louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04409522: Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
Official title: Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
* Oxygen saturation drop below 93%
* Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the patient's previous normal systolic blood pressure
* Fever
* Dry cough
* Positive PCR for COVID-19
* Laboratory indices include CRP and ESR indicating COVID-19

Exclusion Criteria:

* Patient dissatisfaction
* Existence of drug interactions
* Lack of proper conditions for receiving medication

Primary outcomes:
measure: Melatonin
timeFrame: up to 10 days
Secondary outcomes:
measure: Inflammatory cytokines
timeFrame: up to 10 days
measure: C-reactive protein (CRP)
timeFrame: up to 10 days
measure: Cough
timeFrame: up to 10 days
measure: Oxygen saturation of the blood
timeFrame: up to 10 days
measure: ESR
timeFrame: up to 10 days
measure: Radiological Treatment Response
timeFrame: up to 10 days
measure: Inflammatory route
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References:
Clinical trial NCT01303822: Mindfulness-based Stress Reduction in Cancer Treatment
Official title: Mindfulness-based Stress Reduction in Supportive Cancer Treatment: Effects of a Day-care Clinic Group Program on Psychometric Parameters in Cancer Patients (Stressbewältigung Durch Achtsamkeit in Der Supportiven Onkologischen Therapie (SASO): Auswirkung Eines Tagesklinischen Gruppenprogramms Auf Psychometrische Parameter Bei Krebspatienten)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 117
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: Emotional and mental symptoms are common consequences of cancer diagnosis and treatment. Coping with these symptoms seems to be influenced by interpretation of illness, locus of health control and spiritual attitudes in dealing with illness.

Mindfulness-based stress reduction has been shown to reduce physical and mental symptoms in cancer patients.

The aim of this study is to investigate the effect of a mindfulness-based day-care clinic group program on quality of life, anxiety and depression in cancer patients and to evaluate the association with coping styles, spiritual attitudes in dealing with illness, mindfulness and interpretation of illness.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer
* Physical and mental ability to participate in the program

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Health-related quality of life
timeFrame: Week 11
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Week 32
measure: Anxiety and depression
timeFrame: Week 11; week 32
measure: Life satisfaction
timeFrame: Week 11; week 32
measure: Mindfulness
timeFrame: Week 11; week 32
measure: Adaptive coping styles
timeFrame: Week 11; week 32
measure: Spiritual and religious attitudes in dealing with illness
timeFrame: Week 11; week 32
measure: Interpretation of illness
timeFrame: Week 11; week 32
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
state: Northrhine-Westphalia
Study officials:
References:
Clinical trial NCT00912522: Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
Official title: Magnetic Prefrontal Stimulation for Studying the Role of the Cortex in High-level Cognition Processes and Reward System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Volunteers
Keywords: reward
TMS
cognition
Motivation
Perception
Decision making
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2009-06-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators intend to study the role of the cortex in high- level cognition processes and sensory adaptation, by the use of non-invasive Transcranial Magnetic stimulation and various cognitive tests.


Eligibility criteria: Inclusion Criteria:

* healthy men and women, age of 18-60
* answered negatively to questions of TMS safety questionnaire
* signed and declared about their agreement to participate in the study
* hebrew speaker

Exclusion Criteria:

* self history of significant mental disorder
* self history or first-degree relatives history of epilepsy

Primary outcomes:
measure: Changes in scoring of different tests and questionnaires
timeFrame: One year
Secondary outcomes:
measure: Correlation of different tests and questionnaires
timeFrame: One year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah medical org
Study officials:
affiliation: Hadassa Medical Organization
name: Moshe Isserles, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01792622: Patient Reported Outcomes in Pulmonary Arterial Hypertension
Official title: Patient Reported Outcomes in Pulmonary Arterial Hypertension
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pulmonary Arterial Hypertension
Keywords: Instrument Development
Patient Reported Outcomes
Pulmonary Arterial Hypertension.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
name: Mayo Clinic
name: Vanderbilt University
First posted: 2013-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary arterial hypertension

Brief summary: Develop a brief, new, patient reported outcome instrument that is valid for use in clinical practice and clinical trials.

Detailed description: This study will use the Clinical Impact Method to develop a patient reported outcome for use in patients with pulmonary arterial hypertension Clinical personnel at the study sites will approach and discuss possible participation in Phase I and II of the study with subjects from the existing pool of patients currently receiving usual and customary care at the site.

Eligibility criteria: Inclusion Criteria:

* Evidence of a personally signed and dated informed consent
* Subjects aged \>=18 who have documented PAH
* Speak English
* Subjects who provide written informed consent to participate in the study before being screened for the study.

Exclusion Criteria:

* Patients with non-PAH Pulmonary Hypertension
* Physical inability to complete the interview process
* Subjects who are currently enrolled in an experimental drug study

Primary outcomes:
measure: The primary endpoint for the study will be a composite symptom score derived from items in the instrument.
timeFrame: Patients in Phase 1 and 2 shall be engaged in the study for approximately one hour's time; Phase 1 will take 3 to 6 weeks, and Phase 2 will proceed until sufficient sample size is obtained (saturation); we anticipate completion by September 2013.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00790322: Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Oral Mucositis
Keywords: Cancer
Radiation therapy
Radiotherapy
Oral Mucositis
SBG
Lead sponsor: Biotec Pharmacon ASA
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 130
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 and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

Detailed description: The objective of the study is to evaluate the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on oral mucositis compared to placebo in head and neck cancer patients undergoing radiation therapy with or without chemotherapy.

Eligibility criteria: * Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study.
* Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.

Primary outcomes:
measure: Compare the proportion of patients in the two arms who develop severe oral mucositis
timeFrame: During radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif Cédex
country: France
facility: Institute Gustave Roussy
Study officials:
References:
Clinical trial NCT01888822: Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
Official title: Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cholelithiasis
Keywords: Laparoscopic cholecystectomy
Prophylactic antibiotics
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 138
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 trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

Detailed description: All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic cholecystectomy;
* patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.

Exclusion Criteria:

* acute cholecystitis;
* acute cholangitis;
* acute pancreatitis;
* pregnant or lactating women;
* antibiotic allergy;
* antibiotic therapy within 48 hours to 7 days prior to surgery;
* clinically active infection at the moment of surgery;
* evidence of common bile duct stones;
* contraindications for laparoscopic cholecystectomy;
* no other additional procedure;
* indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).
* patients unable to give informed consent.

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days after operation
Secondary outcomes:
measure: Extra-abdominal infections
timeFrame: 30 days
measure: Adverse events.
timeFrame: 30 days
measure: Quality of life
timeFrame: 30 days
Other outcomes:
Locations:
city: Terracina
country: Italy
facility: Sapienza University of Rome- Polo Pontino
state: Latina
Study officials:
affiliation: University of Roma La Sapienza
name: Erasmo Spaziani, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD005265. doi: 10.1002/14651858.CD005265.pub2.
Clinical trial NCT02693522: Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
Official title: Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 52
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 and safety of recombinant human growth hormone on adult growth hormone deficiency


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and up
* Patients with maximum serum growth hormone concentration of less than 5 ng/ml
* Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
* Persons who have agreed in writing to participate in this study

Exclusion Criteria:

* Persons who are currently under treatment after being diagnosed with a malignant tumor
* Hepatosis
* Renal function disorder
* Intra-cranial hypertension
* Proliferative diabetic retinopathy
* Persons who carry acromegaly activity
* Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
* Mental patients and/or drug addicts and alcoholics
* Patients who had participated in the other drug study within the last 30 days prior to participating in this study
* Patients considered unfit for this study by the attending physician

Primary outcomes:
measure: Degree of fat mass (FM) reduction
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Degree of variation in Lean Body Mass
timeFrame: baseline and 24 weeks
measure: Degree of variation in Waist to Hip Ratio
timeFrame: baseline and 24 weeks
measure: Degree of variation in IGF-1
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital
Study officials:
References:
Clinical trial NCT03095222: Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
Official title: Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2017-03-29
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 purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.

Detailed description: This Aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. While the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. Findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.

Eligibility criteria: Inclusion Criteria:

* Acute burn injury comprising 10-30% of total body surface. Burns severity may include second or third degree burns
* Burn injury must have occurred within 72 hours of enrollment and randomization
* Subjects may be opioid-naïve or opioid non-naïve
* Anticipated stay in the burn unit is greater than 4 days, which is typically the minimum length of stay for patients with this level of burn injury

Exclusion Criteria:

* Burn injury older than 72 hours
* Acute burn injury comprising \>30% total body surface
* Patients who are intubated
* Patients who have contraindication to ketamine administration

Primary outcomes:
measure: Change in pain severity
timeFrame: Day 4
Secondary outcomes:
measure: Opioid Analgesic Consumption
timeFrame: Day 4
measure: Side effects / Adverse effects
timeFrame: Days 1-4
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Andrea Nicol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545322: Image Guided Adaptive Radiotherapy in the Head-and-neck Region
Official title: Image Guided Adaptive Radiotherapy Based on Elastic Image Registration for Improved Tumor Coverage and Reduction of Side Effect in Normal Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine.

Detailed description: Aim of this study is the clinical evaluation of an image-guided adaptive radiotherapy (ART) concept. This involves the adaption of the radiotherapy treatment plan according to changes in tissues and variations in patients position and posture during a radiotherapy treatment course, based on repeat CT scans.

It is prospectively investigated, if dosimetric improvements can be achieved using this approach and if the method using the software-package "ReDeform" can be implemented in clinical Routine. For that purpose 2 repeat CT scans are acquired during the radiotherapy course (week 3 and week 5 of radiotherapy). The Initial CT scan is "matched" to the follow-up CT-scan by means of deformable image registration.

Eligibility criteria: Inclusion Criteria:

* Patients with histo-pathologically verified malignancies in the head-and-neck without clinical signs of dissemination, who consented in radiotherapy or radio-chemotherapy.

Exclusion Criteria:

* previous radiation therapy for head-and-neck

Primary outcomes:
measure: Planning Target Volume (PTV) Coverage Parameter D98%
timeFrame: week 5
Secondary outcomes:
measure: Volumetric Changes
timeFrame: week 5
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Graz
name: Karin S Kapp, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05311722: Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.
Official title: Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post-Surgical Complication
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2022-04-05
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 drugs were given to patients
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Detailed description: Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed

Eligibility criteria: Inclusion Criteria:

* Woman of age 18-60
* Pregnant woman in outdoor patient department and emergency

Exclusion Criteria:

* patient. with history of hypersensitivity to opioids,
* ketamine or bupivacaine
* History of cardiovascular disease,
* Hypertension,
* psychosis,
* antepartum hemorrhage,
* cord prolapse,
* fetal distress

Primary outcomes:
measure: Assessment of post spinal shivering by observing grades of shivering
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: