louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04480645: CivaDerm(TM) Surface Therapy Pilot Study
Official title: CivaDerm(TM) Surface Therapy Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma of the Skin
Keywords: radiation
brachytherapy
skin cancer
Lead sponsor: CivaTech Oncology
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study
Primary purpose: TREATMENT

Brief summary: This is a pilot study to determine the usefulness of new brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit basal cell and squamous cell carcinoma patients by providing conformal radiation therapy to the surface of the skin.


Eligibility criteria: Inclusion Criteria:

* subject signed informed consent
* Confirmed superficial or nodular basal cell or squamous cell carcinoma
* Biopsy proven on chest, stomach, back, arms, legs, feet (trunk and extremities)
* \>5 mm of residual tumor
* tumors \< 3 cm
* Capable of complying with Patient Release Instructions

Exclusion Criteria:

* Is unable or unwilling to comply with the protocol requirements
* Pregnant or breast feeding
* Metastases

Primary outcomes:
measure: skin toxicity events
timeFrame: within 2 months of treatment
Secondary outcomes:
measure: dose delivered to target
timeFrame: 1 week
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: CivaDerm Oncology PLLC
state: North Carolina
Study officials:
References:
Clinical trial NCT05156645: A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19
Official title: An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 0
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 comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC).


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
* Participants should have at least one of COVID-19 risk factor;
* Participants should have at least 2 COVID-19 related symptoms;
* Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤10 days before randomization;
* First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;

Exclusion Criteria:

* Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
* Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
* Require mechanical ventilation or anticipated impending need for mechanical ventilation;
* Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
* Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;

Primary outcomes:
measure: Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
timeFrame: Day 29
measure: Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
timeFrame: Day 8
Secondary outcomes:
measure: Time to sustained resolution of all COVID-19-related symptoms
timeFrame: Day 29
measure: Change in symptom score (total of ratings)
timeFrame: Day 3, 5, 7, 11, 15, 22, and 29
measure: Time to symptom improvement
timeFrame: Day 29
measure: Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
timeFrame: Day 29
measure: Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
timeFrame: Day 120
measure: Mean concentration-time profiles of SCTA01 and SCTA01C
timeFrame: Day 120
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01008345: Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol
Official title: Effect of Ezetimibe on Oxidized LDL Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes
Lead sponsor: Hotel Dieu de France Hospital
Sponsor class: OTHER
Collaborators: name: Pharmaline, Lebanon
First posted: 2009-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL


Eligibility criteria: Inclusion Criteria:

* CAD or CAD equivalent

Exclusion Criteria:

* Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage \>2 Creatinin clearance \< 30 ml/min

Primary outcomes:
measure: level of oxidized LDL cholesterol at end of study
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: small dense LDL level
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Achrafieh
country: Lebanon
facility: Hotel Dieu de France Hospital
state: Beirut
Study officials:
affiliation: Hotel Dieu
name: rabih azar, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767845: Symptom Management in African-American Men With Localized Prostate Cancer
Official title: PROSTATE CANCER SYMPTOM MANAGEMENT FOR LOW LITERACY MEN
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: psychosocial effects of cancer and its treatment
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Gathering information about symptom management from patients with localized prostate cancer may help doctors improve patients' quality of life.

PURPOSE: This clinical trial is studying symptom management in African-American men with localized prostate cancer.

Detailed description: OBJECTIVES:

* Develop a symptom management intervention for African-American men treated for localized prostate cancer, with a particular emphasis on low health literacy men.

OUTLINE: Participants are interviewed by the principal investigator over the phone or meet the principal investigator at the Veterans Administration prostate cancer clinic. If the interview is conducted in the clinic, it is held in a private room in the clinic.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Biopsy-proven localized prostate cancer

  * Has received treatment for prostate cancer
* Patient self-identifies as being of African-American descent

PATIENT CHARACTERISTICS:

* Able to speak and read in English
* Has an address in order to receive study materials by mail (a street address or post office box)
* Has either a telephone in order to be interviewed OR is able to meet the principal investigator at the Veterans Administration prostate clinic and be interviewed there

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Symptom management taxonomy
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M. Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05774145: Dexmeditomedine Versus No Sedation in Management of Agitation in COPD Patients Receiving Noninvasive Ventilation
Official title: Dexmeditomedine Versus No Sedation in Management of Agitation in COPD Patients Receiving Noninvasive Ventilation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: COPD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: observational study

Brief summary: The aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated COPD patients receiving NIV

Detailed description: The aim is to compare sedation using dexmedetomidine to sedation -free approach in management of agitated COPD patients receiving NIV

Eligibility criteria: Inclusion critera

* age\>18
* Agitation
* NIV intolerance Exclusion criteria
* cardiac dysfunction
* Hepatic dysfunction
* Haemodynamic instability

Primary outcomes:
measure: precedex on COPD irritable on non invasive machine
timeFrame: 3/2023_3/2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01676545: Genetics of Periodontal Diseases in Chinese
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Lead sponsor: Shanghai Stomatological Disease Center
Sponsor class: OTHER
Collaborators: name: Interleukin Genetics, Inc.
First posted: 2012-08-31
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study subjects will be selected from a pre-existing patient database in Shanghai. All chronic periodontitis cases and controls will be subjects who were at least 35 years old at time of enrollment.

Classification of chronic periodontitis will be based on the extent of periodontal tissue destruction with consideration of tooth loss.

Brief summary: (A retrospective case control study to validate the association between Interleukin-1 gene variations and adult chronic periodontal disease in Chinese (Shanghai))


Eligibility criteria: Inclusion Criteria:

- To be included in this study, an individual needs to be Han Chinese of 35 years of age or older at time of enrollment.

Exclusion Criteria:

- 1) Age younger than 35 years old. 2) Patients with diagnosis of rheumatoid arthritis, psoriasis, inflammatory bowel disease, glomerulonephritis/kidney disease, cancer, or Sjogren's syndrome.

3) Organ transplant recipients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00389545: Intracoronary Stem Cells in Large Myocardial Infarction
Official title: Intracoronary Stem Cells in Large Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myocardial Infarction
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2006-10-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the widespread use of effective reperfusion therapies, the patients presenting late with large myocardial infarction have poor outcomes. The aim of the study was to investigate the safety and efficacy of intracoronary injection of autologous bone marrow-derived mononuclear cells (BMNCs) in patients with large myocardial infarction

Detailed description: In the current era, up to 30% of patients with ST-segment elevation myocardial infarction, usually those presenting late, show ongoing left ventricular (LV) remodeling and poor clinical outcome despite primary percutaneous coronary intervention (PCI). Cardiac transfer of bone marrow-derived stem and progenitor cells has been investigated as an adjunctive therapy to promote regeneration of infarcted myocardium. Therefore, we designed a multicenter, randomized study to test the safety and efficacy of intracoronary injection of autologous BMNCs in patients with large acute anterior myocardial infarction and late presentation, who were treated with successful primary PCI.

Eligibility criteria: Inclusion Criteria:

* Patients with the first ST-segment elevation acute anterior myocardial infarction due to occlusion of the proximal left anterior ascending coronary artery (LAD), who will underwent successful primary stented PCI. Patients are eligible if they have primary PCI from 4 to 12 hours after symptoms onset and show reduced LV ejection fraction ≤ 45% with at least 3 akinetic segments in the LAD perfusion territory at echocardiogram performed 24 hours after PCI.

Exclusion Criteria:

* Exclusion criteria are age ≥ 80 years, cardiogenic shock (Killip IV), multivessel coronary artery disease, serious renal or hepatic disease, blood cells disorders, documented cancer or terminal illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Charles University, Prague, Czech Republic
name: Martin Penicka
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329845: Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries
Official title: Myth and Facts About the Evolving Role of Laparoscopic Splenectomy in Isolated High Grades Splenic Injuries in Hemodynamically Stable Patients With Blunt Abdominal Trauma .Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: laparoscopy
laparotomy
non-penetrating
splenectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-04-01
Enrollment: 2
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Trauma laparoscopic splenectomy has no defined reasons. Compared trauma patient characteristics and results with laparoscopic and open splenectomies.

Methods: Patients aged 15 or older with blunt splenic injuries from January 2012 to July 2017 needed splenectomy. Demographics, splenic damage grade, approach (open or laparoscopic), surgery duration, intra-operative blood loss, transfusions, hospital stay, complications, and death were variables.

Detailed description: The spleen might be injured in left lower chest or upper abdomen trauma. Rib cage, diaphragm, pancreas, and bowel injuries may occur with splenic injuries. Hemodynamic instability, a rising heart rate, and low blood pressure are symptoms of damage, however the mechanism of injury requires a high index of suspicion.

Eligibility criteria: Inclusion Criteria:

* • At least 15 years old.

  * Male and female (not pregnant) patients; • Sonar and CT scans before surgery showed single splenic damage;

Exclusion Criteria:

* • Other damage to the abdomen, thorax, or nerves were found before surgery.

  * good use of non-surgical treatment or embolization
  * Woman who is pregnant.
  * Splenic cuts that go deep.
  * Previous surgery in the upper abdomen using a laparoscopic method. • Other injuries to the abdomen found during surgery, such as liver, intestine, or bladder injuries.

Primary outcomes:
measure: mortality
timeFrame: 1.5 years
Secondary outcomes:
measure: intraoperative complications
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Zagazig University
name: tamer A. alnaimy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03460145: Lavender Oil on Preoperative Anxiety and Sedation Requirement in General Anaesthesia
Official title: Lavender Aromatherapy; Its Effect on Preoperative Anxiety and Propofol Requirement for Anaesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preoperative Anxiety
Keywords: Lavender Oil,
Propofol
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assessment of how Lavender oil reduces preoperative anxiety and subsequently influences requirement of induction agents for general anesthesia.

Detailed description: This study aims to use aromatherapy (Lavender oil) to reduce Preoperative Anxiety among Female patients coming for elective surgeries under General Anesthesia.

As a consequence of that, the effect is also evaluated on how that influences the amount of intravenous sedation is required during induction for General Anesthesia.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Female

Exclusion Criteria:

* Patients on B-blockers and or antidepressants.
* BMI \> 35kg/m2
* History of atopy
* History of alcoholism, substance abuse, smoking
* Patients with cancer

Primary outcomes:
measure: 1. Visual Analog Scoring for Anxiety
timeFrame: 1 day
Secondary outcomes:
measure: 1. Amount of sedation used to achieve Loss of Consciousness
timeFrame: Less than 30minutes
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Kebangsaan Malaysia
state: Cheras
Study officials:
affiliation: Consultant Anesthesiologist
name: Raha Abdul Rahman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810745: What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
Official title: What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rectal Prolapse
Keywords: ODS
stapled transanal rectal resection
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.

Detailed description: From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.

Eligibility criteria: Inclusion Criteria:

* Rectal prolapse
* Rectocele
* ODS score \> 15
* Continence score \< 3
* Resting pressure \> 40 mm/Hg

Exclusion Criteria:

* Previous anorectal surgery
* Ods score \< 15
* Continence score \> 3
* Resting pressure \< 40
* Concomitant pelvic floor diseases
* Psychiatric diseases
* Absolute contraindications to surgery

Primary outcomes:
measure: incidence of recurrences
timeFrame: 2 years
Secondary outcomes:
measure: outcomes on symptoms and defecography
timeFrame: 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: First department of general surgery university of milan
city: Milan
country: Italy
facility: First Department of General Surgery
Study officials:
affiliation: 1 department of general surgery
name: paolo boccasanta, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01169545: Cancer, Vulnerability, and Financial Quality of Life: A Mixed Methods Study
Official title: Cancer, Vulnerability, and Financial Quality of Life: A Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: any type of cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent

Brief summary: The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life.

Detailed description: The primary purpose of this study is to examine how vulnerabilities in psychological and social situations affect financial quality of life. For people who are experiencing financial hardship, a cancer diagnosis can be devastating. For others, cancer may cause or even worsen financial stress, for example, with their work, their ability to maintain benefits such as health insurance, their ability to pay bills, and their ability to get the cancer treatment they need. The impact of cancer on financial quality of life is an important area of study within cancer care. Considering the financial burden of cancer also lends greater appreciation for the problems that people face if they cannot handle cancer's costs, or if needed resources are either not present or are too stretched to help with the care they need. For this study, up to 180 cancer patients will be interviewed with a written questionnaire. Of this group, 15 people will also be asked if they would like to participate in a follow-up personal interview with the researcher. The major hypothesis of this study is: The greater the vulnerabilities in predisposing factors and enabling factors, the greater the need factors with respect to cancer diagnosis and treatment, and the lower the perceived ability to adhere to treatment, the poorer will be the financial quality of life.

Eligibility criteria: Inclusion Criteria:

* Any cancer patient over the age of 18 who can speak and understand English and can provide informed consent

Exclusion Criteria:

* Pediatric patients; non-English-speaking patients

Primary outcomes:
measure: Identification of Potential Vulnerabilities
timeFrame: May 2010 to October 2012
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of America
name: Christine C. Callahan, MSW
role: PRINCIPAL_INVESTIGATOR
References: