louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02409641: A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Official title: A Pilot Study Investigating the Impact of Different IOL Designs on Subjective 2D and 3D Image Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lenses
Intraocular Sensitivity
Visual Acuity
Keywords: IOL
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The WHO, states that age related cataracts account for 51 percent of worldwide blindness and affect about 20 million people. Surgery with intraocular lens (IOL) implantation is the first line treatment for cataracts, thus there is an on going effort to improve IOL design and performance.

It is planned to compare three different IOL designs in a psychophysical test setting. Most IOL testing is done in 2D scenarios such as Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity or contrast sensitivity testing. The use of 3D scenario would allow testing a more real-life situation.

As various downsides of different IOL designs have been reported, testing of IOLs before surgical implantation is a promising approach to maximise patient satisfaction. Known deficiencies include amongst others reduced contrast sensitivity or light intensity.

To test three different IOL designs, it is planned to have 2D healthy young subjects look through a stable, table mounted spectacle frame, in which the different IOLs can be inserted. This allows for subjective testing of IOL's in a 2D and 3D scenario.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings
* Refractive spherical error between between -1 and +1 diopters, refractive cylindrical error between -0,25 and +0,25 diopters
* Dominant eye : right eye ( used as study eye)

Exclusion Criteria:

* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Primary outcomes:
measure: Visual Acuity measured by Early Treatment of Diabetic Retinopathy Study Chart
timeFrame: 1 study day
Secondary outcomes:
measure: Contrast Sensitivity measured by Pelli-Robson Contrast Sensitivity Chart
timeFrame: 1 study day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Doreen Schmidl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535041: Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
Official title: Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Keywords: Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot trial of pre-operative chemo/RT using Xeloda and external beam RT followed by definite surgery in patients with localized rectal CA


Eligibility criteria: Inclusion Criteria:

* Patients with localized rectal CA

Primary outcomes:
measure: safety
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KFSH&RC
Study officials:
affiliation: KFSH&RC
name: Shouki Bazarbashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061641: Prediction and Prevention of Twin Premature Birth 2021
Official title: Study on the Prediction and Prevention of Twin Premature Birth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preterm Birth
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort study
Primary purpose: TREATMENT

Brief summary: Research Objectives:

1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks.

Detailed description: Research Objectives:

1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection

Eligibility criteria: Inclusion Criteria:

twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy

Exclusion Criteria:

Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal abnormalities

Primary outcomes:
measure: Neonatal prognosis
timeFrame: one week
Secondary outcomes:
measure: Gestational age and prolongation of gestational age at delivery
timeFrame: one year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: caixia Liu
state: Liaoning
Study officials:
affiliation: 1050880483@qq.com
name: Wei jun, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT06026241: Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.
Official title: Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End-of-life Care
Keywords: End of life care
Geriatric
Death
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 75 years old who died in the geriatric short-stay departments of Saint-Etienne University Hospital

Brief summary: End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life management is deciding when to discontinue active care measures (for example blood pressure monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective observational study, the investigators looked at the care measures, treatments and paraclinical exams received by geriatric patients both one week and 24 hours before their death.

Detailed description: This analysis provides information on the differences in geriatric physicians' practices regarding the anticipation of the end of life, by showing on average when active care measures were stopped before death. Secondly, the investigators looked at patient criteria that could explain a prolongation of active care and a delay in the implementation of exclusive comfort care.

Eligibility criteria: Inclusion Criteria:

* All patients over 75 years old who died in a geriatric short-stay department at Saint-Etienne University Hospital.

Exclusion Criteria:

- Patients under 75 years old

Primary outcomes:
measure: Prevalence of care and treatments received during the last week of life, and during the last 24 hours of life
timeFrame: In the last week of life and 24 hours before death
Secondary outcomes:
measure: Patient criteria that may have explained the pursuit of care
timeFrame: In the last week of life and 24 hours before death
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Ludovic LAFAIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03896841: Ocular Findings of Polycystic Ovary Syndrome
Official title: Ocular Surface Disease Test Results, Corneal Biomechanical Properties, and Structural Parameters in Patients With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 38
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a prospective, case-control study in which 23 premenopausal patients with PCOS diagnoses and 15 non-pregnant healthy control subjects were included.

Brief summary: Purpose: This study aimed to compare the ocular surface disease test results, anterior segment parameters, and ocular response analyzer (ORA) findings of polycystic ovary syndrome (PCOS) patients with those of healthy reproductive age female controls.


Eligibility criteria: Inclusion Criteria:

* premenopausal with PCOS

Exclusion Criteria:

* patients with external ocular disease other than dry eye complaints,
* use of topical drops that can affect the tear film layer,
* contact lens use histories,
* those who received hormone therapy for 6 months,
* those who have systemic medication or systemic disease that may affect the tear film layer and reproductive physiology,
* previous eye surgeries,
* smokers and alcohol users,
* those having diseases (Cushing's syndrome or androgen-secreting tumors) causing similar clinical findings.

Primary outcomes:
measure: Comparison of the anterior segment parameter results (Pentacam).
timeFrame: 1 year
measure: Comparison of the corneal biomechanical parameter results (ocular response analyzer).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07007741: Digital Therapy for Fatty Liver Disease
Official title: A Randomised Controlled Trial Study of the Effect of Fatty Liver Data Analysis and Management Software on the Effectiveness of Intervention in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Steatohepatitis, Nonalcoholic
Nonalcoholic Fatty Liver
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomised controlled trial of the clinical application of the Fatty Liver Data Analysis and Intervention System (FLDAS) to compare the effectiveness of traditional lifestyle interventions in patients with fatty liver with digital therapies combining software and hardware devices; to validate the effectiveness of digital therapies in patients with fatty liver; and to evaluate the effectiveness of remote lifestyle (diet and exercise) interventions.

Researchers conducted a randomised controlled trial to compare the effectiveness of a traditional lifestyle intervention for patients with fatty liver with a remote lifestyle (diet and exercise) intervention combining digital therapy software and hardware devices. When the effectiveness of this programme is validated, it could help clinicians improve the efficiency of lifestyle interventions for patients with fatty liver and address the growing need for primary care for patients with fatty liver as an innovative approach to disease intervention.


Eligibility criteria: Inclusion Criteria:

* NAFLD patient (CAP value \>248 (dB/m))
* Age 18-65 years old, 24kg/m2 ≤ BMI ≤ 35kg/m2
* Must be able to use smartphone

Exclusion Criteria:

* Inherited metabolic or autoimmune liver disease
* Drug/toxic/alcoholic/biliary liver injury, cirrhosis or any end-stage liver disease
* Hepatic or extrahepatic malignant tumours
* Pregnant and lactating women
* Patients considered ineligible by the investigator's clinical judgment

Primary outcomes:
measure: Reduced body weight rate
timeFrame: Week 12 & Week 24
Secondary outcomes:
measure: Decreased CAP Value (Indicating Reduced Liver Fat)
timeFrame: Week 12 & Week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01282541: Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora
Official title: Determination of the Optimum Delivery Route for the Intraglandular Administration of Botulinum Toxin A in Patients With Refractory Epiphora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epiphora
Keywords: Tearing, Epiphora, Botulinum Toxin A
Lead sponsor: Merbs, Shannath, M.D., Ph.D.
Sponsor class: INDIV
First posted: 2011-01-25
Enrollment: 26
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: Epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. There is a growing consensus that injection of Botulinum Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes have been successful in symptom relief with minimal complications. However, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. Also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. The investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route (the most common route described in the literature). The investigators will also compare the side effect profile of each delivery route.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* ability to give informed consent
* symptoms of epiphora in the setting of either a patent lacrimal outflow system or an obstructed outflow system for which the patient does not desire surgical therapy or is a poor surgical candidate

Exclusion Criteria:

* pregnancy
* ocular motility abnormalities
* prior ptosis, and/or strabismus surgery
* more than 2 mm of pre-existing ptosis
* inability to give informed consent
* history of a bleeding disorder

Primary outcomes:
measure: Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up
timeFrame: 24 weeks
Secondary outcomes:
measure: Comparison of side effect between each treatment group
timeFrame: 24 weeks
measure: Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Shannath Merbs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356041: The Role of a Clinical Pharmacist in Lifestyle Modification in Type 2 Diabetic Patients With Peripheral Neuropathy
Official title: The Role of a Clinical Pharmacist in Lifestyle Modification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this study are to determine the prevalence of diabetic peripheral neuropathy among the diabetic patients, to determine the association between the clinical profiles of the diabetic patients (diabetes type, diabetes duration, HbA1c, body mass index, hypertension, total cholesterol) and the diabetic peripheral neuropathy DPN and the rational poly pharmacy used to control pain.


Eligibility criteria: Inclusion criteria

1. Aged 18 years or older.
2. Both sex.
3. Diagnosed with type 2 diabetes at least one year previously.
4. Took at least one prescribed medication for diabetes.
5. Diagnosed as diabetic peripheral neuropathy based on clinical

Exclusion Criteria:

1. History of alcohol consumption.
2. Thyroid gland disorder.
3. Any kidney disorder.
4. Any conditions that could confound assessment of pain due to diabetic peripheral neuropathy.
5. Have foot injury or open sore.
6. Pregnant females or who plan to become pregnant during the study period.
7. Any serious medical condition that might prevent completion or hinder compliance with exercise.

   -

Primary outcomes:
measure: Estimating Summary of diabetes self-care activity (SDSCA)
timeFrame: Three months
measure: Adherence to treatment according to Morisky scale
timeFrame: Three months
measure: Douleur Neuropathique 4 (DN4), Neuropathic Pain Scale (NPS),
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Prof. Kawa Dizaye
Study officials:
References:
Clinical trial NCT00666341: Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens
Official title: A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type I-Allergy
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 50
Sex: ALL
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: Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)


Eligibility criteria: Inclusion Criteria:

* main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens
* positive SPT
* positive EAST
* positive specific provocation test

Exclusion Criteria:

* serious chronic diseases
* other perennial allergies

Primary outcomes:
measure: Systemic reaction (according to Tryba)
timeFrame: uptitration phase
Secondary outcomes:
measure: Late Phase Reactions
timeFrame: before and at the end of the double-blind phase
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Prof. Dr. med. Ludger Klimek
state: Baden-W.
Study officials:
affiliation: Universitätsklinikum Mannheim GMBH
name: Karl Hörmann, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03714919: A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Official title: A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenoid Hypertrophy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposed study will assess analgesic efficacy of a multi-modal, non-opioid analgesic regimen for providing surgical analgesia in pediatric patients undergoing adenoidectomy and to assess recovery characteristics in the post-anesthesia care unit (PACU) and at home following surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing adenoidectomy ± bilateral ear tube placement
2. Have a parent/guardian who are compliant with routine medical care, capable of subjective evaluation and able to read, understand and sign the informed consent in accordance with IRB regulations

Exclusion Criteria:

1. An American Society of Anesthesiologists Physical Status ≥ 4 (severe disease that is life threatening);
2. A known hypersensitivity or allergy to any of the study medications;
3. A history of chronic opioid use prior to surgery;
4. Coexisting renal or hepatic disease;
5. Morbid obesity (BMI% ≥ 99).

Primary outcomes:
measure: Average Pain Score
timeFrame: 1 hr post-op
Secondary outcomes:
measure: Extubation Time
timeFrame: 1 hr post-op
measure: Time in PACU
timeFrame: 1-2 hr post-op
measure: Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
timeFrame: 2 hours post-op
measure: End of Surgery to Hospital Discharge
timeFrame: 2-3 hours post-op
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Arlyne Thung, MD
role: PRINCIPAL_INVESTIGATOR
References: