louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04644900: Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask
Official title: Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Sore Throat
Keywords: sore throat, Laryngeal Mask , Chewing Gum , Mouthwash
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively or mouthwash can reduce the incidence of POST after general anaesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA).


Eligibility criteria: Inclusion Criteria:

American Society of Anaesthesiologists(ASA)class I or II 20\~65 years body mass index(BMI)scores\<30 undergoing elective hysteroscopic surgery

Exclusion Criteria:

chronic laryngitis chronic bronchitis asthma gastroesophageal reflux allergies to study drugs recent use of non-steroidal anti-inflammatory drugs(NSAIDS) a history of upper respiratory tract infection in the past one week Mallampati grade\>2 a history of steroid therapy.

Primary outcomes:
measure: the incidence of POST scores>3
timeFrame: within 24 hours after surgery.
Secondary outcomes:
measure: the POST scores
timeFrame: 2 hours,6 hours and 24 hours after surgery.
Other outcomes:
measure: subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
timeFrame: Immediately after removal of laryngeal mask
Locations:
city: Shanghai
country: China
facility: Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Study officials:
References:
Clinical trial NCT03268200: The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy
Official title: The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 450
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.

Detailed description: The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale \[BBPS\] score \<2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.

A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy

Exclusion Criteria:

* Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
* If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale \[BBPS\] score \<2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 7 days
Secondary outcomes:
measure: Per-patient adenoma detection rate (ADR) at each segment of colon
timeFrame: 7 days
measure: per-patient polyp detection rate
timeFrame: 7 days
measure: Withdrawal time
timeFrame: 1 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's hospital, Catholic university of Korea
Study officials:
References:
Clinical trial NCT05809700: Injection Therapy for Neuropathic Pain
Official title: The Clinical Study of Injection of Freshly Prepared HA35 in the Treatment of Shoulder, Neck, Back, Temporal and Herpes Zoster Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-04-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Shoulder, neck, back and temporal pain and herpes zoster pain are neuropathic pain. Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can relieve neuropathic pain. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

Detailed description: In this study, the recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20) of bovine testicular sperm acrosomes were used to cleave macromolecular HA. Regardless of the cutting time, the HA fragment HA35, with an average molecular weight of 35 kDa, was produced (Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used off label to degrade excessive components used in cosmetic injections, such as cross-linked macromolecular HA fillers (https://www.realself.com/news/hyaluronidase-dissolve-fillers). In this study, HA35 was prepared by mixing hyaluronidase extracted from bovine testis (hyaluronidase for injection, H31022111) and HA (sodium hyaluronate for injection, H20174089) at room temperature for 20 minutes. The analgesic effect of HA35 on herpes zoster and shoulder, neck, back, and temporal pain was studied. This was a single-arm, open-label prospective clinical study in which patients were evaluated before and after treatment.

Eligibility criteria: Inclusion Criteria:

* The course of neck, back and temporal pain ranged from 0 to 8 months.
* The course of herpes zoster of 0-2 months.
* Adults aged 18-60 years.
* Be willing and capable of giving informed consent.
* Have a clinical diagnosis of neuropathic pain as determined by a multidisciplinary study team.
* Subject must sign the informed consent in person prior to beginning any screening procedure.

Exclusion Criteria:

* Have a persistent pain resulted from other medical conditions or unknown causes.
* Pregnant females.
* Be concomitantly participating in another clinical study.
* Have been immunocompromised.

Primary outcomes:
measure: the Numerical Pain Rating Scale (NPRS) scores
timeFrame: 30 min to 3 hours
measure: the General Comfort Questionnaire (GCQ) scores
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
state: Shandong
Study officials:
References:
Clinical trial NCT03750500: Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People
Official title: Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fall
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.

The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.

The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.


Eligibility criteria: Inclusion Criteria:

1. Patients aged over 65 years old
2. Ability to walk at least 20 meters, unaided or with unilateral support
3. Ability to understand motor complex commands
4. Mini-Mental State Examination (MMSE) score \> 24 points
5. Functional independence for instrumental activities of daily living
6. Risk of recurrent falls, defined as 5xSST score \> 15,00 seconds

Exclusion Criteria:

1. Patients residing in nursing homes, daycare units or assisted-living facilities
2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
3. Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
7. Other medical complications, which prevent the patient from complying with a home-based exercise program
8. Illiteracy

Primary outcomes:
measure: Change in the 5 Times Sit to Stand Test
timeFrame: Baseline; week 4; week 8; week 12 and then week 24
Secondary outcomes:
measure: Change in the Timed Up and Go Test score
timeFrame: Baseline; week 4; week 8; week 12 and then week 24
measure: Change in the Berg Balance Scale
timeFrame: Baseline; week 4; week 8; week 12 and then week 24
measure: Change in the Shorts Falls Efficacy Scale-International
timeFrame: Baseline; week 4; week 8; week 12 and then week 24
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: USF Aldoar
Study officials:
References:
Clinical trial NCT04222400: Comparison of Different Frailty Assessment Tools
Official title: Feasibility and Comparison of the Impact of Different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Advanced Heart Failure
Ventricular Assist Device
Heart Transplantation
Frailty
Sarcopenia
Bioelectrical Impedance Analysis
Muscle Mass
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2020-01-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Feasibility and Comparison of the Impact of different Frailty Assessment Tools on the Outcome of Ventricular Assist Device Implantation and Heart Transplantation in advanced heart failure patients

Detailed description: Comparison of the feasibility and results of the following frailty assessment tools in advanced heart failure patients treated with ventricular assist device Implantation or awaiting heart transplantation in Eurotransplant-Status "high urgency":

* Evaluation of the muscle mass in the preoperative CT-Scan
* Bioelectrical Impedance Analysis
* 6 Minute Walk Test
* Grip Strength Measurement
* Questionnaires: EQ5D-5L, Rockwood Frailty Scale

The assessment will be conducted prior to surgery, after surgery and at 6 Month Follow-up

Eligibility criteria: Inclusion Criteria:

* Planned VAD Implantation/ HU-Status awaiting Heart Transplantation
* Signature on Informed Consent

Exclusion Criteria:

* \< 18 years old
* Informed consent not possible/not signed
* Pregnancy/Breastfeeding

Primary outcomes:
measure: Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
timeFrame: Pre-operative measurements,
measure: Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
timeFrame: post-operative measurements in the week before discharge (average 4 weeks)
measure: Incidence of not performed tests due to clinical concerns/inability of the patient (feasibility and safety)
timeFrame: 6 Month Follow-up
measure: Impact of frailty estimated by the different frailty assessment tools on the outcome 6 month mortality and/or prolonged ventilation time
timeFrame: After 6 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: German Heart Center
Study officials:
affiliation: German Heart Center Berlin
name: Felix Schoenrath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roehrich L, Sundermann SH, Just IA, Kopp Fernandes L, Stein J, Solowjowa N, Mulzer J, Mueller M, Hummel M, Knierim J, Potapov E, Falk V, Schoenrath F. Comparison of feasibility and results of frailty assessment methods prior to left ventricular assist device implantation. ESC Heart Fail. 2022 Apr;9(2):1038-1049. doi: 10.1002/ehf2.13764. Epub 2022 Jan 6.
Clinical trial NCT05863000: Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?
Official title: Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Comparison, Social
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population consists of patients connected to a hospital clinic in Region H. We aim for a representative sample of patients in general and specific patient groups connected to a hospital within Region Hovedstaden

Brief summary: This study investigates how the behavior within different patient groups are affected differently by illness and disease. The investigators ask how participants experience and approach their own health in order to gain insight on the implications of illness and disease on the individual's everyday life and how participants act and think regarding their own health and wellbeing across different patient groups. The investigators' hypothesis is that illness and disease is experienced as a great disturbance and an actor of change in a person's everyday life. Each person has their own individual experience and reaction to this disturbance. Still, there is less evidence for how disparate resources and socioeconomic statuses shape how patients react to this great change in their lives. Here the investigators expect to find demographic patterns across patient groups. The study carries a quantitative and qualitative approach with a broad target population which includes both patients with acute or chronic, serious, or less serious, somatic as well as psychiatric illnesses. The study is placed within the academic traditions of sociological health and disease mapping.


Eligibility criteria: Inclusion Criteria:

* The patient is assigned to Region H
* The patient is over the age of 18
* The patient is able to answer the questions

Exclusion Criteria:

* - The patient refuses to give informed consent
* The patient doesn't speak danish

Primary outcomes:
measure: Online questionnaire/survey
timeFrame: six months
Secondary outcomes:
measure: Multiple correspondence analysis
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Anette Lykke Hindhede
Study officials:
References:
Clinical trial NCT01270100: Recovery Management Intervention in China
Official title: Reducing HIV/AIDS and Drug Abuse Among Heroin Addicts Released From Compulsory Rehabilitation in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methadone
HIV Infections
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the study is to develop and pilot-test a Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China.

The project has the following specific aims:

Primary aims:

Aim 1. To engage key stakeholders in the local communities involved in supporting the transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2. To identify potential barriers for participating in MMT in China; Aim 3. To develop and deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain preliminary outcome data associated with RMI, relative to enhanced standard care.

Secondary aim:

Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.

It is hypothesized that the intervention will reduce drug use relapse and the negative consequences associated with relapse, including HIV risk behaviors


Eligibility criteria: Inclusion Criteria:The study population will be drawn from all adult patients at participating compulsory rehabilitation facilities who:

1. have been incarcerated for at least one year and would have been eligible for MMT at the time of incarceration,
2. have at least 1 month remaining before release,
3. met the DSM-IV criteria for heroin dependence at the time of incarceration,
4. are willing to enroll in methadone maintenance treatment, and
5. are Shanghai residents who reside in the areas of Shanghai targeted by the study.

Exclusion Criteria: Individuals diagnosed with severe mental illness will not be eligible to participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References:
citation: Hser YI, Fu L, Wu F, Du J, Zhao M. Pilot trial of a recovery management intervention for heroin addicts released from compulsory rehabilitation in China. J Subst Abuse Treat. 2013 Jan;44(1):78-83. doi: 10.1016/j.jsat.2012.03.009. Epub 2012 Apr 18.
Clinical trial NCT00275600: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain
Official title: Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Cyclical Breast Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cyclical Breast Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: New Health International
First posted: 2006-01-12
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to find out what effects Vitamin E or Evening Oil of Primrose has on cyclical breast pain.

Detailed description: Cyclical mastalgia is a common complaint of women presenting to their primary care physicians. Cyclical breast pain is defined as prementstrual breast discomfort associated with hormonal fluctuations during the menstrual cycle. A clinical breast examination and sometimes additional imaging, such as sonography or mammography, is required as part of the evaluation to exclude malignancy. For most women, the symptoms are effectively managed with reassurance and conservative treatment measures such as the use of a supportive bra or over the counter pain medication such as acetaminophen or anti-inflammatories. However, a small number of women will require additional drug treatment with danazol after failing to respond to conservative measures. Unfortunately, danazol is associated with significant side effects. In the Mayo Breast Clinic, women with cyclical breast pain are managed with Vitamin E and Evening oil of primrose (EOP) either as single agents or in combination. These over the counter supplements are readily available, acceptable due to minial side effects and appear to lead to significant reduction in breast pain. We propose a randomized placebo controlled trial to determine if any vitamin E or EOP or the combination of both are effective in managing cyclical breast pain.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* premenopausal
* cyclical breast pain
* breast pain survey indicating 3 or more on scale of 1-10
* if \> 40 years of age, need normal mammogram and/or ultrasound if indicated and if not done within the last year
* if \< 40 years of age, a directed ultrasound in the area of pain
* can be on oral contraceptives

Primary outcomes:
measure: Test if Vitamin E improves cyclical breast pain
measure: Test if Evening Oil of Primrose improves cyclical breast pain
measure: Test if combination of Evening Oil of Primrose and Vitamin E works synergistically for cyclial breast pain
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sandhya Pruthi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: