louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01452399: A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
Official title: A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 251
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.


Eligibility criteria: Inclusion Criteria:

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
2. Women ≥ 18 years of age.
3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have received previous neoadjuvant chemotherapy
2. Patients who require a total mastectomy
3. Known metastatic breast cancer.

Primary outcomes:
measure: Optimal surgical treatment
timeFrame: 12 months
Secondary outcomes:
measure: Cosmesis
timeFrame: 12 months
measure: Operative time
timeFrame: 12 months
measure: Volume of tissue resected
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: The Breast Center -- Smilow Cancer Hospital at Yale-New Haven
name: Anees Chagpar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chagpar AB, Horowitz NR, Killelea BK, Tsangaris T, Longley P, Grizzle S, Loftus M, Li F, Butler M, Stavris K, Yao X, Harigopal M, Bossuyt V, Lannin DR, Pusztai L, Davidoff AJ, Gross CP. Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial. Ann Surg. 2017 Jan;265(1):39-44. doi: 10.1097/SLA.0000000000001799.
citation: Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.
Clinical trial NCT01356199: Effect of Artronat on the Quality of Life of Patient With Osteoarthritis
Official title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Gonalgia
Quality of Life
Dietary supplement
Nutrition
Lead sponsor: Lescuyer Laboratory
Sponsor class: INDUSTRY
Collaborators: name: RDVC Produit de Santé.
name: Association Nationale de Prévention Médicale.
First posted: 2011-05-19
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

Detailed description: Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.

Eligibility criteria: Inclusion Criteria:

* age 40-75 years
* BMI 18.5-30
* osteoarthritis type II or III

Exclusion Criteria:

* osteoarthritis type I or IV
* allergy to one of the component of the supplement
* blood pressure \> 14/8
* history of knee surgery

Primary outcomes:
measure: Reduction of gonalgia
timeFrame: T8 months
Secondary outcomes:
measure: Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.
timeFrame: T2, T4, T6, T8 months
Other outcomes:
Locations:
city: Treviou Treguignec
country: France
facility: Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion
Study officials:
affiliation: Association Nationale de Prevention Medicale
name: Maurice Cloarec, MD
role: STUDY_CHAIR
affiliation: Hospital Center of Lanion
name: Dominique Baron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139099: The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia
Official title: Department of Psychiatry of NTUH Yun-Lin Branch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2010-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the patients with schizophrenia can be treated with new generation of antipsychotics medication, additional approaches are necessary to improve schizophrenics' cognitive functions, interpersonal relationships as well as social adjustment. When some of patients return to community, they expose to practical pressure that contribute to worsen and relapse of disease. That further damages patient's cognitive functions. Integrated Psychological Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has formed structured treatment gradually on relieving illusion, hallucination as well as negative symptoms. This study aims at conducting 12-week structured IPT group therapy. The intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community, outpatient and inpatient service. The overall treatments are designed to provide 1-2 hours weekly group therapy which focuses on relieving illusions, hallucination, and negative symptoms. Patients' cognitive functions, ability of emotional adjustment and interpersonal relationship would be evaluated in pre-test and post-test to indicate whether the significant difference exists. There is a controlled group, in which patients who still receive treatment as usual (TAU). The study also compares the evaluation results between IPT group and TAU group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* schizophrenia,
* can concentrate in group for 30 minutes.

Exclusion Criteria:

* substance abuse (alcohol, illegal medication),
* self harm history.

Primary outcomes:
measure: re-hospitalization rate
timeFrame: after 3 months of the group psychotherapy
Secondary outcomes:
measure: Cognitive functions, ability of emotional adjustment, and interpersonal relationship
timeFrame: 12 months of the group tpsychotherapy
measure: The Positive and Negative Syndrome Scale, Beck depression scale, Beck anxiety scale, Beck suicial ideation scale, Cognitive tests (visual spatial test), CPT-IP for attention test
timeFrame: 12 months of the group psychotherapy
Other outcomes:
Locations:
city: Yun-lin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: Department of Psychiatry in National Taiwan University Hospital Yun-Lin Branch
name: Li-Ren Chang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05410899: Exercise and Pelvic Floor Health Education Program Effectiveness
Official title: Investigation of Effectiveness of Pelvic Floor Health Education and Exercise Program Effectiveness on Women With Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Pelvic Floor Disorders
Exercise Addiction
Keywords: urinary incontinence
exercise
pelvic floor
health education
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 96
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The ages between 18 -65 women with urinary incontinence, applying pelvic floor muscle exercise

Brief summary: The aim of the study is investigation of the effectiveness of Pelvic Floor Health Education and exercise program in women with Urinary Incontinence. Women diagnosed with both stress and mixed type urinary incontinence were included the study. Pelvic Floor Health Education and exercise program were applied to women for 12 weeks.

Detailed description: 3 group were created; the first group will applied Pelvic floor health education composed presentation about women health,urinary incontinence, teaching anatomy of the pelvic floor and bladder training ,second group will applied both pelvic floor health education and exercise of pelvic floor muscles for 12 weeks and third group will be control group.Women with urinary incontinence were included the study are continued 12 weeks . First evaluation is done before education and exercise program, and second evaluation in 6.week and last evaluation after 12 weeks exercise and education program.

Eligibility criteria: Inclusion Criteria:

1. The ages between 18-65 with urinary incontinence
2. Volunteer women who can regularly apply the Pelvic floor muscle exercise program

Exclusion Criteria:

1. Having pelvic organ prolapse (Stage≥2),
2. Women who are in the neonatal and postnatal period (up to 3 months after birth),
3. Situations that will prevent evaluation or communication (cognitive problems, etc.).
4. Having a neurological disorder,having urinary tract infection,
5. Those who received urinary incontinence treatment or had an operation, • Women who have received training on the pelvic floor before

Primary outcomes:
measure: Incontinence severity
timeFrame: 3 month
Secondary outcomes:
measure: Life style
timeFrame: 3 month
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University Hospital
state: Turkey/Şanlıurfa
Study officials:
References:
Clinical trial NCT02895399: Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers
Official title: Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Viruses
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 643
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women from 20 to 65 years living on the Maroni and the Oyapock rivers having already had sexual intercourse

Brief summary: Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection.

Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.


Eligibility criteria: Inclusion Criteria:

* Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )
* Having already had sexual intercourse
* Having given after information , consent to the inclusion in the study

Exclusion Criteria:

* Age \< 20 or age\> 65 years
* Being pregnant more than 3 months
* Have had a hysterectomy
* Denial of participation

Primary outcomes:
measure: Prevalence and distribution of Human Papillomaviruses genotypes
timeFrame: At the time of inclusion (baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06392399: Interventions for the Management of Perineal Cancer Pain
Official title: Cooled Radiofrequency in Comparison to Either Conventional Radiofrequency Thermocoagulation or Neurolytic Block of Ganglion Impar in the Management of Perineal Cancer Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Rectum
Cancer Vulva
Cancer Vagina
Keywords: cooled radiofrequency , conventional radiofrequency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain associated with neoplasms may be of somatic, visceral, or neuropathic origin.Visceral pain or pain that is mediated by the sympathetic fibers in the perineal area associated with malignancy in the pelvis may be effectively treated with neurolysis of impar ganglion.In recent years, radiofrequency lesioning of the ganglion Impar has evolved as a novel non pharmacological technique for the management of patients suffering from intractable perineal pain.


Eligibility criteria: Inclusion Criteria:

1. Cancer patients aged from 20-70 years old, with lower third cancer rectum, caner vulva, cancer vagina and cancer perineum.
2. The intensity of perineal pain on VAS score ≥ 5.
3. Unsatisfactory treatment with tramadol (400 mg daily) , Pregabalin (150 mg daily) or presence of side effects of tramadol as headache, dizziness, constipation, rash, sweating, dry mouth.
4. Included participants should show adequate response to diagnostic ganglion impar block , i.e. reduction of VAS pain score \> 50% at least for 2 hours.

Exclusion Criteria:

1. Infection of the skin at or near site of needle puncture.
2. Coagulopathy or prolonged bleeding time.
3. Drug hypersensitivity or allergy to the studied drugs.
4. Central or peripheral neuropathy .
5. Significant organ dysfunction as respiratory , liver or renal failure.
6. Any psychiatric illness that would interfere with the perception and the assessment of pain.
7. Vertebral anomalies.

   -

Primary outcomes:
measure: Percentage of patients gaining ≥ 50% reduction of their pre procedural pain at VAS Score from baseline value.
timeFrame: 2 hours, 24 hours,1 week, 2 weeks, 1 month, 3 months.
Secondary outcomes:
measure: Total Tramadol consumption
timeFrame: at 2 weeks, 1 month, 2 months and 3 months' post procedural.
Other outcomes:
measure: Patient's satisfaction by the Global Perceived Effect questionnaire
timeFrame: at baseline, 2 weeks, 1 month, 3 months.
Locations:
Study officials:
affiliation: Assiut University
name: aya ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04110899: Paratracheal Force Required for Occluding the Upper Esophagus
Official title: Paratracheal Force Required for Occluding the Upper Esophagus in Anesthetized and Paralyzed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Paratracheal force for occluding the upper esophagus is evaluated using the up-and-down sequential method.
Primary purpose: PREVENTION

Brief summary: In this study, the median paratracheal force for occluding the upper esophagus are evaluated in anesthetized and paralyzed patients using the up-and-down technique.


Eligibility criteria: Inclusion Criteria:

* patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* diseases or anatomical abnormalities in the neck, larynx, pharynx or esophagus
* aspiration tendency
* history of carotid artery diseases or cerebrovascular diseases
* suspicious of thrombus in carotid artery on ultrasonographic examination

Primary outcomes:
measure: Median paratracheal force
timeFrame: During 1 min after the completion of anesthesia induction
Secondary outcomes:
measure: The 95% paratracheal force
timeFrame: During 1 min after the completion of anesthesia induction
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT04784299: To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume
Official title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midface Volume Deficit
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 105
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

Detailed description: This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Eligibility criteria: Inclusion Criteria:

* Male and female aged between 21 to 75 years (inclusive)
* 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
* Desire cheek augmentation to correct volume deficit in the midface.
* Agree to use contraception
* Sign Informed Consent Form

Exclusion Criteria:

* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
* have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
* have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
* have history of bleeding disorder
* have a tendency to develop hypertrophic scarring or keloid

Primary outcomes:
measure: Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine
timeFrame: 24 weeks from baseline
measure: Responder rate of YVOIRE volume plus
timeFrame: 24 weeks from baseline
Secondary outcomes:
measure: Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)
timeFrame: 4, 8, 12, 52 weeks from baseline
measure: Responder rate of YVOIRE volume plus
timeFrame: 4, 8, 12, 52 weeks from baseline
measure: Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)
timeFrame: 4, 8, 12, 24, 52 weeks from baseline
measure: The mean scores of the GAIS
timeFrame: 4, 8, 12, 24, 52 weeks from baseline
measure: Mean change in mid-face volume
timeFrame: 24 weeks from baseline
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LG Chem investigational site 01
Study officials:
affiliation: LG Chem Investigational site 01
name: Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006199: Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cancer
Keywords: solid tumor
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed.

This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit
* Therapy with no more than 3 prior chemotherapy regimens
* Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation)
* Adequate organ function
* Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study.
* Good performance status
* Anticipate life expectancy of at least 6 months
* Not pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception.
* Be able to give signed, written informed consent.
* No gastrointestinal condition that could affect the absorption of the drug
* No active infection requiring systemic medical therapy one week prior to chemotherapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
Study officials:
References: