louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02828449: Assesment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
Official title: Assessment of the Implementation of a Therapeutic Educational Intervention Affecting Adherence to Oral Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasm
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: Centre Leon Berard
First posted: 2016-07-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Therapeutic education is an effective way to support the prescription of oral chemotherapy in oncology. It aims to increase adherence to treatment, to better control the side effects and reduce unplanned readmissions. The three major oncology institutions in the Rhône-Alpes region (Hospices Civils de Lyon, the Centre Léon Bérard Cancer Institute and Lucien Neuwirth) decided to collaborate on a project to implement an adapted Therapeutic Education Program context of each of these institutions.

The objective of this study is to evaluate the implementation of the intervention in the 3 participating centers, over 1 year:

1. Assess the achievement of the target population
2. Evaluate the adaptation of intervention in context
3. Evaluate the effectiveness of the intervention (impact): effectiveness in real life, identification of interactions with the environment linked to the center, identification of unintended effects of the intervention.
4. Assessing the sustainability of the intervention


Eligibility criteria: Inclusion Criteria:

* Patient care in medical oncology services of the Cancer Institute of Lucien Neuwirth, the Lyon-Sud hospital and the Centre Léon Bérard:
* Age over 18 years
* Introducing an active cancer (local extension, locoregional or metastatic)
* Oral chemotherapy as monotherapy or in combination with other treatments, initiated or in progress

Exclusion Criteria:

* Refusal to participate, protected adult patient under guardianship.
* Patient disability to understand the course of the study, the Therapeutic education program, or failure to follow the educational sessions.
* Patient with documented history of cognitive or psychiatric disorders.
* Patient on adjuvant therapy or hormone therapy for prostate cancer

Primary outcomes:
measure: percentage of affected population
timeFrame: 3 months
measure: Level of acquisition of knowledge
timeFrame: 3 months
measure: Anxiety and Depression
timeFrame: 3 months
measure: Quality of Life Questionnaire
timeFrame: 3 months
measure: Morisky Measurement Adherence Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
city: Pierre Bénite
country: France
facility: CH Lyon Sud
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
References:
Clinical trial NCT00598949: Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma
Official title: Prevalence of Pituitary Incidentaloma in Relatives of Patients With Pituitary Adenoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Tumor
Keywords: Pituitary
Adenoma
Tumor
Acromegaly
Prolactinoma
Cushing's
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary referral center

Brief summary: The purpose of the study is to determine genetic links among blood-relatives and between spouses of patients with pituitary tumors.

Detailed description: The purpose of the family study is to investigate the genetic basis for the development of pituitary tumors by assessing the prevalence of pituitary tumors in relatives of probands with the disease as compared to the prevalence in unrelated spouses sharing a similar environment.

Eligibility criteria: Inclusion Criteria:

* patients harboring secretory or non-secretory adenomas and/or siblings and/or spouses

Exclusion Criteria:

* patient without consenting siblings and/or siblings and/or spouses

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Pituitary Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Vivian Bonert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367549: Nutrition as a Determinant of Labor Outcome
Official title: Nutrition as Determinant of Labor Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor, Obstetric
Keywords: Labor
instrumental delivery
nutrition
epidural anesthesia
oxytocin
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2006-08-23
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blind trial looking at how nutrition intake is associated with labor progress and complications.

Detailed description: Insufficient intake of energy during labor may result in poor labor progress. The study investigates the effect of an energy supplement during labor.

Eligibility criteria: Inclusion Criteria:

* Women at gestational age \> 36 weeks, parity 0

Exclusion Criteria:

* Gestational age \< 36 weeks
* Signs of fetal pathology:

  * Different or abnormal (pathological) CTG test performed just before start of the test
  * Abnormal Doppler registrations (PI in the arteria umbilicae \> 2SD for the gestational age)
  * Established notch in the arteria uterinae or notch bilaterally or PI \> 2SD \> 24 weeks
  * Diverging in the weight of the fetus \> - 22% or diverging in the growth of the fetus - 10% or more, and established structural pathology in the fetus, oligohydramnion (amniotic fluid index \< 6)
* Maternal diseases and pregnancy complications

  * diabetes in pregnancy
  * high blood pressure
  * cardiovascular diseases
  * rheumatic disease
  * epilepsia
  * lung disease, etc.

CTG test: cardiotocographic test (a measure of fetal activity)

PI: pulsatory index (velocity pattern)

SD: standard deviation

Primary outcomes:
measure: The course of the labor by women (parity 0) at gestational age > 36 weeks, including: total labor time
timeFrame: At time of birth
Secondary outcomes:
measure: Length of stage 1 (cervical opening < 10 cm) and stage 2 (pushing time)
measure: Use of epidural anesthetics
measure: Use of contraction-stimulating drugs
measure: Instrumental delivery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Kristin Kardel
Study officials:
affiliation: Oslo University Hospital
name: Tore Henriksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609449: A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
Official title: A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass: Early Outcomes of a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Metabolic Surgery
Roux-en-Y Gastric Bypass
Lead sponsor: Hospital General Tlahuac
Sponsor class: OTHER_GOV
First posted: 2020-10-30
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.


Eligibility criteria: Inclusion Criteria:

* Patient submitted to bariatric surgery
* All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity

Exclusion Criteria:

•Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery

Primary outcomes:
measure: Weight loss
timeFrame: 12 months
measure: Weight loss
timeFrame: 12 months
measure: Weight loss
timeFrame: 12 months
measure: Weight loss
timeFrame: 12 months
Secondary outcomes:
measure: Complete Diabetes Remission Rate
timeFrame: 12 months
measure: Major early complications
timeFrame: First 30 days
measure: Major late complications
timeFrame: 2-12 months
measure: Nutritional status
timeFrame: 12 months
measure: Nutritional status
timeFrame: 12 months
measure: Nutritional status
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital General Tlahuac
Study officials:
affiliation: Head of Department. The Obesity Clinic at Hospital General Tlahuac
name: Carlos Zerrweck, MD
role: STUDY_DIRECTOR
affiliation: The Obesity Clinic at Hospital General Tlahuac
name: Antonio Herrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06229249: Effectiveness of Carpal Ligament Self-myofascial Stretching in Carpal Tunnel Syndrome
Official title: Effectiveness of Carpal Ligament Self-myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage i and ii Carpal Tunnel Syndrome - a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Myo-fascial stretching
Pain
Function
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is common in the age group of 40-60 years. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS-thirty-six subjects with stage I and II (mild) CTS were recruited. Thirty-six subjects who fulfilled the inclusion criteria were randomly assigned to the experimental group and control group, with 18 patients in each group. The experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy, while the control group received traditional physical therapy alone. The duration of the treatment was six weeks. The outcome measures used were the Boston Carpal Tunnel Questionnaire and the Visual Analogue Scale.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CTS between age group 30 - 60 years.
* Patients with stage I and II (mild) CTS, confirmed by nerve conduction study (EMG diagnosed by a medical professional).
* Patients who are able to read and understand English.

Exclusion Criteria:

* Presence of polyneuropathy.
* Consistent use of adaptive equipment, such as wheel chair or cane.
* Patients presenting with shoulder pathologies.
* Patients with other neurological or musculoskeletal conditions including Cervical radiculopathy, History of wrist and hand fractures, Upper extremity joint dislocations, Brachial plexus injuries, Cubital tunnel syndrome, Rheumatoid arthritis, De quervain's tenosynovitis, Cut injuries of hand.
* Patients who have underwent recent carpal tunnel release (within 1 year).

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire
timeFrame: 6 weeks
measure: Visual Analogue Scale
timeFrame: 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05055349: Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus
Official title: "Comparison Between Intrastromal Corneal Ring Segments and Toric Phakic Posterior Intra-ocular Lenses Implantation in Keratoconus"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare visual and refractive measurements of intrastromal corneal ring segments versus toric phakic posterior intra-ocular lenses implantation in keratoconus

Detailed description: * The study is a prospective comparative interventional case series. It will be conducted in Minia university hospital and Roaa Laser Vision Correction Center.
* Fourty eyes will be evenly allocated into two groups:

Group (A): 20 eyes will undergo corneal collagen cross linking (epithelium off) 1 month after Femtosecond laser assisted intrastromal corneal keraring segments.

Group (B): 20 eyes will undergo toric phakic posterior IOL implantation 1 year after corneal collagen cross linking (epithelium off).

• An informed written consent to be involved in the study will be obtained from each patient.

Eligibility criteria: Inclusion Criteria:

* Keratoconus grade I to III according to the Amsler-Krumeich classification

Exclusion Criteria:

* Acute hydrops or grade IV keratoconus
* Any ocular diseases or surgeries
* Corneal thickness less than 400 µm at the thinnest corneal point, and at least 450 µm at the incision site for ICRS group
* Corneal pacities

Primary outcomes:
measure: pentacam readings
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Ahmed Maher Khalafallah
Study officials:
References:
Clinical trial NCT03341949: Soluble CD146 and Proteinuria in Chronic Renal Disease
Official title: Soluble CD146 and Proteinuria in Chronic Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 204
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: Chronic renal disease (CKD) is defined as a decrease in glomerular filtration rate (GFR) and / or proteinuria or albuminuria (a protein present in urine). Albuminuria is considered a marker of endothelial dysfunction. Proteinuria and / or albuminuria are recognized as cardiovascular risk factors in both diabetic and non-diabetic populations, independently of GFR. It is also a marker of progression of kidney disease. cluster of differentiation 146 (CD146) is an endothelial adhesion molecule with preferential localization in the junction. Soluble CD146 (or CD146s). CD146s is a biomarker of endothelial dysfunction that is easy to assay. The increase in CD146 levels was described during the MRC, especially in diabetic patients with significant proteinuria. In two independent cohorts of patients with CDR, CD146s did not correlate with creatinine or GFR but appeared to correlate with proteinuria.

The aim of our study is to determine whether the blood concentration of CD146s is correlated with proteinuria independently of GFR. For this purpose, we propose this study in the kidney nephrology and transplantation center of Conception Hospital, with the objective of highlighting the link between proteinuria and serum CD146 levels in patients with CKD, whatever their renal function and / or underlying pathology. 205 patients will be included over two years with dosing of CD146s and proteinuria at the same time. These 205 patients will be recruited at each stage of the CKD (41 in each arm). CD146s could be a new biomarker predicting the risk of renal function impairment or cardiovascular risk independent of renal function.


Eligibility criteria: Inclusion Criteria:

* Adult subject aged 18 years or over
* Subject capable of giving informed consent
* Patient with chronic kidney disease (stage 1 to 5 CKD regardless of etiology)

Exclusion Criteria:

* Pregnant or lactating woman
* Person deprived of liberty or hospitalized without consent
* Major under legal protection or unable to express his consent
* Refusal of the patient
* Patient with a history of kidney transplantation
* Evolutionary cancer

Primary outcomes:
measure: Serum CD146s assay
timeFrame: 12 months
measure: The dosage of proteinuria
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03679949: Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Official title: Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Abuse, Drug
Keywords: experimental pain
Cannabis
Cannabidiol
THC
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, cross-over, double-blind, placebo-controlled study. All participants will partake in each arm and receive all interventions.
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to assess the impact of cannabis on the analgesic and abuse-liability effects of a sub-threshold dose of a commonly used analgesic.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female aged 21-53 years
* Previous cannabis use
* Previous opioid use
* Urine test positive for recent cannabis use
* Being able to perform all study procedures
* Currently practicing an effective form of birth control (women only)

Exclusion Criteria:

* Meeting criteria for some Use Disorders
* Report regular illicit drug use
* If medical history, physical and psychiatric examination, or laboratory tests performed during the screening process revealed any significant illness

Primary outcomes:
measure: Subjective Effects
timeFrame: 6 weeks
measure: Cold Pressor Test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York Psychiatric Institute
name: Caroline A Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00562549: Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension
Official title: A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

Detailed description: 1. Office seated peripheral systolic and diastolic blood pressure
2. Adverse events and vital signs
3. Plasma concentrations of SLx-2101

Eligibility criteria: Inclusion Criteria:

* Male or females between 18 and 80 years, inclusive
* Moderate to severe hypertension
* Body weight within a body mass index range of 18 - 32 kg/m2

Exclusion Criteria:

* Subject is receiving more than four antihypertensive agents
* History of drug abuse
* Exposure to a new chemical entity within 3 months prior to the first day of dosing

Primary outcomes:
measure: Office seated peripheral systolic and diastolic blood pressure
timeFrame: 12 days
Secondary outcomes:
measure: Adverse events and changes in vital signs
timeFrame: 12 days
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
Study officials:
affiliation: Addenbrooke's Hospital, Cambridge
name: Ian B Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00214149: Multi-catheter High Dose Rate (HDR) Breast Brachytherapy
Official title: A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.


Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is \< 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension

Primary outcomes:
measure: To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
timeFrame: 5 years
Secondary outcomes:
measure: To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years
timeFrame: 3 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Rakesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21.