louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03555760: Patients' Readings of Pre-operative Informed Consent Forms
Official title: Observational Investigation of Patients' Readings of Pre-operative Informed Consent Forms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Awareness
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for surgery and legal guardian of patients under the age of 18.

Brief summary: Patient informed consent is a form which contains the patient's probable outcome of the procedure to be performed, and the probable risk and benefit of the patient's knowledge of the illness. On the form, completely honest and detailed information based on the facts are shared with the patient. It will be beneficial to both the physician and the patient to make a correct and complete consent procedure. The view, feelings and thoughts including the continuous and mutual understanding effort between the patient individual and the follow-up health team (physician, nurse, etc.) are essential in this sense.

The information that must be provided covers all of the following:

* The health status of the patient and the diagnosis,
* The type of treatment proposed,
* The chances of success and duration,
* The risk that the treatment modality carries for the patient's health,
* The use of medicines and possible side effects,
* The consequences of the illness if the hospital does not accept the recommended treatment,
* Alternative treatment options and risks. The informed consent is different from the signing of the patient indicating that he approves the procedure to be performed. The main purpose is to provide information to the patient and to understand this knowledge. For this reason, before the signing of the proclamation, it is necessary to ensure that the patient is informed in accordance with his or her own cultural and educational level. In addition, the patient must be audited that he/she understands the given information.

The purpose of this study is to investigate whether the informed consent forms given to the patient after informing by the physician were read as the first reflex before signing.


Eligibility criteria: Inclusion Criteria:

* Being scheduled for surgery.
* Accept being part of the study and share information such as inform consent form readings and demographics.

Exclusion Criteria:

* Not to accept being part of the study and share information such as inform consent form readings and demographics.

Primary outcomes:
measure: Observations of patient readings of informed consent forms
timeFrame: 15 minutes
measure: Patient demographics
timeFrame: Will be noted after outcome 1- 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Dentistry
state: Yenimahalle
Study officials:
References:
Clinical trial NCT02662660: Analgesia iv vs Epidural Analgesia vs Port-sites Infiltration After Laparoscopic Sleeve Gastrectomy
Official title: Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 147
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be divided into 3 groups: Analgesia iv exclusively (Group 1), epidural analgesia+analgesia iv (Group 2) and port-sites infiltration+analgesia iv (Group 3). Pain will be quantified by means of a Visual Analogic Scale and morphine rescue needs were determined 24 hours after surgery.

Detailed description: A prospective randomized study of patients undergoing laparoscopic sleeve gastrectomy between 2012 and 2015 will be performed. Patients will be randomized using a computerized simple randomization scheme in a 1:1:1 ratio into 3 groups: those patients receiving only intravenous analgesia (Group 1), those ones receiving intravenous analgesia associated to epidural analgesia (Group 2) and those patients receiving intravenous analgesia associated with port-sites infiltration with bupivacaine. Pain quantification as measured by Visual Analogic Scale (VAS), ranging from 0 (absence of pain) to 10 (unbearable pain) will be evaluated 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion Criteria:

* patients undergoing other bariatric techniques
* severe underlying cardiovascular diseases
* chronic renal failure
* hepatic dysfunction
* previous foregut surgery
* patients with any contraindication for bariatric surgery

Primary outcomes:
measure: Postoperative pain measured by Visual Analogic Scale
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Elche
name: Manuel Duran, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.
Clinical trial NCT05328960: The Pandemic's Effect on Diagnosis and Treatment of Rectal Cancer
Official title: An Analysis of Covid-19 Effect on Patients With Colorectal Cancer - Follow-up Regarding Tumour Stage, Neoadjuvant Treatment, Delay and Long-term Survival
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are diagnosed with rectal cancer and identified in the Swedish ColoRectal Cancer Registry will be included. They will be contacted by phone and mail regarding a questionnaire.

Brief summary: Colorectal cancer is common with an annual prevalence of 6000. The majority can be cured and the five year survival rate is over 60%. In december 2019 reports came in about SARS-Cov-2, which later was named Covid-19. The World Health Organization classified it as a pandemic in March 2020. In Sweden the number of patients with Covid-19 increased mainly in the urban areas in March 2020. Care for patients with other diseases were affected and local changes from guidelines were adopted. In some regions and countries the indications for adjuvant and neoadjuvant treatment for colorectal cancer were somewhat changed. The number of patients diagnosed with colorectal cancer also decreased, as well as other types of cancer. The true effect on outcome with a delayed diagnosis remains unknown.

The aim of this study is to evaluate the effects of the Covid-19 pandemic on the diagnosis, treatment and survival of patients with colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Rectal cancer diagnosis 2019-2022

Exclusion Criteria:

* No rectal cancer diagnosis 2019-2022

Primary outcomes:
measure: Yearly incidence of rectal cancer
timeFrame: 2019-2022
Secondary outcomes:
measure: Symptoms at diagnosis
timeFrame: 6 months prior diagnosis
measure: Patient's delay
timeFrame: 12 months prior diagnosis
measure: Doctor's delay
timeFrame: 12 months prior diagnosis
measure: Treatment changes
timeFrame: Diagnosis and 12 months following
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT06383260: Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study
Official title: Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Finding the Prevalence of ADHD in Undiagnosed Young Adults
Lead sponsor: Jinnah Sindh Medical University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Young adults between age group of 18-24

Brief summary: To asses the prevalence of Attention deficit hyperactivity disrorder in undiagnosed young adults.

Detailed description: Finding the prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in undiagnosed young adults using the questionnaire provided by WHO ,

Eligibility criteria: Inclusion Criteria:

* undiagnosed

Exclusion Criteria:

* diagnosed with any mental disability

Primary outcomes:
measure: Assess the prevalence of undiagnosed ADHD in Young adults
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: JSMU
state: Sindh
Study officials:
affiliation: Jinnah Sindh Medical University
name: Aina M Syed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01681160: Study of Maggot Therapy in Diabetic Foot Ulcers
Official title: Maggot Therapy in Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DIABETIC FOOT ULCERS
Keywords: MAGGOT THERAPY
DIABETIC FOOT
NURSING CARE
DRESSING
Lead sponsor: Kerman Medical University
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.


Eligibility criteria: Inclusion Criteria:

* Have a chronic illness more than 7 weeks.
* The age of the patients between 40- 90 years old.
* Not having capillary disease (Blockage of artery, Rinold).
* Not user of anticoagulants and corticosteroids drugs.
* Patients without history of allergy to drugs and foods.
* Having diabetic type 2

Exclusion Criteria:

* patients who refer to critical clinical care unit
* patients who have amputation

Primary outcomes:
measure: change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 3days and change from baseline in BATES-JENSEN WOUND ASSESSMENT score at 6 days
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06212960: Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines
Official title: Double-blind, Randomized, Parallel Design, Active-controlled Phase 1 Clinical Trial to Evaluate the Efficacy and Safety of DWP712 and Botox® in Adult Patients in Need of Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glabellar Lines
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.


Eligibility criteria: Inclusion Criteria:

* Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening

Exclusion Criteria:

-

Primary outcomes:
measure: Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0
timeFrame: At 4, 8, 12 week after the injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beom Joon Kim, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284660: Docosahexaenoic Acid (DHA) Effects on Cognitive Function, Craving and Psychosocial Factors in Heavy Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HEAVY TOBACCO SMOKERS
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on novel supplement on quality of life, cognitive function, craving and psychosocial factors in heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers treated with DHA supplement


Eligibility criteria: Inclusion Criteria:

* Nicotine dependence
* Smoked at least 10 cigarettes per day for the past 12 months and not interested in quitting

Exclusion Criteria:

* Serious kidney, lun, neurological and cardiovascular diseases
* Suicide risk, acute psychosis, severe depression, organic brain syndromes
* Dependence on psychoactive substances other than nicotine

Primary outcomes:
measure: Reduction in smoking urges and craving
timeFrame: One and a half years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar Ilan University
Study officials:
References:
Clinical trial NCT06166160: Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Primary Molars
Official title: Clinical Performance of a Flowable Bulk Fill Composite Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Management of Dental Caries of Primary Molars
Keywords: bulk-fill flowable composite , high viscous GIC ,
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study was conducted to compare and evaluate the clinical performance of EQUIA Forte and SDR® flow+ in class II cavities in primary molar

Detailed description: Initial intra-oral periapical bitewing radiographs of the teeth to be treated were taken before the procedure. After obtaining partial isolation using cotton rolls and saliva ejector, caries excavation and removal of undermined enamel will be done using high-speed diamond burs with water cooling and hand instruments. After finishing the cavity, a matrix band will be placed with the interproximal wedge. The prepared cavities will be restored using Equia Forte or flowable bulk-fill composite resin according to the manufacturer's instructions.

Eligibility criteria: Inclusion Criteria:

1. 4 to 8 years old medically free children.
2. Cooperative children are classified as class 3 or 4 based on Frankel et al. classification.
3. Children who had at least one active dentinal carious lesion on the proximal surface of primary molars

Exclusion Criteria:

1. Refusal of the parents to sign the informed consent
2. Presence of deep bite or any pictures of malocclusion and parafunctional habits.

Primary outcomes:
measure: clinical performance
timeFrame: one-year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry .Ain shams university
city: Cairo
country: Egypt
facility: Marina Fakhry Fahmy
Study officials:
affiliation: assistant lecturer of pediatric dentistry ,faculty of dentistry ASU
name: Marina F Fahmy, ass.lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726660: The General Use of Robots in Stroke Recovery
Official title: Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Cerebrovascular Accident
Cerebral stroke
CVA
robotic therapy
upper extremity recovery
kinematic training
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-11-15
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 determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)

Exclusion Criteria:

* Prior experience with robotic arm therapy
* Fixed contraction of the affected limb
* Complete flaccid paralysis of the affected limb

Primary outcomes:
measure: Change from baseline in Upper Extremity Fugl Meyer Motor Assessment
timeFrame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Secondary outcomes:
measure: Change from baseline in Kinematic Data
timeFrame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
measure: Change from baseline in Fugl Meyer Sensation Scale
timeFrame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
measure: Change from baseline in Fugl Meyer Proprioception Scale
timeFrame: 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Bruce T Volpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. doi: 10.1097/01.phm.0000137313.14480.ce.
Clinical trial NCT03521960: Buspirone for Opioid Tapering
Official title: Buspirone as an Adjunctive Medication for Opioid Tapering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Dependency (Psychology)
Pain, Chronic
Opiate Withdrawal Syndrome
Keywords: Buspirone
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient completing a residential stay on the Pain Treatment Unit in which this study is being conducted will be enrolled and randomly assigned to receive either buspirone or placebo.
Primary purpose: TREATMENT

Brief summary: This is a pilot study to collect preliminary data to support a grant application. The goal of the study is to evaluate whether the Food and Drug Administration (FDA)-approved and generically-available medication buspirone reduces symptoms of opioid withdrawal among patients undergoing a clinically-indicated and supervised taper from their opioid pain medications. This is premised on strong preclinical scientific support but has not yet be well-examined in humans.

Detailed description: Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper. Buspirone may have pharmacologic activity in specific neurotransmitter systems that preclinical evidence suggests may be implicated in the manifestation of opioid withdrawal symptoms. Administration of buspirone during an opioid taper may improve outcomes relative to placebo. The goal of this study is to collect preliminary feasibility and efficacy data from a sample of patients undergoing clinically-indicated opioid tapering. Participant enrollment will occur at the beginning of their residential stay on the Pain Treatment Unit at Johns Hopkins Hospital. Participants will be randomly assigned to receive buspirone (15 milligrams, three times daily, for daily dose of 45 milligrams) or placebo. Daily assessments for withdrawal and requests for additional symptomatic medications will be evaluated as evidence of initial efficacy. Feasibility measures include willingness to participate and study retention.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Be undergoing taper of prescribed opioid pain medications at the study site

Exclusion Criteria:

* Being pregnant or breastfeeding
* Past 7-day use of grapefruit juice or other strong Cytochrome (CYP) P450 inhibitors or inducers
* Have medical or psychiatric condition that is contraindicated with buspirone administration
* Current suicidality as assessed by clinic staff or the Columbia Suicide Severity Rating Scale

Primary outcomes:
measure: Taper Completion
timeFrame: 28 days
measure: Opioid Withdrawal Symptom Severity
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References: