louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00933413: Dermacyd Silver Frutal (Lactic Acid) - Acceptability.
Official title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow-up (Dermacyd Silver Frutal (Lactic Acid)).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.


Eligibility criteria: Inclusion criteria:

* Integral vaginal mucosa in the product analysis region
* Use the same category cosmetics products
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

* Use of Anti-inflammatory, immunossupression or antihistaminics drugs
* Allergic or atopic history to cosmetics products
* Cutaneous active disease (local and/or general) in the evaluated area
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Endocrinology pathology such as thyroid gland, ovary and adrenal gland
* Intensive solar exposure until 15 days before evaluation
* Gynecological treatment until four weeks before the study
* Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.
timeFrame: From the treatment start to the end of the study (treatment period 21 consecutive days)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00569036: Multiple Dose Study In Cancer Patients: Safety and Tolerability of BMS-754807 in Advanced or Metastatic Solid Tumors
Official title: A Phase I Multiple Ascending Dose Study of BMS-754807 in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Solid Tumors
Metastases
Keywords: Advanced or Metastatic Solid Tumors or Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 63
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: This is a Phase 1 dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BMS-754807 in patients with advanced or metastatic solid tumors. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 for Phase 2 studies


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate
* ECOG performance status 0-1
* at least 4 weeks between surgery or last dose prior anti-cancer therapy

Exclusion Criteria:

* symptomatic brain metastases
* any disorder or dysregulation of glucose homeostasis {e.g. diabetes)
* uncontrolled or significant cardiovascular disease
* inadequate bone marrow, liver or kidney function

Primary outcomes:
measure: Safety - Toxicities will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3
timeFrame: Continuous assessment throughout the duration of the trial
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: assessed during the first 4 weeks of the study
measure: Pharmacodynamics
timeFrame: assessed during the first 4 weeks of the study
measure: Metabolic measures
timeFrame: assessed during the first 4 weeks of the study
measure: ECG
timeFrame: assessed during the first 4 weeks of the study
measure: Efficacy Measures
timeFrame: assessed every 8 weeks
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Footscray
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05821036: Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome
Official title: Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome :Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
activity management
pain management
occupational balance
occupational performance
occupational therapy
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).

In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.

Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer

Exclusion Criteria:

* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy

Primary outcomes:
measure: The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)
timeFrame: 15 minute
measure: Canadian Occupational Performance Measurement (COPM)
timeFrame: 20 minute
measure: Patterns of Activity Measure" (POAM-P)
timeFrame: 15 minute
measure: Nottingham Health Profile (NSP)
timeFrame: 15 minute
measure: Hospital anxiety depression scale (HADS)
timeFrame: 15 minute
measure: Ocupational Balance Questionnaire (OB-Quest)
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
Study officials:
References:
Clinical trial NCT01098136: Pelvic Girdle Pain in a Pregnant Population in Western Norway.
Official title: A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: Pelvic girdle pain
Chiropractic
Single-blinded
Outcome study
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Stavanger
First posted: 2010-04-02
Enrollment: 650
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objectives in this study are

1. to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery.
2. to examine the outcome of chiropractic management for a dominating one-sided PGP subgroup of pregnant women in a single-blinded controlled study, and to use efficacy measures that include pain, functional impairment, and sick-leave frequency.
3. to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.


Eligibility criteria: Inclusion Criteria:

* Lumbopelvic pain
* Pelvic pain
* Performed ultrasound examination at 18th pregnancy week
* Expected normal pregnancy without complications
* Good competency in Norwegian language

Primary outcomes:
measure: P4/thigh thrust
timeFrame: Outcome is assessed at follow-up examination 6 weeks post-partum
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Outcome is assessed at follow-up examination 6 weeks post-partum
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Obstetrics and Gynaecology
Study officials:
affiliation: Helse Stavanger HF
name: Stefan Malmquist, DC MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gausel AM, Kjaermann I, Malmqvist S, Andersen K, Dalen I, Larsen JP, Okland I. Chiropractic management of dominating one-sided pelvic girdle pain in pregnant women; a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Sep 29;17(1):331. doi: 10.1186/s12884-017-1528-9.
Clinical trial NCT01256736: To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 89
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: The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.


Eligibility criteria: Inclusion Criteria:

* Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
* Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
* Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
* Willing to give written informed consent

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
* ALT or AST \> ULNⅹ2.5
* Platelet count \< 100ⅹ103/ μL
* WBC \< 3,000/mm3
* Absolute neutrophil count \< 1,000/mm3
* Absolute lymphocyte count \< 500/mm3
* Total bilirubin \> ULNⅹ2

Primary outcomes:
measure: Safety results
timeFrame: 48weeks
Secondary outcomes:
measure: Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
timeFrame: 48weeks
measure: Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
timeFrame: 48weeks
measure: Change of individual parameter in ACR core set
timeFrame: 48weeks
measure: Change of individual parameter in DAS28
timeFrame: 48weeks
measure: Change of individual parameter in Rheumatoid factor
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Univ. Hospital
Study officials:
References:
citation: Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
Clinical trial NCT01859936: Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment
Official title: Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Neoplasm
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Uppsala University Hospital
First posted: 2013-05-22
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?

Detailed description: Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)

Eligibility criteria: Inclusion Criteria:

* Women under 56 years of age
* Newly diagnosed breast cancer
* Swedish or English speaking

Exclusion Criteria:

* Claustrophobia
* Pregnancy
* Renal failure
* Metal items in patients

Primary outcomes:
measure: Change of treatment plan
timeFrame: 14 days
Secondary outcomes:
measure: Did breast magnetic resonance imaging reduce the number of reoperation during primary management
timeFrame: 6 months
measure: Did breast magnetic resonance imaging increase the number of mastectomies
timeFrame: 6 months
measure: Did breast magnetic resonance imaging affect cost
timeFrame: 6 months
Other outcomes:
measure: Is the sensitivity of breast MRI dependant on density and/or on age
timeFrame: 14 days
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Univeristy Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Brita Arver, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez V, Arver B, Lofgren L, Bergkvist L, Sandelin K, Eriksson S. Impact of preoperative breast MRI on 10-year survival of patients included in the Swedish randomized multicentre POMB trial. BJS Open. 2021 Sep 6;5(5):zrab088. doi: 10.1093/bjsopen/zrab088.
Clinical trial NCT04418336: Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
Official title: Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.


Eligibility criteria: Inclusion Criteria:

* patients with symptoms from sacrococcygeal pilonidal sinus .

Exclusion Criteria:

* Abscess formation
* Immunodeficiency.
* Patients with congenital asymptomatic pits.
* Patient with psychiatric disease disabling surgical intervention. . Pregnant females.

Primary outcomes:
measure: Recurrence
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT02812836: 3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children
Official title: 3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children
Constipation
Keywords: anorectal manometry
children
constipation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.

Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.

Detailed description: Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.

During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.

After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.

Data from manometry will be correlated with the success rate of BET.

Eligibility criteria: Inclusion Criteria:

* Constipation
* Parental agreement

Exclusion Criteria:

* after surgery on lower gastrointestinal tract
* diagnosis of inflammatory bowel disease
* diagnosis of other disorder that may affect anorectum function
* parental disagreement

Primary outcomes:
measure: Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.
timeFrame: 30 min
Secondary outcomes:
measure: Bear down manoeuver pressure differential
timeFrame: 1 min
measure: puborectalis muscle pressure
timeFrame: 1 min
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Gastroenterology and Nutrition
Study officials:
affiliation: Medical University of Warsaw
name: Marcin Banasiuk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981318: Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Official title: Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Keywords: Acquired Immunodeficiency Syndrome
HIV
AIDS
treatment experienced
Lead sponsor: Rodwick, Barry M., M.D.
Sponsor class: INDIV
Collaborators: name: Abbott
First posted: 2009-09-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy.

Detailed description: As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen.

Eligibility criteria: Inclusion Criteria:

* HIV viral load \> 1,000 on current antiviral medications
* No resistance to study medications
* Over 18 years of age

Exclusion Criteria:

* Hepatitis B co-infection
* Pregnancy
* Previous therapy with either of the study medications
* Ongoing substance abuse
* Significant history of other physical disease

Primary outcomes:
measure: Virologic response defined as viral load reduction of >/= 1 log
timeFrame: 48 weeks
Secondary outcomes:
measure: Assess proportion of patients with HIV-1 viral load < 48 copies
timeFrame: 48 weks
measure: Assess time to loss of virologic response
timeFrame: 48 weeks
measure: Assess development of resistance mutations in patients who develop rebound
timeFrame: 48 weeks
measure: Compare serum lipid profile changes
timeFrame: 48 weeks
measure: Assess safety and tolerability
timeFrame: 48 weeks
measure: Assess degree of immune reconstitution
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Safety Harbor
country: United States
facility: Barry M. Rodwick, M. D.
state: Florida
Study officials:
affiliation: Barry M. Rodwick, M. D.
name: Barry M. Rodwick, M. D.
role: PRINCIPAL_INVESTIGATOR
References: