louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02361255: Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism
Official title: Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Secondary Parkinsonism
Parkinson's Disease
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
First posted: 2015-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: antipsychotic treated patients with or without parkinsonism

Brief summary: Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically indistinguishable and DIP sometimes represents "unmasking of underlying PD. The objective of this study is to determine the relationship of underlying Parkinson's disease (PD) to the incidence and clinical outcome in DIP using non-motor assessments as a marker for nigrostriatal degeneration.

Research Design: This is a nested case-control design to investigate risk factors associated with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.

Methodology: We will examine objective olfactory function (via objective olfactory testing), other non-motor symptoms of PD (via standardized validated questionnaires), and motor findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects) compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed prospectively after a change in AP treatment. Additionally, in patients where it was performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker of nigrostriatal integrity examining the ability of qualitative and semi-quantitative analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and examine their relationship with clinical and radiologic status.


Eligibility criteria: Inclusion Criteria:

antipsychotic treated patients with or without parkinsonism

Exclusion Criteria:

parkinson's disease, dementia

Primary outcomes:
measure: normal or abnormal DAT SPECT
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: PVAMC
state: Pennsylvania
Study officials:
affiliation: PVAMC
name: James Morley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00135655: A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
Official title: A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Macular Edema, Cystoid
Keywords: macular edema
post cataract extraction
cystoid macular edema
post cataract extraction macular edema
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 0
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: The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.


Eligibility criteria: Inclusion Criteria:

* Have persistent post cataract extraction macular edema whose condition is stable
* Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
* Have at least one eligible eye to be treated in the study
* Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
* Have macular edema confirmed by fluorescein angiography

Exclusion Criteria:

* Have proliferative vitreoretinopathy greater than grade B in either eye
* Have ocular disorders in the study eye that may confound interpretation of study results
* Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
* Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
* Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
* Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
* Have had any ocular implant device for the delivery of therapeutic agents
* Be taking any excluded medications that could obscure or confound study results

Primary outcomes:
measure: safety
measure: tolerability
measure: retinal thickness
measure: visual acuity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02391155: Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients
Official title: Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: follicular flushing
IVF
poor responders
oocyte retrival
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.

Detailed description: This study will include:

1. women with less than four follicles on the day of hCG administration
2. women between 20-45 age old
3. The value of progesterone on the day of hCG administration will be under 1.5ng/ml

Eligibility criteria: Inclusion Criteria:

1. women between 20-45 years old
2. the number of follicles less than 5 on the day of HCG administration
3. the value of progesteron on the day of hCG administration must be under 1.5ng/ml

Exclusion Criteria:

1. women under 20 years and older than 45 year
2. on the day of hCG administration if the follicle number is more than 5
3. if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml

Primary outcomes:
measure: number of metaphase 2 oocyte
timeFrame: Six months
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: eigth months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Bulent Haydardedeoglu
Study officials:
References:
Clinical trial NCT01647555: Radiotherapy in Association With Cetuximab in Patients Treated for an Epidermoid Cancer
Official title: Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epidermoid Head and Neck Cancer
Keywords: Cetuximab
radiotherapy
epidermoid head and neck cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-23
Enrollment: 57
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: Patient with epidermoid head and neck cancer locally advanced

Brief summary: This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Epidermoid head and neck carcinoma locally advanced
* Indication of Cetuximab and radiotherapy
* Karnofsky \>= 60
* Patients participating to another compatible study could be included after consultation with the study director Patients could be beforehand treated for an other ORL cancer

The radiotherapy will be delivered for curative aim (minimal dose 66 Gy)

Exclusion Criteria:

* other histology
* Metastatic disease
* Recurrent patients

Primary outcomes:
measure: Skin toxicities
timeFrame: until week 38
Secondary outcomes:
measure: Healthcare and evolution of skin toxicities
timeFrame: until week 38
measure: Quality of life
timeFrame: baseline, week 4, month 6
measure: tumoral efficacy
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Croix
country: France
facility: Clinique du Parc
city: Douai
country: France
facility: Centre Leonard de Vinci
city: Lille
country: France
facility: Centre Bourgogne
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre Galilée
city: Maubeuge
country: France
facility: Centre Gray
city: Saint Martin Les Boulogne
country: France
facility: Centre Joliot Curie
Study officials:
affiliation: Oscar Lambret Center
name: Eric LARTIGAU, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05481255: Association With Spinal Needle-puncture Pain and Menstrual Phase
Official title: Does the Menstrual Phase Affect Skin Puncture Pain During Spinal Anesthesia? Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 female patients who are of reproductive age and have had a regular menstrual cycle for at least six months

Brief summary: This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and spinal needle-puncture pain during spinal anesthesia in female patients of reproductive age.

Detailed description: Before the spinal anesthesia procedure, the anxiety and depression levels of the patients will be evaluated with the 14-scale 'hospital anxiety and depression scale.' The spinal anesthesia procedure will be performed by the anesthesiologist responsible for the patient. At the end of the spinal anesthesia procedure, a researcher with no knowledge of the patient's menstrual phase information will ask rate the spinal needle-puncture pain felt during spinal anesthesia with a numerical rating scale (NRS), which is graded from 1 to 10 (0: no pain, 10: very severe pain).

Eligibility criteria: Inclusion Criteria:

* Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

Exclusion Criteria:

* Pregnancy
* ASA physical status III and IV
* Patients with psychiatric disorders,
* Emergency surgeries
* Mentally retarded patients,
* Patients with multiple spinal anesthesia trials
* Patients with previous spinal surgery experience

Primary outcomes:
measure: spinal needle-puncture pain
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Education and Training Hospital
Study officials:
References:
Clinical trial NCT01076855: Guidance for Elderly With Cognitive Disorders
Official title: Guidance Programme for Elderly With Cognitive Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Dementia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly (\>70 years) with mild dementia in presence of a carer.

Brief summary: The purpose of the programme is to facilitate the anticipation of dementia both in elderly patients suffering from this disease and in their carers and to diminish care burden in order to improve quality of life and daily functioning.


Eligibility criteria: Inclusion Criteria:

* elderly (\> 70 years) with mild dementia in presence of a carer.

Primary outcomes:
measure: Quality of life and care burden at 0, 3 and 6 months.
timeFrame: 0, 3 and 6 months
Secondary outcomes:
measure: Cognitive, behavioural and affective status
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Mirko Petrovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02431455: The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
Official title: The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Complications of Bariatric Procedures
Pulmonary Atelectasis
Pneumonia
Keywords: Bariatric Surgery
obesity, morbid
incentive spirometry
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.

Detailed description: Incentive spirometry is speculated to improve pulmonary function in the postoperative period, though data to support this is lacking. Patients undergoing bariatric surgery are at increased risk for pulmonary compromise as they are obese and undergoing foregut surgery.

This study aims to examine the effect of incentive spirometry after bariatric surgery by performing a prospective randomized trial. Subjects will be randomized to either receive an incentive spirometer or not. The primary outcome measure of oxygen saturation off of supplemental oxygen will be taken preoperatively and at 6,12, and 24 hours postoperatively. Secondary outcome measures include rate of pulmonary complications, and time to wean off of supplemental oxygen.

Eligibility criteria: Inclusion Criteria:

* Patients medically cleared to undergo bariatric surgery per the usual screening process

Exclusion Criteria:

* None

Primary outcomes:
measure: Hypoxia 6 Hours Postoperative
timeFrame: 6 hours postoperative
measure: Hypoxia 12 Hours Postoperative
timeFrame: 12 hours postoperative
measure: Hypoxia 24 Hours Postoperative
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Postoperative Respiratory Complication
timeFrame: entire inpatient say, usually 1 to 7 days
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Clinic General Surgery
name: Dmitry Nepomnayshy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pantel H, Hwang J, Brams D, Schnelldorfer T, Nepomnayshy D. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 May 1;152(5):422-428. doi: 10.1001/jamasurg.2016.4981.
Clinical trial NCT00593255: Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
Official title: A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-14
Enrollment: 220
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 trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetes for at least 4 weeks
* Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
* HbA1c: 7.5-13.5%
* Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria:

* Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
* History of drug abuse or alcohol dependence

Primary outcomes:
measure: 2-hours postprandial plasma glucose (PPPG)
timeFrame: after 12 weeks of treatment
Secondary outcomes:
measure: Percentage of subjects achieving 2-hours PPPG treatment target
measure: Percentage of subjects achieving HbA1c treatment target
measure: HbA1c
measure: Fasting plasma glucose
measure: Hypoglycaemic episodes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Harbin
country: China
facility: Novo Nordisk Investigational Site
state: Heilongjiang
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Gao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)
Clinical trial NCT00970255: Frenotomy of the Labial Frenulum in Infants With Breastfeeding Difficulties
Official title: Effect of Labial Frenulum Clipping on Nipple Pain and Latch Problems in Breastfeeding Infants
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding difficulties
lingual frenulum
labial frenulum
frenotomy
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-09-02
Enrollment: 40
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Upper lingual frenulum have been implicated as a cause for pain during breastfeeding and latch problems. The investigators hypothesize that performing frenotomy of the frenulum may improve breastfeeding. The investigators will include breastfeeding infants with pain or latch problems in whom the lingual frenulum had been treated but breastfeeding problems were not resolved. The investigators plan to study the effect of frenotomy of the upper lingual frenulum on maternal pain (using pain score by visual analog scale) and/or latch score.


Eligibility criteria: Inclusion Criteria:

* breastfeeding infants
* maternal nipple pain
* latching problems

Exclusion Criteria:

* oral cavity anomalies
* breast anatomical anomalies
* untreated tongue-tie in infant

Primary outcomes:
measure: Pain score by Visual Analog Scale
timeFrame: Within 30 minutes
measure: Latch Score
timeFrame: Within 30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center-Neonatology
Study officials:
References:
Clinical trial NCT05242055: Integrated Diagnosis and Treatment of CKD on Outcomes
Official title: A Prospective, Cohort, and Observational Study of the Effect of Integrated Diagnosis and Treatment of Chronic Kidney Disease (CKD) on Clinical Outcomes in Real World Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Hypertension
Hyperglycemia
Hyperlipidemias
Anemia
Chronic Kidney Disease-Mineral and Bone Disorder
Malnutrition
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD following up more than 6 months in Beijing Jishuitan Hospital.

Brief summary: Objective: To establish a study cohort and follow up of patients with CKD in our hospital, and evaluate the status of integrated CKD diagnosis and treatment according to guidelines in the real world, as well as the clinical prognosis of patients with different stratification.

Methods: By establishing a cohort of 1000 patients with CKD and conducting long-term follow-up, integrated diagnosis and treatment for CKD was performed, namely: Regular monitoring, control of blood pressure, blood glucose, blood lipid, correction of anemia, minerals - bone metabolic abnormalities, malnutrition, acid and alkali, and electrolyte disorder, diet and exercise, such as the guidance of integrated management, non intrusive, observational studies, prospective cohort were analyzed retrospectively, describe the implementation of the integration of diagnosis and treatment, chronic kidney disease (CKD) Stratified analysis and risk factor analysis were performed for cardiovascular disease and other main endpoint events, so as to objectively reflect the status of integrated treatment of CKD and provide data support for continuous quality improvement of CKD diagnosis and treatment and improvement of clinical prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old;
* Voluntarily signed informed consent;
* Patients who are estimated to develop CKD.

Exclusion Criteria:

* Age \< 18 or ≥100 years;
* Unable to comply with the procedures stipulated in this study;
* Estimated follow-up time ≤6 months.

Primary outcomes:
measure: Rate of cardiovascular cerebrovascular adverse events
timeFrame: Six months or more
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: Six months or more
Other outcomes:
Locations:
city: Beijing
country: China
facility: Nephrology Department of Beijing Jishuitan Hospital
state: Beijing
Study officials:
References: