louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05086094: Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)
Official title: Intermediate-Size Patient Population Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple System Atrophy (MSA)
Keywords: Multiple System Atrophy
MSA
verdiperstat
BHV3241
MPO inhibitor
Myeloperoxidase inhibitor
MSA-P
MSA-C
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.


Eligibility criteria: Inclusion Criteria:

1. with a diagnosis of probable or possible MSA documented by a physician according to consensus clinical criteria,5 including patients with MSA of either subtype, MSA-P or MSA-C.
2. able to swallow whole tablets without crushing or chewing.
3. with established care with a physician at the specialized MSA center involved in the protocol and will maintain this clinical care throughout the duration of the EAP.
4. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing EAP for MSA

Exclusion Criteria:

1. Based on the Physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the EAP instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason.
2. Presence of clinically significant thyroid disease despite treatment and/or TSH \>10 mIU/ L at Screening/Baseline, confirmed by repeat.
3. Patient is known to have acute or chronic liver disease that is clinically significant in the Prescriber's judgment
4. First or second dose of COVID-19 vaccination within 7 days of first dose of verdiperstat.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: PPD
state: North Carolina
Study officials:
References:
Clinical trial NCT04030494: Validation Study of an Advanced Blood Pressure Monitor
Official title: Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Hypertension
Valvular Heart Disease
Keywords: blood pressure
Arrhythmias, Cardiac
atrial fibrillation
valvular disease
blood pressure monitors
electrocardiography
Doppler echocardiography
Heart diseases
Cardiovascular diseases
Lead sponsor: Withings
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2019-07-24
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.

The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years old,
* Subject who signed the consent form,
* Subject affiliated to a social security scheme or entitled.

Exclusion Criteria:

* Underage subject;
* Subject who refused to participate in the study;
* Subject participating in other research or clinical studies;
* Subject with body mass index greater than 35 kg/m2;
* Subject in linguistic or psychic incapacity to sign an informed consent;
* Subject with congenital cardiomyopathy;
* Subject with aorto-venous fistula;
* Subject with pulmonary pathology that may degrade the quality of the recording;
* Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;
* Subject with an arm injury incompatible with the use of an armband sphygmomanometer;
* Subject receiving an intravenous perfusion on the left arm;
* Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator;
* Subject with prosthetic heart valve;
* Subject under kidney dialysis;
* Hemodynamically unstable subject (acute heart failure or cardiac assistance).

Primary outcomes:
measure: BP precision and accuracy
timeFrame: 1 visit (45 minutes)
measure: AF and SR classification accuracy
timeFrame: 1 visit (30 minutes)
measure: VHD detection accuracy
timeFrame: 1 visit (30 minutes)
Secondary outcomes:
measure: safety evaluation
timeFrame: 1 visit (1 hour)
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Clinique AXIUM Centre de cardiologie
Study officials:
References:
Clinical trial NCT00591994: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Official title: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
piribedil
acoustic otoemissions
ECoG
Lead sponsor: Faculdade de Medicina de Valenca
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.


Eligibility criteria: Inclusion Criteria:

* tinnitus for more than 6 months
* THI \> 38
* no central acting drugs in the last 6 months
* tympanogram type A-n

Exclusion Criteria:

* vascular and muscular tinnitus
* concomitant TMJ disorders
* abnormal otoscopy
* mixed and conductive hearing losses

Primary outcomes:
measure: THI - Tinnitus Handicap Inventory
timeFrame: Months 3 and 6
Secondary outcomes:
measure: VAS - Visual Analog Scale
timeFrame: Months 3 and 6
Other outcomes:
Locations:
city: Volta Redonda
country: Brazil
facility: OTOSUL,Otorrinolaringologia Sul-Fluminense
state: RJ
Study officials:
affiliation: Faculdade de Medicina de Valença
name: Ricardo R Figueiredo, M.D.,M.Sc
role: STUDY_CHAIR
affiliation: Otosul -Otorrinolaringologia Sul-Fluminense
name: Andréia A Azevedo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Azevedo AA, Langguth B, de Oliveira PM, Rodrigues Figueiredo R. Tinnitus treatment with piribedil guided by electrocochleography and acoustic otoemissions. Otol Neurotol. 2009 Aug;30(5):676-80. doi: 10.1097/MAO.0b013e3181ab8fd5.
Clinical trial NCT00911794: Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease
Official title: Pulmonary Therapy and Supplemental Written Disclosure Therapy for Chronic Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lung Diseases
COPD
Pulmonary Fibrosis
Keywords: Dyspnea
Written Disclosure Therapy
COPD
Pulmonary Fibrosis
Chronic Lung Diseases
Pulmonary Rehabilitation
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
Collaborators: name: Stony Wold-Herbert Fund, Inc.
First posted: 2009-06-02
Enrollment: 66
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 purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any benefit to patients with chronic lung diseases who are participating in pulmonary rehabilitation.

Detailed description: Chronic lung diseases are typically associated with impaired quality of life, stress, and anxiety. Written disclosure therapy (WDT) reduces stress in patients with a variety of chronic illnesses. We sought to determine if written disclosure therapy benefits patients with chronic lung diseases when it is added as a component to the pulmonary rehabilitation program.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD or Pulmonary Fibrosis
* First time participants in Pulmonary Rehabilitation program

Exclusion Criteria:

* Dementia
* Prior significant psychiatric illness
* Inability to complete the questionnaires
* Inability cooperate with spirometry
* Inability or to participate in outpatient follow-up over the six-month

Primary outcomes:
measure: Dyspnea and quality of life
timeFrame: Two-month and six-month time
Secondary outcomes:
measure: Six-minute walk distance
timeFrame: Two-month and six-month time
measure: Spirometry values (FEV1 and FVC)
timeFrame: Two-month and six-month time
Other outcomes:
Locations:
Study officials:
affiliation: Winthrop University Hospital
name: Adam Hurewitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600794: To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization
Official title: To Evaluate The Androgens and Ovary Function Impact on The Pregnancy Outcome in In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: In Vitro Fertilization
Keywords: In Vitro Fertilization (IVF)
androgens
ovary function
This study include the patients who are evaluated by the doctors and are sure to process the In Vitro Fertilization cycle.
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.

Brief summary: Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is collected by Bureau of Health Promotion, Department of Health shows that there are about 7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to know how to estimate and approve the ovary function that lead to increase the live birth rate. The investigators plan to estimate the correlation between the serum androgens levels and pregnancy outcome in the women who have infertility problem. Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect from stimulated drugs used on previous cycle. It's important to understand the ovary function for IVF patient to choose the appropriate drugs and dose.

The investigators use blood and clinical test to analyze, the items for analysis are below:

1. Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、
2. Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S
3. Clinical test: Ultrasound
4. Personal condition. In order to finishing the test, every patient will be asked to collect about 10 to 15 cc blood for the research.


Eligibility criteria: Inclusion Criteria:

* This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle.

Exclusion Criteria:

* This study exclude the patients who are not evaluated by the doctors and are not sure to process the IVF cycle.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05574894: Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Official title: Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone
Advanced Maternal Age
PGT-A
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 692
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.

Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.

Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.


Eligibility criteria: Inclusion Criteria:

* Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner

Exclusion Criteria:

* Endometriosis grade 3 or higher, untreat hydrosalpinx;
* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);
* Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
* Women who received other supplement drugs during ovarian stimulation

Primary outcomes:
measure: Proportion of cycles which obtained euploid blastocysts
timeFrame: 1 month after oocyte retrieval
Secondary outcomes:
measure: Euploid blastocyst rate per cohort
timeFrame: 1 month after oocyte retrieval
measure: Euploidy rate per cycle
timeFrame: 1 month after oocyte retrieval
Other outcomes:
measure: Embryo implantation
timeFrame: 14 days after embryo transfer
measure: Clinical pregnancy
timeFrame: 30 days after embryo transfer
measure: Ongoing pregnancy
timeFrame: 12 weeks' gestation
Locations:
city: Shanghai
country: China
facility: Shanghai JIAI Genetics and IVF Institute
state: Shanghai
Study officials:
affiliation: Shanghai JIAI Genetics and IVF Institute
name: Xiaoxi Sun, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02223494: Safety of Terbogrel in Patients With Primary Pulmonary Hypertension
Official title: An Open-label, Long-term Safety Evaluation of Terbogrel in Patients With Primary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension, Pulmonary
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to assess the safety of terbogrel during open-label, long-term treatment in medically stable or improving patients with primary pulmonary hypertension who have completed the 12-week, double-blind randomized trial of terbogrel (protocol 528.19)


Eligibility criteria: Inclusion Criteria:

Patients who

* completed the preceding primary pulmonary hypertension, double-blinded clinical trial of terbogrel (protocol 528.19)
* provide informed consent to participate in this trial
* are in a stable or improving medical condition, in the opinion of the investigator
* enter the study immediately upon their completion of the preceding double-blind Trial 528.19, or enter the study within one month of completing the preceding trial as long as their medical condition has remained stable or continues to improve in the interim

Exclusion Criteria:

* Development of an unstable medical condition during or following completion of the preceding clinical trial which, in the investigator's opinion, may be worsened by treatment with terbogrel
* Premature discontinuation of the preceding terbogrel clinical trial due to an adverse event or for any other reason
* Pregnant or nursing women, or women of childbearing potential (less than one year postmenopausal or not surgically sterilized) who are not using adequate methods of birth control

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 18 months
measure: Number of patients with clinically significant findings in laboratory tests
timeFrame: up to 18 months
measure: Number of patients with clinically significant changes in ECG
timeFrame: up to 18 months
Secondary outcomes:
measure: Change in patient status
timeFrame: baseline, up to 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01760694: Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Official title: Multi-Modality Therapy for Untreated Patients With Resectable or Marginally Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic
Pancreas
Intraoperative Radiation Therapy
Chemotherapy
Lead sponsor: Southwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the ability of a combination of updated and approved modalities in the treatment of first line pancreatic cancer patients to increase the time to Progression Free Survival

Detailed description: For resectable patient; surgery with Intraoperative Radiation Therapy (IORT). Radiation Therapy within 6-8 weeks after surgery followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery.

For marginally resectable patients; the patients will have 2-3 cycles of neoadjuvant chemotherapy of FOLFIRINOX and then restaged, undergo surgery with IORT within 2-4 weeks following chemotherapy. Then radiation therapy starting within 6-8 weeks. Followed by FOLFIRINOX every 2 weeks starting within 12 weeks of surgery for a total of 2-4 cycles.

Eligibility criteria: Inclusion Criteria:

* Histologically proven Exocrine Adenocarcinoma of the pancreas
* Clinically resectable or marginally resectable disease
* No prior radiation or chemotherapy for carcinoma of the pancreas
* ECOG performance status of 0-1
* Patients must be medically able to undergo surgical resection
* Patients of child bearing potential must follow study specific precautions
* Women that are lactating will not be excluded on the condition that they dispose their breast milk.
* Adequate hematologic and biochemical parameters.

Exclusion Criteria:

* Prior treatment for pancreatic cancer.
* Concurrent investigational treatments.
* Unresectable pancreatic mass.
* Neuroendocrine Histological pancreatic cancer
* Distant Metastatic disease
* Any condition that, in the option of the investigator, would compromise the well being of the patient or anything that would prevent the patient from meeting or performing study requirements

Primary outcomes:
measure: Efficacy - Progression Free Survival
timeFrame: 2 years after last patient enrolled
Secondary outcomes:
measure: Safety
timeFrame: 2 years after last patient enrolled
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Southwestern Regional Medical Center, Inc.
state: Oklahoma
Study officials:
affiliation: Southwestern Regional Medical Center, Inc.
name: Theodore Pollock, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02206594: Combined Cataract Surgery and Planned Descemetorhexis
Official title: Combined Cataract Surgery and Planned Descemetorhexis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fuchs' Corneal Dystrophy
Cataract
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 2
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: A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.


Eligibility criteria: General Inclusion Criteria:

* Patient \>18 years old
* Willing and able to provide informed consent

Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):

* Fuchs' corneal dystrophy diagnosed
* Cataract present
* Best corrected visual acuity ≤ 20/40
* Candidate for current endothelial transplant procedure (DSAEK, DMEK)

General Exclusion Criteria:

* \<18 years old
* Medically unstable patient
* Monocular patient
* Unwilling or unable to provide informed consent

Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):

* Corneal dystrophy other than Fuchs'
* Central corneal scar or central opacity not related to Fuchs'
* Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
* History of prior vitreoretinal surgery
* Advanced or unstable glaucoma
* Known steroid responders with glaucoma

Primary outcomes:
measure: Corneal clarity as assessed by slit lamp photography
timeFrame: Assessed up to 1 year following descemetorhexis
Secondary outcomes:
measure: Resolution of edema as assessed by slit lamp photography
timeFrame: Assessed up to 1 year following descemetorhexis
Other outcomes:
measure: Reconstitution of the endothelial cell layer as assessed by specular microscopy
timeFrame: Assessed up to 1 year following descemetorhexis
Locations:
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
References: