louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01483014: Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Official title: Phase ll Study of Imatinib Mesylate for the Neoadjuvant Treatment of Patients With Gastrointestinal Stromal Tumors (GIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal,
stromal,
neoadjuvant,
imatinib,
mesylate,
pre-operatory
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, tolerability of imatinib in the neoadjuvant treatment (pre-operatory) of patients with GIST. It will also evaluate the potential of imatinib to convert a tumor from inoperable to operable.


Eligibility criteria: Inclusion Criteria:

* patients with age between 18 and 80 years
* diagnosis of GIST not previously treated
* Patients will be included in the protocol regardless of operability; in the case of an operable tumor, patients are eligible if, in the opinion of the surgeon, resection would be suboptimal, disfiguring or functionally disabling (i.e. incomplete resection or other which cold compromise severely the quality of life or other GI function)

Exclusion criteria:

* presence of metastatic disease
* use of other antineoplastic treatment (chemotherapy, immunotherapy, radiotherapy)

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Objective response using the RECIST criteria
timeFrame: 16 weeks
Secondary outcomes:
measure: Progression free survival
timeFrame: 16 weeks
measure: Time and duration of response
timeFrame: 16 weeks
measure: Time to treatment failure
timeFrame: 16 weeks
measure: Overall survival
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Florianopolis
country: Brazil
facility: Novartis Investigative Site
state: SC
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Belo Horizonte
country: Brazil
facility: Novartis Investivative site
city: Florianopolis
country: Brazil
facility: Novartis Investivative site
city: Porto Alegre
country: Brazil
facility: Novartis Investivative site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investivative site
city: Sao Paulo
country: Brazil
facility: Novartis Investivative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01788995: BOVARI: A Non-Interventional Study of Avastin (Bevacizumab) as Front-Line Treatment in Patients With Ovarian Cancer
Official title: A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer, Peritoneal Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinomas) with indication for carboplatin/paclitaxel chemotherapy in combination with Avastin

Brief summary: This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with newly diagnosed advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

Exclusion Criteria:

* Contraindications for Avastin according to the Summary of Product Characteristics

Primary outcomes:
measure: Clinical/demographic patient characteristics at initiation of treatment
timeFrame: approximately 4 years
measure: Duration of treatment
timeFrame: approximately 4 years
measure: Treatment discontinuations/modifications
timeFrame: approximately 4 years
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
measure: Progression-free survival
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01301495: Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Official title: Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: M.I.Tech Co., Ltd.
First posted: 2011-02-23
Enrollment: 0
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: In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

Detailed description: The incidence of esophageal cancer is increasing, and despite advances in treatment, the prognosis is still very poor \[1-4\]. At presentation, between 50-60 % of patients have unresectable disease \[5,6\]. For these patients, palliation is the goal with a particular focus on the relief of dysphagia, which is the major etiology of morbidity \[5,6\]. Presently, Self expanding metal stent (SEMS) have become the treatment of choice for dysphagia associated with unresectable esophageal and GE junction malignancies.

In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

The objectives are:

1. To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
2. To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms

Eligibility criteria: Inclusion Criteria:

* Inoperable malignant obstruction of the esophageal or gastric cardia
* Malignant fistula between the esophagus ans respiratory tree
* Recurrent cancer after prior radiation

Exclusion Criteria:

* Patient unstable for endoscopic procedure
* Previous esophageal stenting
* Tumor growth within 2 cm of the upper esophageal sphincter
* Pregnant women (self reported, no pregnancy test will be done per protocol)

Primary outcomes:
measure: Palliation assessment based on Dysphagia Scores
timeFrame: 2 years
Secondary outcomes:
measure: Assessment of Complications and MD Anderson Dysphagia Score
timeFrame: 2-4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06159595: Behavioral and Neuronal Correlates of Human Mood States
Official title: Behavioral and Neuronal Correlates of Human Mood States
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Epilepsy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Optimizing treatments in mental health requires an easy to obtain, continuous, and objective measure of internal mood. Unfortunately, current standard-of-care clinical scales are sparsely sampled, subject to recency bias, underutilized, and are not validated for acute mood monitoring. The recent shift to remote care also requires novel methods to measure internal mood. Recent advances in computer vision have allowed the accurate quantification of observable speech patterns and facial representations. The continuous and objective nature of these audio-facial behavioral outputs also enable the study of their neural correlates. Here, the investigators hypothesize that video-derived audio-facial behaviors have discrete neural representations in the limbic network and can provide a critical set of reliable longitudinal estimates of mood at low cost across home and clinic settings.


Eligibility criteria: Inclusion Criteria:

* Age range between 18 and 65
* Major depressive disorder (MDD) in a current major depressive episode diagnosed with the Mini-International Neuropsychiatric Interview (MINI)
* No medical or surgical contraindication to electrode implantation
* Patient capable of understanding the scope of our project or signing informed consent independently.

Exclusion Criteria:

* Diffuse epilepsy involving several lobes of the brain

Primary outcomes:
measure: Quantitative Audio-Facial Change
timeFrame: 5 minutes
measure: Quantitative Mood Change
timeFrame: 5 minutes
Secondary outcomes:
measure: Correlation between Audio-Facial and Mood Change
timeFrame: 5 minutes
measure: Qualitative Mood Change
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT04381455: Evaluation of OSSIX® Bone in Sinus Elevation
Official title: Evaluation of OSSIX® Bone in Maxillary Sinus Floor Augmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillary Sinus Floor Augmentation
Lead sponsor: Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that need sinus elevation

Brief summary: A post marketing observational study to evaluate clinical performance of OSSIX Bone in maxillary sinus elevation procedure.


Eligibility criteria: Inclusion Criteria:

1. Patient requiring vertical elevation of the maxillary sinus.
2. Residual alveolar bone height of edentulous maxilla below the floor of the maxillary sinus of \> 4-5mm.
3. Males and females between 30-80 years old
4. Patients with healthy periodontal conditions (Treated periodontitis, PI\<25%, BoP\<25%)
5. Patients that are willing to sign an informed consent and participate in a clinical study
6. Generally fit and healthy and able to undergo oral surgical procedures under local anesthesia.
7. Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation.

Exclusion Criteria:

1. Patients who smoke over 5 cigarettes/day
2. Pregnancy (confirmed by verbal inquiry)
3. Chronic systemic pathologies (e.g. diabetes) and neoplastic of the Oro-Facial District 4.
4. Patients taking bisphosphonates
5. Any sites where an implant already failed sites
6. Untreated Periodontitis
7. Dental sites with acute infections
8. Chronic inflammatory diseases of the oral cavity
9. Autoimmune diseases (cortisone intake)
10. Allergy declared to one or more medicaments to be used during treatment
11. Alcoholics patients and/or drug addicts
12. Patients with known collagen hypersensitivity.
13. Patients with sensitivity to porcine-derived materials.
14. History or malignant tumours of the maxillary sinus
15. History of local radiation therapy

Primary outcomes:
measure: Difference in Bone height from baseline
timeFrame: 1 year
measure: Difference in bone volume
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Studio Odont.Associato Dr.P.Cicchese E L.Canullo
Study officials:
affiliation: Study site
name: Luigi Canullo, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04316455: Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Official title: Impact of Self-managed Integrative Yoga Therapy for Older Adults Living With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Hindu Swayamsevak Sangh (UK)
name: Leicester Ageing Together
First posted: 2020-03-20
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic pain self-management skills can help patients improve daily functioning and quality of life. The goal of this study is to evaluate chronic pain self-managed Integrative Yoga Therapy intervention delivered in a sample of 25 older adults recruited from community site in Leicester.


Eligibility criteria: Inclusion Criteria:

* Willing to provide informed consent
* Age \>= 60 years
* Ambulatory
* Community-living
* Self-reported chronic musculoskeletal pain \> 3 months having pain made it difficult to do usual activities
* Ability to attend sessions one in a week for 6-weeks

Exclusion Criteria:

* Serious illness or hospitalisation in last 3-month
* Planned surgery in next six months
* Significant cognitive impairment
* Other severe physical or psychiatric disorder

Primary outcomes:
measure: Pain severity and interference: Brief Pain Inventory (BPI) questionnaire
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: Participant Global Impression of Change
timeFrame: From baseline to 6-week post intervention
measure: Participant satisfaction: Likert-scale questions
timeFrame: From baseline to 6-week post intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Karyalaya
state: Leicestershire
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
affiliation: Hindu Swayamsevak Sangh (UK)
name: Usha Solanki
role: STUDY_CHAIR
affiliation: Leicester Ageing Together UK
name: Bharti Mistry
role: STUDY_CHAIR
References:
Clinical trial NCT03695055: Maintenance Therapy Post-HSCT in High-risk Aggressive Lymphoma
Official title: Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in High-risk Aggressive Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: High-risk Aggressive Lymphoma After Auto-HSCT
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Relapse after autologous hematopoietic stem cell transplantation (ASCT) is still challenging for high-risk aggressive lymphoma. This study was to investigate the efficacy and safety of maintenance therapy post-ASCT.


Eligibility criteria: Inclusion Criteria:

* Age 14-70 years
* High-risk aggressive lymphoma underwent auto-HSCT
* Presence of 2 or more signs of unfavorable prognosis (IPI 2-4)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate hematological function
* Offer informed consent

Exclusion Criteria:

* Concomitant other cancer
* Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
* Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
* Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
* Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea \> 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
* Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
* Pregnancy

Primary outcomes:
measure: Relapse rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Treatment-related mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT03826355: Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Official title: Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis Ovary
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
Primary purpose: TREATMENT

Brief summary: Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate \> 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45.
* Bilateral endometriomas.
* Endometrioma size \> 3 cm.
* Pain and/or infertility as indication to surgical treatment.

Exclusion Criteria:

* History of cancer.
* Suspected malignancy.
* Evidence of premature ovarian failure.

Primary outcomes:
measure: Ovarian reserve
timeFrame: 7 months
measure: Ovarian volume
timeFrame: 7 months
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 6 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Francisco Carmona, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570555: Strabismus Surgery and Driving Ability
Official title: Strabismus Surgery and Driving Ability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus
Esotropia
Exotropia
Keywords: driving
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with strabismus tested before and after the eye surgery Control patients.

Brief summary: The strabismus impacts binocular visual acuity and stereoscopy. Thus, driving capacities of patients with strabismus may be reduced. The goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; Patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.


Eligibility criteria: Inclusion Criteria:

* Strabismus
* Age \> 18 yrs old
* Driving license

Exclusion Criteria:

* Inability to driving under French law

Primary outcomes:
measure: The effectiveness of strabismus surgery on driving ability by using a Performance score (number of errors, braking velocity, speed variations of the vehicle position).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Sevice d'ophtalmologie Les hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Arnaud Sauer, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: