louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00822913: Botulinum A Toxin in Patients With Parkinson's Disease
Official title: The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson's Disease
Multiple System Atrophy
Detrusor Overactivity
Keywords: Botulinum A toxin
Parkinson's disease
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2009-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The researchers investigated the effectiveness and safety of BoNT/A injected into the detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity unresponsive to conventional medical therapy.

Detailed description: Patients included will have overactive bladder symptoms refractory to medical therapy. Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. None of the patients will be under anticoagulant therapy or drugs interfering with neuromuscular transmission. The study was approved by the local ethical committee and patients gave their informed consent. Patients will be informed about the possible need for intermittent catheterization after BoNT/A treatment.

As outcome measures we assessed clinical and urodynamic variables.

Eligibility criteria: Inclusion Criteria:

* Patients with overactive bladder symptoms refractory to medical therapy.

Exclusion Criteria:

* Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded.
* Concomitant anticoagulant therapy or drugs interfering with neuromuscular transmission.
* Neuromuscular disease like Lambert-Eaton syndrome.

Primary outcomes:
measure: As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
timeFrame: One, three and five months after intravesical treatment
Secondary outcomes:
measure: Urodynamic assessment, and samples were obtained for urinalysis and culture.
timeFrame: One, three and five months follow up
Other outcomes:
Locations:
Study officials:
affiliation: University Of Perugia
name: Antonella Giannantoni, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686113: Free Fatty Acids: Short Exposure Study
Official title: Free Fatty Acids: Short Exposure Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypogeusia
Keywords: Taste
Fat Taste
Threshold Testing
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2012-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine whether or not short, daily exposures change a person's ability to detect free fatty acids in a solution by its taste. Repeated exposure should improve a person's ability to detect free fatty acids.

Detailed description: The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste - is a relatively new area of research. Previous work suggests that subjects require an average of between two and three testing sessions of approximately an hour each before they can reliably detect NEFA, and the average number of visits to get the lowest threshold is six. Streamlining this process is of great interest to researchers who wish to test many people as quickly as possible. Other taste qualities, including umami and sweet, have shown improvement in detection sensitivity in subjects that have undergone ten second exposures to these taste qualities for 10 days upon subsequent re-testing. We seek to determine if the same improvements can be seen with fat taste.

Eligibility criteria: Inclusion Criteria:

* good health
* available for multiple testing visits

Exclusion Criteria:

* have participated in a fat taste study in the past 6 months

Primary outcomes:
measure: NEFA detection threshold
timeFrame: 10 days
Secondary outcomes:
measure: Hunger
timeFrame: 2 days
measure: BMI
timeFrame: 1 day
measure: Taste descriptor
timeFrame: 10 days
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510913: A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Official title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Graft Rejection
Kidney Transplantation
Keywords: Treatment efficacy
Transplantation rejection
Kidney transplantation
Cyclosporine
tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Detailed description: A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy

Eligibility criteria: Inclusion Criteria:

* Patient has been on cyclosporine-based immunosuppression regimen since the transplant
* Patient has at least one pre-defined risk factor for chronic allograft failure

Exclusion Criteria:

* Patient is dialysis dependent
* Patient is recipient of a solid organ transplant other than the kidney

Primary outcomes:
measure: Graft Survival
timeFrame: 5 years
Secondary outcomes:
measure: Patient survival, Graft Loss
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Inc
name: John Holman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05830513: OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up
Official title: OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
IVF
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 43 years
* IVF with follicular aspiration of one to tree follicles
* Written informed consent signed by the participant must be obtained prior to OPU

Exclusion Criteria:

* OPU with more than tree follicular aspiration
* Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV)
* Application of analgesics within eight hours before OPU
* hearing impairments
* migraines
* seizure disorder
* vestibular abnormalities
* history of motion sickness

Primary outcomes:
measure: VAS
timeFrame: post OPU (line from 0: no pain to 10:worst pain) immediately post OPU
Secondary outcomes:
measure: VAS for anxiety
timeFrame: Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU
measure: state-trait anxiety inventory form (STAI)
timeFrame: Pre-OPU
measure: vital parameters: pulse rate
timeFrame: Intraoperative
measure: vital parameters: blood pressure
timeFrame: Intraoperative
measure: vital parameters : oxygen saturation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: PD. Dr. med. Kohl Schwartz, Alexandra
Study officials:
References:
Clinical trial NCT00572013: Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Official title: A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Detailed description: Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.

This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.

Eligibility criteria: Inclusion Criteria:

* Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR).

  o Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
* At least 19 years of age
* Signed written informed consent
* Expected survival of at least 6 months
* WHO performance status greater or equal to 2
* Male or female subjects of reproductive potential who are able to follow accepted birth control measures.

Exclusion Criteria:

* No history of T-cell lymphoma
* Not pregnant or lactating women
* No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study

Primary outcomes:
measure: Response rate
timeFrame: 100 day
Secondary outcomes:
measure: Overall survival
timeFrame: diagnosis until death
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Section of Oncology/Hematology
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Julie M Vose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733213: Depiction of Prostate Cancer Treatment Alternatives in Greece
Official title: Depiction of Prostate Cancer Treatment Alternatives in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic Prostate Cancer.
Keywords: Prostate Cancer, Treatment alternatives, Metastasis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 310
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Target Group: Patients diagnosed with Locally advanced or Metastatic Prostate Cancer

Brief summary: A retrospective, registry analysis of the socio-economic and demographic characteristics of patients suffering from locally advanced or metastatic prostate cancer, as well as the depiction of the therapeutic algorithms followed in the Greek clinical practice.

* Target Group: Patients with locally advanced or metastatic prostate cancer.
* The first 10 consecutive patients records that meet the entry criteria.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Locally advanced or Metastatic Prostate Cancer after 2002.
* Patients that received Hormonal therapy.

Exclusion Criteria:

* Males that are aged less than 18 years

Primary outcomes:
measure: Percentage of patients treated by each treatment alternative.
timeFrame: Between 2002 - 2008
Secondary outcomes:
measure: To depict sociodemographic characteristics and comorbidities.
timeFrame: Between 2002 - 2008
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Research Site
city: Karditsa
country: Greece
facility: Research Site
city: Serres
country: Greece
facility: Research Site
city: Xsanthi
country: Greece
facility: Research Site
Study officials:
affiliation: AstraZeneca Greece
name: Panagiotis Pontikis, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00261313: ACCELERATE: Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Pegfilgrastim and Darbepoetin Alfa Support for the Treatment of Women With Breast Cancer
Official title: An Open Label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel Delivered Every 14 Days With Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Doses dense chemotherapy
Growth factor support
Adjuvant Breast Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of dose dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel (Taxol; T) with pegfilgrastim (Neulasta) and darbepoetin alfa support in the adjuvant breast cancer setting.


Eligibility criteria: Inclusion Criteria:

* Breast cancer diagnosis node-positive or high risk node negative
* Estrogen receptor (ER) negative or ER positive (stage IIA, IIB or IIIA) disease.

Exclusion Criteria:

* Metastatic breast cancer
* Clinically significant cardiac disease

Primary outcomes:
measure: The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study
timeFrame: 3 months
Secondary outcomes:
measure: Febrile neutropenic events and adverse event profile will be assessed
timeFrame: 4 months
measure: To assess chemotherapy and subject dose delays and reductions which are specific and/or non specific to haematological toxicities
timeFrame: 3 months
measure: Frequency of red blood cell (RBC) transfusions
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04904913: A Study of IBI362 Evaluating Weight Loss in Obese and Overweight Chinese Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of IBI362 in Chinese Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight/ Obesity
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 328
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: This is a study of IBI362 in participants with overweight and obesity. The main purpose is to learn more about how IBI362 affects body weight. The study period including 4-8 weeks dose titration and 40-44 weeks maintain treatment and 12 weeks follow up.


Eligibility criteria: Inclusion Criteria:

1. Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea
2. History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

1. Diabetes mellitus
2. Weight change \> 5.0% after diet and exercise control for at least 12 weeks before screening
3. Have used or are currently using weight loss drugs within 3 months before screening
4. History of pancreatitis
5. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. History of moderate to severe depression，or have a history of serious mental illness
7. Any lifetime history of a suicide attempt

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline ,week 24
Secondary outcomes:
measure: Safety and mental health
timeFrame: Baseline to week 36( 12 weeks after the end of treatment)
measure: The percentage change of body weight relative to baseline
timeFrame: Baseline ，week 24( 24 weeks of continuous treatment) ，week 36( 12 weeks after the end of treatment)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University people's hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01420913: Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
Official title: Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-22
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2


Eligibility criteria: Inclusion Criteria:

* 20\~45 years old, healthy adult male subject
* \>55 Kg(Body weight) and \< ideal body weight ± 20%

Exclusion Criteria:

* AST or ALT \> 1.25 \* Upper normal range (Lab)
* Total bilirubin \> 1.5 \* Upper normal range
* Systolic BP \>140 OR \<100, Diastolic BP \>90 OR \<65

Primary outcomes:
measure: Cmax,ss
timeFrame: 36 hr
measure: AUCtau
timeFrame: 36 hr
measure: Safety monitoring
timeFrame: 14 days
Secondary outcomes:
measure: AUClast AUCinfinity Tmax,ss t1/2
timeFrame: 36 hour
measure: AUCinfinity
timeFrame: 36 hr
measure: Tmax,ss
timeFrame: 36 hr
measure: t 1/2
timeFrame: 36 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul ST.Mary Hospital
Study officials:
References:
Clinical trial NCT00185913: Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers
Official title: Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with lung cancer who are undergoing surgical resection of their tumors

Brief summary: The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in patients with lung cancers.


Eligibility criteria: Inclusion Criteria:- Newly diagnosed patients with lung cancer who are undergoing surgical resection of their tumors Exclusion Criteria:- Patients without non-small cell lung cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References: