louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02029196: A Study to Evaluate the Safety Profile of an e-Vapour Product
Official title: A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Imperial Brands PLC
Sponsor class: INDUSTRY
First posted: 2014-01-07
Enrollment: 408
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety of an e-vapour product.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18-35kg/m2
* Subjects must be established smokers
* Subjects must have smoked five to 30 cigarettes per day for at least one year

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy within 14 days of the screening
* Subjects who have donated blood within 12 months preceding study
* Subjects with relevant illness history
* Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV)
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable
* Subjects who are trying to stop smoking
* Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Exhaled Carbon Monoxide
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit
state: England
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research
state: Wales
Study officials:
affiliation: Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds LS2 9LH, UK
name: Jim Bush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Simbec Research, Merthyr Tydfil, CF48 4DR, UK
name: Girish Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01332396: Drug Use Investigation for TYKERB Tablet (All Case Investigation)
Official title: Drug Use Investigation for TYKERB Tablet (All Case Investigation)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 4054
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have "HER2 overexpressing inoperable or recurrent breast cancer" and have received TYKERB for the first time

Brief summary: Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.


Eligibility criteria: Inclusion Criteria:

* Patients with HER2 overexpressing inoperable or recurrent breast cancer

Exclusion Criteria:

* Patients with hypersensitivity to lapatinib or any components
* Pregnant women and women suspected of being pregnant

Primary outcomes:
measure: The incidence of adverse events in Japanese patients treated with TYKERB based on prescribing information under the conditions of general clinical practice
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06701396: Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Official title: A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Gene Mutations and Other Alterations Nec
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.


Eligibility criteria: Inclusion Criteria:

* Ability and acceptance to provide written informed consent.
* A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
* Carrier of CRY1Δ11 variant.
* Men or women between 18 - 75 years, inclusive.
* Body Mass Index (BMI) of ≥ 18 and ≤ 40 kg/m\^2.

Exclusion Criteria:

* Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
* Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
* A positive test for substances of abuse.
* Current tobacco user.

Primary outcomes:
measure: Latency to Persistent Sleep, as measured by polysomnography.
timeFrame: Two Nights
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Vanda Investigational Site
state: Ankara
Study officials:
References:
Clinical trial NCT00000496: Platelet Drug Trial in Coronary Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.

Detailed description: BACKGROUND:

Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world. Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction, especially in those patients who enter the hospital early, its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital. When the trial was initiated in 1979, new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy. This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced. Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy.

DESIGN NARRATIVE:

Randomized, double-blind. The patients in the experimental group were treated with dipyridamole and aspirin for five years. Patients in the control group received a lactose placebo. The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease. Secondary endpoints included total mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new myocardial infarction. Recruitment ended in December 1982.

The study completion date listed in this record was obtained from the statement immediately above ("Recruitment ended in December 1982") and was confirmed from the Query/View/Report (QVR) System.

Eligibility criteria: Patients aged 65 or less. Angiographically identified coronary heart disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00756496: Case Collection Study to Support Digital Mammography Image Software Change
Official title: A Multi-center Feature Analysis Study to Compare the Diagnostic Accuracy of Siemens' Image Processing (SIP) Algorithms With Lorad's Image Processing (LIP) Algorithms in Detecting and Characterizing Breast Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Siemens Medical Solutions USA - CSG
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 442
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.


Eligibility criteria: Inclusion Criteria:

* Female
* \> 40 years

Exclusion Criteria:

* Pregnant women, or women who may become pregnant
* Mammographic evidence of breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident in the mammogram (but may include breast implants)
* Palpable lesion or one that is visible by another modality
* Inmates

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic (ROC) Curve to Compare Diagnostic Accuracy of 2 Algorithms in Breast Cancer Diagnosis
timeFrame: ~1 year. Women with negative or biopsy benign findings at baseline (study entry) were followed for 1 year to confirm the negative status at 1-year follow-up mammography exam. Women diagnosed with cancer were not followed up.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Siemens Medical Solutions USA, Inc
name: Raymond C Duhamel, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05946096: Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
Official title: Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Keywords: trunk control
dynamic surface exercise therapy
gross motor
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 38 children with CP were randomly assigned to 2 groups. 1 group was interventional group and second group was control group. Both the groups were provided with therapy ( interventional group was provided with conventional therapy and intervention. control group was provided with conventional therapy only) and results were analyzed based on performance of both groups.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.

Detailed description: A clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. The trial enrolled 38 children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. Children were randomly assigned to either the DSET or conventional physiotherapy training groups. Both groups underwent 60-minute vigorous exercise program four days a week for two months. The trunk control measurement scale was used to assess trunk control, while the GMFM-88 was used to assess gross motor function. Trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.

Eligibility criteria: Inclusion Criteria

* Diplegic children having Cerebral Palsy
* Children of age 5 - 12 years
* Children of GMFCS- E \&R level III and IV
* Children who can follow verbal commands

Exclusion Criteria:

* Children with epileptic fits
* Children presenting with lower limb muscular contractures
* Children with scoliosis

Primary outcomes:
measure: Gross motor function measure- 88
timeFrame: change in baseline scores and 8th week scores
measure: trunk control measurement scale
timeFrame: change in baseline scores and 8th week scores
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Ayesha Hameed, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06625996: Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery
Official title: Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery: A Comprehensive Analysis of Protocol Compliance and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: RAK Medical and Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The concept of Enhanced Recovery After Surgery (ERAS) protocols has revolutionized perioperative care by promoting a series of evidence-based practices aimed at reducing surgical stress and improving patient outcomes. Among these practices, preoperative carbohydrate loading has emerged as a significant intervention designed to mitigate the adverse metabolic effects of surgery


Eligibility criteria: Inclusion Criteria:

- Cardiovascular disease

Exclusion Criteria:

Insulin dependent diabetes

-

Primary outcomes:
measure: Length of hospital stay post cardio thoracic surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01739296: Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis
Official title: Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
osteoarthritis, knee
foot orthoses
orthotic insoles
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Detailed description: The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

Eligibility criteria: Inclusion Criteria:

* Meet the American College of Rheumatology criteria for knee Osteoarthritis
* Varus malalignment of the knee
* Absence of previous fracture on the index knee
* Absence of previous surgery on the index knee
* Absence of Rheumatoid Arthritis
* No Intra-articular injection on the index knee in the past 6 months
* Receiving usual care for Osteoarthritis for at least 6 months
* Be able to understand and agree with the informed consent

Exclusion Criteria:

* Undergo surgery during the study
* Undergo Intra-articular injection during the study
* Develop articular infection of the index joint during the study

Primary outcomes:
measure: Symptoms
timeFrame: 24 weeks
Secondary outcomes:
measure: Ankle pain
timeFrame: 24 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Ortopedia e Traumatologia HC-FMUSP
state: SP
Study officials:
affiliation: FMUSP
name: Gustavo C Campos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03422796: The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Official title: The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, the model can be used to test new drug candidates.

Detailed description: There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol induces a migraine-like headache in MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility criteria: Inclusion Criteria:

* Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
* 18-70 years
* 45-95 kg.

Exclusion Criteria:

* Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week)
* Serious somatic or psychiatric disease
* Pregnancy
* Intake of daily medication (except oral contraceptives)
* Triptan non-responders

Primary outcomes:
measure: Difference in median headache score after sumatriptan/placebo
timeFrame: 2hours
measure: difference in AUC 0-4h post treatment
timeFrame: 4hours
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
Study officials:
References:
citation: Falkenberg K, Bjerg HR, Olesen J. Subcutaneous sumatriptan reduces cilostazol induced headache in migraine patients. Cephalalgia. 2020 Jul;40(8):842-850. doi: 10.1177/0333102420915166. Epub 2020 Mar 26.
Clinical trial NCT06633796: Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis
Official title: Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthrosis
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 35
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, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.


Eligibility criteria: Inclusion criteria:

* Male and female patients aged between 35 and 70 years.
* Diagnosis of erosive osteoarthritis of the fingers confirmed clinically and radiologically.
* Presence of persistent functional limitation (at least 6 months) in finger flexion
* VAS value pain referred only to the hands \> 5 in the week prior to enrollment in the study.
* Patients not responding to anti-inflammatory and steroid therapy used in the last 2 years.
* Patients eligible for occupational therapy and paraffin therapy.
* Signature of the Informed Consent Form for participation in the study and processing of personal data.

Exclusion criteria:

* Patients aged \< 35 years and \> 70 years.
* Patients with diagnosis of overlapping arthritic pathologies.
* Patients undergoing hand surgery in the 6 months prior to the evaluation.
* Patients with functional alterations to the hands due to trauma.
* Patients with cognitive or mental disorders.
* Corticosteroid use within 6 months prior to baseline.
* Patients unable to use robots with mechanical arms

Primary outcomes:
measure: VAS functionality
timeFrame: Baseline, 1, 3 and 6 months after treatment
measure: Dreiser index
timeFrame: Baseline, 1, 3 and 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria di Negrar
state: Verona
Study officials:
References: