louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04417582: Life Style Modification Medical and Surgical Management in Patients With Obesity
Official title: Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Weight Change, Body
Obesity; Endocrine
Obesity, Metabolically Benign
Keywords: obesity
weight loss
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese patients refered to our tertiary center for obesity evaluation or treatment

Brief summary: In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years

Detailed description: Following available clinical and laboratory parameters will be collected for 5 years Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits quality of life body mass index , blood pressure body fat distribution (impedance measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid, albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine ,forarm)

Eligibility criteria: Inclusion Criteria:

Body mass index over 30 kg/m2 age between 18-65 years

Exclusion Criteria:

active malignancy pregnancy during involvement period chronic inflamatuar diseases

Primary outcomes:
measure: weight loss
timeFrame: 6 months interval
measure: metabolic improvement
timeFrame: 6 months interval
measure: metabolic improvement
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Medical School Section of Endocrinology and Metabolism
Study officials:
References:
Clinical trial NCT04588831: Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy
Official title: Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy: a Single-center, Single Blind Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Protectors
Keywords: mouth protectors
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2020-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: There is no current evidence on the comfort or wearability of orthodontic mouthguards. These mouthguards adapt to the mouth without the need for dental impressions and laboratory facilities and are suggested to be more comfortable for orthodontic patients by allowing the teeth to move during treatment without the need for them to be replaced regularly during treatment. This study aims to assess and compare the comfort and wearability of orthodontic mouthguards with custom-fitted mouthguards. The results of this study will allow orthodontists to provide evidence-based information to individuals undergoing fixed appliance therapy.


Eligibility criteria: Inclusion Criteria:

* Undergoing active orthodontic treatment with pre-adjusted edgewise fixed appliances only for a minimum period of 9 months
* Playing sports where the use of a mouthguard is recommended
* Playing at least 120 minutes of sport (match or training) during a 6-8 week period
* Class I, II or mild III (edge-to-edge) incisor malocclusion
* Able to complete a VAS questionnaire
* No diagnosed sensory processing disorder

Exclusion Criteria:

* Undergoing active orthodontic treatment that is not pre-adjusted edgewise fixed appliances, or requires a fixed expander, or treatment is likely to be completed within 9 months
* Playing sports where the use of a mouthguard is not recommended Playing less than 120 minutes of sport (match or training) during a 6-8 week period
* Moderate to severe class III (reverse overjet) incisor malocclusion
* Unable to complete a VAS questionnaire
* Have a diagnosed sensory processing disorder

Primary outcomes:
measure: Comfort and wearability of all three mouthguards
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kalra A, Harrington C, Minhas G, Papageorgiou SN, Cobourne MT. Wearability and preference of mouthguard during sport in patients undergoing orthodontic treatment with fixed appliances: a randomized clinical trial. Eur J Orthod. 2022 Jan 25;44(1):101-109. doi: 10.1093/ejo/cjab062.
Clinical trial NCT02077231: Study of Vitamin A and Carbomer in Comforting the Ocular Surface Irritations of Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open-angle Glaucoma
Lead sponsor: Shanghai Jinshan Hospital
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 30
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: Most of the patients under long application of anti-glaucoma eyedrops endure severe ocular surface irritation, which interrupt their quality of life a lot. Lots of studies aimed to search for new drugs for therapy. The investigators hypothesized that the artificial tears containing vitamin A or carbomer may be a great substitute. Both of the two drugs were in common use and had already been tested in animals.


Eligibility criteria: Inclusion Criteria:

- diagnosed primary open-angle glaucoma or normal tension glaucoma patients with prostaglandin analogs treatment for more than one year.

Exclusion Criteria:

1. any systemic diseases which may cause ocular damage;
2. previous ocular trauma or surgery;
3. contact lens wear history in previous 6 months;
4. application of any artificial tears 3 months ago;
5. allergic to any of the drugs we used during examination.

Primary outcomes:
measure: change of the density of conjunctival goblet cells
timeFrame: change from Baseline in goblet cell density at 6 months
Secondary outcomes:
measure: tear film parameters changes in patients
timeFrame: change from baseline in TBUT and Schirmer test at 6 months
measure: changes of ocular irritation in patients
timeFrame: change from baseline in OSDI scores at 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02590731: The Influence of Cognitive Status on Walking Abilities After Femoral Neck Fracture
Official title: The Influence of Cognitive Status on Walking Abilities After Hemiarthroplasty for Femoral Neck Fracture: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Femoral Neck Fracture
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 188
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with displaced femoral neck fractures.

Brief summary: Introduction: Femoral neck fracture is a devastating injury with serious medical and social consequences. One third of these patients have some degree of impaired cognitive status. Despite of this, a high proportion of hip fracture trials exclude patients with cognitive impairment. The investigators aimed to evaluate whether moderate to severe cognitive impairment could predict walking ability, quality of life, functional outcome, reoperations and mortality in elderly patients treated with hemiarthroplasty.

Methods: This cohort study included a consecutive series of 188 patients treated with hemiarthroplasty for an displaced femoral neck fracture. Patient were assessed for estimated preoperative and 1 year postoperatively with regard to walking abilities, cognitive status, quality of life with EQ-5D and hip function with Harris hip score.


Eligibility criteria: Inclusion Criteria:

* 65 year or above
* Displaced femoral neck fracture
* Treated with a hemiarthroplasty

Exclusion Criteria:

* Pathological fractures
* Bilateral femoral neck fractures
* Bed-ridden patients.

Primary outcomes:
measure: Walking abilities
timeFrame: 2 years
Secondary outcomes:
measure: Harris hip score
timeFrame: 2 years
measure: EQ-5D
timeFrame: 2 years
measure: Reoperation
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Sebastian Mukka, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedbeck CJ, Inngul C, Blomfeldt R, Ponzer S, Tornkvist H, Enocson A. Internal fixation versus cemented hemiarthroplasty for displaced femoral neck fractures in patients with severe cognitive dysfunction: a randomized controlled trial. J Orthop Trauma. 2013 Dec;27(12):690-5. doi: 10.1097/BOT.0b013e318291f544.
Clinical trial NCT04960631: Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study
Official title: Evaluation of Clinical Significance and Feasibility of CT Guided Biopsy of Double Site Lesions：A Preliminary Lung Centered Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma of the Lungs
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical data of 134 consecutive patients with suspected malignancy who underwent dual site CT guided biopsy in the Third Hospital of Peking University from January 2011 to October 2014

Brief summary: This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Detailed description: CT guided biopsy is minimally invasive, accurate and low cost. It is often used as an important diagnostic method when the clinical suspect of malignant disease or the treatment effect of the disease is not good. In patients with suspected malignant lung disease, metastasis of other parts of lung, pulmonary door, mediastinum, bone, and distant soft tissue may be combined at the same time. It is the key link of clinical work to evaluate the nature of these coexisting lesions accurately and choose appropriate treatment methods. At present, there is little clinical study on lung centered double site biopsy. This study aims to explore the clinical significance and feasibility of double site biopsy by analyzing the pathological characteristics and the incidence of main complications of CT guided puncture biopsy of lung and other parts coexisting lesions.

Eligibility criteria: Inclusion Criteria:

* patients with suspected malignancy
* underwent dual site CT guided biopsy in the Third Hospital of Peking University

Exclusion Criteria:

-

Primary outcomes:
measure: for the combination of two site biopsies
timeFrame: up to 2weeks
measure: for the combination of two site biopsy approaches 1
timeFrame: up to 2weeks
measure: for the combination of two site biopsy approaches 2
timeFrame: up to 2weeks
measure: for the combination of two site biopsy approaches 3
timeFrame: up to 2weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Huishu Huishu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522531: Effect of Open Kinetic Chain Shoulder Exercises on Scapulothoracic Muscle Activity on Stable and Unstable Ground
Official title: Effect of Open Kinetic Chain Shoulder Exercises on Scapulothoracic Muscle Activity on Stable and Unstable Ground
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness
Exercise
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Exercises used in shoulder rehabilitation compose of open kinetic chain and closed kinetic chain exercises.The force formed on the trunk and legs is transferred to the shoulder in open and closed kinetic chain exercises before shoulder muscles activation. It was shown that trunk and leg muscle activity changes when they are performed in different ground. But it is unknown how this alteration effect shoulder muscle activity. This will be provide a significance approach due to incremented of shoulder muscle activity is important for shoulder rehabilitation setting. To achieve this aim that is rising of muscle activity, various approach is applied including alteration of ground which individual performed exercise on it. And, it was shown that closed cinetic chain exercise which performed on different ground change shoulder muscle activity. However, it is unknown whether alteration of ground effect shoulder muscle activity or not in open cinetic chain exercise. That's why the aim of this study is to investigate alteration of scapulothoracic shoulder muscle activity in open cinetic chain shoulder exercise which enforced different ground.


Eligibility criteria: Inclusion Criteria:

* Being healthy
* Right hand dominant
* Ages between 20-45 years
* To be volunteer participate in the study

Exclusion Criteria:

* Having any shoulder pain in current or in the past
* Any previous surgery
* Pain in any part of the body
* Doing regularly a professional sports
* Neurological disease
* Systemic disease

Primary outcomes:
measure: Muscle recruitment firing
timeFrame: Change from baseline muscle recruitment firing to in 5 minutes after completion of exercise
Secondary outcomes:
measure: Muscle thickness evaluation
timeFrame: Change from baseline muscle recruitment firing to in 5 minutes after completion of exercise
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Universty
state: Sıhhıye
Study officials:
References:
Clinical trial NCT04278131: BS01 in Patients With Retinitis Pigmentosa
Official title: Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP in Patients With Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Retinitis Pigmentosa
Lead sponsor: Bionic Sight LLC
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A Phase 1/2, Safety and Efficacy Trial of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAG-ChronosFP) in Patients with Retinitis Pigmentosa


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of retinitis pigmentosa
* Bare light perception in at least one eye

Exclusion Criteria:

* Prior receipt of any AAV gene therapy product
* Large amplitude nystagmus

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Outcome Measures
timeFrame: 12 months
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: New Jersey Retina
state: New Jersey
Study officials:
affiliation: Bionic Sight LLC
name: Sheila Nirenberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005931: SU5416 in Patients With AIDS-Related Kaposi's Sarcoma Who Have Not Responded to Treatment
Official title: A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Therapy-Refractory Cutaneous AIDS-Related Kaposi's Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma, Kaposi
HIV Infections
Keywords: Skin Neoplasms
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Antineoplastic Agents
Enzyme Inhibitors
SU 5416
Protein-Tyrosine Kinase
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of SU5416 in patients with AIDS-related Kaposi's sarcoma (KS).

Detailed description: Patients are given SU5416 via twice-weekly intravenous infusions in 4-week treatment cycles. Any patient who has not experienced unacceptable toxicity and who is deemed to be responding to the study drug (no evidence of disease progression) is permitted to continue receiving SU5416 in 4-week treatment cycles (up to a maximum of 1 year of therapy) until that patient experiences either unacceptable toxicity or tumor progression, as defined in the protocol.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Have KS.
* Have taken paclitaxel, DaunoXome, or Doxil for KS and they have either not gotten better or could not tolerate treatment therapy.
* Have 1 of the following symptoms for KS: 5 lesions (sores), generalized KS-related edema (swelling) without sores, or KS-related edema of the arms and legs.
* Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are pregnant or breast-feeding.
* Are allergic to Cremophor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Alison L. Hannah
state: California
Study officials:
References:
Clinical trial NCT01919931: Immunological Interaction Between the Host and Candida Albicans Biofilm
Official title: Immunological and Molecular Interaction Between the Host and Candida Albicans Biofilm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis
Keywords: Candida albicans
Candidiasis
Biofilm
Flow cytometry
Mannose Binding Lectin
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Candida albicans infection. Patients with no Candida albicans infection. Healthy volunteers

Brief summary: Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Patients infected with Candida albicans
* Patients not infected with Candida albicans

Exclusion Criteria:

* Underage patients
* Non consenting patients
* Unconscious patients

Primary outcomes:
measure: Immunological phenotyping of patients
timeFrame: 2 months
Secondary outcomes:
measure: Mannose Binding Lectin levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
state: Flemish Brabant
Study officials:
affiliation: Flemish Institute of Biotechnology
name: Adrian Liston, Group Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT01442831: Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
Official title: An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-TR-701 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: metabolic profile of TR-700 in plasma urine
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-09-29
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the single dose pharmacokinetics of total radioactivity in plasma and whole blood following PO administration of \[14C\] TR-701 in healthy adult male subjects.

Detailed description: This study will be an open-label, single-dose study of the absorption, metabolism, and excretion of 200 mg \[14C\]-TR-701 (approximately 100 μCi) administered orally following at least an 8-hour fast. Subjects will receive a single dose of 200 mg \[14C\] TR 701 (approximately 100 μCi) administered as an oral solution.

The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast from food, not including water.

Eligibility criteria: Inclusion Criteria:

1. Males, between 18 and 50 years of age, inclusive.
2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs.

Exclusion Criteria:

1. Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator and Sponsor).
2. History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
3. History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.

Primary outcomes:
measure: To describe the single dose plasma PK of TR-700, the microbiologically active molecule
timeFrame: pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Trius Investigator Site 001
state: Wisconsin
Study officials:
affiliation: Trius Therapeutics
name: Philippe G Prokocimer, MD
role: STUDY_CHAIR
References:
citation: Ong V, Flanagan S, Fang E, Dreskin HJ, Locke JB, Bartizal K, Prokocimer P. Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Drug Metab Dispos. 2014 Aug;42(8):1275-84. doi: 10.1124/dmd.113.056697. Epub 2014 May 29.