louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03509636: A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
Official title: An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ovarian Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-26
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.

Detailed description: Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
* Confirmed documented BRCA1/2 mutation;
* Received 2\~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
* Relapsed/progressive disease as confirmed by radiologic assessment；
* Have measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

* Any previous treatment with a PARP inhibitor;
* Patient with any other malignancy which has been active or treated within the previous 5 years;
* Patients with symptomatic uncontrolled brain metastases;
* Patients unable to swallow orally administered medication.

Primary outcomes:
measure: ORR by RECIST v1.1
timeFrame: every 8 weeks (±7 days) of treatment
Secondary outcomes:
measure: DoR
timeFrame: study data collection expected to last for ~2 years
measure: PFS
timeFrame: expected to last for ~2 years
measure: Response rate by GCIG CA-125
timeFrame: every 8 weeks (±7 days) of treatment expected to last for ~2 years
measure: OS
timeFrame: study data collection expected to last for ~2 years
measure: Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
timeFrame: Every day starting with signing of consent until 30 days after discontinuation of treatment
measure: Trough (Cmin) level of fluzoparib concentrations
timeFrame: Cycle 1 to cycle 4(each cycle is 28 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT00123136: Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy
Official title: Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy. Multi-Center, Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Neuropathies
Keywords: pulsed magnetic field therapy
diabetic peripheral neuropathy
neuromodulation
diabetic peripheral neuropathic pain
sleep benefit
diabetic peripheral neuropathic functioning
Lead sponsor: Weintraub, Michael I., MD, FACP, FAAN
Sponsor class: INDIV
Collaborators: name: Nu-Magnetics Inc.
First posted: 2005-07-22
Enrollment: 250
Sex: ALL
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: The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN).


Eligibility criteria: Inclusion Criteria:

* DPN stage 2 and 3; symptomatic \> 6 months

Exclusion Criteria:

* Pacemaker in patient or mate

Primary outcomes:
measure: reduction of neuropathic foot pain
measure: improve quality of life
Secondary outcomes:
measure: serial changes in EDX, QST, autonomic functions, biopsy
Other outcomes:
Locations:
city: Briarcliff
country: United States
facility: Michael I. Weintraub MD 325 S. Highland Avenue
state: New York
Study officials:
affiliation: New York Medical College
name: Michael Weintraub, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic pain and stimulate neuronal repair: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jul;90(7):1102-9. doi: 10.1016/j.apmr.2009.01.019.
Clinical trial NCT04387136: Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Official title: Intraoperative Sublingual Sufentanil for Acute Pain in the Ambulatory Surgery Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Pain, Acute
Anesthesia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 53
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: The purpose of this study is to determine if a single dose of sublingual sufentanil given 15-30 minutes prior to wake up is efficacious at reducing recovery room time.

Detailed description: This is a level I randomized prospective outcomes study comparing two groups of patients. Within 15-30 minutes of planned wake-up Group 1 will receive 30 mcg of sublingual sufentanil and group 2 will not receive sublingual sufentanil.

Eligibility criteria: Inclusion Criteria:

- Adult patients undergoing outpatient ambulatory surgery undergoing general anesthesia for orthopedic surgery

Exclusion Criteria:

* non-english speaking patients
* patients who have allergy or intolerance to the study drugs or derivatives

Primary outcomes:
measure: Initial Numeric Rating Scale (NRS) Pain Score Upon Arrival
timeFrame: 2 hours
Secondary outcomes:
measure: Opioid Use in Recovery Room
timeFrame: 2 hours
measure: OBAS Score
timeFrame: 2 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron Bern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654936: Effectiveness of a 12 Week Theory Driven Intervention Promoting Adherence to the MIND Diet
Official title: Feasibility and Acceptability of a 12 Week Online Dietary Intervention Promoting the MIND Diet Using the COM-B Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: University of Ulster
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study includes 2 intervention arms and one control group
Primary purpose: PREVENTION

Brief summary: This study aims to test the feasibility and acceptability of a 12 week online dietary promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on cognitive function, mood, quality of life and participants capability, opportunity and motivation towards adoption of the MIND diet.

Detailed description: This study is a randomized controlled prospective follow up study, condition (control Vs intervention) x time(baseline Vs follow up) ANOVA with repeated measures design. Outcome measures for COM-B, cognitive function, mood and quality of life were recorded for both the intervention and control groups. With power set at .80, and alpha = .05, G\*Power indicated that a sample size of 36 would be required. Forty-one participants took part in the study. Participants were healthy male, and female aged between 40-55 years old living in Northern Ireland.

There are 2 intervention arms and one control group. The intervention was designed using the Behaviour Change Wheel, with prior qualitative research informing the intervention.

All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) with significance set at P \< 0.05 throughout

Eligibility criteria: Inclusion Criteria:

. Healthy male and female aged 40-55 living in NI

Exclusion Criteria:

* Anyone on a specific dietary pattern (veganism, vegetarian, Atkins)
* Anyone on a specific diet recommended by their Doctor (eating disorder)
* Specific illnesses such as high cholesterol, diabetes, heart disease, dementia.

Primary outcomes:
measure: Cognitive function
timeFrame: 12 weeks
Secondary outcomes:
measure: Mood
timeFrame: 12 weeks
measure: World Health Organisation Bref Quality of life
timeFrame: 12 weeks
measure: Capability, opportunity, motivation and behaviour model
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Derry
country: United Kingdom
facility: Life and Health Science
Study officials:
affiliation: Ulster University
name: Liz Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901536: Family Foundations Coparenting Pilot Trial
Official title: Promotion of Coparenting During Family Formation Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Keywords: First time parents
Coparenting
Family Foundations
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?


Eligibility criteria: Inclusion Criteria:

* Expecting first child
* Couple living together and planning to raise child together
* 18 years or older

Exclusion Criteria:

* Not first child

Primary outcomes:
measure: Coparenting Quality
timeFrame: up to 3.5 years after baseline
Secondary outcomes:
measure: Parenting Discipline Practices
timeFrame: 3.5 years after baseline
measure: Child Behavior Problems
timeFrame: 3.5 years after baseline
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University, Prevention Research Center
state: Pennsylvania
Study officials:
References:
citation: Feinberg ME, Jones DE, Kan ML, Goslin MC. Effects of family foundations on parents and children: 3.5 years after baseline. J Fam Psychol. 2010 Oct;24(5):532-42. doi: 10.1037/a0020837.
citation: Feinberg ME, Kan ML, Goslin MC. Enhancing coparenting, parenting, and child self-regulation: effects of family foundations 1 year after birth. Prev Sci. 2009 Sep;10(3):276-85. doi: 10.1007/s11121-009-0130-4.
citation: Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.
citation: Moran LJ, Lee JK, Jones D, Fronberg K, Feinberg ME. Coparenting-focused preventive intervention reduces postnatal maternal BMI and buffers impact of cortisol. Obesity (Silver Spring). 2022 Aug;30(8):1564-1572. doi: 10.1002/oby.23466. Epub 2022 Jul 19.
citation: Roettger ME, Schreier HMC, Feinberg ME, Jones DE. Prospective Relations Between Prenatal Maternal Cortisol and Child Health Outcomes. Psychosom Med. 2019 Jul/Aug;81(6):557-565. doi: 10.1097/PSY.0000000000000705.
Clinical trial NCT05767736: A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Official title: An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-03-14
Enrollment: 10500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with MS who are treated with Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate) at the initiation of the treatment and participating in Big Multiple Sclerosis Data (BMSD) network registry.

Brief summary: The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs \[teriflunomide, beta interferons, or glatiramer acetate\]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.


Eligibility criteria: Key Inclusion Criteria:

- Participants with MS treated with at least 1 dose of Vumerity, Tecfidera, or other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), and whose data are captured in the BMSD network will be included in the study.

Key Exclusion Criteria:

- None

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts
timeFrame: Up to 10 years
Secondary outcomes:
measure: Hazard Ratio of Confirmed SAEs in Vumerity, Tecfidera, or Vumerity/Tecfidera Switch Cohorts Versus Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer acetate) Cohort
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01586936: Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
Official title: Special Survey of Production of Antibody Against Coagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-27
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from general practice setting who have been deemed appropriate to receive NovoSeven® (eptacog alpha) as new treatment and as part of routine out-patient care by the prescribing physician

Brief summary: This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.


Eligibility criteria: Inclusion Criteria:

* Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria:

* Investigator decision to measure for antibody as unnecessary medical testing

Primary outcomes:
measure: Antibody production against eptacog alpha
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02077036: Narcolepsy - New Potential Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Narcolepsy
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The overall aim of the study is to investigate the effect of a new, non-pharmacological method that may alleviate the symptoms of narcolepsy and thereby lead to a reduction in the use of medications with potentially serious side effects in patients with this disease.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Diagnosed with narcolepsy (diagnose code G47.4)
* 16 - 60 years of age
* MSLT has shown hypersomnia (sleeping latency \< 8 min) \& 1 episode REM
* HLA-type associated with increased occurrence of narcolepsy

Exclusion Criteria:

* Reduced cognitive function
* Other relevant organ disease (that could affect the study results or put the patient at risk)
* Ongoing bacterial infection in the nose
* Comorbidity that can increase the risk of bleeding
* Has received treatment with an implantable stimulator or other implantable product in the head and / or in the neck
* Known pronounced septal deviation
* Known allergy to polyvinylchloride or medicinal liquid paraffin
* Women not using adequate contraceptives
* Participated in a clinical investigational drug trial within the previous 30 days

Primary outcomes:
measure: Change in scale Epworth Sleep Scale (ESS)
timeFrame: 15-21 days
Secondary outcomes:
measure: Change in multiple sleep latency test (MSLT)
timeFrame: 14 days
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
Clinical trial NCT04740736: Cardiovascular Analysis of PEM
Official title: Cardiovascular Analysis of Post-exertional Malaise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myalgic Encephalomyelitis
Chronic Fatigue Syndrome
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-02-05
Enrollment: 47
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine cardiopulmonary function in Chronic Fatigue Syndrome (CFS) patients and determine how it relates to the common symptom of Post-exertional malaise (PEM). Subjects will complete a maximal exercise test on 2 subsequent days. Total blood volume will be measured prior to each exercise test, and patient with hypovolemia on day 1, will be randomized to either a saline or sham infusion prior to the 2nd exercise test. A total of 80 CFS patients will be enrolled.


Eligibility criteria: Inclusion Criteria:

* Ages 25 to 60
* Meet the 2015 IOM case definition for ME/CFS

Exclusion Criteria:

* Patients with a medical cause for their fatigue
* Patients taking medications that would dampen cardiac response to exercise
* Patients with psychotic illness, bipolar disorder, or current major depressive disorder
* Patients with a history of anorexia or bulimia within 5 years of intake
* Patients with a history of alcohol or drug abuse within 2 years of intake

Primary outcomes:
measure: CPET testing
timeFrame: 2 days
measure: Total Blood Volume
timeFrame: 2 days
measure: Hypovolemia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Benjamin Natelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04141436: Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)
Official title: Open Label, Randomized Controlled Trial, Effect of Hypnofertility on Fertility Preparedness, Cortisol Levels and Pregnancy Outcomes of Women Undergoing In Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Unexplained
Fertility Disorders
Keywords: Hypnofertility
fertility preparedness
cortisol level
pregnancy outcome
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 61
Sex: FEMALE
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.

Detailed description: Objective: To specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.

Design: Randomized, controlled, prospective study. Setting: University Hospital Fertility Center in Izmir. Patients: Sixty-one women with unexplained infertility undergoing IVF treatment.

Interventions: Interventions based on Hypnofertility including affirmations, visualization, dreaming and relaxation from the first day of treatment to the day of pregnancy test.

Main Outcome Measures: Fertility preparedness and cortisol levels (primary outcomes), pregnancy rate (secondary outcome).

Eligibility criteria: Inclusion Criteria:

* primary infertility,
* unexplained infertility,
* going to undergo IVF treatment,
* fresh embryos,
* under 39 years of age
* having a smart phone

Exclusion Criteria:

* participated in any program to reduce stress
* having any psychiatric disorder

Primary outcomes:
measure: Fertility preparedness
timeFrame: through study completion, average 28 days
measure: cortisol levels
timeFrame: through study completion, average 28 days
Secondary outcomes:
measure: pregnancy rate
timeFrame: through study completion, average 28 days
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dr.
name: Sevcan Fata
role: PRINCIPAL_INVESTIGATOR
References: