louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00958412: Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Official title: A Randomized, Double-blind Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Premenopausal Women With Symptomatic Endometriosis-extension Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Pelvic pain
Oral progesterone blocker
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ZPE-201 Extension of treatment

Detailed description: This is an extension of the phase II, three-arm, parallel design, dose-ranging, placebo-controlled, randomized, double-blind, multicenter study in which placebo or one (1) of two (2) dose levels of Proellex® was administered once-daily for four (4) months.

Eligibility criteria: Inclusion Criteria:

* Only subjects treated in the ZPE-201 study will be allowed to enter the extension study.
* Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be invited to participate.

Exclusion Criteria:

* All other subjects

Primary outcomes:
measure: To Evaluate Incidence of Adverse Events (AEs) and Safety of Proellex® Administered Once Daily
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics, LLC
state: Arizona
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Ramon
country: United States
facility: Compass Clinical Research
state: California
city: West Palm Beach
country: United States
facility: Comprehensive Clinical Trials
state: Florida
city: Cary
country: United States
facility: Physicians for Women
state: North Carolina
city: Miamisburg
country: United States
facility: HWC Women's Research Center
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials of Texas/Institute for Women's Health
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas/Seven Oaks Women's Center
state: Texas
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004012: Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: A Phase II Trial of Oral Capecitabine in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-05-25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description: OBJECTIVES: I. Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with oral capecitabine. II. Determine the tolerability and safety of this regimen in these patients.

OUTLINE: Patients receive oral capecitabine twice daily for 14 days. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial carcinoma, fallopian tube cancer, or primary peritoneal cancer previously treated with at least one cisplatin based chemotherapy regimen Prior repeat treatment with a taxane and/or platinum agent allowed Prior repeat treatment with other chemotherapy agent allowed once Recurrent disease defined as: At least one site of measurable disease by radiograph and/or a rise of CA-125 over a minimum of 3 samples to a level of at least 50% of upper limit of normal

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) SGOT less than 2.0 times ULN Alkaline phosphatase less than 2.0 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Must be able to take oral medication

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior fluorouracil based chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Sabbatini, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01504412: Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy
Official title: An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Diabetic Peripheral Neuropathy
Keywords: Pain
Diabetic Peripheral Neuropathy
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2012-01-05
Enrollment: 450
Sex: ALL
Minimum age (years): 20
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 investigate the effectiveness and safety of DS-5565, compared to placebo, in subjects with pain associated with diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* Painful distal symmetric polyneuropathy
* Average daily pain score is great than or equal to 4

Exclusion Criteria:

* HbA1c greater than 9.0

Primary outcomes:
measure: Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
timeFrame: Baseline to Week 7 postdose
Secondary outcomes:
measure: Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy
timeFrame: at Week 7 postdose
Other outcomes:
Locations:
city: Tokyo
country: Japan
city: Seoul
country: Korea, Republic of
city: Taipei
country: Taiwan
Study officials:
References:
citation: Baba M, Kuroha M, Ohwada S, Murayama E, Matsui N. Results of Mirogabalin Treatment for Diabetic Peripheral Neuropathic Pain in Asian Subjects: A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Study. Pain Ther. 2020 Jun;9(1):261-278. doi: 10.1007/s40122-020-00156-6. Epub 2020 Feb 12.
Clinical trial NCT03372512: Fluid Status and T1-mapping by CMR
Official title: Fluid Status Assessed by Bioelectrical Impedance Spectroscopy and Its Association With T1-mapping by Cardiovascular Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
Heart Failure
Valvular Heart Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 200
Sex: ALL
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 undergoing cardiovascular magnetic resonance imaging including T1-mapping are invited to participate in the study where fluid status will be assessed by bioimpedance spectroscopy right before cardiovascular magnetic resonance imaging.

Brief summary: It is unclear to what extent systemic fluid overload has an impact on T1-mapping results by cardiovascular mangetic resonance imaging.

In this study, patients will undergo body composition monitoring assessing systemic fluid overload and T1-mapping using MOLLI by cardiovacular magnetic resonance imaging in order to investigate a possible association with each other.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* patient undergoing cardiovascular magnetic resonance imaging

Exclusion Criteria:

* Unwillingness to participate
* pregnancy

Primary outcomes:
measure: Native T1-mapping
timeFrame: baseline
measure: Extracellular Volume by Cardiovascular magnetic resonance imaging
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01197612: Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Official title: Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Polyposis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Rhinologic Society
First posted: 2010-09-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* hyposmia and nasal obstruction for \>12 weeks
* bilateral nasal polyposis
* candidate for surgery

Exclusion Criteria:

* immunocompromised
* non-English speaking
* prisoner
* pregnant/lactating
* will not attend follow up appointments

Primary outcomes:
measure: Olfaction
timeFrame: 3 weeks post-operation
Secondary outcomes:
measure: Sinonasal Health
timeFrame: 3 weeks post operation
measure: Olfaction
timeFrame: 24 weeks post operation
measure: Sinonasal Health
timeFrame: 24 weeks post operation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Garrett R Griffin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132012: Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
Official title: Skin Health in Young Adults - Preventing Indoor Tanning and Promoting Sun Protection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Neoplasms
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2017-04-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a pilot randomized controlled trial of an Internet-based skin cancer prevention intervention as compared to a standard of care control in 80 non-Hispanic white females ages 20-30.


Eligibility criteria: Inclusion Criteria:

* Tanned indoors in past 12 months
* Able to communicate well in English
* Reliable Internet access

Exclusion Criteria:

* History of skin cancer (self-report)

Primary outcomes:
measure: Intention to indoor tan in next year
timeFrame: Baseline
measure: Intention to indoor tan in next year
timeFrame: 12 Weeks First Follow-up
measure: Intention to indoor tan in next year
timeFrame: 24 Weeks Second Follow-up
measure: Number of indoor tanning sessions in the previous 3 months
timeFrame: 12 weeks preceding baseline
measure: Number of indoor tanning sessions in the previous 3 months
timeFrame: baseline to 12 Weeks (First Follow-up)
measure: Number of indoor tanning sessions in the previous 3 months
timeFrame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Secondary outcomes:
measure: Intention to sunbathe outdoors in the next year
timeFrame: Baseline
measure: Intention to sunbathe outdoors in the next year
timeFrame: 12 weeks First Follow-up
measure: Intention to sunbathe outdoors in the next year
timeFrame: 24 weeks Second Follow-up
measure: Number of outdoor sunbathing sessions in the previous 3 months
timeFrame: 12 weeks preceding baseline
measure: Number of outdoor sunbathing sessions in the previous 3 months
timeFrame: baseline to 12 Weeks (First Follow-up)
measure: Number of outdoor sunbathing sessions in the previous 3 months
timeFrame: From 12 Weeks (first Follow-up) to 24 Weeks (Second Follow-up)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Public Health
state: Connecticut
Study officials:
References:
Clinical trial NCT01614912: Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Official title: Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia <Phase 3>
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patients who are considered by the investigator eligible for the present study with no significant safety concerns
* Patients who are fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provide written voluntarily consent to participate in the study

Exclusion Criteria:

* Patients who are planning pregnancy for the expected duration of the study
* Patients who are otherwise considered ineligible for the study by the investigator

Primary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint
timeFrame: DB baseline and up to 32 weeks (LOCF endpoint)
Secondary outcomes:
measure: Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint
timeFrame: DB baseline and up to 32 weeks (LOCF endpoint)
measure: Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint
timeFrame: DB baseline and up to 32 weeks (LOCF endpoint)
measure: Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint
timeFrame: DB baseline and up to 32 weeks (LOCF endpoint)
measure: Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint
timeFrame: DB baseline and up to 32 weeks (LOCF endpoint)
measure: Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: EXT baseline and up to 26 weeks
measure: Proportion of Participants With TEAEs Leading to Discontinuation
timeFrame: EXT baseline and up to 26 weeks
measure: Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: EXT baseline and up to 26 weeks
Other outcomes:
Locations:
city: Tokyo, Etc
country: Japan
facility: 69 Sites
city: Seoul, Etc
country: Korea, Republic of
facility: 22 Sites
city: Kuala Lumpur, Etc
country: Malaysia
facility: 10 Sites
city: Taipei, Etc
country: Taiwan
facility: 14Sites
Study officials:
References:
Clinical trial NCT01618812: Calcaneal Neck Lengthening Osteotomy in Children With Artificial Bone Graft
Official title: Calcaneal Neck Lengthening Osteotomy - Allogen Bone Graft Material Versus a Hydroxyapatite / β- Tricalcium Phosphate Bone Substitute
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pes Plano Valgus
Flatfeet
Keywords: Artificial bone graft
Hydroxyapatite
Children
Osteotomy
Pes plano valgus
Flatfeet
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-06-13
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • children with planovalgus deformity referred to Dept. of Children's Orthopaedics, Dept of Orthopaedic Surgery E, Aarhus University Hospital from June 2009 until January 2012.

Brief summary: In a group of children with severe and painful flatfeet lengthening procedures of calcaneus can be indicated. In this study the investigators use an artificial bone graft technique to avoid removing bone graft from the iliac crest.

Detailed description: The aim is to study the clinical and radiological effects of calcaneal lengthening with either autogen bonegraft or a HA-βTCP graft material in a group of children with planovalgus. The hypothesis is that it is possible to achieve a stabile osteotomy with HA-βTCP graft material equal to the use of autogen bonegraft thus avoiding the need to obtaining iliac crest graft material at growing children.

Eligibility criteria: Inclusion Criteria:

* pain
* gait disturbance

Exclusion Criteria:

* post traumatic conditions

Primary outcomes:
measure: Healing of osteotomy
timeFrame: 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Martin Gottliebsen, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01196312: Anxiety Sensitivity Treatment for Heroin Users
Official title: Novel Intervention for Drug Use and HIV Risk Among Anxiety Sensitive Heroin Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: anxiety sensitivity
heroin
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2010-09-08
Enrollment: 60
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: Anxiety Sensitivity Treatment for Heroin Users is a development project targeting mild and above levels of anxiety sensitivity that will involve the testing of a specialized protocol for improving treatment retention and outcomes for heroin dependent individuals in a residential substance use treatment. ASTH-HR will integrate established treatment modules such as Healthy Relationships, along with interoceptive exposure, affect management, and psycho-education exercises developed for anxiety prevention and treatment programs with standard substance use treatment.


Eligibility criteria: Inclusion Criteria:

* exhibit a score of 21 on a self-report measure of anxiety sensitivity
* be in 28 days of residential substance use treatment.
* meet criteria for current opioid dependence as determined by SCID interview administered at intake.

Exclusion Criteria:

* evidence of limited mental competency
* the inability to give informed, voluntary, written consent to participate
* current psychosis
* current bipolar disorder.

Primary outcomes:
measure: Anxiety Sensitivity Index-3
timeFrame: 24 weeks
Secondary outcomes:
measure: Timeline Follow Back 90 days
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Salvation Army Harbor Light Treatment Facilitiy
state: District of Columbia
Study officials:
References:
Clinical trial NCT06041412: The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Official title: The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy
electromyography
blood parameters
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.

Brief summary: The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy(DPN).

Detailed description: This is a multicenter study(approximately four) with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).

Eligibility criteria: Inclusion Criteria:

* patients who had undergone nerve conduction examination by electromyography.

Exclusion Criteria:

* pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
* patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
* parathyroid diseases (including hyperthyroidism and hypothyroidism);
* pancreatitis, pancreatectomy or any transplant;
* patients with malignancy and any serious concomitant disease limit the existence of life expectancy

Primary outcomes:
measure: the severity of DPN
timeFrame: From admission to discharge, up to 1 week
measure: the presence of DPN
timeFrame: From admission to discharge, up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: