louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03133780: Sedation During Spinal Anesthesia
Official title: A Comparison of the Sedative Effect of Ketamine and Midazolam During Spinal Anaesthesia for Elective Unilateral Inguinal Hernia Repair: A Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation During Spinal Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients during spinal anesthesia should be sedated.

Detailed description: Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

Eligibility criteria: Inclusion Criteria:

* Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.

Exclusion Criteria:

* Age: younger than 18 or older than 50.
* Psychatric or neurological disorders.
* Cardiovascular disorders.
* Coagulation disorders.
* Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).

Primary outcomes:
measure: Time for the onset of sedation in minutes assessed by modified observer's assessment of alertness/sedation score
timeFrame: 90 minutes after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine Assuit University
state: Asyut
Study officials:
affiliation: Assiut Univerisity
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852280: Effects of Pulsed-Dyed Laser on Scar Formation
Official title: Effects of Pulsed-Dyed Laser on Scar Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Keywords: scars
late effect of burn
burn
pulsed-dye laser
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 17
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify changes in color, thickness, and stiffness, of scars from skin grafting after burns when treated with a pulsed-dyed laser.

Detailed description: Pulsed-dyed lasers have been used in the past to treat scars from minor surgery as well as burns. The laser has been used at different times, close to injury or late after injury. Success or failure of the laser has been judged by subjective observer scales.

In this study we will treat the seams of 1/2 of a skin graft with a pulsed-dyed laser, beginning about one month after surgery. We will use objective measures of color (redness on digital pictures), scar volume(via laser scanning), and elasticity(measured by BTC-2000) as well as subjective assessment by an independent observer and the patient.

Eligibility criteria: Inclusion Criteria:

* \> 9 years old
* not pregnant
* new skin graft to extremity
* able to follow simple instructions

Exclusion Criteria:

* age less than 9 years
* pregnancy
* any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions

Primary outcomes:
measure: Amount of redness of scar
timeFrame: 4 to 12 months after skin grafting
Secondary outcomes:
measure: Scar height
timeFrame: 4-12 months after skin grafting
measure: Scar stiffness
timeFrame: 4-12 months after skin grafting
measure: Patient's assessment of cosmetic outcome
timeFrame: 4-12months after skin grafting
measure: Clinical improvement of appearance of scars assessed by subjective scale
timeFrame: 4-12 months after skin grafting
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospitals for Children, Cincinnati
state: Ohio
Study officials:
affiliation: Shriners Hosptials for Children
name: John K Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05865080: Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Caesarean Delivery.
Official title: Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Keywords: spinal anesthesia
obstetric anesthesia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 126
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose ketamine for intrathecal anesthesia in patients undergoing cesarean delivery

Detailed description: 126 female patients undergoing cesarean deliveries, ASA-(II and III) and 21-40 ys old selected from an attendee of outpatient clinics of the Anesthesia Department. Two groups of patients were random to group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.

Eligibility criteria: Inclusion Criter

1. Female patients and full-term,
2. aged between (21 and 40) y. Old.
3. (ASA)-II or III, and undergoing a cesarean section.

Exclusion criteria:

1. Twins and preterm birth.
2. Hypertensive patients and preeclamptic patients.
3. Morbidly obese patients.
4. Spinal anesthesia contraindication as the patient refused, severe mitral or tricuspid stenosis and local sepsis.

Primary outcomes:
measure: Hemodynamics
timeFrame: Up to 24 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine -Al-Azhar university
Study officials:
References:
Clinical trial NCT05212480: Evaluation of the Efficacy and Safety of Zinc in Viral Infections
Official title: Evaluation of the Efficacy and Safety of Zinc in Viral Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV2 Infection
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the clinical study is to evaluate the efficacy of Zinc supplementation in non-critically ill Covid-19 patients..

Detailed description: The VIZIR study is a national, longitudinal, multi-centre study conducted over a 3-month follow-up period.

The priori hypothesis was that supplementation with zinc would reduce 30-day mortality and need to intensive care unit (ICU) admission among non critically ill patients with Covid-19.

The VIZIR study will be carried out in Tunisia at the level of consultations of general practitioners of both sectors : public and liberal, as well as in the emergency services of Monastir and Sousse.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and over .
* Sars-Cov2 infection Diagnosed with RT PCR , Rapid Test or Chest CT-Scan performed within the less than 5 days of symptoms.

Exclusion Criteria:

* Patients who received zinc before the start of the protocol.
* heart, liver, malignancies, or renal failure (estimated glomerular filtration rate ≤30 mL/min/1.73 m2);
* Mental disorders .
* Chronic Dialysis.
* Hospitalisation in ICU (use of respiratory or cardiovascular organ support (oxygen delivered by high-flow nasal cannula, noninvasive or invasive mechanical ventilation, or the use of vasopressors or inotropes). .
* Known hypersensitivity to zinc.
* unsuitability for oral administration

Primary outcomes:
measure: Mortality rate.
timeFrame: 30 days
measure: need for ICU admission
timeFrame: 30 days
measure: Combined_outcome
timeFrame: 30 days
measure: treatment safety
timeFrame: 30 days
Secondary outcomes:
measure: Need for hospitalization for patients followed up at home
timeFrame: 30 days
measure: lenghth of stay in Hospital
timeFrame: 30 days
measure: resolution of COVID-19 symptoms
timeFrame: 30 days
measure: need for oxygen therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: EPS Fattouma Bourguiba Monastir
Study officials:
affiliation: emergency department of Fattouma Bourguiba Monastir
name: Nouira A semir, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben Abdallah S, Mhalla Y, Trabelsi I, Sekma A, Youssef R, Bel Haj Ali K, Ben Soltane H, Yacoubi H, Msolli MA, Stambouli N, Beltaief K, Grissa MH, Khrouf M, Mezgar Z, Loussaief C, Bouida W, Razgallah R, Hezbri K, Belguith A, Belkacem N, Dridi Z, Boubaker H, Boukef R, Nouira S. Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial. Clin Infect Dis. 2023 Jan 13;76(2):185-191. doi: 10.1093/cid/ciac807.
Clinical trial NCT02824380: Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects With Androgenic Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenic Alopecia
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 14
Sex: MALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Safety of DA-4001 in Healthy Male Subjects with Androgenic Alopecia.


Eligibility criteria: Inclusion Criteria:

* Male, aged between 19 and 65 years, clinically healthy
* BMI between 18.5kg/m2 and 27kg/m2
* Clinical history of Androgenic Alopecia

Exclusion Criteria:

* Subject has any dermatological disorders of the scalp
* Subject has a history of hair transplants, hair weaves
* Subject has hypersensitivity to previously prescribed minoxidil or finasteride
* Subject who is considered inappropriate to participate in the study due to any conditions including screening results at the investigator's discretion

Primary outcomes:
measure: Css,max(Maximum steady state concentration) of Finasteride(ng/mL)
timeFrame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
measure: AUCtau(Area under the plasma concentration versus time curve) of Finasteride (ng·hr/mL)
timeFrame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
measure: Change from baseline of testosterone and DHT(ng/mL)
timeFrame: day1: before administration, day7: before administration and 6, 12, 24h after administration
Secondary outcomes:
measure: Tss,max(Time to reach maximal serum concentrations at steady state)of Finasteride(hr)
timeFrame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
measure: Css,min(Minimum steady state concentration)of Finasteride(ng/mL)
timeFrame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
measure: t1/2β(Elimination Half-life) of Finasteride(hr)
timeFrame: day1, 6: before administration, day7: before administration and 0.5, 1, 2, 3, 4, 6, 8, 12, 24h after administration
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
Study officials:
References:
Clinical trial NCT02732262: Optimal Dose of i.v Oxycodone for Postoperative Pain
Official title: Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: acute pain
postoperative
surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe.

The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.

Detailed description: Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class 1, 2
* Expected surgical time between 2\~ 6hours
* Scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

* Severe dysfunction of liver, heart, kidney, or lung
* Cannot understand numeric rating scale of pain
* Known or suspected allergy to oxycodone
* Previous history of postoperative nausea or vomiting
* Medication of antidepressants
* Postoperative longterm
* ICU care or prolonged mechanical ventilatory support
* Chronic pain
* Drug abuser
* Hypersensitivity reaction to aspirin or NSAIDs
* Refuse to enroll

Primary outcomes:
measure: Resting postoperative pain at 24hr
timeFrame: 24 hr after surgery
Secondary outcomes:
measure: Side effects
timeFrame: 24 hr after surgery
Other outcomes:
measure: Sedation
timeFrame: 24 hr after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02486562: IConquerMS™ - a Patient-Powered Research Network for Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Lead sponsor: Accelerated Cure Project for Multiple Sclerosis
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Ogilvy
name: Arizona State University
First posted: 2015-07-01
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary cohort is people with multiple sclerosis.

Brief summary: iConquerMS™ is a research initiative developed by and for people with multiple sclerosis (MS) to contribute their health data and ideas to advance and accelerate research into MS. iConquerMS welcomes adults with MS and others interested in advancing MS research, children and teens with MS and their family members (via iConquerMS Kids \& Teens) and MS caregivers (via iConquerMS Caregivers) to participate.

Detailed description: The purpose of this study is to create a Multiple Sclerosis Patient-Powered Research Network (MS-PPRN) that includes at least 20,000 people with multiple sclerosis (MS) who contribute data on their health and other topics. Survey data will be made available to research scientists who are studying MS and similar diseases. Our goal is to use this data to answer questions that researchers and people with MS have regarding the disease, including its causes, treatments, and other topics.

While the MS-PPRN is focused on enrolling people with MS, people without MS are also welcome to participate in this research study. Adults are invited to participate via iConquerMS, while children and teens are invited to participate via iConquerMS Kids \& Teens. Adults who are MS caregivers may participate via the dedicated iConquerMS Caregivers site.

This study will be conducted online via the iConquerMS.org website. This is an ongoing study and will last for an indefinite period of time.

Eligibility criteria: Inclusion Criteria:

* 21 years of age or older at the time of informed consent or under 21 with parental consent and participant assent.

Exclusion Criteria:

* Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Number of people with multiple sclerosis who experience health-related quality-of-life changes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Accelerated Cure Project
state: Massachusetts
Study officials:
References:
Clinical trial NCT02868762: Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders
Official title: Correlation of the Neck Disability Index (NDI) and Voice Handicap Index (VHI) in Neck Pain Patients and Patients With Voice Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain and/or a Voice Disorder
Keywords: neck pain, voice disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic patients

Brief summary: This study investigates in patients whose primary complaint is either neck pain and/or a voice disorder , if there are any correlations between subjective neck and voice symptoms according to Neck Disability Index (NDI) and Voice Handicap Index (VHI). NDI and VHI questionnaire results for voice disordered patients will be retrieved from the data base of the Department of Phoniatrics and Speech Pathology, University Hospital Zurich. Neck pain patient questionnaire data will be retrieved from an ongoing study. The agreement between subjective neck handicap (NDI) and voice handicap (VHI) will be statistically analysed.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* primary diagnose of a functional disorder of the muscular structure in the neck area
* primary diagnose of a functional or secondary structural voice disorder

Exclusion Criteria:

* systemic illness of the motion apparatus (i.e., polyarthritis rheumatica)
* acute cancer
* neurogenic voice and swallow disorder
* Intubation within the last 18 months
* lack of german knowledge, (not able to fill out a questionnaire independently)

Primary outcomes:
measure: Correlation between neck disability index and voice handicap index (questionnaire)
timeFrame: 1 day
Secondary outcomes:
measure: Additional neck area handicap in patients with voice disorders (questionnaire)
timeFrame: 1 day
measure: Additional subjective voice disorder in patients with neck pain (questionnaire)
timeFrame: 1 day
measure: Difference in pain strength and quality in patients with functional voice disorder as compared to patients with benign organical vocal fold changes (questionnaire)
timeFrame: 1 day
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: KD Dr. Jörg Bohlender
state: ZH
Study officials:
affiliation: University Hospital Zurich, clinic othorhinolaryngology, 8091 Zurich
name: Jörg Bohlender, KD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216162: PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program
Official title: PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: oncogeriatrics
adjuvant endocrine therapy
compliance
elderly
Taï Chi
Physical training
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 12
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.

Patients in the intervention group will be proposed:

* A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
* An adapted treatment of join pain,
* Weekly sessions of adapted physical activity (Taï Chi),
* And a systematic correction of vitamin D deficits.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 70 years old
* Non metastatic breast cancer, with or without node metastases
* Hormone Receptor (HR) positive breast cancer patients
* Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy
* Introduce an hormonal therapy during 5 years
* Life expectancy \> 6 months (at the discretion of the investigator)
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
* Patient must be available for follow-up
* Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

* No other primary malignant tumor \< 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer
* Patient with an experimental treatment in the 30 days prior to the enrollment
* Evidence of metastatic disease
* Not under any administrative or legal supervision

Primary outcomes:
measure: Compliance of an adjuvant hormonal therapy
timeFrame: 3 years of follow up
Secondary outcomes:
measure: Intensity and duration of musculoskeletal adverse events
timeFrame: 3 years of follow up
measure: Activities of daily living, functional walking capacity and changes in balance
timeFrame: 3 years of follow up
measure: Quality of life
timeFrame: 3 years of follow up
measure: Nutritional status
timeFrame: 3 years of follow up
measure: Analgesics consumption
timeFrame: 3 years of follow up
Other outcomes:
Locations:
city: Lyon
country: France
facility: Claire Falandry
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire Falandry, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: