponsor class: OTHER
Collaborators: name: Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy
First posted: 2006-05-03
Enrollment: 84
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Detailed description: Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).

Eligibility criteria: Inclusion Criteria:

* presenting with unstable angina
* presenting with acute myocardial infarction
* eligibility for percutaneous coronary intervention

Exclusion Criteria:

* presenting with cardiogenic shock

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Novara
country: Italy
facility: Cardiologia 2 - Emodinamica - Ospedale Maggiore
Study officials:
affiliation: Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy
name: Mara Sansa
role: PRINCIPAL_INVESTIGATOR
References: