louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03764267: MAC vs TIVA Ambulatory Breast Augmentation
Official title: Monitored Anesthesia Care Using Remifentanil and Ketofol Results in a Superior Quality of Recovery Compared With Total Intravenous Anesthesia in Ambulatory Breast Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Diseases
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: hypothesis: the combination of LA with remifentanil and ketofol \[monitored anesthesia care (MAC)\] for ambulatory breast augmentation may result in results in better QoR on day of surgery as compared with total i.v. anesthesia (TIVA) . The purpose of this study was to compare the QoR after MAC using remifentanil and ketofol with TIVA during ambulatory breast augmentation .

Detailed description: Breast augmentation surgery is commonly performed on an ambulatory basis under under general anesthesia (GA) with propofol and remifentanil or local anesthesia (LA). Although surgeons perform this operation comfortably under GA, Patients have anxiety and fear of complications due to GA. In addition, they expect a good postoperative quality of recovery (QOR) including ability to resume common activities (work and daily activities) without suffering from moderate to severe pain.

The LA is advantageous over GA in that airway instrumentation is not necessary, favorable recovery profile, decrease postoperative pain and vomiting, increase patient satisfaction and decrease the cost . However, patient anxiety or pain often leading to conversion of LA to GA, which suggests the concomitant use of i.v. sedatives and analgesics as a supplement to LA.

The combination of remifentanil and ketofol (propofol, ketamine) for sedation during regional anesthesia and LA has been shown to be a safe, effective technique, capable of maintains adequate analgesia with conscious sedation, haemodynamic stability, and achieves lower incidence of postoperative nausea and vomiting with shorter recovery times.

Eligibility criteria: Inclusion Criteria:

* ASA I, II

Exclusion Criteria:

* ASA III

Primary outcomes:
measure: Quality of recovery
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Recovery room readiness times
timeFrame: 24 hours postoperative
measure: home readiness times
timeFrame: 24 hours postoperative
measure: adverse events
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01923467: Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
Official title: Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: smoking
nicotine replacement
internet
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-08-15
Enrollment: 767
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.

In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:

Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.

Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.

Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.


Eligibility criteria: Inclusion Criteria:

* Current smoker

Exclusion Criteria:

* Current participation in another stop-smoking program
* Current use of stop smoking medications
* Pregnant or breastfeeding
* Limited internet or email access

Primary outcomes:
measure: Acceptance of Offer to Join Stop Smoking Program
timeFrame: 1 Day of Enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Center for Health Communications Research, University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Lawrence C An, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06864767: Impact of Motor and Oral Motor Function on Quality of Life in Children With SMA
Official title: Impact of Motor and Oral Motor Function on Quality of Life in Children With Type I Spinal Muscular Atrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Muscular Atrophy Type I
Keywords: Spinal Muscular Atrophy Type I
Oral Motor Function
Motor Function
Quality of Life
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study was completed with 23 children between the ages of 2-4 who were followed up with the diagnosis of Spinal Muscular Atrophy (SMA) Type 1 and whose parents volunteered to participate in the study.

Brief summary: The aim of this study is to investigate the impact of motor and oral motor functions on the quality of life in children aged 2-4 years diagnosed with Spinal Muscular Atrophy (SMA) Type I. In the study, the Neuro-Sensory-Motor Developmental Assessment (NSMDA) was used to evaluate motor functions, the Functional Oral Intake Scale (FOIS) to assess oral motor function, the Behavioral Pediatric Feeding Assessment Scale (BPFAS) to evaluate children's attitudes towards feeding, and the Pediatric Quality of Life Inventory (PedsQL) Neuromuscular Module to assess quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Spinal Muscular Atrophy Type I
* Being between the ages of 2-4
* Families volunteering to participate in the study

Exclusion Criteria:

* Accompanied by another chronic disease other than SMA
* The mother or father has a cognitive problem that prevents them from expressing themselves
* The mother or father is illiterate

Primary outcomes:
measure: Neuro-sensory Motor Developmental Assessment
timeFrame: Once, beginning of the study
measure: Functional Oral Intake Scale
timeFrame: Once, beginning of the study
measure: Behavioral Pediatrics Feeding Assessment Scale
timeFrame: Once, beginning of the study
Secondary outcomes:
measure: Pediatric Quality of Life Inventory
timeFrame: Once, beginning of the study
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References:
Clinical trial NCT01074567: DMSO Efficacy in IC/PBS Patients During and After Treatment
Official title: Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystitis, Interstitial
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-02-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

Detailed description: The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known.

All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.

Eligibility criteria: Inclusion Criteria:

* patients with IC according to International Continence Society:

  * more than 6 month of pelvic pain
  * urinary frequency, urgency, dyspareunia

Exclusion Criteria:

* genitourinary tract infection
* known genitourinary malformation

Primary outcomes:
measure: O'leary-Sant interstitial cystitis symptom and problem questionaire
timeFrame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment
Secondary outcomes:
measure: urination diary
timeFrame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment
Other outcomes:
Locations:
city: Zeriffin
country: Israel
facility: Assaf Harofe Medical Center
Study officials:
affiliation: Assaf-Harofe MC
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03114267: Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis
Official title: Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Chronic Lymphocytic Thyroiditis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 64
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: Patients were recruited after PHRC 2005. Written information for the extension of the study will be sent with a copy of the summary of the scientific publication on Enterovirus (PHRC 2005).

Brief summary: Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common.

Viral infections are the main environmental factors suspected of triggering autoimmune diseases. Several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. However, the precise identification of the viruses involved remains to be established.

It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in perioperative specimens of thyroid tissue. However, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies It has been recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.


Eligibility criteria: Inclusion Criteria:

* Patients participating in PHRC 2005 "involvement of enteroviruses in TLC pathogenesis"
* Inclusion of TLC: presence of a significant lymphocyte infiltrate within the thyroid parenchyma defined by the presence of clusters of more than 30 to 50 lymphocytes
* Inclusion of controls: absence of significant lymphocyte infiltrate

Exclusion Criteria:

* Persons refusing to participate in research

Primary outcomes:
measure: Analysis of the viral genome by PCR carried out in the Virology department, Analysis of the presence of capsid protein
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT00668967: Bioequivalence Study Of Verapamil
Official title: Bioequivalence Study Of Verapamil (Covera HS) 240 Mg Extended Release Tablets Produced By Alza Corporation, Vacaville And Pfizer Inc, Puerto Rico: A Two Sequence, Four-Way Crossover Design, Single Dose, Open-Label, Randomized Study In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Cardiovascular Diseases
Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate bioequivalence of single doses of two verapamil formulations


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screen

Primary outcomes:
measure: Primary study endpoints will be AUClast, AUCinf and Cmax of R- and S-verapamil.
timeFrame: 5 months
Secondary outcomes:
measure: Secondary endpoints will include Tmax and t1/2 of R- and S-verapamil and S- and R- norverapamil, as data permit. AUClast, AUCinf and Cmax of R- and S-norverapamil as data permit.
timeFrame: 5 months
measure: Safety and tolerability as assessed by reported adverse events, safety lab test and vital signs
timeFrame: 5 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06977867: The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients
Official title: The Effect of Stress Ball Use on Comfort, Anxiety, and Patient Satisfaction in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hemodialysis Patients
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic kidney disease represents a significant public health issue both in Türkiye and worldwide, with the majority of patients undergoing hemodialysis treatment. Individuals receiving hemodialysis often experience not only physical discomfort but also psychological distress, including heightened anxiety and reduced comfort. The aim of this study is to evaluate the effects of stress ball use on comfort, anxiety, and patient satisfaction among hemodialysis patients. The stress ball is a simple and cost-effective non-pharmacological intervention that aids individuals in managing stress by redirecting their attention. Notably, this study is unique in simultaneously investigating comfort, anxiety, and satisfaction parameters within this patient population.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Being literate
* Having no visual or hearing impairments
* Being able to communicate verbally
* Having no physical disability that would prevent the use of a stress ball
* Not having a diagnosed anxiety disorder and not using medication for it
* Willingness to participate in the study

Exclusion Criteria:

* Currently using sedative medications
* Having a diagnosed psychiatric disorder
* Having any physical limitation that prevents squeezing a stress ball

Primary outcomes:
measure: Level of anxiety
timeFrame: 1 month
measure: Patient's comfort
timeFrame: 1 month
measure: Level of patient satisfaction
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bi̇tli̇s
country: Turkey
facility: Bitlis State Hospital
state: Tatvan
Study officials:
References:
citation: Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, Zhao MH, Lv J, Garg AX, Knight J, Rodgers A, Gallagher M, Kotwal S, Cass A, Perkovic V. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015 May 16;385(9981):1975-82. doi: 10.1016/S0140-6736(14)61601-9. Epub 2015 Mar 13.
Clinical trial NCT00614367: Chromosomal Analysis of Single Cells in Human Embryos
Official title: Chromosomal Analysis of Single Cells in Human Embryos
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chromosomal Abnormalities
Keywords: chromosomal abnormalities in single cells
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3-4 day old human IVF embryos

Brief summary: Optimise genetic screening of human embryos using higher resolution techniques


Eligibility criteria: Inclusion Criteria:

* 3-4 day old embryos from IVF couples with both partners younger than 36 years old

Primary outcomes:
measure: genetic constitution of single blastomeres
timeFrame: 3 day old embryos
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven, Catholic University Leuven
Study officials:
affiliation: University Hospital Leuven, Catholic University Leuven
name: Joris Vermeesch, Prof PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Thomas D'hooghe, Prof MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00951067: Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
Official title: Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Breast Cancer
Upper Extremity
Arm
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: NormaTec Industries LP
First posted: 2009-08-04
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 how well different treatments for acquired lymphedema work.

The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.

Detailed description: This study will compare 5 non-invasive lymphedema treatments.

Patients will be assigned to either:

- A combination of arm exercises, arm elevation, and wearing of a compression garment every day

OR

- One of four possible pneumatic compression devices for just two hours every day.

Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.

None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.

The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with acquired lymphedema of the arm.

Exclusion Criteria:

* Refusal of consent
* Unlikely compliance with the research protocol
* Acute upper extremity DVT

Primary outcomes:
measure: Arm Volume
timeFrame: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Secondary outcomes:
measure: Infection (cellulitis)
timeFrame: Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
measure: Quality of Life Survey
timeFrame: Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Children's Hospital Boston at Waltham
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Arin K Greene, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977740: Chest PNF on Pulmonary Function in Parkinson Disease
Official title: Efficacy of Chest PNF on Pulmonary Function in Patients With Parkinson's Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Background: Parkinson disease (PD) is a progressive neurodegenerative disorder and characterized by tremor, rigidity and bradykinesia. Almost 84% of PD patient develops respiratory abnormalities and pointed as the most common cause of death. Airway obstruction, trunk muscle rigidity is the common cause of respiratory abnormalities.

Purpose: The main purpose of the study will evaluate the efficacy of chest PNF on pulmonary function and chest wall mobility in PD.

Methods: 20 participants will be recruited for study purpose and divide into two groups. Group= A will be the control group and participants will receive conventional treatment which includes deep breathing exercise and segmental breathing exercise, incentive spirometry etc for one week. Group= B participants will receive chest PNF exercise along with conventional treatment for a week. Pretreatment and post-treatment data will be recorded by the help of PFT (FVC, FEV1 \& FEV1/FVC) and chest wall expansion at axillary and xiphisternal level for data analysis. Data analysis will be done by paired t-test for within group and independent t-test will be used for the between-group variable. The level of significance will be set at 0.05.


Eligibility criteria: Inclusion Criteria:

1. Grade 3 to grade 5 Parkinson patients according to Hoehn Yahar scale
2. MMSE score \>23.
3. Age 50-70 yrs.
4. Both Male and Female.

Exclusion Criteria:

1. Previous history of cardiac and pulmonary surgery.
2. History of flail chest.
3. Individual affected by neurological disorder other than PD.
4. Uncooperative patients.
5. Individual with the psychosomatic disorder.

Primary outcomes:
measure: Pulmonary Function Test (PFT)
timeFrame: changes bwtween baseline to 1 week
Secondary outcomes:
measure: chest wall expansion by inch tape
timeFrame: changes bwtween baseline to 1 week
Other outcomes:
Locations:
city: Ambāla
country: India
facility: MMIPR
state: Haryana
Study officials:
References: