louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00835432: Morphometric, Clinical and Histological Study on One Stage Bone Augmentation Using BoneCeramic (BCP) and Collagen Membranes
Official title: Prospective Clinical, Morphometric and Histological Study on Augmentation Using BoneCeramic as Bone Substitute in Combination With Either Cross-Linked or Non Cross-Linked Collagen Membrane in Dehiscent Type of Defects .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dehiscent Type of Alveolar Bone Defect
One Stage Bone Augmentation
Keywords: Lateral augmentation
GBR
BoneCeramic
collagen membrane
histomorphometry
morphometry
reentry
biopsy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized assessment of alveolar ridge alterations after augmenting dehisced areas by applying principles of guided bone regeneration (GBR) subsequently to implant installation.

Ossix as cross-linked and BioGide as non cross-linked degradable collagen membranes, both used in combination with biphasic Calcium-Phosphate (BoneCeramic) as bone substitute. Clinical measurements and impressions from the sites of interest are to be taken at the stage of augmentation and 6 months after. At six months re-entry non-standardized biopsies from augmented sites will be taken to determine newly grown tissue in quality and quantity.

Due to different degradation characteristics of the two collagen membranes used as barrier, amount of newly formed mineralized tissue is suspected to vary in tests and controls, respectively.


Eligibility criteria: Inclusion Criteria:

* alveolar ridge deficiences after tooth loss

Exclusion Criteria:

* systemic disorders (diabetes mellitus, morbus crown, etc.)
* pregnancy or lactating period

Primary outcomes:
measure: Alteration in width of alveolar bone at implant location after augmentation in mm
timeFrame: 6 months
Secondary outcomes:
measure: Histomorphometry in regard to areas occupied by bone to soft tissue to grafting material
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Periodontology Charité Center3 CBF, Assmannshauser Str. 4-6, 14197 Berlin, Germany
name: Anton Friedmann, Dr., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03864432: An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Official title: An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects (aged 19\~45 years at the time of screening)
* Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
* Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
* Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.

Exclusion Criteria:

* Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
* Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
* Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.

Primary outcomes:
measure: AUClast of Gemigliptin
timeFrame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
measure: Cmax of Gemigliptin
timeFrame: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central hospital
Study officials:
affiliation: Shanghai Xuhui District Central Hospital
name: Yan-Mei Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03984032: LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Official title: Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: LMA Protector Cuff Pilot
LMA Supreme
Clinical Performance
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2019-06-12
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: OTHER

Brief summary: Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat


Eligibility criteria: Inclusion Criteria:

* Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

Exclusion Criteria:

* BMI \> 35
* Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
* Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)

Primary outcomes:
measure: Oropharyngeal leak pressure (OLP)
timeFrame: During induction of anaesthesia
Secondary outcomes:
measure: Mean time to insertion
timeFrame: During induction of anaesthesia
measure: Gastric tube insertion
timeFrame: After induction of anaesthesia
measure: Laryngeal view
timeFrame: After induction of anaesthesia
measure: Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Wilayah Persekutuan
Study officials:
References:
Clinical trial NCT05836532: Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Official title: Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Mitral Valve Disease
Mitral Regurgitation
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with degenerative MR, due to P2 prolapse, who underwent surgery with central edge to edge

Brief summary: Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery.

Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed.

The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).


Eligibility criteria: Inclusion Criteria:

* Mitral regurgitation with degenerative etiology
* Mitral pathology exclusively dependent on P2
* Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique.

Exclusion Criteria:

- Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

Primary outcomes:
measure: MR 2+ or more recurrency
timeFrame: through study completion, a minimum of 2 years
Secondary outcomes:
measure: Reintervention
timeFrame: through study completion, a minimum of 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele - Cardiac Surgery Department
Study officials:
References:
Clinical trial NCT05194332: Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
Official title: Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: depression
mental illness
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Must be right-handed
* Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
* Must be healthy (without medical, neurological, psychiatric illness)
* Must be psychotropic medication free (≥ 14 days)

Exclusion Criteria:

* Must not be a smoker
* Females must not be pregnant or nursing
* Must not suffer from claustrophobia
* Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
* Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.

Primary outcomes:
measure: Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
timeFrame: baseline, 5 mins post-LIFUP sonication
measure: Changes in brain resting state functional network as indicated by fMRI scan connectivity measures
timeFrame: baseline, 10-20 mins post-LIFUP sonication
Secondary outcomes:
measure: Change in performance on Reward Task
timeFrame: baseline, 1-hour post-LIFUP sonication
measure: Tolerability of LIFUP sonication as assessed number of adverse events
timeFrame: baseline, immediately after LIFUP sonication
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jair Soares, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06521632: Acupoint Stimulation Improves Cognition Under Hypoxia
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Cognitive Function Under Exposure to Hypoxia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognition
Keywords: transcutaneous electrical acupoint stimulation
cognition
hypoxia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.


Eligibility criteria: Inclusion Criteria:

* Male, age from 18 to 50 years

Exclusion Criteria:

* cardiopulmonary dysfunction;
* History of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases;
* A history of fever or respiratory infection within the last two weeks;
* Drinking alcohol or poor sleep within the last 24 hours

Primary outcomes:
measure: cognitive function measured by eye-tracking at 1 hour after hypoxia
timeFrame: 1 hour after hypoxia
measure: cognitive function measured by eye-tracking at 2 hours after hypoxia
timeFrame: 2 hours after hypoxia
Secondary outcomes:
measure: mean arterial blood pressure
timeFrame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
measure: heart rate
timeFrame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
measure: saturation of pulse oximetry
timeFrame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
measure: Cerebral oxygen saturation
timeFrame: starting from 10 minutes before hypoxia to 2 hours after hypoxia, every 5 minutes for 2 hours and 10 minutes
measure: total sleep time on the first day after hypoxia
timeFrame: the first day after hypoxia, in a total of 24 hours
measure: sleep efficiency(%) on the first day after hypoxia
timeFrame: the first day after hypoxia, in a total of 24 hours
measure: number of awake on the first day after hypoxia
timeFrame: the first day after hypoxia, in a total of 24 hours
measure: time of awake on the first day after hypoxia
timeFrame: the first day after hypoxia, in a total of 24 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT06831032: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response
Official title: A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Adenocarcinoma
Iliac Nodal Disease
Para-aortic Lymph Node Metastasis
Para-aortic Nodal Disease
Oligorecurrence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed prostate adenocarcinoma.
2. Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.
3. ≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.
4. ECOG performance status 0-2.

Exclusion Criteria:

1. Prior radiotherapy to the nodal echelon (PA +/- common iliac).
2. Active secondary malignancy, except for adequately treated non-melanoma skin cancer.
3. Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.
4. Contraindication to radiation.

Primary outcomes:
measure: Quantify adverse events using CTCAE v5.0
timeFrame: 2 years
Secondary outcomes:
measure: QoL using EPIC questionnaire
timeFrame: 2 years
measure: Pain levels using EPIC questionnaire
timeFrame: 2 years
measure: Urinary function using EPIC questionnaire
timeFrame: 2 years
measure: Bowel function using EPIC questionnaire
timeFrame: 2 years
measure: Assessment of adaptive RT approach using dose accumulation
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02621632: SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Official title: SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Insufficiency
Keywords: Compression therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

Detailed description: The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers: age \> 18 years, proband information read, consent form signed
* Patients: age \> 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age \> 18 year, patient information read, consent signed.

Exclusion Criteria:

* Active venous ulcer
* Peripheral arterial disease
* Peripheral neuropathy

Primary outcomes:
measure: Donning success.
timeFrame: Successful donning has to be completed within 5 minutes.
Secondary outcomes:
measure: Interface pressure
timeFrame: Interface pressure is measured within 5 minutes of complete donning of the stocking.
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Dermatology, University Hospital of Zurich, Switzerland
Study officials:
affiliation: University of Zurich
name: Juerg Hafner, Prof. (MD)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822132: Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
Official title: Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
HIV
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-04-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging).

The research is conducted in Portland, OR.


Eligibility criteria: Summary Inclusion Criteria:

* Diagnostic and Statistical Manual (DSM)-IV Methamphetamine Dependence
* Deemed healthy enough to participate by study physician
* Age 18-55
* Right handed
* English-speaking

Summary Exclusion Criteria:

* Current opioid use in the last 30 days; opioid abuse or dependence within past 5 years
* Pregnancy
* MRI contraindications (e.g. metal in head).

The research is conducted in Portland, OR.

Primary outcomes:
measure: Discounting Tasks: Sexual Probability Discounting (SexPD)
timeFrame: 28 days post drug intervention
measure: Discounting Tasks: Standard Delay Discounting (DD)
timeFrame: 28 days post drug intervention
measure: Barrat Impulsiveness Scale (BIS)
timeFrame: 28 days post drug intervention
measure: Risk Assessment Battery (RAB)
timeFrame: 28 days post drug intervention
Secondary outcomes:
measure: Methamphetamine Use
timeFrame: 28 days post drug intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Philip T Korthuis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohno M, Morales AM, Dennis LE, McCready H, Hoffman WF, Korthuis PT. Effects of Naltrexone on Large-Scale Network Interactions in Methamphetamine Use Disorder. Front Psychiatry. 2019 Sep 3;10:603. doi: 10.3389/fpsyt.2019.00603. eCollection 2019.
citation: Kohno M, Dennis LE, McCready H, Schwartz DL, Hoffman WF, Korthuis PT. A preliminary randomized clinical trial of naltrexone reduces striatal resting state functional connectivity in people with methamphetamine use disorder. Drug Alcohol Depend. 2018 Nov 1;192:186-192. doi: 10.1016/j.drugalcdep.2018.07.045. Epub 2018 Sep 21.