louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04606745: Increase of Handgrip Strength After the Use of Removable Partial Dentures.
Official title: Increase of Handgrip Strength After the Use of Removable Partial Dentures.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Keywords: removable partial dentures
Lead sponsor: Comisión Nacional de Investigación Científica y Tecnológica
Sponsor class: OTHER_GOV
First posted: 2020-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Independent octogenarians that consulted in centers of the greater metropolitan area of Santiago, Chile, in search of solving their lack of posterior teeth with dental prostheses

Brief summary: A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?

Detailed description: A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?

Eligibility criteria: Inclusion Criteria:

* agree to participate by signing the voluntary informed consent form
* qualify according to the Eichner Index in any of the categories that represent the loss of premolars and molars: B3-B4-C1-and C2.

Exclusion Criteria:

* not accepting to participate
* cognitive or auditory sensory impairment-
* being dependent in activities of daily living
* belonging to another category of the Eichner Index

Primary outcomes:
measure: Handgrip strength
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de Chile
Study officials:
References:
Clinical trial NCT02470845: Trial of Tian Jiu Therapy for Allergic Rhinitis
Official title: A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis (AR)
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 136
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.

Detailed description: This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a one-week run-in period, eligible subjects will be randomly assigned to the Tian Jiu group, placebo-control group and waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The total study period will be nine weeks.

Eligibility criteria: Inclusion Criteria:

* Positive skin prick tests
* High circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called radioallergosorbent test (RAST)\]
* Clinical history or allergen to have been identified
* Nasal provocation (test)

Exclusion Criteria:

* Allergic asthma, moderate to severe atopic dermatitis, autoimmune disorders, severe chronic inflammatory diseases, history of anaphylactic reactions, hypersensitivity to cetirizine or related drugs, specific immunotherapy during the past 3 years or planned in the next 2 years, pregnancy or breastfeeding.

Primary outcomes:
measure: Change of total nasal symptom score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change of the Rhinitis Quality of Life Questionnaire (RQLQ)
timeFrame: 8 weeks
measure: Change in need for medication
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Baptist University Chinese Medicine Clinic
Study officials:
affiliation: School of Chinese Medicine, Hong Kong Baptist University
name: Zhao Xiang Bian, Ph.D., M. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kun W, Zhong LL, Dai L, Cheng CW, Lu AP, Bian ZX. Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):248. doi: 10.1186/s13063-016-1374-5.
Clinical trial NCT03621345: Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
Official title: Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Hypertrophy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery

Exclusion Criteria:

* Coagulopathy
* Allergy to amide-type local anesthetics
* Infection at the ESP block injection site
* Severe obesity (BMI \> 35 kg/m2)
* Liver or renal deficiency
* Patients with anatomical deformities
* Recent use of analgesic drugs
* Patient refusal or inability to consent

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Intraoperative anesthetic consumption
timeFrame: During operation time
measure: Extubation and recovery time
timeFrame: Through surgical operation completion
measure: Pain assessed by NRS
timeFrame: 24 hours
measure: Degree of sedation
timeFrame: 24 hours
measure: Rate of opioid related side effects
timeFrame: 24 hours
measure: Supplemental and rescue analgesic requirement
timeFrame: 24 hours
measure: Patient satisfaction assessment
timeFrame: At the postoperative 24th hour
measure: Bilateral shoulder mobility
timeFrame: Preoperative and postoperative 4th, 8th, 12th, and 24th hours
measure: Length of stay in hospital
timeFrame: Until discharge from hospital, up to 7 days postoperatively
measure: Rate of block related complications
timeFrame: Until discharge from hospital, up to 7 days postoperatively
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sariçam
Study officials:
References:
Clinical trial NCT05625945: Physical Activity Levels and Statin Therapy
Official title: Physical Activity Levels and Statin Therapy: Differences Between Symptomatic and Asymptomatic Statin Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
HMG COA Reductase Inhibitor Adverse Reaction
Muscle Pain
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic statin users (n=100) and asymptomatic statin users (n=100)

Brief summary: Rationale: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS).

Objective: To identify predictors for SAMS in statin users and to objectively assess physical activity levels and sedentary time between symptomatic and asymptomatic statin users.

Detailed description: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS). Physical activity may exacerbate SAMS, producing decreased physical activity levels or statin nonadherence. However, it is unknown if daily activity patterns differ between symptomatic and asymptomatic statin users.

In this cross-sectional observational study the investigators will assess if physical activity levels and sedentary time differ between symptomatic and asymptomatic statins users. Secondly, questionnaires will be used to assess predictors of SAMS.

Eligibility criteria: Inclusion Criteria:

* Mentally able to give informed consent
* Statin treatment for at least 3 months

Exclusion Criteria:

* Known hereditary muscle defect
* Known mitochondrial disease
* Other diseases known to cause muscle symptoms (e.g. m. Parkinson or rheumatic diseases)

Primary outcomes:
measure: Physical activity
timeFrame: during 1 week
measure: Sedentary time
timeFrame: during 1 week
Secondary outcomes:
measure: Predictors of statin-associated muscle complaints (SAMS)
timeFrame: 1 moment (cross-sectional)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of Physiology
Study officials:
References:
Clinical trial NCT00512447: Normal Values of Brain Oxygenation
Official title: Normal Values of Cerebral Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Arterial Disease
Keywords: Aging
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 171
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery

Brief summary: New technology allows non-invasive monitoring of brain oxygenation (Near-Infrared-Spectroscopy). However, there are no large series of normal values in various adult age groups. We hypothesised that baseline values in patients breathing room air are lower in old patients than in younger subjects and that younger patients respond increase their brain oxygenation more in response to supplemental oxygen.


Eligibility criteria: Inclusion Criteria:

* Age between 25 and 95 years undergoing a elective surgical procedure

Exclusion Criteria:

* History of cerebral disease
* Dependence on supplemental oxygen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anaesthesia, University Hospital Basel
state: BS
Study officials:
affiliation: Department of Anaesthesia, University Hospital Basel, Switzerland
name: Luzius A Steiner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597747: Design Improvements With SONNET 3
Official title: Evaluating Design Improvements With SONNET 3 in Experienced Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Measuring user-reported satisfaction with the latest behind-the-ear (BTE) audio processor model.

Detailed description: This prospective study will use a single-arm, repeated measures design with subjects serving as their own control. Participants will be experienced cochlear implant (CI) users wearing an approved BTE MED-EL audio processor. Participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Eligibility criteria: Inclusion Criteria:

* Implanted with a MED-EL cochlear implant in at least one ear
* ≥ 12 months since activation of the MED-EL audio processor
* Consistently using a SONNET (EAS) or SONNET 2 (EAS) Audio Processor
* Ability to complete all study procedures
* Participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study

Exclusion Criteria:

* Evidence that hearing loss is retrocochlear in origin
* Unable to provide reliable feedback during cochlear implant programming
* Skin or scalp condition precluding use of the study device
* Unrealistic participant or parent (if applicable) motivation or expectations
* Participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.

Primary outcomes:
measure: Number of Participants Reporting Improved Design with SONNET 3 (EAS)
timeFrame: Measured 1 month after baseline
Secondary outcomes:
measure: Summary of Audiologist-Reported Satisfaction Ratings with SONNET 3 (EAS)
timeFrame: Measured at enrollment conclusion
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
References:
Clinical trial NCT04647747: Silent Hypoxia and Awake Proning in COVID-19 Patients
Official title: Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Hypoxemia
Keywords: Silent Hypoxia
Lung Physiotherapy
Home Monitoring
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.


Eligibility criteria: Inclusion Criteria:

* Non dyspneic (NRS =/\< 1) patients with positive SARS-CoV-2 test
* Age 18 - 80 years
* Patients managed at home
* Inclusion within 72 hours from positive test

Exclusion Criteria:

* Chronic hypoxia (SpO2 \< 93 %) and/or first measured SpO2 \< 93 %
* Admitted to hospital for COVID-19 prior to inclusion
* Unable to perform pulse oximetry
* Unable to perform physiotherapy

Primary outcomes:
measure: Number of patients who manage to perform daily measurements of SpO2
timeFrame: January 30, 2021
measure: Incidence rate of silent hypoxia in non-hospitalized COVID-19
timeFrame: January 30, 2021
measure: Association between silent hypoxia and other subjective and objective measurements of disease severity
timeFrame: January 30, 2021
Secondary outcomes:
measure: Effect of a self-managed physiotherapy program on alleviating hypoxia
timeFrame: January 30, 2021
measure: Rate of persistent silent hypoxia episode per patients
timeFrame: January 30, 2021
measure: Rate of silent hypoxia episode per patients
timeFrame: January 30, 2021
measure: Rate of hospital admission and ICU admission
timeFrame: January 30, 2021
measure: Incidence of thromboembolic event in outpatients diagnosed with COVID-19
timeFrame: January 30, 2021
Other outcomes:
Locations:
city: Sarpsborg
country: Norway
facility: Ostfold Hospital
state: Grålum
Study officials:
References:
Clinical trial NCT00361998: Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis
Official title: Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cystitis
Keywords: Uncomplicated Cystitis
Nitrofurantoin Macrocrystals
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2006-08-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.

Detailed description: The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal healthy women
2. Uncomplicated cystitis

Exclusion Criteria:

1. Postmenopausal women
2. Complicated UTI
3. Women with catheter
4. Women with recurrent UTI
5. Pregnancy
6. Diabetes Mellitus

Primary outcomes:
measure: Microbiological efficacy
Secondary outcomes:
measure: Clinical efficacy and side effects
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Research Unit, Clalit Health Services, Haifa and Western Galillee District
Study officials:
affiliation: Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
name: Raul Raz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.
name: Uzi Milman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140398: Endometrial Scratching During Laproscopic Ovarian Drilling in Subfertile PCOS Women
Official title: Endometrial Scratching at Time of Laproscopic Ovarian Drilling in Women With Anovulatory Infertility Due to Polycystic Ovarian Syndrome (PCOS): Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: infertility
PCOS
scratching
endometrial receptivity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic Ovarian Drilling is a valid procedure for infertile anovulatory women with polycystic ovarian syndrome who failed to get pregnant or to ovulate with ovulation induction medications as clomiphene citrate or exogenous gonadotropins. The reasearchers supposed that endometrial curettage at time of laparoscopic ovarian drilling may boost fertility in these women.

Detailed description: Current literature suggests that endometrial biopsy may improve pregnancy rates in infertile women hence the investigators will examine whether this hypothesis will apply to infertile PCOS women undergoing laparoscopic ovarian drilling to overcome ovulatory disfunction or not.

Eligibility criteria: Inclusion Criteria:

1. subfertile women with anovulatory infertility due to polycystic ovarian syndrome (PCOS).
2. Women who failed to get pregnant after at least 6 months of ovulation induction cycles with clomiphene citrate or exogenous gonadotropins
3. Patent Fallopian tubes as confirmed by hysterosalpingography
4. Fertile semen parameters of the partneraccording to criteria of World Health Organization (WHO 2010).

Exclusion Criteria:

1. women with BMI \>30,
2. age \< 18 years or \> 39 years,
3. women with ovarian cysts identified by transvaginal ultrasound
4. male factor infertility
5. Tubal factor infertility as suggested by hystrosalpingogram (HSG)
6. Women with congenital malformations in the uterus as bicornuate or septate uterus as suggested by HSG.

Primary outcomes:
measure: live birth rate per woman randomized
timeFrame: 15 months
Secondary outcomes:
measure: pregnancy rate per woman randomised
timeFrame: 6 months
Other outcomes:
measure: miscarriage rate time to pregnancy interval
timeFrame: 6 months
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Teaching Hospital
Study officials:
affiliation: Mansoura University
name: Ahmed Gibreel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01489098: Effect of the Level of Dietary Protein on Body Composition
Official title: Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life - Three and Five Year Growth and Body Composition Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Acceleration
Keywords: Body composition
Protein Metabolism
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-12-09
Enrollment: 178
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Toddlers and Children who have previously participated in an infant formula trial where various levels of protein were provided and who are now at the age of 3 and 5 years.

Brief summary: The purpose of this study is to determine if toddlers and children who were fed breast milk or infant formulas at different levels of protein between 3 and 12 months of age have differences in growth and body composition at 3 and 5 years of age.


Eligibility criteria: Inclusion Criteria:

* Previous participation in infant formula controlled protein study
* Body composition data from 6 month of age available
* Consent obtained from legal representative
* Within age parameters specified in protocol around the 3 and 5 year age points

Exclusion Criteria:

* Unable to endure testing procedures upon evaluation of the Investigator
* Outside the age range of the study

Primary outcomes:
measure: Mean weight gain
timeFrame: 3 years
measure: Mean weight gain
timeFrame: 5 years
Secondary outcomes:
measure: Body composition
timeFrame: 3 years
measure: Body composition
timeFrame: 5 years
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The Samuel J Fomon Infant Nutrition Unit Department of Pediatrics, University of Iowa
state: Iowa
city: Oklahoma City
country: United States
facility: Department of Pediatrics, University of Oklahoma Health Sciences
state: Oklahoma
Study officials:
References: