louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05741450: A Clinical Comparison of Two Soft Contact Lenses
Official title: A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Primary purpose: TREATMENT

Brief summary: The study objective was to gather short-term clinical performance data for two soft contact lenses.

Detailed description: The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They currently wear soft contact lenses, or have done so within the past two years.
* They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: 15 minutes
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 15 minutes
measure: Subjective Vision
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, PhD, MCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05491850: Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
Official title: Effects of Moderate Physical Activity on Early Symptoms of Peripheral Diabetic Neuropathy in Type-II Diabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Diabetic Neuropathy
Keywords: Type 2 diabetes mellitus, moderate physical activity, HbA1c, diabetic neuropathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 17
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study determines the effects of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes. Most of the literature shows the impact of physical activity to manage/controlling diabetes. Some studies were conducted on animals to study the impact of physical activity on diabetic neuropathy and neurogenesis. There is no study on the impact of physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans. This study finds the impact of moderate physical activity to manage early symptoms of peripheral diabetic neuropathy in patients with type-II diabetes in humans.


Eligibility criteria: Inclusion Criteria:

* Patients with Type-II Diabetes
* Diagnosed cases of Peripheral Diabetic Neuropathy
* Peripheral Diabetic Neuropathy Stage 1 \& 2
* Numbness or reduced ability to feel pain or temperature changes.
* Tingling or burning sensation.
* Sharp pains or cramps.
* Increased sensitivity to touch
* Males and females
* Age: 35-65
* HbA1c above 6.5
* Mild activity level on IPAQ-7 (\< 150min/per week)
* Berg Balance Scale score (\< 45)

Exclusion Criteria:

* Cardiac Issues
* Any neurological issue
* Lower limb deformity
* Acute injury
* Hip and Knee OA
* Patients with walking difficulty
* Diabetic foot

Primary outcomes:
measure: Effect of moderate physical activity on early symptoms of peripheral diabetic neuropathy in type-II diabetes
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: RHS Rehabilitation Center
state: Federal
Study officials:
References:
Clinical trial NCT02569450: Evaluation of Control Chart Impact on Surgical Outcomes
Official title: The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Digestive Surgery
Keywords: Surgery
Performance
Outcome
Control chart
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 157594
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: All patients operated in participating French public and private hospitals (cluster)

Brief summary: This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.


Eligibility criteria: Inclusion Criteria:

- All adults needing a digestive surgery who are hospitalized in one of the 40 departments

Exclusion Criteria:

* Age \< 18 years old
* Hospitalization \<24 hours
* Absence of surgical procedure
* Ambulatory care
* Palliative care
* Organ transplantation

Primary outcomes:
measure: Occurrence of any major adverse event during hospitalization
timeFrame: within 30 days following surgical procedure
Secondary outcomes:
measure: Occurrence of any death during hospitalization within 30 days of surgery
timeFrame: within 30 days following surgical procedure
measure: Occurrence of any complication during hospitalization within 30 days of surgery
timeFrame: at the end of hospitalization
measure: Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery
timeFrame: within 30 days following surgical procedure
measure: Occurrence of reoperation during hospitalization within 30 days of surgery
timeFrame: within 30 days following surgical procedure
measure: Number of hospital bed-days consumed
timeFrame: within 30 days following surgical procedure
measure: Hospitalization costs from a health insurance perspective
timeFrame: within 30 days following surgical procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Pôle IMER
Study officials:
References:
citation: Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840.
Clinical trial NCT02730208: A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Official title: A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.


Eligibility criteria: Inclusion Criteria:

* Homozygous for the F508del CFTR mutation
* Confirmed diagnosis of CF
* Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age, sex, and height during screening.
* Stable CF disease as judged by the investigator

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)
* Pregnant or nursing females.
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements.
* Any contraindication to undergoing chest imaging, as per the site's institutional guidelines

Primary outcomes:
measure: Absolute Change in Total Brody/CF-CT Score
timeFrame: From Baseline at Week 72
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to Week 76
Other outcomes:
Locations:
city: Chermside
country: Australia
city: Melbourne
country: Australia
city: Nedlands
country: Australia
city: New Lambton Heights
country: Australia
city: Parkville SIC
country: Australia
city: Randwick
country: Australia
city: South Brisbane
country: Australia
city: Subiaco
country: Australia
city: Westmead
country: Australia
Study officials:
References:
Clinical trial NCT02301208: Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma
Official title: A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed untreated NPC patients
* T1-2N1-3M0 or T3-4NxM0
* 18-70 years old
* with MRI examinations
* ECOG ≤ 2
* With written consent

Exclusion Criteria:

* With a second cancer
* Pregnancy
* With other severe diseases (blood,liver ,kidney or heart diseases)
* Could not be staged properly
* Without written consent

Primary outcomes:
measure: Response rate
timeFrame: 2 years
measure: Progress-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Tumor response
timeFrame: radiotherapy in 2 week、4 week、7 week
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06550323: Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure
Official title: Göğüs Tüpü Çıkarma İşlemi Sırasında Sanal Gerçeklik Uygulamasının Ağrı, Anksiyete ve Konfora Etkisi
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chest Tube Removal
Keywords: virtual reality
pain
anxiety
comfort
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 82
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: SUPPORTIVE_CARE

Brief summary: Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.


Eligibility criteria: * Study Inclusion Criteria:

  * Must be between the ages of 18-65,
  * Must have undergone coronary artery bypass graft surgery and have a chest tube,
  * Must participate in the study voluntarily,
  * Must not have vision or hearing problems,
  * Must not have disorientation in place and time,
  * Must not have any psychiatric disorders,
* Study Exclusion Criteria:

  * Those with chronic pain and routinely using painkillers,
  * Those using painkillers before the procedure,
  * Those with problems such as migraine, vertigo, dizziness,
  * Patients using prescription glasses and those having vision problems without glasses were not included in the study.

Primary outcomes:
measure: visual analog scale
timeFrame: 5 month
measure: State-Trait Anxiety Inventory Scale
timeFrame: 5 month
measure: comfort scale
timeFrame: 5 month
measure: verbal pain scale
timeFrame: 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT00000223: Alternate-Day Buprenorphine Administration. Phase IV - 5
Official title: Alternate-Day Buprenorphine Administration. Phase IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if three times a subject's daily maintenance dose will hold for 72 hours without changes in agonist and antagonist effects.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Opioid agonist effects
measure: Dose identification
measure: Pupil diameter
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417723: Effect of Maxillary Nerve Block for Septoplasty
Official title: Effect of Maxillary Nerve Block for Septoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: postoperative pain
maxillary nerve block
septoplasty
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2024-05-16
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
Intervention model description: two groups designed from septoplasty patintes for study.

1. only general anesthesia
2. General anesthesia + maxillary nerve block
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.

Detailed description: Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.

The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.

Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.

Eligibility criteria: Inclusion Criteria:

* ASA I-II , Septoplasty patints

Exclusion Criteria:

* ASA III-IV
* Deny to participte in study

Primary outcomes:
measure: The visual analog pain score
timeFrame: three months
Secondary outcomes:
measure: Quality of recovery (QoR -15)
timeFrame: three months
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman Training and Research Hospital
Study officials:
References:
Clinical trial NCT03687723: Observational Study of the Clinical Use of the OCS™ Heart
Official title: Observational Study of the Clinical Use of the Organ Care System (OCS™) in Heart Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplantation
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring heart transplantation who receive OCS™-preserved heart transplants.

Brief summary: Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)

Detailed description: This is an observational study at two centers that will enroll minimum of 60 heart transplant recipients transplanted with donor heart preserved using the OCS™ Heart System. All consented subjects who receive OCS™-preserved heart transplants will be approached for participation. The study will evaluate short and long-term effectiveness of the OCS™ Heart System for heart transplantation.

Eligibility criteria: Inclusion Criteria:

All recipients of heart transplantation with Use of the OCS™ Heart

Exclusion Criteria:

Donor Hearts

* Presence of coronary heart diseases
* acute myocardial infarction
* Presence of heart valve disease (Stenosis or Insufficiency \> first degree)
* Presence of left ventricular hypertrophy (septum and posterior wall thickness \>1.7 cm)
* State of shock of donor (MAP \<60 mmHg, CVP \>15, PCWP \>15 mmHg) with use of Dobutamine \>10 ug/kg/min and/or Norepinephrine \> 0.5 ug/kg/min or Epinephrine \> 0.2 ug/kg/min
* irreversible persistant pulmonary hypertrophy, defined as transpulmonary gradient \>15 mmHg of the recipient

Primary outcomes:
measure: Patient Survival
timeFrame: 12 months
Secondary outcomes:
measure: Patient and Graft Survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Study officials:
affiliation: Hannover Medical School
name: Fabio Ius, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704223: Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes
Official title: Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female above 18 years with type 2 diabetes

Brief summary: This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c over 7%
* No contraindication with NovoMix® 70

Exclusion Criteria:

* Type 1 diabetes
* Subjects participating in a clinical trial or another observational study
* Subjects under previous basis-bolus insulin therapy
* Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Primary outcomes:
measure: number of major and minor hypoglycaemic events and adverse events
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c
timeFrame: 3 months
measure: PPBG
timeFrame: 3 months
measure: FBG
timeFrame: 3 months
Other outcomes:
Locations:
city: Wien
country: Austria
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: