louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03129087: The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Official title: The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adductor Spasmodic Dysphonia
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The proposed study is a randomized, cross-over, clinical trial involving the comparison of two treatments (A and B) separated by a wash-out period (W). The patient participants will be randomized to one of the following two treatment orders: AWB or BWA.
Primary purpose: TREATMENT

Brief summary: This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles.

Exclusion Criteria:

* Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)

Primary outcomes:
measure: Severity of spasmodic dysphonia symptoms
timeFrame: Six weeks post-treatment
measure: Patient-reported outcome measures of symptoms and communication
timeFrame: six weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: LawsonHRI
state: Ontario
Study officials:
References:
Clinical trial NCT05131087: A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
Official title: A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label
Primary purpose: TREATMENT

Brief summary: To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.

Detailed description: CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach

Eligibility criteria: Inclusion Criteria:

* 22-80 years of age.
* moderate to severe refractory glaucoma
* Able to consent

Exclusion Criteria:

* Women of child-bearing potential
* Intraocular surgery or laser within the last 3 months
* Ocular infection or inflammation within the last 6 months or currently active
* Current use of anti-coagulant therapy
* History of bleeding disorder or coagulopathies
* Subject plans to undergo any ocular surgery (including cataract surgery) during the study period
* History of corneal transplantation
* History of ICE Syndrome or epithelial ingrowth/downgrowth
* History of congenital glaucoma
* Elevated episcleral venous pressure

  -. Persistent angle closure-
* Previous glaucoma filtration surgery- -Presence of conjunctival scarring -
* neovascular glaucoma
* AC lens or scleral sutured IOL
* Aphakia
* inability to DC contact lenses
* Presence of intraocular silicone oil
* Vitreous in AC

Primary outcomes:
measure: Assessment of AEs
timeFrame: 12 months
Secondary outcomes:
measure: Surgical Experience Evaluation
timeFrame: 12 months
measure: Change in IOP
timeFrame: 12 months
measure: Change in IOP Lowering Medications
timeFrame: 12 months
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Clinica Laser y Ultrasonido Ocular de Puebla
Study officials:
affiliation: New World Medical, Inc.
name: Mark Sun, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00971633: A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Official title: An Open-Label, Randomized, Single Dose, 3-period Crossover Study to Determine the Bioequivalence of 3 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 12
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: This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.


Eligibility criteria: Inclusion Criteria:

* If female, subject is not pregnant or breast-feeding
* Subject is a nonsmoker
* Subject is in good general health

Exclusion Criteria:

* Subject has a history of high blood pressure, asthma, or cardiovascular, liver, neurologic, or kidney disease
* Subject is taking prescription or nonprescription drugs that can not be discontinued during the study
* Subject is a habitual and heavy consumer of caffeine

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC) of Ondansetron
timeFrame: 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours post dose
measure: Maximum Plasma Concentration (Cmax) of Ondansetron
timeFrame: 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06716333: The Effects of Periodic Training on Physical and Motor Performance in Wrestlers
Official title: The Effects of Periodic Training on Physical and Motor Performance in Wrestlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of 12 Weeks of Wrestling Training
Keywords: Training
Wrestling
Motor performance
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 33
Sex: MALE
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study was to investigate the effects of 12 weeks wrestling training on the physical and motor performance parameters of wrestlers in athlete training centers. The effect of 12 weeks of intensive training was investigated in 33 wrestlers aged 12-14 years in athlete training centers in Çorum province. Paired samples t-test was used in the statistical procedures.


Eligibility criteria: Inclusion Criteria:

Male wrestlers aged 12-14 years. Participants enrolled in athlete training centers in Çorum province. Those who have given informed consent and whose legal guardians have also provided consent.

Participants who have no physical or medical conditions preventing them from performing intense physical activity.

Participants who are actively attending training sessions during the study period.

Exclusion Criteria:

Wrestlers with chronic illnesses or injuries that could interfere with physical training.

Participants who do not regularly attend the training program. Individuals who did not provide informed consent or whose guardians did not consent.

Primary outcomes:
measure: Effects of Periodic Training on Physical and Motor Performance in Male Wrestlers
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Wrestling Center
Study officials:
References:
Clinical trial NCT02816333: Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type B Aortic Dissection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type B aortic dissection requiring thoracic endovascular aortic repair

Brief summary: Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.

Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.


Eligibility criteria: Inclusion Criteria:

1. a) In case of acute Type B dissection (14 days from first dissection)

   * Maximum aortic diameter \>40 mm or
   * Increase in aortic diameter \>2 mm from baseline b) In case of subacute (15\~90 days) or chronic (90 days \~ 1 year) Type B
   * Maximum aortic diameter \>55 mm or
   * Increase in aortic diameter \>4 mm from baseline
2. Age 19-80 years.
3. Aorta anatomy appropriate for stent graft therapy,

   1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.
   2. Proximal landing zone length \>20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.
4. Declaration of voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

1. Endorgan ischemia or evidence of malperfusion due to aortic dissection
2. Aortic rupture or impeding rupture due to aortic dissection
3. Renal dysfunction with serum Cr level \>2.0 mg/dL
4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
5. Uncontrolled active infection or active vasculitis.
6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.
7. Previous thoracic aorta surgery or stent-graft implantation
8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
9. Women with positive pregnancy test or at child bearing age
10. Life expectancy \<1 year due to comorbidity

Primary outcomes:
measure: Major adverse event
timeFrame: 12 months
Secondary outcomes:
measure: Aortic remodeling
timeFrame: 12 months
measure: Aorta-related complications
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02665533: Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
Official title: Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Edema
Trismus
Keywords: pain measurement
edema
trismus
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Detailed description: The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Eligibility criteria: Inclusion Criteria:

* Patients with indication of asymptomatic bilateral extractions of lower third molars;
* Aged 18 years or older;
* Have a good health and no disease;

Exclusion Criteria:

* Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.

Primary outcomes:
measure: Post-surgical swelling of third molar extraction determined using linear measures in the face
timeFrame: Up to seven days post-surgical
measure: Post-surgical trismus of third molar extraction determined by maximum mouth opening
timeFrame: Up to seven days post-surgical
measure: Post-surgical pain of third molar extraction using visual analogic scale
timeFrame: Up to seven days post-surgical
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Up to seven days post-surgical
measure: Duration of surgery
timeFrame: Up to seven days post-surgical
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Universidade Federal dos Vales do Jequitinhonha e Mucuri
state: Minas Gerais
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Thiago Lima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02009033: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery. A Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Disorders of Coagulation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 40
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 investigate the effect of thin fluid with starch versus thin fluid without starch on coagulation in elective surgery when the patient is normovolæmic during operation.

Detailed description: The primary goal is to register coagulation on basis of blood samples inclusive thromboelastography results.

The secondary goal is to register blood loss and use of blood products during operation.

The trial concerns 40 patients.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years.
* Indication for elective surgery with removal of the urine bladder.
* Patient without anticoagulative, acethylsalisylsyre or NSAID medicine during the last 5 days,if using.

Exclusion Criteria:

* Cerebral haemorrhage
* Renal insufficiency demanding dialysis
* Manifest cardiac and hepatic insufficiency
* Disturbance in coagulation
* Hypernatriæmi
* Hyperchloræmi
* Pregnant or nursing
* Allergic to hydroxyethylstarch
* Participating in another trial-if interferring the present trial
* Incapable of managing his own affairs.

Primary outcomes:
measure: Estimate coagulation on basis of bloodsamples
timeFrame: 6 months
Secondary outcomes:
measure: Estimate coagulation by bloodloss and need for transfusion
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet , Dept. 2042, 2100 Copenhagen
name: Niels Henry Secher, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03823833: Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors
Official title: Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Dermoid Cyst
Mucinous Cyst
Keywords: Oocyte freezing
fertility preservation
ovarian cysts
benign ovarian tumor
endometrioma
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Young women with benign ovarian tumors and high risk of further infertility due to surgery

Brief summary: Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be necessary to identify the nature of the cyst and assess its benignity. In some case, cysts are recurrent and multiple surgeries are needed leading to a significant risk of ovarian damage by follicular depletion. Oocyte cryopreservation is no longer considered as an experimental technique of Fertility Preservation since 2013 as it has been recognized to be efficient and safe. According to reproductive medicine scientific committees and the French ethic law, fertility preservation has to be proposed in every situation of infertility risk. To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in this specific subgroup of patients. The purpose of the study is to prospectively evaluate the oocyte number and quality after controlled ovarian hyperstimulation in patients with recurrent ovarian cysts.


Eligibility criteria: Inclusion Criteria:

* women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma, dermoid cysts or mucinous cysts.
* women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst diameter higher than 5 cms
* Having a social insurance
* Able to give an informed consent

Exclusion Criteria:

* Borderline tumors
* Undetectable AMH levels
* Personal history of thrombo-embolic events
* pregnancy

Primary outcomes:
measure: Number of mature oocytes eligible for cryopreservation
timeFrame: After 15 days of controlled ovarian hyperstimulation (COH)
Secondary outcomes:
measure: Percentage of immature or morphologically abnormal oocytes
timeFrame: Real-time, the day of egg retrieval
measure: Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation
timeFrame: The day of HCG triggering at the end of ovarian stimulation
measure: Questionnaire on tolerance and complications
timeFrame: One week after the egg retrieval
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Christine Decanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02800733: Effects of Saffron on Mild to Moderate Generalized Anxiety Disorder (GAD)
Official title: The Effect of Saffron (Crocus Satious L.) in the Treatment of Mild to Moderate Generalized Anxiety Disorder: a Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Patients With Mild to Moderate GAD
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: anxiety disorder is one of the major public health problems worldwide. 25% of people experience anxiety disorders throughout life. Generalized anxiety disorder (GAD) is known as the most prevalent anxiety disorder. Saffron has previously approved as an effective adjuvant therapy in depression and might alleviate GAD symptoms.Since up to the best of our knowledge no human studies have assessed the therapeutic effect of saffron as an adjuvant therapy in GAD patients, Therefore, this study is planned to evaluateThe effect of saffron (Crocus satious L.) in the treatment of mild to moderate generalized anxiety disorder:


Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed with GAD according to DSM-V criteria, Hamilton score of 18-25

Exclusion Criteria:

* pregnancy and lactation
* receiving antipsychotic medications in a month prior to the recruitment
* suffered from other psychological disorders (e.g. bipolar disorder, schizophrenia, mood disorders), and drug abuse

Primary outcomes:
measure: Hamilton anxiety score
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04588233: Melatonin Adolescent Research Study
Official title: Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorders in Children
Keywords: Melatonin
Sleep Disturbance
Adolescents
Daytime Functioning
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).


Eligibility criteria: Inclusion Criteria:

* Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
* Ages 13 to 17 years old
* Able to understand, read, and write in English
* Melatonin naive

Exclusion Criteria:

* Obesity
* Use of psychiatric medication
* Drug(s), or supplements known to affect sleep
* History of head injury or concussion with loss of consciousness \>1 minute
* Daily consumption of \>1 caffeinated beverage
* Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)

Primary outcomes:
measure: Change in Objective Sleep Duration During Melatonin Administration
timeFrame: Change between baseline and two weeks
measure: Change in Objective Sleep Duration During Placebo Administration
timeFrame: Change between baseline and two weeks
Secondary outcomes:
measure: Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
timeFrame: Change between baseline and two weeks
measure: Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)
timeFrame: Change between baseline and two weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Loma Linda
country: United States
facility: Loma Linda U
state: California
Study officials:
affiliation: Loma Linda University
name: Tori Van Dyk, PhD
role: PRINCIPAL_INVESTIGATOR
References: