louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05152108: Hybrid Brain Computer Interface for Control of Sensory - Motor Coupling in Post - Stroke Rehabilitation
Official title: Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: HYBIS project aims to develop an innovative and unique hybrid Brain-Computer Interface (BCI) system. This BCI system is envisioned as a novel tool for targeted reinforcement of sensory motor coupling, specifically dedicated for upper-limb post-stroke rehabilitation.


Eligibility criteria: Inclusion Criteria:

* age over 18 years old at the time of enrolment
* history of cerebrovascular insult verified by computerized tomography or magnetic resonance imaging;
* stoke occurred not more than 6 months prior to study enrolment;
* subject need to be medically and neurologically stable determined by medical history and documented neurological examination;
* ability to understand, communicate and cooperate with the research team;
* ability to sit for at least 45 minutes and the ability to adhere to the study rehabilitation protocol.

Exclusion Criteria:

* any neurologic condition (beyond the stroke) or physical condition that impaired function of the affected arm
* a substantial cardiopulmonary or metabolic disorder or other major medical complication;
* history of seizures;
* moderate to severe hemispatial neglect or anosognosia involving the affected arm;
* severe sensory deficit;
* inability to understand, cooperate, and adhere to the study procedures;
* severe spasticity defined as Ashworth scale score of 4 in the affected arm;
* contraindication to stimulation system placement;
* nursing a child;
* pregnancy.

Primary outcomes:
measure: Electrotactile BCI system accuracy
timeFrame: within 30 minutes after experimental session
measure: Motor Imagery BCI system accuracy
timeFrame: within 30 minutes after experimental session
Secondary outcomes:
measure: Fugl Meyer sensory score for upper extremity
timeFrame: immediately after experimental session
measure: NASA-TLX
timeFrame: within 30 minutes after experimental session
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References:
Clinical trial NCT05479708: ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma
Official title: Postoperative ctDNA-based Minimal Residual Disease Detection for Resected Pancreatic Adenocarcinoma: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pancreatic Cancer Resectable
Keywords: circulating tumor DNA
minimal residual disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: GeneCast Biotechnology Co., Ltd.
First posted: 2022-07-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The pathologically diagnosed stage I-III PAAD patients who underwent resections carried KRAS mutations in tumor tissues. Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy).

Brief summary: Short-term relapse and poor survival are prevalent in patients with pancreatic adenocarcinoma (PAAD) after surgeries. Despite the importance of adjuvant treatments for resected PAAD patients, there is currently no suitable biomarker to identify those individuals with high risk of recurrence and inform therapeutic decision making. In this study, we aim to examine whether postoperative circulating tumor DNA (ctDNA) could be used as a biomarker for early detection of minimal residual disease (MRD) and predicting relapse in resected PAAD through high-depth targeted next-generation sequencing.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed pancreatic adenocarcinoma (stage I-III)
* KRAS mutations identified in resected tumor tissues
* Margin negative (R0) or no imaging recurrence/metastasis and CA 19-9\<37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Receiving adjuvant chemotherapy
* ECOG 0-2
* Signed informed consent

Exclusion Criteria:

* With serious internal medicine diseases, infectious diseases, other solid tumors (except PAAD) or hematologic disorders
* Distant organ metastasis or malignant ascites
* Receiving neo-adjuvant therapy before surgery
* Imaging recurrence/metastasis or CA 19-9\>37 U/ml in postoperative 4-8 weeks (before adjuvant chemotherapy)
* Pregnant or breastfeeding at time of enrollment
* Prior transplantation of bone marrow, stem cell or organ

Primary outcomes:
measure: Death and overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Baiyong Shen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455208: A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Official title: Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Osteoarthritis
Lead sponsor: Cura Biotech LLC
Sponsor class: INDUSTRY
First posted: 2007-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.

Detailed description: This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study will be used in the study. The study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. The healthy volunteers are also included to study the safety of the intervention.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
* Able and willing to comply with study visits and procedures specified in this protocol for at least six months period
* Able to understand and willing to sign and date the written informed consent form prior to admission of the study
* Able and willing to provide adequate information for locator purposes
* Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation

Exclusion Criteria:

* Pregnant women
* Over-weighted
* Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
* Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
* Unable to spend 3 hours for treatment at the study center

Primary outcomes:
measure: The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
Secondary outcomes:
measure: The secondary outcome is the reduction in signs and symptoms of rheumatoid arthritis and osteoarthritis for a continuous three or six month period, measured with ACR20 and the change from baseline in HAQ.
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Cura Biotech LLC
state: California
Study officials:
affiliation: Cura Biotech LLC
name: Victor Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01128608: The Effect of High PCO2 Solution on Esophageal Acid Sensation
Official title: The Effect of High PCO2 Solution on Esophageal Acid Sensation in Healthy Patients Versus Those With Non-Erosive Reflux Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Heartburn
Acid Reflux
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
First posted: 2010-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To determine the effect of intraesophageal high PCO2 solution as compared to acidic and saline solutions on subjects' heartburn sensation using stiumlus-response functions.

Detailed description: Presently, the exact mechanism of GERD and the role of CO2 in pathogenesis of heartburn symptoms is unclear. CO2 conversion to protons may play a key role in the mechanism for heartburn sensation. This is a prospective, randomized study that will help further explore the mechanism for heartburn sensation in GERD patients and can be a prelude for further studies examining the role of new class antireflux agents such as carbonic anhydrase inhibitors in the treatment of patients with heartburn.

Eligibility criteria: Inclusion Criteria:

10 Healthy Controls

* Normal EGD, Normal 24-hr pH
* 18-80 Years of age
* Able to read, understand and complete study questionnaires and diary
* Able to understand study procedures and sign informed consent
* Albe to comply with all study requirements

  10 NERD (Non-Erosive Reflux Disease)
* 18-80 Years of age
* Willing to stop PPI/H2 Blocker prior to EGD
* Have heartburn symptoms 2+ times per week for at least 3 months.

Exclusion Criteria:

* Esophageal erosions, Barretts, or peptic stricture on EGD
* Previous esophageal, gastric or duodenal surgery
* underlying co-morbidities
* Diabetes mellitus (requires insulin), scleroderms, or neuromuscular disorder
* Upper airway symptoms
* Tricyclic antidepressants, antispasmodics, selective serotonin receptor inhibitors, thiazides, bile acid-binding agents or prokinetics
* Patients who cannot or are unwilling to sign ICF

Primary outcomes:
measure: The Mechanism of GERD
timeFrame: NA There is no exact timeframe.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona Veterans Health Care System
state: Arizona
Study officials:
affiliation: Southern Arizona Veterans Health Care System
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05297708: Office, Home, and Ambulatory Blood Pressure
Official title: Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Elevated Blood Pressure
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be pediatric patients 6 years to \<19 years years of age who were referred for elevated blood pressure to the Recruitment Hypertension clinic, Lipid Clinic, or Center for Better Health and Nutrition.

Brief summary: This will be a prospective observational study. The population would be pediatric patients 6 years to \<19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.


Eligibility criteria: Inclusion Criteria:

1. Age 6 years to \<19 years old;
2. Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;
3. Tolerate ABPM 24 hours;
4. Tolerate HBP; and
5. Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
6. On stable doses of medications known to affect BP such as:

   1. Corticosteroids
   2. Calcineurin inhibitors
   3. Oral decongestants;
7. Clinically stable

Exclusion Criteria:

1. On antihypertension medications or treated in the last 6 months;
2. Pregnant;
3. Structural heart disease such as:

   1. Obstructive valvular disease
   2. Coarctation of the aorta
   3. Cardiomyopathy;
4. Other secondary causes such as:

   1. Renal artery stenosis
   2. Neurological condition with dysautonomia;
5. Recent initiation of medications known to affect BP such as:

   1. Corticosteroids
   2. Calcineurin inhibitors
   3. Oral decongestants;

Primary outcomes:
measure: Determine blood pressure phenotype
timeFrame: 6-12 months after enrollment
Secondary outcomes:
measure: HBP correlation with end organ damage
timeFrame: 6-12 months after enrollment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Elaine Urbina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04283708: Esthetic Outcome of Isolated Advancement Genioplasty With and Without Submental Liposuction in Treatment of Skeletal Chin Deficiency
Official title: Measuring the Eshetic Difference Between Advancement Genioplasty With and Without Submental Liposuction in Treatment of Skeletal Chin Deficiency in Double Chin Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Receding Chin
Keywords: Submental liposuction
Advancement genioplasty
Double chin patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to measure the eshetic outcome of of isolated advancement genioplasty with and without submental liposuction in treatment of skeletal chin deficiency in double chin patients

Detailed description: Many methods used to treat skeletal chin deficiency in double chin patients, the aim of this study is to measure the advancement genioplasty with and without submental liposuction

Eligibility criteria: Inclusion Criteria:

* skeletal chin deficiency
* double chin patients
* Ages from 18 to 45
* systemic free

Exclusion Criteria:

* body mass index greater than 28
* ages greater than 45
* systemically diseased

Primary outcomes:
measure: % of patient satisfaction
timeFrame: 6 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwan mohamed atef ahmed lotfy
Study officials:
References:
Clinical trial NCT01820208: Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis
Official title: Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Alcoholic Hepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 28
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: TREATMENT

Brief summary: After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score \[\>0.45\] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.


Eligibility criteria: Inclusion Criteria:

- Severe alcoholic hepatitis patients \[Maddrey's score \> 32\] aged between 18 to 65 years.

Exclusion Criteria:

* Presence of active infections
* Acute GI bleed
* Hepatorenal syndrome
* Patient unwilling
* DF\>120
* Autoimmune hepatitis
* Hepatitis B, Hepatitis C, HIV cases
* Pregnancy

Primary outcomes:
measure: Proportion of Survival of subjects in both group
timeFrame: 4 weeks and 12 weeks
Secondary outcomes:
measure: Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients
timeFrame: 4 weeks and 12 weeks
measure: Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients
timeFrame: 4 weeks and 12 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
References:
citation: Shasthry SM, Sharma MK, Shasthry V, Pande A, Sarin SK. Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial. Hepatology. 2019 Sep;70(3):802-811. doi: 10.1002/hep.30516. Epub 2019 Mar 25.
Clinical trial NCT03042208: Weight Watchers and Families
Official title: Ripple Effect of a Nationally Available Weight Loss Program on Untreated Family Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2017-02-03
Enrollment: 260
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Participants will be randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month waiting period. Participants and untreated spouses (and any children in the home) will be assessed at baseline, 3, and 6 months.


Eligibility criteria: Inclusion Criteria:

* body mass index between 27.0-40.0 kg/m2
* married or living with a significant other who had a BMI \> 25 kg/m2

Exclusion Criteria:

* currently in a weight loss program, dieting, or taking medications that might affect weight
* had participated in a weight loss program in the past year
* lost \> 5% of their body weight in the past 6 months
* were planning to or had undergone weight loss surgery
* had any orthopedic limitations or contraindications to physical activity
* were pregnant, lactating, or less than 6 months postpartum, or were planning to become pregnant in the next year
* reported uncontrolled hypertension, history of coronary heart disease, stroke, or peripheral arterial disease; reported chronic gastrointestinal disease
* endorsed having hepatitis B or C, cirrhosis, or HIV
* had a history of cancer within the past 5 years
* reported a significant psychiatric illness that might interfere with completion of the study.

Primary outcomes:
measure: Change in Weight
timeFrame: 0, 3, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gorin AA, Lenz EM, Cornelius T, Huedo-Medina T, Wojtanowski AC, Foster GD. Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses. Obesity (Silver Spring). 2018 Mar;26(3):499-504. doi: 10.1002/oby.22098. Epub 2018 Feb 1.
Clinical trial NCT01778608: Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness
Official title: Feasibility Test of a Handset Device to Detect Sedation Levels and Loss of Consciousness During Propofol Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conscious Sedation
Keywords: Sedation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II or III

Brief summary: Sedation is often administered to relieve anxiety and discomfort during uncomfortable procedures in elderly patients. Patient control of sedation offers many potential benefits for patients and healthcare professionals, including improved safety and patient satisfaction. The investigators overall goal is to develop a patient controlled intravenous sedation system that is effective but very safe for the patient, and requires minimal supervision by a doctor or nurse. To fulfill these criteria, a sedation system should incorporate fail-safe safety mechanisms. A key safety-critical component is a method of objectively assessing the degree of sedation of the patient, and of preventing him from self-administering unsafe doses of the sedative drug. The investigators have designed a new sedation system that uses a measure of the speed of response of the patient to a defined non-noxious stimulus to determine whether or not it is safe to allow him to self-administer further levels of sedation. Before being able to execute a volunteer study in order to determine a rational selection of optimal threshold response time, a feasibility test on the handset device is required.


Eligibility criteria: Inclusion Criteria:

* age 50-72 years

Exclusion Criteria:

* volunteer refusal
* patient age \>72 years
* significant cardiovascular or respiratory disease
* latex allergy

Primary outcomes:
measure: Response times
timeFrame: Continuously shortly before (baseline)
measure: response time
timeFrame: during induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: