louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05202470: Effectiveness of Telehealth Program in Patients With Type 2 Diabetes
Official title: Effectiveness of Telehealth Program in Patients With Type 2 Diabetes: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-01-21
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: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Detailed description: The use of telehealth technologies in the field of health is becoming more and more widespread. Telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
* Those between the ages of 18-65,
* Receiving oral antidiabetic and/or insulin therapy,
* Having a mobile phone capable of receiving and playing video messages,
* Does not have hearing, speech and psychiatric problems that prevent communication,

Exclusion Criteria:

* Individuals who do not volunteered to participate in the study
* Patients who have hearing, speech and psychiatric problems that prevent communication

Primary outcomes:
measure: International Survey of Physical Activity (IPAQ)
timeFrame: 4 weeks
measure: Goal orientation in exercise measure (GOEM)
timeFrame: 4 weeks
measure: Mini Nutritional Assessment
timeFrame: 4 weeks
measure: The Problem Areas in Diabetes Scale (PADS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Training and Research Hospital
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Serap Tuna, PhD
role: STUDY_CHAIR
affiliation: Muğla Sıtkı Koçman University
name: Emine Neşe Yeniçeri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: Cem Şahin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00605670: Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
Official title: Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Surgery
Breast Reconstruction
Breast Reduction
Breast Augmentation
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: McMaster University
name: University College, London
name: Dartmouth-Hitchcock Medical Center
name: University of British Columbia
name: Johns Hopkins University
name: University of Pittsburgh
First posted: 2008-01-31
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinics at the various sites

Brief summary: The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.


Eligibility criteria: Inclusion Criteria:

* All stages (1-4)
* Age \> or = to 18 to 85 years.
* Postoperative Group: Male and Female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago

Or

* Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery

Exclusion Criteria:

* Inability to speak or understand English
* Active psychiatric illness, cognitive or sensory impairment
* Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions

Primary outcomes:
measure: To develop and validate a new patient derived measure of satisfaction with breast surgery.
timeFrame: conclusion of study
Secondary outcomes:
measure: Determining variations in satisfaction related to patient characteristics and preoperative expectations.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins Medical Center
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth Medical Center
state: New Hampshire
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Pusic, M.D., M.H.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03158870: Surgeon-Anesthesiologist Collaboration
Official title: Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pheochromocytoma
Collaboration
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 1122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for pheochromocytoma

Brief summary: Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent surgical procedure for pheochromocytoma in 8 French university hospitals from January 2000 to December 2016

Exclusion Criteria:

* Age \< 18 years old
* Patients operated for incidentaloma or with paraganglioma diagnosis

Primary outcomes:
measure: Presence of an intraoperative hemodynamic instability
timeFrame: At the time of surgery (less than 4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT04003870: Orthotics and Achilles Load in Runners
Official title: Controlled Trial to Compare the Achilles Tendon Load During Running in Flatfeet Subjects Using a Customized Arch Support Orthoses vs an Orthotic Heel Lift
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Flatfoot
Sports Injury
Lead sponsor: North District Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

Detailed description: This was a controlled laboratorial, within subject, repeated measures study. The aim of this study was to compare two clinically applied treatment options: Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet. It implicated to provide a better understanding of the types of foot orthoses for flatfeet runners and additional biomechanical evidence for the clinical field to guide orthotic prescription as well as selection for Achilles tendinopathy management.

Eligibility criteria: Inclusion:

* Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study.
* All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months.
* no previous surgery.
* not previously attempted any foot orthoses intervention before this study.

Exclusion:

* leg-length discrepancy
* rigid forefoot varus deformity
* gastrocnemius equinus
* structural hallux limitus, or rigidus
* Any musculoskeletal or neurological disorders

Primary outcomes:
measure: Peak plantarflexion moment
timeFrame: Day 0
measure: Peak Achilles tendon load
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: CUHK
Study officials:
References:
citation: Lee KKW, Ling SKK, Yung PSH. Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift. BMC Musculoskelet Disord. 2019 Nov 13;20(1):535. doi: 10.1186/s12891-019-2898-0.
Clinical trial NCT05692570: A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers
Official title: A Phase 1, Open-label Drug Interaction Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug-drug Interaction
Lead sponsor: Pyramid Biosciences
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-sequence, three-periods
Primary purpose: TREATMENT

Brief summary: This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or cobicistat on the pharmacokinetics (PK) of PBI-200.

Detailed description: This is an open-label, single-sequence, three-period drug-drug interaction study in healthy male and female volunteers to evaluate the effect of a potent CYP3A inhibitor, ritonavir or cobicistat, on the single dose PK of orally administered PBI-200. It is expected that co-administration of ritonavir or cobicistat with PBI-200 will increase the exposure of PBI 200.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 55 years of age (inclusive).
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).
* Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
* History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
* Intolerance to repeated venipuncture.
* Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
* Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
* Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.

Primary outcomes:
measure: Maximum Plasma Concentration [C(max)] of PBI-200
timeFrame: 11 days
measure: Area Under the Concentration-Time Curve (AUC) from time zero to the time of the last measurable concentration [AUC(0-t)]
timeFrame: 11 days
measure: AUC from time zero to infinity [AUC(0-inf)]
timeFrame: 11 days
measure: Terminal elimination half-life [T(1/2)]
timeFrame: 11 days
measure: Incidence, frequency and severity of adverse events (AEs)
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
affiliation: Pyramid Biosciences
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01750970: Endoscopic Resection of Bladder Tumors
Official title: Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Tumor
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 68
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: To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.


Eligibility criteria: Inclusion Criteria:

- 18 year-old and older male and female subjects having high grade non-muscle invasive bladder tumor, with urinary cytology , imaging examination (Ultrasound, urography, or scan) and endoscopic examination

Exclusion Criteria:

- Less than 18 years of age, and having no:

* Non-muscle invasive tumor, and of low grade.
* Bladder tumor infiltrating the muscular layer shown by pre-operative test, with absence of urinary cytology
* No blue light source in sustainable way

Primary outcomes:
measure: Number of extra lesions revealed by blue light compared to the resection performed in white light
timeFrame: 2 to 6 weeks after resection
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
affiliation: Hôpital FOCH 40, rue Worth 92150 Suresnes
name: Henry BOTTO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neuzillet Y, Methorst C, Schneider M, Lebret T, Rouanne M, Radulescu C, Molinie V, Dreyfus JF, Pelcat V, Botto H. Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non-muscle-invasive bladder cancer with positive results on urine cytology. Urol Oncol. 2014 Nov;32(8):1135-40. doi: 10.1016/j.urolonc.2014.04.005. Epub 2014 Jul 9.
Clinical trial NCT06558370: Bladder Distension for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy
Official title: Bladder Filling for Pain Relief in Nullliparous Patients Undergoing Diagnostic Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hysteroscopy
Keywords: Hysteroscopy
Full bladder
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Bedaya Hospital
First posted: 2024-08-16
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is conducted to assess whether the passive uterine straightening of the uterus by means of bladder filling is associated with less pain experienced by nulliparous women during office hysteroscopy.

Detailed description: A randomized controlled study revealed that bladder filling before office hysteroscopy was associated with less pain experienced by parous women . On the other hand, a randomized study revealed that misoprostol was more effective than bladder filling in minimizing the pain experienced by postmenopausal women during office hysteroscopy. Till now , no studies were conducted to detect the effect of bladder filling on the pain experienced by nulliparous women during office hysteroscopy.

Eligibility criteria: Inclusion Criteria:

* Nulliparity

Exclusion Criteria:

* Parous patients
* Cervical pathology
* Previous cervical surgery
* Severe vaginal bleeding.

Primary outcomes:
measure: Intensity of pain
timeFrame: Immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fouda UM, Elshaer HS, Elsetohy KA, Youssef MA. Misoprostol versus uterine straightening by bladder distension for pain relief in postmenopausal patients undergoing diagnostic office hysteroscopy: a randomised controlled non-inferiority trial. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:326-30. doi: 10.1016/j.ejogrb.2016.06.024. Epub 2016 Jul 1.
Clinical trial NCT04015570: Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
Official title: A Randomized Controlled Trial to Study the Efficacy and Safety of Plasma Exchange Compared to Standard Medical Therapy in Patients With Severe Drug Induced Liver Injury With or Without Underlying Chronic Liver Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Liver Disease
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomized study subject will be randomized into two groups Group A will receive Standard Medical Treatment (Albumin + High Caloric Diet) Group B will continue Standard Medical Treatment with High Volume Plasma Exchange. All other interventions will be at the discretion of clinicians.


Eligibility criteria: Inclusion Criteria:

* Age-18-70 years
* Preferably Biopsy proven or history suggestive of DILI (Drug Induced Liver Injury)

  1. Grade IV DILI With T.B \> 15
  2. DILI Manifesting as ACLF (Acute on chronic Liver failure) /ALF (Acute Liver Failure) with no transplant option

Exclusion Criteria:

* Evidence of active infection
* Refusal of consent or assent
* Patients with clinical suspicion of irreversible brain injury
* Pregnancy
* HCC (Hepatocellular Carcinoma) or any other malignancy
* Kidney failure
* Portal vein thrombosis
* Upper GastroIntestinal bleed
* Transplant

Primary outcomes:
measure: Transplant free survival in both group
timeFrame: Day 28
Secondary outcomes:
measure: Number of participants with the development of organ dysfunction or failure in both group
timeFrame: Day 7
measure: Number of participants with the development of organ dysfunction or failure in both group
timeFrame: Day 15
measure: Number of participants with the development of organ dysfunction or failure in both group
timeFrame: Day 28
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT00252070: Fitness and Exercise for People With Arthritis
Official title: Fitness and Functional Exercise for People With Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis
Keywords: arthritis
exercise
function
pain
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-11-11
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.

Detailed description: There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:

1. To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.
2. Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.
3. Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.
4. Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.

Eligibility criteria: Inclusion Criteria:

* Self-reported doctor-diagnosed arthritis
* No physical limitations precluding exercise participation
* Negative screen for CVD (PAR-Q)
* Age 20+
* English or Spanish speaking

Exclusion Criteria:

* Presence of any condition for which exercise is contraindicated
* Physical inability to complete exercise program

Primary outcomes:
measure: Six-minute walk
measure: 8-foot up-and-go
measure: Arm curl
measure: Back scratch
measure: AIMS-2
Secondary outcomes:
measure: Arthritis self-efficacy
measure: Physical activity level
measure: Pain VAS
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Jennifer M Hootman, PhD
role: STUDY_CHAIR
References: