louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987870: Safety and Efficacy of BFH772 in Psoriasis Patients
Official title: A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Arthritis
Keywords: Stable plaque Psoriasis
inflammatory skin
with or without arthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.


Eligibility criteria: Inclusion Criteria:

* Stable mild to moderate plaque psoriasis (BSA involvement \< 10% or PASI \< 10
* Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
* Diagnosed or history of psoriasis for at least 6 months prior to screening

Exclusion Criteria:

* Nonplaque forms of psoriasis
* Drug-induced psoriasis
* Current use of beta blockers
* Congestive heart failure (NYHA \>III), QT interval \>450msec or poorly controlled diabetes mellitus

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Plaque PASI score
timeFrame: 4 weeks
Secondary outcomes:
measure: Measure: Local tolerability
timeFrame: Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion
measure: Measure: BFH772 concentration in plasma
timeFrame: Day 1: Pre-dose; 4h post dose.
measure: Measure: BFH772 concentration in skin
timeFrame: Week 4
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03615170: Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer
Official title: Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Neoplasms
Neoadjuvant Therapy
Circulating Tumor DNA
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Locally advanced rectal cancer, who need to receive neoadjuvant radiotherapy and radical operation

Brief summary: Application of circulating tumor DNA detection in diagnosis and treatment of locally advanced rectal cancer. First, to explore the feasibility of ctDNA as a detection index for rectal cancer. Second, evaluate the accuracy of ctDNA detection in rectal cancer. Third, to explore whether ctDNA can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. Fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. Fifth, search for possible recurrence related mutations.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed primary rectal cancer；
* First treatment；
* 18 years of age or older, male or female；
* According to the indications of operation, surgical treatment can be carried out；
* According to the indications of radiotherapy, radiotherapy can be carried out；
* The physical status score of ECOG was 0\~1；
* Organ function is appropriate;
* Expected survival time more than 3 months；
* During the treatment period and 6 months after treatment, contraception was not in lactation；
* The patient volunteered and signed the informed consent.

Exclusion Criteria:

* Poor compliance and failure to receive medication or follow up according to plan；
* There are other serious violations of the programme;
* At present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research；
* It has a history of other cancers. Unless the cancer is completely relieved, the disease is not treated for more than 3 years.

Primary outcomes:
measure: Disease free survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01279070: Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Official title: Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Indication for Modification of Patient Cognitive Status
Keywords: Schizophrenia
Cognitive remediation
Group training
Executive function
Social functioning
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 62
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: The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* More than 2 years illness duration
* Literate
* Mini Mental Status Examination score over 24
* Global Assessment of Functioning scores between 40 and 70

Exclusion Criteria:

* Current acute illness exacerbation
* Mental Retardation
* Neurological disorder which impairs cognition
* Currently participating in social skills training or cognitive remediation
* Change of antipsychotic medication one month before the trial or during the 40 study weeks
* Diagnosis of alcohol or drug dependence within 6 months of trial commencement.

Primary outcomes:
measure: Executive Function
timeFrame: Change from baseline in executive function at 16 weeks (post-treatment)
measure: Executive Function
timeFrame: Change from baseline in executive functioning at 40 weeks
Secondary outcomes:
measure: Psychosocial Functioning
timeFrame: Change from baseline in social functioning scales at 16 weeks
measure: Psychosocial Functioning
timeFrame: Change from baseline in social functioning scales at 40 weeks
measure: Psychiatric Symptoms
timeFrame: Change from baseline in psychiatric symptoms scales at 16 weeks
measure: Psychiatric Symptoms
timeFrame: Change from baseline in psychiatric symptoms scales at 40 weeks
Other outcomes:
Locations:
city: Sant Boi de Llobregat
country: Spain
facility: Parc Sanitari Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Fundació Sant Joan de Déu
name: Aida Farreny, PhD Psycho.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163370: Creatine Supplementation and Bone Mass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Osteoporosis
Keywords: creatine supplementation
resistance training
osteopenia
osteoporosis
bone mineral density
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.


Eligibility criteria: Inclusion Criteria:

* osteopenia and osteoporosis
* women older than 60 years old

Exclusion Criteria:

* cardiovascular diseases or muscular disturbances precluding exercise training
* drugs affecting bone metabolism

Primary outcomes:
measure: bone mineral density
timeFrame: six months
Secondary outcomes:
measure: cognition
timeFrame: six months
measure: physical capacity
timeFrame: six months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: School of Medicine - Division of Rheumatology
Study officials:
affiliation: University of Sao Paulo
name: Rosa MR Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632670: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
Official title: FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Endothelial Dysfunction
Keywords: music
cardiac catheterization
endothelial function
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2012-07-03
Enrollment: 70
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: The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization).

The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Referred for clinically-indicated cardiac catheterization

Exclusion Criteria:

1. Refusal or inability to provide signed informed consent
2. Significant hearing loss

Primary outcomes:
measure: change in reactive hyperemia index measured by peripheral arterial tonometry
timeFrame: PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization
Secondary outcomes:
measure: Stress and anxiety questionnaire
timeFrame: questionnaire will be completed within 2 hours after the end of cardiac catheterization
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05655442: Arthroscopic Partial Meniscectomy Time Window
Official title: Effect of Early vs Delayed Arthroscopic Partial Meniscectomy on the Knee Function of Patients With Degenerative Meniscus Lesions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Meniscus Lesion
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose was to assess knee function outcomes between early arthroscopic partial meniscectomy(APM) and delayed APM for patients with degenerative meniscus lesions(DMLs)

Detailed description: Whether early APM surgery or delayed APM surgery will more benefit for patients with DMLs. The study was to determine the early APM vs delayed APM effect on knee function outcomes for patients with DMLs for 1 year follow-up.

Eligibility criteria: Inclusion Criteria:

* • Clinical diagnosis of degenerative meniscus lesions based on knee MRI

Exclusion Criteria:

* • Must be able to have no acute knee injury such as car crash or acute sports injury;

  * Must be able to have no knee surgeries history;
  * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
  * Must be able to have no contraindications to MRI;
  * Must be able to have no severe cardiopulmonary disease;
  * Must be able to have no musculoskeletal or neuromuscular impairments ;
  * Must be able to have good visual, hearing, or cognitive;

Primary outcomes:
measure: the Knee Injury and Osteoarthritis Outcome Score (KOOS) change
timeFrame: change from baseline up to 12 months
measure: International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC Score) change
timeFrame: change from baseline up to 12 months
measure: Kellgren-Lawrence (K/L) grade change
timeFrame: change from baseline up to 12 months
measure: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) change
timeFrame: change from baseline up to 12 months
Secondary outcomes:
measure: KOOS pain score change
timeFrame: change from baseline up to 12 months
measure: KOOS symptoms score change
timeFrame: change from baseline up to 12 months
measure: KOOS activities of daily living score change
timeFrame: change from baseline up to 12 months
measure: KOOS function in sport and recreation score change
timeFrame: change from baseline up to 12 months
measure: KOOS knee related quality of life score change
timeFrame: change from baseline up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen People's Hospital
name: Hongyu Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01326442: Vitamin D and Omega-3 Inhibit Metabolic Syndrome
Official title: Phase 3 Study of Vitamin D and Omega-3 Supplementation to Reduce Risk of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Hypertension
Hyperlipidemia
Obesity
Keywords: weight loss
overweight
body composition
visceral obesity
insulin
glucose tolerance
cholesterol
hypertriglyceridemia
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 40
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: The study will test the hypothesis that supplementing the diet of subjects with Metabolic Syndrome with 2000 IU vitamin D and 1.8 g omega-3 fatty acids (EPA + DHA) per day, will facilitate weight loss, improve body composition and reduce metabolic and biochemical risk factors associated with type II diabetes and cardiovascular disease. Adult men and women who meet the International Diabetes Federation criteria for Metabolic Syndrome will be enrolled and embark on a 16 week diet and exercise intervention using a low glycemic index diet with or without the supplementary vitamin D and omega-3. Subjects will be counseled weekly and blood collected at weeks 0 and 16.


Eligibility criteria: Inclusion Criteria:

* must have Metabolic Syndrome as defined by International Diabetes Federation
* must be able to swallow tablets and capsules
* must be 18 years of age or older
* must be physically capable of moderate intensity exercise

Exclusion Criteria:

* pregnant or lactating
* vegetarian

Primary outcomes:
measure: body weight
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: up to 16 weeks
measure: Blood lipids
timeFrame: up to 16 weeks
measure: Glucose homeostasis
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
affiliation: University of Guelph
name: Kelly A Meckling, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02658942: Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones
Official title: Flexible Ureteroscopy Versus ESWL in the Management of Lower Calyceal Stones: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: renal stones
lower calyx
Ureteroscopy
Shockwave lithotripsy
Holmium laser
Adult
Kidney
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to assess safety, efficacy of Flexible ureteroscopy (FURS) holmium:YAG laser lithotripsy (LL) compared to extracorporeal shockwave lithotripsy (ESWL) in management of lower calyceal stones (LC) stones.

Detailed description: to assess stone free rate, number of sessions and complications of flexible ureteroscopy holmium:YAG laser lithotripsy compared to extracorporeal shockwave lithotripsy in the management of lower calyceal stones less than 2 cm in size.

Eligibility criteria: Inclusion Criteria:

* unilateral
* radiopaque stone(s)
* \< 2 cm
* located in the lower calyx.

Exclusion Criteria:

* Bleeding tendency
* distal obstruction
* Anomalies of the urinary tract
* Solitary kidney

Primary outcomes:
measure: Stone free rate
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: Mohammed S ElSheemy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04168242: Scalp Cooling in Gynecologic Cancer Patients
Official title: The Psychological Impact of Scalp Cooling in Patients Receiving Chemotherapy for Primary Gynecologic Cancers: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Chemotherapy-Induced Change
Keywords: Gynecologic cancer
chemotherapy-induced alopecia
scalp cooling
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In gynecologic cancers, many common chemotherapy agents can lead to chemotherapy-induced alopecia. Currently scalp cooling is the most well studied preventive measure. However, its acceptability and its impact on patients' QOL in Asian population is unclear.

Detailed description: Dynamic scalp cooling system prevents alopecia by inducing vasoconstriction leading to a reduction of scalp blood flow, thus reducing the delivery of cytotoxic drugs to the hair follicles and reducing follicular metabolic activities. One recent meta-analysis included 10 studies showed that the efficacy was 43% in general.

Eligibility criteria: Inclusion Criteria:

1. Patients must be at least 18 years old.
2. Patients with primary gynecologic cancers.
3. Patients who are going to receive at least four cycles of chemotherapy that are known to induce alopecia, such as carboplatin, paclitaxel, taxotere, topotecan, etoposide, vincristine and ifosfamide.
4. Patients who are fit to give informed consent.

Exclusion Criteria:

1. Patients who have pre-existing alopecia of CTCAE v5.0 grade 1 or above will be excluded.
2. Patients who have the following conditions will be excluded:

   1. migraine
   2. scalp or brain metastasis
   3. hypothyroidism
   4. uncontrolled diabetes
   5. liver and / or renal derangement (where liver enzymes and / or creatinine are 1.5x more than upper normal limit)
   6. severe untreated anaemia
   7. cold sensitivity
   8. cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
3. Patients who had brain irradiation.
4. Patients who have documented psychiatric disorders will be excluded.
5. Patients who are pregnant.

Primary outcomes:
measure: Incidence and grading of chemotherapy induced alopecia
timeFrame: 9 months
Secondary outcomes:
measure: Quality-of-life scale
timeFrame: 9 months
measure: Anxiety / depression level
timeFrame: 9 months
measure: Incidence and grading of treatment-related adverse events
timeFrame: 9 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka Yu Tse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01566942: FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer
Official title: FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: FOLFIRI
FOLFOX
adjuvant chemotherapy
advanced colorectal cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2012-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed adenocarcinoma in colorectal cancer
* clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
* no cancer cells were found in ascites
* Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
* male or female, between 18 and 75 years old
* adequate hematologic, hepatic and renal functions
* without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
* not enrolled into others clinical trial during this study
* all patients should sign the informed consent

Exclusion Criteria:

* can not be tolerated operation
* receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
* can not be tolerated the adverse effect of drugs in these regimens
* major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
* metastatic disease more than one organ
* pregnant or lactating women

Primary outcomes:
measure: disease-free survival（DFS）
timeFrame: 3-year disease-free survival rate
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 5-year survival
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: YULONG HE, PhD
role: STUDY_CHAIR
References: