louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05143008: A Pilot Study to Evaluate an Intervention for Gestational Weight Gain
Official title: Strategies for Self-Management Around the Reproductive Transition: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Weight Gain
Maternal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will be provided with counseling sessions throughout the course of their pregnancy.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to enable the investigator to conduct proof of concept work related to the feasibility, acceptability, initial efficacy and mechanisms of action (focusing on maternal and infant modifiable factors) for a novel self-management intervention for pregnant women.

Detailed description: This proposed study aims to adapt intervention to address excessive gestational weight gain and psychosocial functioning among a socioeconomically and racially diverse sample of pregnant women .Additionally, data on behavioral mechanisms associated with self-regulatory capacity, such as impulsive control and the ability to delay rewards, that may be linked to self-regulation during pregnancy are needed to support future interventions.

In this study, the investigators will develop and adapt an intervention (Self-Management Around the Reproductive Transition; SMART) that addresses maternal weight, stress, and mood, and document the feasibility, acceptability and initial efficacy of the SMART intervention.

Eligibility criteria: Inclusion Criteria:

* At least 14 years of age
* Less than 16 weeks gestation
* English speaking
* Singleton pregnancy
* Receiving care at Magee-Womens Hospital, Latterman family health or other UPMC practices that provide obstetric care

Exclusion Criteria:

* Preexisting diabetes
* Use of medications known to affect weight
* Enrolled in current weight management programming
* History of weight loss surgery
* Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate care

Primary outcomes:
measure: Number of sessions attended among women enrolled in the study
timeFrame: Approximately 9 months
measure: Number of self-monitoring forms returned
timeFrame: Approximately 9 months
measure: Gestational weight gain
timeFrame: Approximately 9 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Approximately 12 months
measure: Perceived stress symptoms
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michele Levine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01543308: The Alteration of HDL Protein Composition in Patients With Coronary Heart Disease Before and After Statins Treatment
Official title: Phase 1 Study of Coronary Heart Disease Proteomics Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
name: Beijing Proteome Research Center
First posted: 2012-03-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical indication for coronary heart disease and no lipid-lowering therapy in the past 2 weeks

Brief summary: The protein composition of HDL is complicated. The investigators have identified 40 distinct proteins associated with HDL by proteomics technology, and these proteins have been confirmed to be related to the function of anti-inflammation, anti-oxidation, improvement of endothelial function, inhibition of thrombosis and so on. And the investigators also found that the levels of some proteins in HDL changed in patients with coronary heart disease, compared with the healthy control group.

So, this study is to conduct in the two following aspects: enlarge the sample size to verify the preliminary results to find new research ideas of pathogenesis and biomarkers for coronary heart disease; and study the changes of HDL protein composition in patients with coronary heart disease before and after statins treatment using proteomics technology in order to find the mechanism of statins pleiotropic effects and indicators for evaluating the treatment effectiveness.


Eligibility criteria: Inclusion Criteria:

Angiographic evidence of coronary artery disease, and no lipid-lowering therapy in the past 2 weeks for treatment group;

Exclusion Criteria:

* Use of potent lipid-lowering therapy for more than 2 weeks; myocardial infarction or percutaneous coronary intervention in the past 6 months; severe congestive heart failure, valvular heart disease and other non-coronary heart disease cardiovascular disease; liver or renal dysfunction; connective tissue disease; infection, Malignancy; and other conditions that physicians considered inappropriate to the study.

Primary outcomes:
measure: Differential Proteins and the levels of Differential Proteins
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Key Laboratory of Clinical Trial Research in Cardiovascular Drugs, FuWai Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Hong Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03941808: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.
Official title: Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo. A Randomized Double Blind Placebo Controlled Monocentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 50
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 role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.

Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.

The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.


Eligibility criteria: Inclusion Criteria:

* Vitiligo
* Vitiligo, SOD, UVB
* Non-segmental vitiligo with BSA\>5%

Exclusion Criteria:

* Criteria of non-inclusion

  * Segmental or mixed vitiligo
  * Pregnancy
  * Vitiligo lesions localized only on hands and feet
  * Immuno-suppressive drugs
  * Corticosteroids
  * Photosensitive drugs
  * Photodermatosis
  * Personal history of skin cancer
  * Allergy to gluten

Primary outcomes:
measure: Evaluation Vitiligo
timeFrame: At Baseline and at 6 weeks
Secondary outcomes:
measure: Quality of life of patient
timeFrame: At Baseline and at 6 weeks
Other outcomes:
measure: Vitiligo activity score
timeFrame: At baseline and at 6 months
Locations:
city: Nice
country: France
facility: Passeron
state: Alpes-Maritime
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Passeron Thierry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766323: Palliative Morphine With or Without Concurrent Modafinil
Official title: Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cancer
Pain Palliation
Excessive Sleepiness
Keywords: Morphine
Palliation
Cancer
Hospice
Sleepiness
Modafinil
Lead sponsor: Dr. Rajendra Prasad Government Medical College
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. However, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. Given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. Given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and confirmed malignancy
* Able to orally consume tablets
* Blood Pressure: Systolic \<144mmHg; Diastolic \<92mmHg
* Normal blood sugar
* No active systemic infections
* Consenting
* Oral morphine being consumed as a part of terminal symptom palliation

Exclusion Criteria:

* Candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future
* Poor performance status (Karnofsky Performance Status score \<50)
* Prior history of hypertension, diabetes, tuberculosis, epilepsy
* Prior history of psychiatric and neurological illness

Primary outcomes:
measure: Patient reported sleepiness scores
timeFrame: Three months from enrollment
Secondary outcomes:
measure: Mood changes
timeFrame: Three months from enrollment
Other outcomes:
Locations:
city: Kangra
country: India
facility: Tanda Government Medical College and Hospital
state: Himachal Pradesh
Study officials:
affiliation: Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology
name: Swaroop Revannasiddaiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College
name: Muninder K Negi, MD
role: STUDY_DIRECTOR
affiliation: Bangalore Institute of Oncology
name: Sridhar P Susheela, MD
role: STUDY_CHAIR
affiliation: Ram Manohar Lohia Insitute of Medical Sciences
name: Madhup Rastogi, MD
role: STUDY_CHAIR
affiliation: Indira Gandhi Medical College, Shimla
name: Manoj K Gupta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06022523: Accuracy of Pulse Oximeters With Profound Hypoxia
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxemia
Keywords: Hypoxia
Pulse oximetry
Lead sponsor: Consolidated Research, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 \& 2018-02.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Pregnancy -

Primary outcomes:
measure: Saturation level measurement
timeFrame: Within 12 months of subject recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Consolidated Research, Inc.
state: Ohio
Study officials:
References:
Clinical trial NCT06758323: Acute Effects of Beetroot Juice and Caffeine Co-ingestion on Lower-limb Strength and Muscular Endurance in Females
Official title: Effect of Beetroot Juice Supplements with Caffeine Co-ingestion on Lower-limb Strength in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beetroot Juice
Caffeine
Placebo
Beetroot Juice with Caffeine Co-ingestion
Keywords: beetroot juice
nitrate
caffeine
resistance training
dietary supplement
female
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-Blind Crossover Randomized Trial
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the acute effects of beetroot juice and caffeine, consumed individually or in combination, on lower-limb strength and muscular endurance in physically active women. The main questions it aims to answer are:

* Does the co-ingestion of beetroot juice and caffeine enhance lower-limb strength and muscular endurance more than either substance alone or a placebo?
* How do the acute effects of beetroot juice interact with caffeine on physical performance?

The study was conducted using a randomized, crossover design to evaluate the following four conditions:

Beetroot juice with placebo Caffeine with placebo Beetroot juice with caffeine Placebo only

Each participant completed all conditions, with a sufficient washout period between sessions to eliminate potential carryover effects. This design allowed for a direct comparison of the acute effects of each supplementation strategy on lower-limb strength and muscular endurance.

Participant Protocol

Participants consumed their assigned supplement on a single testing day for each condition. After supplementation, they performed standardized tests to measure lower-limb strength and muscular endurance. Progress was monitored, and data from all conditions were collected to assess the acute effects of each intervention.


Eligibility criteria: Inclusion Criteria:

* Minimal experience of six months of strength training
* Be familiarized with the exercise test: counter movement jump (CMJ), barbell back squats, leg press and knee extension.

Exclusion Criteria:

* Supplementation consumption
* Sports injuries

Primary outcomes:
measure: Change of height reached in jump
timeFrame: Visit 1 (Day 1), Visit 2 (Day 5), Visit 3 (Day 9), Visit 4 (Day 13)
Secondary outcomes:
measure: Movement velocity
timeFrame: Visit 1 (Day 1), Visit 2 (Day 5), Visit 3 (Day 9), Visit 4 (Day 13)
measure: Muscular endurance test
timeFrame: Visit 1 (Day 1), Visit 2 (Day 5), Visit 3 (Day 9), Visit 4 (Day 13)
measure: Rating of perceived exertion (RPE).
timeFrame: Visit 1 (Day 1), Visit 2 (Day 5), Visit 3 (Day 9), Visit 4 (Day 13)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Edificio IMIBIC Avda Menéndez Pidal s/n
Study officials:
References:
Clinical trial NCT06281223: Study of Brain-spinal Cord Neural Connectivity in Spasticity
Official title: Study of Brain-spinal Cord Neural Connectivity in Spasticity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spasticity, Muscle
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2024-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of spasticity requiring selective rhizotomy in neurosurgery.

Brief summary: Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.


Eligibility criteria: Inclusion Criteria:

* Patients aged 3 to 17 years included
* scheduled for selective rhizotomy surgery
* Having received informed consent to participate in the study (written consent from both parents)
* Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Contraindications to selective rhizotomy
* History of epilepsy
* Known neurological and/or psychiatric disorders with past and/or current medical treatment, or drug addiction
* Patient under legal protection
* Pregnant or breast-feeding women

Primary outcomes:
measure: variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hpu Lenval
city: Paris
country: France
facility: HFAR
Study officials:
affiliation: HFAR
name: Pia VAYSSIERE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02165423: Discharge to Home and Chronic Illness Care Pilot
Official title: Discharge to Home and Chronic Illness Care Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Organ Transplant
Keywords: pediatric
solid organ transplant
parents
heart
kidney
liver
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's National Research Institute
First posted: 2014-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to address a gap in knowledge needed for care of children with solid organ transplantation (SOT) and their parents by combining mHealth technology with an individualized family centered self-management intervention (referred to as myFAMI). This study is critical to the increased understanding of hospital to home transition and family management at home with the potential to transform the way clinicians approach the care of complex chronic illness children and families.


Eligibility criteria: Inclusion Criteria:

* parent's child has undergone a heart, kidney, or liver transplant and is being discharged home from the hospital
* the parent is English speaking (to date the tools being used have been validated for English participants only)
* parent is 18 years of age or older
* patient is 17 years of age and younger.

Exclusion Criteria:

* presence of significant communication or cognitive impairment on the part of the parent that would preclude completion of questionnaires based on self-report
* parent and child has experienced the discharge to home transition from a previous transplant.

Primary outcomes:
measure: Evaluate the effectiveness of myFAMI on 30-day post-discharge outcomes.
timeFrame: 30 days following enrollment
Secondary outcomes:
measure: Examine the acceptability of myFAMI:
timeFrame: Enrollment plus 30 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Stacee Lerret, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800123: EtCO2 Monitoring in Acute Self-poisoning
Official title: Continuous EtCO2 Monitoring in Acute Self Poisoned Patients Admitted in an Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Intentional Overdose
Keywords: Intoxication, overdose, poisoning, EtCO2, emergency medicine
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 200
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: All patients over 18y/o admitted in the ED for acute self poisoning.

Brief summary: There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value.

The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis.

Several clinical studies have recently shown that EtCO2 monitoring can be valuable in procedural sedation in the emergency department. It is able to predict hypoxemia before any SaO2 decrease and any complications related to these procedures.

We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring in the ED.


Eligibility criteria: Inclusion Criteria:

* \>18y/o
* acute self poisoning patients
* patients requiring monitoring according to physician's opinion
* patients not requiring invasive ventilation at ED admission

Exclusion Criteria:

* Pregnant woman
* patients deprived of liberty

Primary outcomes:
measure: ROC curve of maximal EtCO2 to predict poisoning complication
timeFrame: During the first 2 hours of ED admission
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Genoble university hospital
Study officials:
References:
citation: Viglino D, Bourez D, Collomb-Muret R, Schwebel C, Tazarourte K, Dumanoir P, Paquier C, Danel V, Debaty G, Maignan M. Noninvasive End Tidal CO2 Is Unhelpful in the Prediction of Complications in Deliberate Drug Poisoning. Ann Emerg Med. 2016 Jul;68(1):62-70.e1. doi: 10.1016/j.annemergmed.2015.11.037. Epub 2016 Jan 23.
Clinical trial NCT06962423: AI-driven Automated Biomedical Research
Official title: A Study on Artificial Intelligence-based Automated Biomedical Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biomedical Research
Artificial Intelligence (AI)
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate the effects of the AI system developed by our team on biomedical research.

Detailed description: It i a randomized-controlled study. Participants will be randomly assigned to the Intervention Group using our AI system and the Control Group. Both groups will perform the same biomedical research tasks and submit reports. At the end of the study, the research performance of the two groups will be evaluated.

Eligibility criteria: Inclusion Criteria:

* (1) Age ≥ 18 years old;
* (2) Agree to sign consent form and invest time in this study;
* (3) Able to understand and complete research tasks.

Exclusion Criteria:

* (1) Currently participating in other projects that may interfere with this research and unable to ensure participation time;
* (2) Have a history of major diseases or poor physical condition in the past three months that may affect research participation;
* (3) Unwilling or unable to understand and complete the research tasks.

Primary outcomes:
measure: Research quality evaluation scale
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
measure: Model performance
timeFrame: Through study completion, an average of 1 week
measure: Research time cost
timeFrame: Through study completion, an average of 1 week
measure: User evaluation
timeFrame: Through study completion, an average of 1 week
measure: Model resource consumption
timeFrame: Through study completion, an average of 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua University
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Tien Yin Wong
role: PRINCIPAL_INVESTIGATOR
References: