louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04175496: Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods
Official title: Glycemic and Insulinemic Responses of Low-Carbohydrate Snack Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Glycemic index
Insulinemic index
Low carbohydrate
Snack
Type 1 diabetes
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is develop recipes containing CHO less than ICR, prepare new snacks alternatives that could be consumed without need for additional insulin doses, and evaluate the glycemic and insulinemic responses of these recipes. A randomized crossover trial will include 15 healthy adults aged 19-30 years. All participants will consume 3 test foods and reference food (glucose solution, 2 times) in a random order. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min. Glucose and insulin analyzes will be performed from blood samples. The results of these time points will be marked on the chart and the incremental area under the curve (iAUC) will be calculated for both glucose and insulin.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Normal body weight (18.5-25 kg / m2 BMI)
* 19-30 years old

Exclusion Criteria:

* use of tobacco,
* weight change of \>5 kg in the last 3 months
* the presence of any chronic disease or lactose intolerance,
* regular medicine use,
* pregnancy or lactation,
* performing competitive sports or endurance sports,
* fasting plasma glucose concentration \>100 mg / dL,
* the presence of eating disorder,
* sensitivity or allergies to any food that used in the study

Primary outcomes:
measure: Postprandial glucose response
timeFrame: two hours postprandial period
measure: Postprandial insulin response
timeFrame: two hours postprandial period
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT04076696: Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis
Official title: Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Keywords: Chest
Lung
Tomography
Scatter
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Detailed description: Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray based imaging.

The investigators have developed an approach that measures scatter through a low dose (3% of the conventional scan) scatter measurement technique. Preliminary studies have shown that scatter reduction in DCT can significantly improve quality. The approach will characterize the reader confidence in lung nodule detection in a scatter corrected chest tomosynthesis imaging approach as compared to the conventional chest tomosynthesis.

Fifty (50) patients who have undergone a clinical non-contrast CT with lung nodules will be asked to have an s-DCT (scan) within 4 weeks (+/- 2 week) of their clinical CT with no intervening procedures or therapies (i.e. biopsy of lung nodules). Investigators will then perform a reader study to evaluate the radiologist reader confidence in images generated from the scatter reduction technique versus more conventional chest tomosynthesis imaging.

Eligibility criteria: Inclusion Criteria:

* Patients with known lung lesion(s)
* Patients having undergone a chest CT
* Patients 18 years of age and older
* Patients able to provide informed consent

Exclusion Criteria:

* Patients who may not fit on a 35 x 35 detector (BMI \> 35)
* Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion)
* Any woman who is pregnant, has reason to believe she is pregnant, or is lactating

Primary outcomes:
measure: Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)
timeFrame: Baseline
Secondary outcomes:
measure: Sensitivity of s-DCT Images (Percentage of Positive Scans)
timeFrame: Baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Hospitals
name: Ertan Pamuklar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00701896: Smoking Cessation Using Motivational Therapy and Varenicline
Official title: Smoking Cessation and the Natural History of HIV-Associated Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
HIV Infections
Keywords: HIV
Positive
Smokers
Varenicline
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-06-19
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

Detailed description: HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age and older;
2. diagnosis of HIV;
3. self-reported smoking on a daily basis;
4. provide informed written consent

Exclusion Criteria:

1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
2. unable to understand spoken English
3. age less than 18 years.
4. pregnant women

Primary outcomes:
measure: To Determine the Safety of Varenicline in PLWH Who Smoke
timeFrame: 3 months
Secondary outcomes:
measure: To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip T. Diaz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421096: Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer
Official title: Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Cervical Cancer
Keywords: uterine cervical cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years old
* Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB\> or = 4 cm to IV, according to FIGO classification) histologically proven
* Measurable lesions,clinically and by MRI assessed
* PS-WHO \< or = 2 ou Karnofsky Index \>70 per cent
* Life expectancy \> 3 months
* Hematologic function: leukocytes \< or = 3 G/l, polynuclear neutrophil leukocytes \> or = 1.5 G/l, platelets \> or = 100 G/l, hemoglobin \> or = 10 g/dl
* Hepatic function: ASAT and ALAT \< 2.5 ULN
* Renal function: creatininemia \< 1.5 ULN, clearance \> 60 ml/min
* No prior chemotherapy or radiotherapy
* Contraception
* Written informed consent signed

Exclusion Criteria:

* Stage IB \< 4 cm or IVB
* Other histology than epidermoid or adenocarcinoma
* Distant metastases, including sus-clavicular adenopathy
* Contraindication to MRI
* Pregnant or lactating woman
* Auto-immune disease
* Peripheric neuropathy, autograft or homograft, psychiatric disease
* Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
* Active infection
* Other clinical trial with an experimental drug
* Known positive serology (HIV, HbC, HbS)

Primary outcomes:
measure: Progression-free survival
timeFrame: 3 years after the end of study treament
Secondary outcomes:
measure: Global survival
timeFrame: 5 years after the end of study treatment
measure: safety
timeFrame: untill 5 years after study treatment
Other outcomes:
Locations:
city: Dechy
country: France
facility: Centre Leonard de Vinci
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: BELKACEMI Yazid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06887296: Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality
Official title: Assessment of the Impact of Polycystic Ovary Syndrome on Women's Sexuality
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Polycystic Ovarian Syndrome (PCOS)
Keywords: Polycystic Ovary Syndrome
Female Sexuality
Quality of Life
Sexual Health
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of women with or without polycystic ovary syndrome to constitute 2 groups of 40 participants.

Brief summary: This study, titled SexOPK, aims to evaluate the impact of polycystic ovary syndrome (PCOS) on women's sexual health. PCOS is a common endocrine disorder affecting 5-20% of women of reproductive age, often leading to hormonal imbalances, metabolic issues, and psychological distress. Despite existing studies on the subject, the level of sexual distress associated with PCOS-related sexual dysfunction remains unclear.

The study will compare sexual function and distress levels between women diagnosed with PCOS and a control group without PCOS. Participants will complete an online questionnaire assessing various aspects of sexual health, body image, anxiety, and depression. The findings may help healthcare professionals better understand and address sexual dysfunction in women with PCOS.


Eligibility criteria: Inclusion Criteria:

For patients in the test group (PCOS):

* Adults
* Carriers of medically diagnosed polycystic ovarian syndrome
* Non-opposition

For patients in the control group:

* Adults
* Not carriers of polycystic ovarian syndrome
* Unopposed

Exclusion Criteria:

* Patient under court protection, guardianship, or curatorship
* Does not understand or speak French

Primary outcomes:
measure: Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using BISF-W Scores
timeFrame: Day 1
measure: Evaluation of Sexual Function and Distress in Women with Polycystic Ovary Syndrome Using FSDS-R Scores
timeFrame: Day 1
Secondary outcomes:
measure: Assessment of Body Image Satisfaction Using the QIC Questionnaire
timeFrame: Day 1
measure: Evaluation of Anxiety and Depression Using the HADS Scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Paule de Viguier
Study officials:
affiliation: University Hospital of Toulouse
name: Anna Gosset
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612996: Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering
Official title: Comparative Study Between Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering Post Intrathecal Anesthesia a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Lower Extremity Chronic Venous Ulcers
Varicose Veins Leg
Hernia
Keywords: Tramadol
Magnesium Sulphate
Shivering
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.

Exclusion Criteria:

* history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \&gt;38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake

Primary outcomes:
measure: Shivering score
timeFrame: 90 minutes postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03431896: Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
Official title: Monitoring of Early Disease Progression in Hereditary Transthyretin Amyloidosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyloidosis
Amyloid
Amyloid Neuropathies, Familial
Amyloid Cardiomyopathy
Amyloid - Primary
Transthyretin Amyloidosis
AL Amyloidosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified through clinical practice and from Amyloid support groups

Brief summary: This study measures circulating, misfolded ATTR oligomers in asymptomatic ATTRm amyloidosis genetic carriers longitudinally over five years.

Detailed description: Recent advances in genetic testing have allowed for pathogenic mutation identification in family members of affected individuals prior to onset of symptoms. While the presence of mutation and the corresponding TTR kinetic stability have been directly linked to disease development, the molecular drivers of tissue specific degeneration have not been defined. We hypothesize that soluble misfolded TTR oligomer species may be circulating within the blood of these patients possibly years prior to amyloid deposition and could serve as an early biomarker and/or driver for disease development. In this line, The Scripps Research Institute has developed a peptide-based probe that specifically labels and integrates into misfolded TTR oligomers allowing the relative circulating concentration in the bloodstream to be determined. Longitudinal monitoring of untreated, asymptomatic TTR amyloid genetic carriers utilizing the Scripps probe is likely to provide novel insight into early disease progression. We also plan to utilize the Scripps probe to monitor disease progression in TTR amyloid genetic carriers currently undergoing treatment by observing how treatments affect the circulating misfolded TTR oligomers. Through enhanced understanding of early disease progression and treatment efficacy, our hope is to limit amyloid accumulation in cardiac and nerve tissue and delay the development of the invariably fatal TTR amyloid cardiomyopathy/neuropathy.

Eligibility criteria: Inclusion Criteria:

* Patients with known hereditary ATTR amyloidosis genetic mutations as identified by genetic testing.

Exclusion Criteria:

* Patients with ATTR amyloidosis identified as wild-type.

Primary outcomes:
measure: Average % change in oligomers in patients with new onset TTR amyloid symptoms
timeFrame: Annually over 5 years
Secondary outcomes:
measure: % change of oligomer levels relative to baseline level in patients with ATTR specific medication changes
timeFrame: Annually over 5 years
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mazen A Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802096: Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation
Official title: Effects of Inspiratory Muscle Training in Addition to Pulmonary Rehabilitation in Patients With COPD Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exacerbation Copd
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Inspiratory muscle weakness, limited functional exercise capacity and worse quality of life have been shown in patients with exacerbation of chronic obstructive pulmonary disease (COPD). Recommendations from clinical practice guideline state that promoting pulmonary rehabilitation after exacerbation can improve the conditions above. Inspiratory muscle training (IMT) has been proven to enhance inspiratory muscle strength and endurance in patient with stable COPD. However, there is less research on whether IMT in addition to pulmonary rehabilitation after exacerbation can benefit inspiratory muscle function, functional exercise capacity and quality of life in patients with COPD. The purpose of this study is to examine the effects of IMT in addition to pulmonary rehabilitation on respiratory muscle function, functional exercise capacity and quality of life in patients with exacerbation of chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* age \> 20 years old
* diagnosed as exacerbation of COPD
* maximal inspiratory pressure (MIP) \< 80 cmH2O

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study

Primary outcomes:
measure: Diaphragm muscle activation
timeFrame: 10 minutes
measure: Sternocleidomastoid muscle activation
timeFrame: 10 minutes
Secondary outcomes:
measure: The mean median frequency of diaphragm and sternocleidomastoid muscle
timeFrame: 10 minutes
measure: Functional exercise capacity
timeFrame: Considering time of test and recovery, it will be expected to take totally 10 minutes.
measure: Quality of life evaluation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy of National Taiwan University
state: Zhongzheng Dist
Study officials:
affiliation: National Taiwan University
name: Li-Ying Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00762996: The Clinical Evaluation of Two Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eurolens Research
First posted: 2008-09-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. \< 1.00 DC).
* They have worn soft contact lenses within six months of starting the study.

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 has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
* They have diabetes.
* They are currently taking part in any other clinical study or research.

Primary outcomes:
measure: Distance Visual Acuity
timeFrame: 1 week
Secondary outcomes:
measure: Lens Comfort
timeFrame: 1 week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
References: