louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03642925: Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
Official title: Efficacy of Balanced Nutrition Meal Replacement Along With a Caloric Restriction on Body Weight Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diet Modification
Nutrient; Excess
Keywords: Meal replacement
calorie restriction
body weight
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects.
Primary purpose: TREATMENT

Brief summary: The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in Taiwanese obese subjects. Various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (TC, LDL-c and TG), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.

Detailed description: The present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in Taiwanese obese subjects. Obese subjects (BMI\>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.

Eligibility criteria: Inclusion Criteria:

* Healthy obese subject (BMI \>27)
* Aged between 20 to 80 of both genders with a desire to lose weight.

Exclusion Criteria:

* Subjects with cancer
* Hyperglycemic (diabetic)
* Hypertension,
* Stroke
* Renal dysfunction
* Cardiac or hepatic dysfunctio
* allergic to the dairy product and eating disorders
* Pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects

Primary outcomes:
measure: Calorie intake in obese subjects
timeFrame: 8 weeks
measure: Anthropometric parameter
timeFrame: 8 weeks
measure: Anthropometric parameter
timeFrame: 8 Weeks
measure: Cardiovascular (CV) risk factors
timeFrame: 8 Weeks
measure: Glycemic markers
timeFrame: 8 Weeks
measure: Lipid profile
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: Chung Shan Medical University
state: Taichung
Study officials:
References:
Clinical trial NCT06826625: Oxidative Stress in Polycystic Ovary Syndrome
Official title: Elucidation of the Oxidative Mechanism Effective in Polycystic Ovary Syndrome: a Randomized Controlled Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovarian Syndrome (PCOS)
Oxidative Stress
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman with and without polycystic ovary syndrome

Brief summary: The aim of the study was to determine changes in hematological and biochemical parameters and specific oxidative stress markers in patients with PCOS.


Eligibility criteria: Inclusion Criteria:

The PCOS group included patients with oligomenorrhea (menstrual period intervals of more than 35 days), clinical signs of hyperandrogenism (acne or hirsutism), biochemical signs of hyperandrogenism (with total testosterone of 100 ng/dL and above and patients with dehydroepiandrosterone sulfate of 400 g/dl and above), an LH/FSH ratio of over 3 on the second day of the menstrual period, a body mass index of 25 and above, and polycystic ovaries detected in suprapubic ultrasonography.

Exclusion Criteria:

Pregnant individuals, individuals with diabetes mellitus, metabolic syndrome, adrenal pathology, pelvic mass, and malignancy were not included in the study.

Primary outcomes:
measure: Oxidative stress markers
timeFrame: From January 2021 to December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Alanya Training and Research Hospital Gynecology and Obstetrics Department
Study officials:
References:
Clinical trial NCT01756625: PREMIUM, Observational Study
Official title: Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: First Line WT KRAS mCRC
Keywords: cetuximab
nicotine
magnesium
Lead sponsor: Institut Sainte Catherine
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
name: BESPIM, CHU Nîmes (data analysis)
First posted: 2012-12-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients from private and public centers

Brief summary: PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.

Detailed description: Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.

Eligibility criteria: Inclusion Criteria:

* patients \> 18 years old diagnosed with mCRC
* patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab
* all patients receiving cetuximab in first line treatment associated or not with CT
* patients relapsed \< 6 months after an adjuvant therapy

Exclusion Criteria:

* patients participating to clinical trials

Primary outcomes:
measure: To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
timeFrame: 3 years
Secondary outcomes:
measure: ORR at 1 year (ITT and subgroup analysis)
timeFrame: 3 years
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte-Catherine
state: Vaucluse
Study officials:
References:
citation: Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.
Clinical trial NCT03633825: Brief Online Help-seeking Barrier Reduction Intervention
Official title: Randomized Controlled Trial of an Online Machine Learning-Driven Risk Assessment and Intervention Platform for Increasing the Use of Crisis Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crisis Intervention
Suicide and Depression
Keywords: suicide
mental health crisis
crisis referrals
help-seeking
risk assessment
treatment barrier
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 39450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: Mental illness is a leading cause of disease burden; however, many barriers prevent people from seeking mental health services. Technological innovations may improve the ability to reach under-served populations by overcoming many existing barriers. The investigators evaluated a brief, automated risk assessment and intervention platform designed to increase the use of crisis resources provided to individuals who were online and in crisis. Hypothesis: The investigators hypothesized that individuals assigned to the intervention condition would report using crisis resources at higher rates than individuals in the control condition. Method: Participants, users of the digital mental health app Koko, were randomly assigned to treatment or control conditions upon accessing the app and were included in the study after their posts were identified by machine learning classifiers as signaling a current mental health crisis. Participants in the treatment condition received a brief Barrier Reduction Intervention (BRI) designed to increase the use of crisis service referrals provided on the app. Participants were followed-up several hours later to assess the use of crisis services.


Eligibility criteria: Inclusion Criteria:

* Participants identified as experiencing a mental health crisis by a hybrid human-machine computation system evaluating semantic content of posts made on digital platforms.

Exclusion Criteria:

* Participants who were not identified as experiencing a mental health crisis.

Primary outcomes:
measure: Number of Participants Reporting Use of Crisis-referrals
timeFrame: 5 hours post intervention
Secondary outcomes:
measure: Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was "Good"
timeFrame: 5 hours post intervention
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
References:
citation: Jaroszewski AC, Morris RR, Nock MK. Randomized controlled trial of an online machine learning-driven risk assessment and intervention platform for increasing the use of crisis services. J Consult Clin Psychol. 2019 Apr;87(4):370-379. doi: 10.1037/ccp0000389.
Clinical trial NCT01364025: Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse
Official title: Prophylactic Uterosacral Ligament Suspension at the Time of Hysterectomy for Prevention of Vaginal Vault Prolapse (PULS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prolapse of Vaginal Vault After Hysterectomy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2011-06-02
Enrollment: 800
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Is routine uterosacral ligament suspension an appropriate clinical adjunct at the time of hysterectomy?

The answers to these questions will facilitate the treatment of many American women. With the results of this study, the investigators would anticipate a reduction in the number of surgeries for pelvic organ prolapse. In addition, if uterosacral ligament suspension was shown to be ineffective, it would not be used routinely in the setting of hysterectomy and women will be spared the additional procedure and possibility of side effects or complications.

The relative risks and benefits of adding a prophylactic uterosacral ligament suspension at the time of hysterectomy in women without symptomatic prolapse symptoms have never been studied prospectively.


Eligibility criteria: Inclusion Criteria:

* Eligibility for primary procedure (hysterectomy either total or supracervical, performed either vaginally or abdominally, via laparoscopic or open approach)
* Eligibility for secondary procedure (uterosacral ligament suspension colpopexy)
* Prolapse in any compartment not extending beyond the hymen as measured by Pelvic Organ Prolapse Quantitative system
* No subjective complaints of Pelvic Organ Prolapse as determined by answer "no" to questions #3 of the short form of Pelvic Floor Distress Inventory: #3. Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?

Exclusion Criteria:

* Contraindication for uterosacral ligament suspension colpopexy. (Surgeon's judgment that a contraindication to uterosacral ligament suspension colpopexy exists).
* Anticipated geographic relocation within the 12 months after surgery
* Inability to provide informed consent or to complete testing or data collection.

Primary outcomes:
measure: To compare the occurrence of objective findings of pelvic organ prolapse beyond hymen after uterosacral ligament suspension of the vaginal apex at the time of hysterectomy vs. hysterectomy alone using Pelvic Floor Quantitative Examination
timeFrame: one year and annual thereafter for 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente San Diego
state: California
Study officials:
affiliation: Kaiser Permanente
name: Marianna Alperin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04257825: Use of Temperature Controlling Mattress Pad for Sleep Improvement
Official title: The Chili + OURA Sleep Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Kryo Inc
First posted: 2020-02-06
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the four week study, participants were randomized into multiple arms, and asked to not use their device for 1 week, and then use it the next. Arms alternated back and forth.
Primary purpose: OTHER

Brief summary: A dual arm interventional study in which chliipad and ooler sleep system users voluntarily opt out of using their device for 2 out of 4 weeks. Assessments of sleep via self report and Oura Ring sleep quality and duration.


Eligibility criteria: Inclusion Criteria:

* has a chili sleep system
* has an Oura Ring

Exclusion Criteria:

* medically treatable issue
* recent injury
* expected significant travel over study period

Primary outcomes:
measure: Change in Deep Sleep as Measured by Oura Ring
timeFrame: From week 1 to week 2
measure: Change in self-reported sleep quality via Jenkins Sleep Scale
timeFrame: From week 1 to week 2
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Virtual Study: https://p.proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT06947525: Effects of Shotblocker and Manual Pressure on Pain and Satisfaction
Official title: Effects of Shotblocker and Manual Pressure on Pain and Satisfaction During Peripheral Venous Catheter Placement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Satisfaction
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine the effects of shotblocker and manual pressure applied during peripheral venous catheter placement on pain and satisfaction. 81 patients hospitalized in the Urology clinic will be included in the study. Patients will be assigned to three groups as shotblocker (n=27), manual pressure (n=27) and control group (n=27) by block randomization method.

Research Hypotheses

* H1-1: The mean pain scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
* H1-2: The mean pain scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.
* H1-3: The mean satisfaction scores of the intervention group to which shotblocker was applied during peripheral intravenous catheterization are different from the control group.
* H1-4: The mean satisfaction scores of the intervention group to which manual pressure was applied during peripheral intravenous catheterization are different from the control group.


Eligibility criteria: Inclusion Criteria:

* Admission to the urology clinic,
* No verbal, perceptual and visual communication problems,
* Between the ages of 18 and 65,
* Literate,
* Volunteer to participate in the study,
* Not using medication that will create a chronic analgesic effect,
* Not having chronic or acute pain,
* No intervention has been performed on the vein where the PIC is placed in the last month,
* No scar tissue or infection in the areas where the PIC will be placed,
* Not having a disease that will cause problems in feeling pain (such as neuropathy)

Exclusion Criteria:

* The individual wants to leave the study,
* Feels unwell during the PIC placement (such as dizziness, palpitations),
* Uses sedatives or alcohol,

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: The peripheral venous catheter will be filled within 1 minute after insertion.
Secondary outcomes:
measure: Patient Satisfaction Scale
timeFrame: The peripheral venous catheter will be filled within 1 minute after insertion.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05269225: Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)
Official title: Organic Diet in Pregnancy and Risk Markers of Health Effects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nutrition
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2022-03-07
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.


Eligibility criteria: Inclusion Criteria:

* Nulli- or multipara pregnant in first trimester

Exclusion Criteria:

* Consuming an organic diet regularly
* Using medication regularly that might interfere with study adherence or - outcomes
* Diagnosed with a chronic disorder or cancer
* Having a food allergy or intolerance

Primary outcomes:
measure: Maternal urinary excretion level of dialkylphosphates
timeFrame: 2.5 years
Secondary outcomes:
measure: Blood concentration of cholesterol
timeFrame: 2.5 years
measure: Abundance and species-types of gut microbiota (e.g. staphylococci and enterobacter) sampled from stool samples
timeFrame: 2.5 years
measure: DNA methylation patterns in leucocytes as a marker of altered epigenetic programming
timeFrame: 2.5 years
measure: Child body weight
timeFrame: 2 years
measure: Child urinary excretion level of dialkylphosphates
timeFrame: 2 years
measure: Blood concentration HbA1c
timeFrame: 2.5 years
measure: Blood concentration CRP
timeFrame: 2.5 years
measure: Child body length
timeFrame: 2 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References:
Clinical trial NCT00823225: Urokinase Therapy in Patients With Diabetic Foot Syndrome
Official title: Low Dose Urokinase Therapy in Patients With Diabetic Foot Syndrome and Critical Limb Ischemia Versus Conventional Standard Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Foot
Arterial Occlusive Disease
Ischemia
Keywords: Diabetes
urokinase
ulcer healing
major amputation
survival
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 5
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: The purpose of this study is to determine whether the additional therapy with low dose urokinase is more effective than only a conventional standard therapy concerning ulcer-healing, rate of major amputation and survival.

Detailed description: Patients with diabetic foot ulceration and critical limb ischemia have a high risk of major amputation, especially if limbs can not be revascularized. Urokinase is effective in critical limb ischemia by lowering fibrinogen and might improve outcomes. The effect and safety of urokinase treatment was investigated in a phase II clinical trial. Based on the results this trial was planned to investigate the effect and safety of an additional therapy with urokinase versus a single conventional therapy.

Eligibility criteria: Inclusion Criteria:

* Diabetic patients with angiopathic or angioneuropathic diabetic foot syndrome and criticial limb ischemia
* No surgical or interventional treatment option
* No healing tendency of ulcerations despite of antibiosis and wound debridement after two-week treatment
* Fibrinogen \> 4.0 g/l
* No previous major amputation

Exclusion Criteria:

* Prior treatment of the current ulceration with urokinase
* Need for dialysis and/or creatinine-clearance \< 20ml/min
* INR \> 1,5 at screening
* Any kind of cerebral event within 3 months prior inclusion
* Proliferative retinopathy
* Uncontrolled hypertension
* Hemorraghic diathesis
* Gastrointestinal bleeding
* Pregnancy
* No compliance and/or participation in another trial

Primary outcomes:
measure: Major amputation free survival
timeFrame: Within twelve months after randomisation
Secondary outcomes:
measure: Total survival, major amputation rate, rate of complete ulcer healing, rate of adverse events
timeFrame: Within twelve month after randomisation
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Franziskus Krankenhaus
city: Dortmund
country: Germany
facility: Klinikum Dortmund Nord GmbH
city: Dresden
country: Germany
facility: Krankenhaus Dresden-Neustadt
city: Dresden
country: Germany
facility: Universitätsklinik
city: Freital
country: Germany
facility: Weißeritztal-Kliniken GmbH
city: Karlsbad
country: Germany
facility: Klinikum Karlsbad Langensteinbach
Study officials:
affiliation: Krankenhaus Dresden-Friedrichstadt, Germany
name: Sebastian Schellong, MD
role: PRINCIPAL_INVESTIGATOR
References: