louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06728176: Safety and PK of Multiple Doses of MT1988
Official title: A Single Centre, Double Blinded, Randomised, Parallel Arm, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of MT1988 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Lead sponsor: Monument Therapeutics Limited
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the tolerability and amount of drug in the blood when four dose levels of MT1988 are administered for 14 days to healthy volunteers. The main question it aims to answer is:

* what side effects are seen while administering MT1988 for 14 days?
* how much of MT1988 can be measured in the blood at the beginning and end of administering MT1988 for 14 days?

Researchers will include a placebo arm (dummy drug) to compare the side effects.

Participants will:

* take MT1988 every day for 14 days
* visit the clinic once per week for assessments
* keep a diary to record information between clinic appointments.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* providing informed consent
* for females of child-bearing potential with fertile male partner - willing to comply with contraception requirements

Exclusion Criteria:

* no current or past condition which may compromise the study objectives or participant safety
* no clinically significant finding at screening, including physical examination, blood tests, medical history, concomitant medication
* history of drug abuse or dependence within the previous 2 years

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: From Day 1 to end of follow up (Day 21-28)
Secondary outcomes:
measure: Pharmacokinetics of single dose of MT1988 across four dose levels - Cmax
timeFrame: Days 1-2
measure: Pharmacokinetics of multiple doses of MT1988 across four dose levels - Cmax
timeFrame: Days 14 to 17
measure: Pharmacokinetics of single doses of MT1988 across four dose levels - Tmax
timeFrame: Days 1-2
measure: Pharmacokinetics of multiple doses of MT1988 across four dose levels - Tmax
timeFrame: Days 14 to 17
measure: Pharmacokinetics of single doses of MT1988 across four dose levels - AUC
timeFrame: Days 1-2
measure: Pharmacokinetics of multiple doses of MT1988 across four dose levels - AUC
timeFrame: Days 14 to 17
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: BDD Pharma Ltd
Study officials:
affiliation: BDD Pharma
name: Medical Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134976: Wound Complications in Head and Neck Surgery
Official title: Wound Complications in Head and Neck Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism; Surgery
Head and Neck Cancer
Wound Heal
Laryngeal Cancer
Laryngeal Fistula
Keywords: Salvage surgery
Head and neck cancer
Wound healing
Hypothyroidism
Levothyroxine
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the University of Michigan Department of Otolaryngology- Head and Neck Surgery.

Brief summary: This is a prospective observational study evaluating wound complications following head and neck surgery. Patients undergoing major head and neck surgery will be included in the study. Patients meeting eligibility criteria will be identified by members of the University of Michigan Head and Neck Oncology Division of the Department of Otolaryngology. The primary aim of this study is to identify risk factors for poor wound healing as well as biologic markers associated with wound related complications in head and neck surgery. Most specifically, this study evaluates the effects of thyroid hormone on wound healing. This study will also evaluate pre-operative labs and comorbidities as well as reconstructive factors, post-operative labs, and other variables associated with wound healing. All interventions regarding wound healing fall under current standards of care and standard practice. Data regarding post-operative wound complications will be collected in a prospective fashion on the variables under study using study-specific datasheets. Data sheet will be entered into a secure database for analysis.


Eligibility criteria: Inclusion Criteria:

* In both groups: subjects must be 18 years or older with biopsy confirmed cancer of the head and neck.

Exclusion Criteria:

* Children and vulnerable populations are not eligible for participation. Patients undergoing functional (non cancer related) surgery, patients who have undergone more than 1 course of radiation to the head and neck, patients with a history of thyroid cancer, patients presenting initially with a malignant fistula, patients with previous intolerance or allergy to levothyroxine, and patients without a cancer diagnosis are not eligible. Patients may enroll if they are currently hypothyroid, but will be excluded from the study if thyroid function is not normalized by the time of surgery.

Primary outcomes:
measure: Number of patients treated with Levothyroxine who develop pharyngocutaneous fistula after salvage laryngectomy
timeFrame: 30 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05337176: Impact of Sleeve Gastrectomy on Balance and Cognitive Function
Official title: Impact of Sleeve Gastrectomy on Balance and Cognitive Function: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Sleeve Gastrostomy in Both Cognition and Balance
Keywords: sleeve gastrectomy
Balance
cognition
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: participants for gender (male and Female) , age ranged from 20 to 60 years old, were randomly involved After bariatric surgery from different regions across Saudi Arabia

Brief summary: Purpose of the study:

Purpose of study is to determine the effect of sleeve gastrectomy on balance and cognitive function in Saudi Arabia.

Aim of study:

To investigate if there is any change of balance and cognitive function disturbance after sleeve gastrectomy on participant.

Research hypothesis:

Sleeve gastrectomy have no impact on balance and cognitive function.

Inclusion criteria:

The participant will be selected according to the following criteria: 1.History of sleeve gastrectomy within 1 to 5 years.

2. Their age between (20-60 years). 3.Ability to walk without any assistive device. 4.All participant should be able to understand all requested instructions

Exclusion criteria:

The participant will be excluded if they have:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.
4. Pregnancy.

Material:

1. Introduction survey (willingness of participant) to recruit sittable participant.
2. Assessment form survey to collected data and result (include MOCA and App-coo application)


Eligibility criteria: Inclusion Criteria:

-

The participant will be selected according to the following criteria:

1. History of sleeve gastrectomy within 1 to 5 years.
2. Their age between (20-60 years).
3. Ability to walk without any assistive device.
4. All participant should be able to understand all requested instructions

Exclusion Criteria:

-

The participant will be excluded if they have:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.

Primary outcomes:
measure: impact of sleeve gastrectomy on cognition
timeFrame: 2 to 3 month
Secondary outcomes:
measure: impact of sleeve gastrectomy on balance
timeFrame: 2 to 3 months
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Rawan Alwafi
Study officials:
References:
Clinical trial NCT05710276: Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
Official title: Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Infrared Thermography
Child
Keywords: Crohn Disease
Infrared thermography
Faecal Calprotectin
PCDAI
Child
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 43
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions.

In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI.

All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CD according to the Porto criteria \[6\]
* Aged from 4 years to 17 years-old
* Follow-up at the Amiens Picardie University Hospital (CHU Amiens Picardie)
* Child's affirmative agreement and assent and permission of their parents to participate in research

Exclusion Criteria:

* Recent abdominal surgery
* Other Inflammatory bowel disease

Primary outcomes:
measure: correlation between the quantification of abdominal infrared radiation and faecal calprotectin concentration
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05911776: Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries
Official title: Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Packing
Dexmedetomidine
Turbinate
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
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: Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.

Detailed description: Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration. Potentially desirable effects include decreased requirements for other anesthetics and analgesics.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years
* Both sexes
* American Society of Anesthesiologists (ASA) physical status classification I or II.
* Undergo turbinate surgery

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2 existing or recent significant disease.
* Contraindications to the use of dexmedetomidine .
* History or presence of a significant disease significant cardiovascular disease risk factors.
* Significant coronary artery disease or any known genetic predisposition.
* History of any kind of drug allergy,
* Drug abuse.
* Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
* Known systemic disease requiring the use of anticoagulants,
* Patients with a history of previous turbinate surgery.

Primary outcomes:
measure: Amount of intraoperative blood loss
timeFrame: Intraoperative up to 6hours
Secondary outcomes:
measure: Pain score
timeFrame: 24 hours postoperative
measure: Quality of intraoperative surgical field
timeFrame: Intraoperative up to 6hours
measure: Patient's general satisfaction
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Karelsheikh University Hospital
state: Karelsheikh
Study officials:
References:
Clinical trial NCT03218176: Tourniquets Type Combat Application Tourniquet: Proximal or Distal Location, Simple or Staggered on Upper and Lower Limb
Official title: Tourniquets Type Combat Application Tourniquet (CAT): Vascular Suffering According to the Proximal or Distal Location, Simple or Staggered. Study to Upper and Lower Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A tourniquet is used to stop abundant bleeding when simple compression is not effective. The investigators will study the vascular suffering of the tourniquets according to their location on the limb: limb (arm / thigh) or distal (forearm / leg). Vascular suffering will be evaluated by the loss of the radial doppler flux for the tourniquets placed on the upper limb and in the tibial anterior to the lower limb by the loss of the pulse oximetry pulse and the collection of the signs described by the volunteers (pain, Paresthesia, cold sensation).


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years (major)
* Volunteer to participate in research

Exclusion Criteria:

* Age less than 18 years
* Known coagulation disorder
* Known vascular disorder
* Known neurological disorder of the limbs
* Known muscle disorders of the limbs
* Presence of an implant in one of the limbs (vascular, contraceptive ...)
* Simultaneous participation in research involving anticoagulant therapy
* History of phlebitis
* Persons of full age who are subject to legal protection (safeguard of justice, person placed in curatorship, guardianship), persons deprived of their liberty.
* Pregnant women

Primary outcomes:
measure: Upper limb : Assessment of Pain by Digital Evaluation (EN) after 10 min of compression
timeFrame: 10 min
measure: Lower limb : Pressure (mmHg) needed to abolish the pulse
timeFrame: 10 min
Secondary outcomes:
measure: Lower limb pain
timeFrame: 10 min
measure: Upper limb pressure under tourniquet
timeFrame: 10 min
measure: Pulse oximetry
timeFrame: 10 min
measure: Loss of arterial Doppler pulse
timeFrame: 10 min
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: CHU de Brest
name: Emilie Gelin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680376: Thyroid Hormone Values and Anti-thyroid Peroxidase Antibody Positivity in Recurrent Pregnancy Loss
Official title: Relationship Between Habitual Abortion With Thyroid Hormone Values and Anti-TPO (Anti-thyroid Peroxidase Antibody) Positivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Thyroiditis
Recurrent Miscarriage
Keywords: Thyroid Hormones
Anti Thyroid Peroxidase Antibody
Recurrent pregnancy loss
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was carried out with a total of 103 patients by retrospectively examining the patients who applied to the Gynecology and Obstetrics Clinic of Bülent Ecevit University Faculty of Medicine between 2018-2022

Brief summary: The aim of this study is to compare the thyroid hormone values and anti-thyroid peroxidase (anti-TPO) levels of women with a diagnosis of recurrent pregnancy loss (RPL) and healthy pregnancies. The primary objective is to find out the relationship between recurrent pregnancy loss with thyroid hormone levels and anti-TPO positivity.


Eligibility criteria: Inclusion Criteria:

* women with 2 or more pregnancy loses
* for controls women with least one healthy baby

Exclusion Criteria:

* any other metabolic disease
* women with one miscarriage

Primary outcomes:
measure: Anti-thyroid Peroxidase Antibodies
timeFrame: 4 years
measure: Thyroid Hormone Levels
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bulent Ecevit University Faculty of Medicine
Study officials:
References:
Clinical trial NCT00160576: Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
Official title: A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Parkinson Disease
Keywords: Idiopathic Parkinson's Disease, levodopa induced dyskinesia,
Levetiracetam, Keppra
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.


Eligibility criteria: Inclusion Criteria:

1. Male / female adult, 30 years old or more;
2. Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
3. Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
4. Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:

   1. with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
   2. with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).

Exclusion Criteria:

1. Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
2. Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
3. Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
4. Subject Who had undergone or who was scheduled for functional neurosurgery for Parkinson's disease during the trial period;

Primary outcomes:
measure: Evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease by assessing the reduction in mean duration of dyskinesias during "on" period at 10-week
Secondary outcomes:
measure: Reduction in mean duration of dyskinesias per day at 9 month;Safety
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05732376: Effectiveness of Two Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings
Official title: Investigation of the Effectiveness of Simulation-Based Functional Nasopharyngoscopic Velopharyngeal Assessment Trainings Given to Speech and Language Therapy Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Keywords: simulation
nasopharyngoscopy training
speech and language therapy
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial was to compare the effectiveness of functional nasopharyngoscopic velopharyngeal assessment training given to undergraduate speech and language therapy students on a 3D printed endoscopy training model and a ready-made endoscopy training model.


Eligibility criteria: Inclusion Criteria:

* To be a 4th year undergraduate student of speech and language therapy
* To have taken the course of cleft lip and palate or an equivalent course

Exclusion Criteria:

* Receiving previous hand-on flexible endoscopy training
* Having any health problem in the upper extremities

Primary outcomes:
measure: Nasopharyngoscopic Velopharyngeal Evaluation Clinician Experience
timeFrame: 2 Months
Secondary outcomes:
measure: Procedure time
timeFrame: 2 Months
measure: Volunteer Experience for Nasopharyngoscopic Velopharyngeal Evaluation
timeFrame: 2 Months
measure: Training Satisfaction Survey
timeFrame: 2 Months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Istanbul Medipol University, Institute of Health Sciences, Department of Speech and Language Therapy
name: Namık Y. Birol, Doctoral Student
role: PRINCIPAL_INVESTIGATOR
References: