louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04700293: Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Official title: Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: Aymes International Limited
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

Detailed description: To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'AMSTERDAM' (to allow for prescription in the community at NHS expense).

Eligibility criteria: Inclusion Criteria:

* Male and female participants.
* ≥ 18 years of age.
* Participants of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days.
* Patient is able and willing to provide written informed consent.

Exclusion Criteria:

* Participants with medical or dietary contraindication to any feed ingredients.
* Participants requiring sole enteral tube feeding or parenteral nutrition.
* Participants with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
* Participants with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
* Participants with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Participants for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.

Primary outcomes:
measure: Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM
timeFrame: 7 days
Secondary outcomes:
measure: Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
timeFrame: 7 days
Other outcomes:
Locations:
city: Haywards Heath
country: United Kingdom
facility: AYMES International Ltd.
Study officials:
References:
Clinical trial NCT04944693: Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament Reconstruction.
Official title: A Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior tibial subluxation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anterior cruciate ligament-injured patients that had suffered from anterior cruciate ligament injury.

Brief summary: To identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.

Detailed description: The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.

Eligibility criteria: Inclusion Criteria: (1) Diagnosed anterior cruciate ligament injuries; (2) available preoperative MRI scans at our hospital.

-

Exclusion Criteria: Patients were excluded in the case of under 18 years of age, bilateral anterior cruciate ligament injuries, concomitant posterior cruciate ligament injuries, concomitant collateral ligament injuries, and no access to the preoperative MRI scan at our hospital.

-

Primary outcomes:
measure: Patients reported outcomes
timeFrame: at least 1-year postoperatively
Secondary outcomes:
measure: MRI images
timeFrame: at least 1-year postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Cheng Wang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00177593: The Effect of HealthWear on Short-Term Weight Loss
Official title: The Effect of HealthWear on Short-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Weight Loss
Obesity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2005-09-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of a computer tracking system and energy expenditure device on weight loss in adults.


Eligibility criteria: Inclusion Criteria:

1. 18-55 years of age.
2. Body mass index (BMI) between 25.0-39.9 kg/m2.
3. Access to a computer, Internet access, and will demonstrate proficiency with using the Internet and Web-based software programs. Potential participants will be asked to provide the type of computer they have, the name of their internet service provider, and will have to demonstrate their ability to search the internet during their screening visit.

Exclusion Criteria:

1. Report losing \>5% of current body weight in the previous 6 months.
2. Report participating in a research project involving weight loss or physical activity in the previous 6 months.
3. For women, report being pregnant during the previous 6 months, or planning on becoming pregnant over the following 3 months of the intervention. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. In addition, this will also be obtained as part of the signed medical clearance from the individual's personal physician.)
4. Currently being treated for any medical condition that could impact body weight (i.e., diabetes mellitus, cancer, etc.).
5. History of myocardial infarction, or a history of undergoing heart surgery such as bypass or angioplasty.
6. Taking medication that would affect heart rate or blood pressure responses to exercise (e.g., beta blockers).
7. Taking medication that could affect metabolism and/or contribute to a change in body weight (e.g., synthroid).
8. Being treated by a therapist for psychological issues or problems, taking pyschotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
9. No exclusion criteria shall be based on race, ethnicity, or gender.

Primary outcomes:
measure: weight loss
Secondary outcomes:
measure: fitness
measure: physical activity
measure: dietary intake
measure: mediators
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782093: A Phase 1 Ascending and Parallel Group Trial to Establish the Safety, Tolerability and Pharmacokinetics Profile of Volociximab (Alpha 5 Beta 1 Integrin Antagonist) in Subjects With Neovascular Age- Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-related Macular Degeneration
Keywords: AMD
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of volociximab intravitreous injection in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominantly classic, minimally classic or occult no classic) as documented by fluorescein angiogram.

Exclusion Criteria:

* Any prior treatment for AMD or any intravitreal treatment for any indication in the study eye prior to the screening visit, except oral supplements of vitamins and minerals.
* Previous or concomitant therapy with intravitreous corticosteroids.
* Any of the following underlying diseases including:
* Diabetic retinopathy
* History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
* History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
* Clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. Patients with results outside these ranges may be enrolled in consultation with Ophthotech.
* Stroke (within 12 months of trial entry).
* Any major surgical procedure within one month of trial entry.
* Previous therapeutic radiation in the region of the study eye.
* Any treatment with an investigational agent in the past 60 days for any condition.
* Women who are pregnant or nursing.
* Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the volociximab formulation.

Primary outcomes:
measure: The primary safety endpoint is the presence of any dose limiting toxicity (DLT)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06481293: Tackling Dry Socket Via Laser Therapy in Smokers
Official title: Tackling Dry Socket Via Dual Wavelength Laser Diode Therapy in Smokers: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alveolar Osteitis
Keywords: Diode laser
Dry socket
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included two groups. One group receives dual wavelength laser diode therapy and the other group receives topical aveogyl dressing.
Primary purpose: TREATMENT

Brief summary: This study examines the efficiency of diode laser therapy to manage dry sockets after tooth extraction.

Detailed description: The study compares the efficiency of diode laser therapy and using only alveogyl to accelerate the healing of dry sockets after tooth extraction in smokers. Smoker patients with dry sockets were enrolled randomly into two different groups. Group 1 received dual wavelength laser diode therapy, three times per week. While group 2 received only a topical application of alveogl. The treatment lasted for two consecutive weeks. The treatment efficiency was evaluated by measuring the volume of the socket using the syringe method. The pain level was measured by the visual analog scale.

Eligibility criteria: Inclusion Criteria:

* Smokers patient

Exclusion Criteria:

* Females on contraceptives.
* Diabetic patients
* Hepatitis C virus patients
* Patients on corticosteroids
* Patients with renal diseases
* Anemic patients

Primary outcomes:
measure: Socket volume
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain level
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University in Cairo
Study officials:
affiliation: Badr University in Cairo
name: reham Elkalla, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06197893: Modified Sling and Conventional Suture Techniques in Free Gingival Graft Operations
Official title: Comparison of Conventional and Modified Sling Suture Techniques In Free Gingival Graft Operations With CAIRO Type 2 and Type 3 Localized Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Localized
Keywords: Gingival unit graft
Sling suture
Shrinkage
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

Detailed description: Background: The aim of this study is to investigate the effects of conventional suture (CS) and modified sling suture (MSS) techniques, applied in free gingival graft (FGG) surgery using gingival unit graft (GUG) and conventional graft (CG) techniques, on clinical parameters and graft dimensions.

METHODS: 52 individuals having Cairo Type 2 (RT2) and Type 3 (RT3) gingival recessions in mandibular anterior region were divided into four groups as a) GUG+MSS (n=13), b) GUG+CS (n=13), c) CG+MSS (n=13) and d) CG+CS (n=13). Keratinized gingival width (KGW), keratinized tissue thickness (KGT), relative gingival recession height (rGRH), and relative vestibule depth (rVD) measurements were recorded using a digital caliper and periodontal probe UNC 15. Dimensional changes (Δ) of the graft surface area (GSA) was determined by ImageJ software. All measurements were done at baseline and repeated 1st and 3rd months.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals
* \<1 mm of attached gingiva on mandibular incisors
* PI and GI scores \<1
* Patients who had not previously undergone soft tissue surgery in the relevant area

Exclusion Criteria:

* Pregnant or lactating women
* Patients younger than 18 years old
* Mandibular incisors with having restoration, probing depth ≥ 3 mm, malposition and/or endodontic problem
* Maxillary premolars with gingival recession in the palatal area and/or prosthetic restoration

Primary outcomes:
measure: Graft shrinkage
timeFrame: baseline, 1-, 3-months after FGG surgery
Secondary outcomes:
measure: Keratinized tissue weight gain (KTW)
timeFrame: baseline, 1-, 3-months after FGG surgery
Other outcomes:
measure: Relative vestibule depth (rVD)
timeFrame: baseline, 1-, 3-months after FGG surgery
measure: Probing pocket depth (PD)
timeFrame: baseline, 1-, 3-months after FGG surgery
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
affiliation: Bezmialem Vakif University
name: Sadiye GUNPINAR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427593: Severe PID With Lymphoproliferation and Neutropenia
Official title: Phenotype-genotype Correlation in a Sub-population of Severe Primary Immunodeficiency With Lymphoproliferation and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Immune-Deficiency (PID) Common Variable Immune Deficiency (CVID)
Keywords: CVID
Neutropenia
Autoimmunity
Lymphoproliferation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to analyse the phenotype in a sub-population of adults with severe primary immunodeficiency with lymphoproliferation and neutropenia and to decipher the possible pathways involved, especially under the hypothesis of a CTLA4/LRBA schema


Eligibility criteria: Inclusion Criteria :

* \>18 years old
* CVID (Common Variable Immunodeficiency)
* Neutropenia
* Lymphoproliferation

Exclusion Criteria :

- Secondary immunodeficiency

Primary outcomes:
measure: Identification of known mutations by target sequencing of all known genes involved in CVID phenotypes.
timeFrame: Day 0 (inclusion)
measure: Identification of new mutations in new genes in CVID by WES (whole exome sequencing) strategy.
timeFrame: Day 0 (inclusion)
measure: Validation or not of a pathological pathway involving CTLA4/LRBA or a related pathway in T-cells. Validation by the mean of functional analysis of T-cells in vitro of CTLA4 expression and response to stimulation. RNA-sequencing in sorted cells.
timeFrame: Day 0 (inclusion)
Secondary outcomes:
measure: Deciphering of new possible genes involved in the phenotype : Patient without known mutation in genes involved in PID will benefit of an extended analyse of the WES to find a possible condidate genes
timeFrame: Day 0 (inclusion)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Immunologie Clinique et VIH - Hôpital Civil
Study officials:
References:
Clinical trial NCT01242293: Intrapartum Hydration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Stage, First
Labor Stage, Second
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine that maternal hydration during labor with fluids containing glucose at a rate of 125 ml per hour does not affect the duration of labor compared to Ringer Lactate at a rate of 250 ml per hour.

Detailed description: During labor it is a common practice that the parturient is fastening and having fluid replacement through intravenous hydration (IVH), the rational being to avoid aspiration of gastric content in a situation of need for urgent intervention and general anesthesia with tracheal intubation. It is acceptable to infuse 125 ml per hour of a physiological solution that does not contain sugar, but the volume is not adjusted to the weight of mother, the level of effort or relaxation she is experiencing and it may well be below the required amount. From studies in the field of sport medicine it is clear that the amount of fluid reaching the muscle has an impact on the efficiency of the muscle at the level of tissue and the level of personal achievement in sports. Only few studies dealt with the amount and contents of IVH during labor that will be sufficient and meet all physiologic requirements of the parturient and her fetus.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women
* Gestational age 37-41 weeks
* Cervical dilatation 1-3 cm
* Vertex presentation
* Singleton

Exclusion Criteria:

* Diabetes
* Preeclampsia
* Intra uterine fetal growth restriction
* Duration of labor less than an hour
* Maternal chronic disease
* Maternal fever upon admission.

Primary outcomes:
measure: Length of time from enrollment until delivery
timeFrame: within the first 48 hours after delivery
Secondary outcomes:
measure: Mode of delivery
timeFrame: within the first 48 hours after delivery
measure: Neonatal outcome
timeFrame: within the first 48 hours after delivery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Dep OB/GYN, HaEmek Medical Center
Study officials:
affiliation: Dep. OB/GYN, HaEmek Medical Center, Afula, Israel
name: Raed Salim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garmi G, Zuarez-Easton S, Zafran N, Ohel I, Berkovich I, Salim R. The effect of type and volume of fluid hydration on labor duration of nulliparous women: a randomized controlled trial. Arch Gynecol Obstet. 2017 Jun;295(6):1407-1412. doi: 10.1007/s00404-017-4381-1. Epub 2017 May 3.
Clinical trial NCT03417193: Opioid Free Anesthesia and Major Spine Surgery
Official title: Opioid Free Anesthesia in Major Spine Surgery: a Prospective, Double-blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Spine Disease
Keywords: Lidocaine
Dexmedetomidine
Opioid-free
Lead sponsor: Lebanese American University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the intraoperative opioid free anesthesia approach in multilevel spine posterior instrumentation surgery to a conventional opioid-based anesthesia. Half of participants will receive opioid free anesthesia with dexmedetomidine, lidocaine and ketamine while the other half will receive opioid based anesthesia with fentanyl, remi-fentanyl and ketamine

Detailed description: Opioid analgesics are commonly used in clinical practice for per and postoperative pain treatment. However their use is associated with a lot of undesirable effects. From this comes the idea of using opioid free anesthesia intra-operatively in an attempt to decrease opioids postoperative use and accordingly, their associated side effects.

Intravenous (IV) lidocaine has been found to have analgesic, antihyperalgesic, and anti-inflammatory properties. It was found to significantly improve postoperative pain, when its intraoperative use was compared with placebo .

Dexmedetomidine is a selective alpha-two adrenergic receptor agonist that has antinociceptive, analgesic, opioid sparing and sedative properties. Similar to lidocaine, dexmedetomidine was shown to lower postoperative pain, opioid consumption and accordingly, opioid related side effects.

Eligibility criteria: Inclusion Criteria:

* Age group: 18-80 years old
* American Society of Anesthesiologists (ASA )class I, II and III
* Elective spine posterior instrumentation surgery of at least two levels.

Exclusion Criteria:

* Renal, hepatic or cardiac insufficiency.
* Alcohol or drug abuse.
* Psychiatric disease.
* Allergy or contraindication to any of the study drugs.
* Inability to comprehend pain assessment or inability to use a Patient Controlled Analgesia (PCA) device.

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Postoperative morphine Side effects: Sedation score .
timeFrame: 48 hours post operative.
measure: Postoperative morphine Side effects:Respiratory depression
timeFrame: 48 hours
measure: Postoperative morphine Side effects: Nausea vomiting
timeFrame: 48 hours
measure: Postoperative morphine Side effects: Itching
timeFrame: 48 hours
measure: Postoperative pain score
timeFrame: 48 hours post operative.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: LAU Medical Center
Study officials:
affiliation: Lebanese American University/ LAU Medical Center
name: Hanane MD
role: PRINCIPAL_INVESTIGATOR
References: