louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01385475: Resistance Training to Improve Physical Function in the Elderly
Official title: Efficacy of Resistance Training Guidelines to Improve Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Function
Keywords: Resistance Training
Physical Function
Older Adults
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-06-30
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to examine the effectiveness of the current resistance training guidelines for older adults proposed by ACSM/AHA to improve physical function in individuals with reduced physical abilities. A randomized controlled intervention trial will be used to compare change in physical function pre- and post-intervention between a treatment group receiving the minimum recommendations of the guidelines and a control group asked not to change their physical activity participation. To better understand the clinical significance of such an occurrence, a secondary purpose was to determine if older adults with reduced physical abilities who adhere to the recommended intervention dosage will experience a change such that they can be reclassified to a more favorable level of functioning. It is hypothesized that the minimum recommended dosage of the guidelines would be sufficient to both improve physical function and improve functional classification in older adults with reduced physical abilities.


Eligibility criteria: Inclusion Criteria:

* Older Adults aged \>65yrs; reduced physical function

Exclusion Criteria:

* Those with a history of resistance training

Primary outcomes:
measure: Functionality
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Physical Activity & Health Research Laboratory
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Milwaukee
name: Scott J Strath, PhD
role: STUDY_DIRECTOR
References:
citation: Gennuso KP, Zalewski K, Cashin SE, Strath SJ. Resistance training congruent with minimal guidelines improves function in older adults: a pilot study. J Phys Act Health. 2013 Aug;10(6):769-76. doi: 10.1123/jpah.10.6.769. Epub 2012 Oct 10.
Clinical trial NCT00275275: Pramipexole Conversion to Ropinirole Controlled Release (CR)
Official title: An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: PD
Parkinson's
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-01-11
Enrollment: 61
Sex: ALL
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: A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.

Detailed description: Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Parkinson Disease
* Currently taking pramipexole
* Never have taken Requip CR

Exclusion Criteria:

* Can not have significant adverse effects to standard Requip
* Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases
* Can not have unstable medical conditions
* Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less)
* Female patients of childbearing potential must be using an effective method of contraception.
* Can not be pregnant or lactating.

This may not be a complete list; there may be additional criteria which may apply.

Primary outcomes:
measure: Adverse Effects Experienced
timeFrame: Week 4
Secondary outcomes:
measure: Number of Dose Adjustments
timeFrame: Week 4
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Rajesh Pahwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792475: Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
Official title: Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Diseases
Lead sponsor: TaiHao Medical Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-31
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A standard of truth "SOT" is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast cancer (CADe function). Estimate the detectability of the CADe function by comparing.


Eligibility criteria: Inclusion Criteria:

* Female patients aged 20 to 69, including those with and without breast lesions.

Exclusion Criteria:

* Have a pacemaker or prosthetic valve.
* A post-surgery follow-up patient.

Primary outcomes:
measure: The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
timeFrame: 1 week
Secondary outcomes:
measure: The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.
timeFrame: 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TaiHao Medical Inc
Study officials:
References:
Clinical trial NCT06394375: Opioid Free Anesthesia in Abdominal Laparoscopic Surgery
Official title: Effectiveness of Opioid Free Anesthesia Using Dexmedetomidine Inhibiting Nociception in Abdominal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Laparoscopic Surgery
Abdominal Surgery
Keywords: Abdominal surgery
Laparoscopic surgery
Dexmedetomidine
Opioid free anesthesia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized into two groups for control (opioid balanced anesthesia) or intervention (opioid free anesthesia)
Primary purpose: TREATMENT

Brief summary: Effectiveness of opioid free anesthesia using Dexmedetomidine to inhibit nociception in abdominal laparoscopic surgery

Detailed description: Abdominal laparoscopic surgery is one of the most common procedures worldwide, commonly facilitated with opioid balanced anesthesia or regional anesthesia. Despite being a controversy, there are issues that suggest opioid to have an influence in tumor recurrence. The investigators performed general anesthesia without opioid in laparoscopic abdominal surgery, and compared the hemodynamic instability, total consumption of fentanyl rescue, qNOX score, Ephedrine intraoperative, and Numerical Rating Scale.

Eligibility criteria: Inclusion criteria

* Patients undergoing abdominal laparoscopic surgery (digestive, urologic, gynecologic surgery) with general anesthesia
* BMI \<= 30 kg/m2
* Assessed with ASA 1-3
* Willing to participate in this study

Exclusion Criteria:

* Allergy to dexmedetomidine
* Heart rate \< 60 or systolic blood pressure \<100 mmHg
* Severe cardiovascular, uncontrolled hypertension (stage 2) or hepatic or renal disorder
* Sepsis
* Pregnancy
* Difficult airway

Drop out Criteria:

* Intraoperative emergency
* Convert to open laparatomy
* Decided to withdraw from the study

Primary outcomes:
measure: Blood pressure
timeFrame: Intraoperative
measure: Heart rate
timeFrame: Intraoperative
Secondary outcomes:
measure: Total consumption of Opioid
timeFrame: Intraoperative
measure: quantium nociception index (qNOX)
timeFrame: Intraoperative
measure: Ephedrine
timeFrame: intraoperative
measure: Pain score
timeFrame: 24 hour
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT01190475: BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Infertility
Pain
Vaginal Diseases
Uterine Diseases
Lead sponsor: Mereo BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2010-08-27
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.


Eligibility criteria: Inclusion Criteria:

* Premenopausal women with documented moderate to severe endometriosis. Occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment.
* Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening).
* Patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile.
* Patients must have a score of at least 4 on the numerical rating scale (NRS) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia

Exclusion Criteria:

* Estrogen replacement therapy using either prescription medications or estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical estrogens.
* Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or Arimidex (anastrozole) within the past 12 months.
* Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., Reclast, pamidronate) \< 15 months from screening.
* Systemic glucocorticoid therapy within the past 4 weeks.
* Contra-indications to oral contraceptive use.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
timeFrame: 8 months
Secondary outcomes:
measure: Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
timeFrame: 8 hours
measure: Pharmacokinetic Profile of BGS649 as Described by Cmax
timeFrame: 8 hours
measure: Pharmacokinetic Profile of BGS649 as Described by Tmax
timeFrame: 8 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novartis Investigative Site
state: California
Study officials:
affiliation: Mereo BioPharma
name: Jacqueline Parkin, PhD FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004275: Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome
Official title: Phase II Randomized Study of Oxandrolone vs Placebo for Growth Hormone-Treated Girls With Turner's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Turner's Syndrome
Keywords: Turner's syndrome
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Jefferson Medical College of Thomas Jefferson University
First posted: 1999-10-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome.

PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo.

GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2.

A study duration of 8 years is anticipated.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Medical College of Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Jefferson Medical College of Thomas Jefferson University
name: Judith L Ross
role: STUDY_CHAIR
References:
Clinical trial NCT00709475: Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
Official title: Observational Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 747
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries


Eligibility criteria: Inclusion Criteria:

* After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for the final visit;
* Subjects currently being treated with insulin detemir;
* Subjects who previously enrolled in this study or studies related to NovoMix 30;
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

Primary outcomes:
measure: Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events
timeFrame: For the duration of the study (32 weeks)
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: For the duration of the study
measure: Number of all adverse events
timeFrame: For the duration of the study
measure: Number of all - daytime and nocturnal - hypoglycaemic events
timeFrame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits
measure: Weight changes compared to baseline
timeFrame: At the end of the study
measure: HbA1c compared to baseline
timeFrame: At the end of the study
measure: Fasting glucose level control compared to baseline as measured by FBG
timeFrame: After 16 and 32 weeks of treatment
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04738175: Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Official title: A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Detailed description: Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

Eligibility criteria: Inclusion Criteria:

* Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
* No medical or psychiatric conditions that could put the subject at risk
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinical signs of COVID-19 indicative of impending hospitalization
* Documented infection in addition to COVID-19 that requires systemic treatment
* Medical condition that could adversely impact safety, in the Investigator's opinion
* Is or planning to be pregnant or lactating
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Has received or will receive during study participation a vaccine for COVID-19
* Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject

Primary outcomes:
measure: Incidence of adverse events by type, frequency, severity, and causality (safety)
timeFrame: Randomization through study completion at Day 70
measure: Changes in viral shedding from Baseline to Day 15
timeFrame: Randomization to Day 15
Secondary outcomes:
measure: Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
timeFrame: Randomization to Day 8, 29, 43, 70
measure: Time to viral RNA negativity
timeFrame: Randomization through study completion at Day 70
measure: Time to resolution of symptoms
timeFrame: Randomization through study completion at Day 70
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05610475: Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass
Official title: Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Injury, Acute
Keywords: Cardiopulmonary Bypass
Calpain
Lung injury
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum calpains, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Underwent cardiac surgery using CPB technology.

Exclusion criteria :

* Patient's lack of consent to participate;
* Presence of abnormal liver, kidney or other organ function;
* Pulmonary inflammation, chronic obstructive pulmonary disease or tumors;
* Underwent cardiac surgery without CPB technology;
* Postoperative need for extracorporeal membrane oxygenation support.

Primary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: Change from beginning of CPB to 48 h after CPB
measure: lung-injury scores
timeFrame: The 24 and 48 hours after CPB
Secondary outcomes:
measure: Perioperative serum calpains' concentrations
timeFrame: The day before CPB and 1, 12, 24, 48 hours after CPB
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University
state: Jiangsu
Study officials:
References: