louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00455624: Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
Official title: Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: androgen deprivation therapy
insulin resistance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
First posted: 2007-04-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men identified with prostate cancer.

Brief summary: The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

Detailed description: * This is a non-treatment study. This study has no effect on the care the participant will receive.
* In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate, clinical stage M0
* About to initiate GnRH agonist therapy
* Karnofsky Performance Status 90 or 100
* Serum creatinine \< 2.0mg/dl

Exclusion Criteria:

* Hormone therapy within 12 months
* History of diabetes mellitus or glucose intolerance
* Anabolic agents or metabolic agents known to affect insulin or glucose levels
* Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)

Primary outcomes:
measure: insulin sensitity
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthew Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.
Clinical trial NCT06668324: Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation
Official title: Multiple Sclerosis Patient Experience on Kesimpta and Ocrevus Subcutaneous Formulation (MS-PEKOS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MS who are prescribed and initiating OMB or OCR SC and who are living in the US at the time of the survey will be invited to participate following a referral from their healthcare providers

Brief summary: The study aims to compare the experiences, including injection-related reactions (IRRs) of patients newly receiving ofatumumab to those starting to receive ocrelizumab SC formulation


Eligibility criteria: Inclusion Criteria:

1. Ability to use a mobile device or computer with broadband internet access (or data streaming available)
2. Ability to read, understand, and respond in English
3. Adult aged 18 years of age or over at the time of the survey
4. Self-confirmed diagnosis of MS
5. Prescribed either OMB or OCR SC and will receive their first injection (Day 0) followed by completing the study survey between Day 1 and Day 7

Exclusion Criteria:

1. Participated in an OMB or OCR randomized clinical trial
2. Previously treated with OMB or OCR SC
3. Cognitive impairment that impacts the patient's ability to participate in a survey study

Primary outcomes:
measure: Proportion of patients reported local injection-related reaction post first injection
timeFrame: Day 1- 7 post first injection, at the time of survey completion
Secondary outcomes:
measure: Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post first injection)
timeFrame: Day 1 - 7 post first injection, at the time of survey completion
measure: Proportion of patients reported local injection-related reaction post second injection
timeFrame: Day 1- 7 post second injection, at the time of survey completion
measure: Proportion of patients in a 5-Likert scale for satisfaction on injection-related experience (post second injection)
timeFrame: Day 1- 7 post second injection, at the time of survey completion
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative site
state: New Jersey
Study officials:
References:
Clinical trial NCT04902924: Cold and Warm Water for Performance Recovery
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of Repeated Cold- and Warm Water Immersion on Performance Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: cold water immersion
warm water immersion
muscle damage
recovery
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim of this study is, to evaluate the effectiveness of repeated cold- and warm water immersion on performance recovery after muscle damage.

Detailed description: Participants perform a muscle-damage protocol, which comprises 5x20 drop jumps. After the exercise protocol is finished, the participants will undergo one of three recovery interventions. Cold-water immersion, Warm-water immersion or the control-intervention. During the exercise protocol and the recovery intervention following parameters will be assessed: Blood oxygenation, Muscle oxygenation, heart-rate, skin temperature and core temperature.

Then, performance recovery will be assessed during the following 72 hrs (in a 24 hrs interval).

At each time-point, following measurements will be conducted: vertical-jump performance, maximum voluntary isometric contraction of the m.quadriceps femoris muscle, muscle swelling and delayed-onset of muscle soreness.

Eligibility criteria: Inclusion Criteria:

* Healthy participants
* No surgeries
* No previous injuries
* Anticonceptiva allowed

Exclusion Criteria:

* Acute injuries or current pain situations
* Cryophobia
* Fear
* Pregnancy
* Raynaud syndrome
* Medication intake

Primary outcomes:
measure: maximun voluntary isometric contraction (Nm)
timeFrame: baseline to 72 hours
measure: vertical jump performance (cm)
timeFrame: baseline to 72 hours
measure: delayed onset of muscle soreness (units)
timeFrame: baseline to 72 hours
measure: muscle swelling (mm)
timeFrame: baseline to 72 hours
measure: Creatine-kinase (U/l)
timeFrame: baseline to 72 hours
measure: blood oxygenation (%)
timeFrame: through recovery intervention up to 1 hour
measure: muscle blood oxygenation (%)
timeFrame: through recovery intervention up to 1 hour
measure: skin temperature (°C)
timeFrame: through recovery intervention up to 1 hour
measure: core temperature (°C)
timeFrame: through recovery intervention up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: University of Applied Sciences and Arts of Southern Switzerland
state: GR
Study officials:
affiliation: University of Applied Sciences and Arts of Southern Switzerland
name: Ron Clijsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01028924: Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
Official title: A Randomised, 4-period, Placebo and Active-controlled, Single-dose, Change-over Trial to Evaluate the Effects of Teduglutide on Cardiac Repolarisation and Conduction in Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Thorough QTc-Study
Short Bowel Syndrome
Cardiac safety
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate if teduglutide has an effect on cardiac repolarisation (QT, QTc interval). Secondary objectives are the investigation of possible effects on heart rate and cardiac conduction (RR and PR intervals, QRS duration), pharmacokinetics and safety and tolerability in healthy subjects, and to determine the effect of the positive control, moxifloxacin, for sensitivity analysis. The trial will consist of a screening and a treatment phase of four treatment periods. There is a washout period of at least 7 days and 4 weeks at maximum between administrations. The expected total trial duration for the individual subject will be about 7 weeks (maximum 17) weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers
* Normal body weight (body mass index within ≥18 and 29 kg/m2 (inclusive) and a body weight \>50 kg (females) and \>60 kg (males).

Primary outcomes:
measure: ECG measurement/assessment to determine the effect of a single dose of teduglutide on cardiac repolarisation (QT, QTc interval).
timeFrame: until 24 h post dose
Secondary outcomes:
measure: ECG measurement/assessment to determine the effect of a single dose of a positive control, moxifloxacin, on cardiac repolarisation, heart rate, and conduction
timeFrame: until 24 h post dose
measure: ECG measurement/assessment to determine the effect of a single dose of teduglutide on heart rate and cardiac conduction (RR and PR intervals, QRS duration)
timeFrame: until 24 h post dose
measure: PK blood samples to investigate pharmacokinetics of teduglutide in plasma
timeFrame: until 24 h post dose
measure: PK blood samples to explore the concentration effect relationship on QT/QTc intervals
timeFrame: until 24 h post dose
measure: ECG measurement/assessment and PK blood samples to investigate safety and tolerability of teduglutide
timeFrame: within 14 days after trial medication administration
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: Nycomed GmbH
Study officials:
References:
Clinical trial NCT06972524: Effects of Milk Probiotics Intervention on Blood Glucose Control Middle-aged and Elderly People With Pre-diabetes
Official title: Improvements of Probiotics Intervention on Blood Glucose Control in Middle-aged and Older Adults: A 8 Weeks Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-biabetes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to conduct a 8-week probiotics intervention involving for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control in comparison to placebo


Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 75 years, regardless of gender.
2. Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol).
3. Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
4. Signed informed consent form and voluntarily agreed to participate in the project.

Exclusion Criteria:

1. Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
2. Individuals with lactose intolerance or dairy product intolerance.
3. Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
4. Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
5. Alcohol consumption \> 40g/day.
6. Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
7. Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc.
8. Participation in or current involvement in other clinical trials within the past three months.
9. No use of antibiotic medications within the past three months.

Primary outcomes:
measure: fasting blood glucose
timeFrame: up to 8 weeks
measure: 2h-piAUC after standardized breakfast
timeFrame: up to 8 weeks
measure: TIR (time in range)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: up to 8 weeks
measure: weight
timeFrame: up to 8 weeks
measure: intestinal bacteria
timeFrame: up to 8 weeks
measure: lipid metabolism
timeFrame: up to 8 weeks
measure: sleep quality
timeFrame: up to 8 weeks
measure: blood pressure
timeFrame: up to 8 weeks
measure: Continuous Glucose Monitoring (CGM) Data
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01632124: Rituximab-induced Pulmonary Function Changes
Official title: Rituximab-induced Pulmonary Function Changes - an Observational Study in Patients With Rheumatoid Arthritis and Inflammatory Myositis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Inflammatory Myositis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 80
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: Ambulatory patients at University Hospital

Brief summary: Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

Detailed description: The objective of this study is to investigate whether rituximab (RTX), a drug commonly prescribed in patients with rheumatoid arthritis (RA) or inflammatory myositis, is associated with subclinical interstitial lung disease (ILD). Surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (FVC) and/or the diffusing capacity of the lung for carbon monoxide (DLCO). However, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with RTX according to the principles of "good clinical practice". We will perform pulmonary function testing (spirometry) including measurement of the DLCO in patients with RA, who are going to be treated with RTX. A baseline lung function measurement will be performed immediately before RTX therapy is started. Follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of RTX therapy. A reduction in forced vital capacity (FVC) of \>10% or a fall of \>15% in DLCO will be defined as indicative for ILD.

Eligibility criteria: Inclusion criteria: - Patients with established diagnosis of RA or inflammatory myositis, in whom a de novo RTX treatment is indicated

* Age \>18 y
* Informed consent of patient

Exclusion criteria: - Acute infection

* Pre-existing interstitial pulmonary disease
* Patients with impaired forced vital capacity (FVC) on spirometry (\<80% predicted) or with impaired DLCO (\<75% predicted).
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Internal Medicine
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Internal Medicine
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173024: Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
Official title: Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Von Willebrand Disease (VWD)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-12-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von Willebrand Disease (VWD). This post-trial access program enables continued access to children and adults who are benefitting from treatment on study SHP677-304 (NCT03879135) study.

Detailed description: This is a post-trial access program in which the drug being given is called TAK-577. This study will provide access to TAK-577 before marketing authorization for eligible participants with severe VWD who are benefitting from treatment on study SHP677-304 and cannot adequately be treated via the current standard of care and cannot enter a clinical trial.

All participants will receive TAK-577 as a sequential intravenous infusion based on their weight.

This is a multi-center, international program. Participants will continue treatment until a benefit is no longer derived from the treatment (or treatment is no longer tolerable), the sponsor decision to end the program, the participant chooses to discontinue the treatment, or TAK-577 becomes commercially available for children.

Eligibility criteria: Inclusion Criteria:

1. Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment).
2. Participant had good clinical response to rVWF treatment.
3. Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level.
4. Participant will be/has been negatively impacted by discontinuation of rVWF.
5. Participant and/or a parent(s)/legal guardian is informed of the nature of the post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment).

Exclusion Criteria:

1. Participants with known hypersensitivity/intolerance to the study drug will not be eligible for this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04757324: Breast Milk and Breastfeeding Education Given in the Antenatal Period
Official title: The Influence of Breast Milk and Breastfeeding Education Given in the Antenatal Period on Breastfeeding Success and Breastfeeding Self-efficacy: Randomize Control Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding success
Breastfeeding education
Breastfeeding self-efficacy perception
Breast milk
Antenatal period
Lead sponsor: Uludag University
Sponsor class: OTHER
Collaborators: name: Balikesir University
First posted: 2021-02-17
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We aimed to examine the influence of breast milk and breastfeeding education given in the ante-natal period on LATCH score and breastfeeding self-efficacy score.

Detailed description: Practices for increasing breastfeeding self-efficacy are of vital importance and they increase the level of breastfeeding self-efficacy. Breast milk and breastfeeding educations have given in the ante-natal period are another way of increasing the success of breastfeeding.

In this experimental investigation, 80 pregnant women who attended a baby-friendly hospital were randomly assigned to the education (n = 40) or control (n = 40) groups. The pregnant women in the intervention group received 4 hours of human milk and breastfeeding educational sessions along with routine care and furthermore, a brochure prepared by the researcher was given. All women whose estimated delivery date had approximated were questioned about whether they had given birth or not, and the sociodemographic data form, the LATCH Breastfeeding Assessment Tool and the Breastfeeding Self-efficacy Scale-short form were applied to the subjects in the education and the control group by visiting them at home when the post-partum first week had been completed.

Eligibility criteria: inclusion criteria Being above 18 years of age, Having completed the 26th gestational week (At training phase), Having no problem with vision and hearing, Having no disease that can prevent breastfeeding, Having a pregnancy with no risk, Having no systemic disease, Planning to breastfeed after birth

excusion criteria the mother stops researching. treating the baby in neonatal intensive care

Primary outcomes:
measure: Change from baseline in self-efficacy on the 70 points Breastfeeding Self-efficacy Scale-short form at week 1
timeFrame: baseline and week 1
measure: Change from baseline in LATCH score on the 70 points LATCH Breastfeeding Assessment Toolform at week 1
timeFrame: baseline in week 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ozturk R, Ergun S, Ozyazicioglu N. Effect of antenatal educational intervention on maternal breastfeeding self-efficacy and breastfeeding success: a quasi-experimental study. Rev Esc Enferm USP. 2022 Apr 4;56:e20210428. doi: 10.1590/1980-220X-REEUSP-2021-0428. eCollection 2022.