louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03779009: Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Official title: Minimally INvasive Colon Cancer Surgery Through IMmunomics and Optical Mapping of the Sentinel Lymph Node.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Sentinel Lymph Node
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
First posted: 2018-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The project investigates the feasibility of laparoscopic fluorescent imaging for the intraoperative detection of the sentinel lymph node (SLN) in colon cancer patients. In addition, the topology of immunological and microenvironmental changes in normal and invaded lymph nodes (LN's) will be correlated to the LN location (anatomical mapping).


Eligibility criteria: Inclusion Criteria:

* Tumor type: proven adenocarcinoma of the colon
* Extent of disease (AJCC 7th edition): clinically node negative (stage II) non-metastatic colon cancer
* Locally resectable disease
* Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent
* Laboratory data

  * Serum creatinine ≤ 1.5 mg/dl or a calculated GFR ≥ 60 mL/min/1.73 m2
  * Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
  * Platelet count \> 100,000/µl
  * Hemoglobin \> 9g/dl
  * Neutrophil granulocytes \> 1,500/ml
  * International Normalized Ratio (INR) ≤ 2
* Absence of alcohol and/or drug abuse
* No inclusion in other clinical trials interfering with the study protocol
* No concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy
* Absence of any severe organ insufficiency
* No pregnancy or breast feeding
* Adequate contraception in fertile patients
* Written informed consent

Exclusion Criteria:

* Node positive and/or metastatic disease
* Locally unresectable disease
* Medically unfit patients (Karnofsky index \< 70%)
* Allergies to any of the procedural substances (allergy to iodides, hypersensitivity to products containing human albumin)

Primary outcomes:
measure: Tumor status of the sentinel lymph node (SLN) and other lymph nodes (LN's)
timeFrame: up to 1 month after surgery
Secondary outcomes:
measure: Immunological markers
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Ghent University Hospital
Study officials:
References:
Clinical trial NCT06498609: Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors
Official title: Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors: A Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors.


Eligibility criteria: Inclusion Criteria:

1. An age range from 15 to 25 years.
2. Participants who had a full set of permanent dentitions excluding the third molar.
3. Participants who had moderate crowding in the mandibular arch according to Little's irregularity index that necessitates non-extraction treatment in the mandibular arch.
4. Normal vertical facial proportions.
5. Participants who had good oral hygiene and no periodontal disease.
6. No systemic diseases or regular medication that could interfere and/or affect orthodontic teeth movement.
7. No evidence of craniofacial anomalies, such as clef lip and palate or previous history of trauma, bruxism, or parafunction.
8. No tooth size, shape, or root abnormalities visible on patient's radiographic records.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Any skeletal dysplasia or craniofacial malformation.
3. Retained primary or missing permanent teeth in the anterior area, and any kind of tooth/root shape anomaly or history of trauma affecting the incisors.
4. Systemic diseases or regular use of medications that could interfere with OTM.
5. Patients with root resorption, impacted canines, or dental anomalies.
6. Poor oral hygiene and uncontrolled periodontal diseases.

Primary outcomes:
measure: assessment of acceleration of leveling and alignment of mandibular incisors
timeFrame: post interventional at 4months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
Study officials:
affiliation: Al-Azhar University
name: Hasan Fares, Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177709: Metformin for Weight Loss in Schizophrenia
Official title: Evaluation of the Efficacy of Metformin for Weight Loss and Metabolic Effects In Overweight Psychiatric Patients Treated With Antipsychotic Medication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Obesity
Keywords: schizophrenia
antipsychotics
obesity
diabetes
Lead sponsor: Nathan Kline Institute for Psychiatric Research
Sponsor class: OTHER
First posted: 2010-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study hypothesis is that patients on antipsychotics medication treated with metformin will show loss in weight and improved measures of glucose metabolism.

Detailed description: Patients who had gained more than 10 lbs of weight in the last 3 months or had BMI of 35 or greater were treated with metformin up to 2500 mg/day in an open label study of up to 3 months time. Changes in weight and glucose measures were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients will be 18-70 years of age;
* Currently hospitalized or an outpatient at MPC;
* BMI ≥ 35 or excessive recent weight gain ( \> than 10 lb weight gain in the past 3 months);
* Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

* Age below 18 or over 70;
* Patient is currently already treated with metformin.

Primary outcomes:
measure: Weight (wt) in Pounds (Lbs)..
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Glucose Levels
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Insulin Level
timeFrame: baseline, 4 weks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhatan Psychiatric Center
state: New York
Study officials:
affiliation: Nathan Kline Institute for Psychiatric Research
name: Robert C. Smith, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410109: Developing an Integrated Model for Home Visitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-04-07
Enrollment: 178
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Perinatal depression is a significant concern, particularly for low-income women. Many cases of perinatal depression are complicated by comorbidities such as post-traumatic stress disorder symptoms, anxiety, and intimate partner violence. Providing perinatal mental health services to women in home visiting programs could have considerable public health significance. This study will develop and test an integrated model of mental health services embedded within home visitation (HV) programs. This model will (1) incorporate a protocol for systematic screening and referral; (2) strengthen formal linkages between HV programs and other components of service systems; (3) promote the capacity of service systems to provide evidence-based early intervention and treatment for depression; and (4) facilitate the receipt of early intervention and treatment services for perinatal depression and comorbid conditions. This will be the first model to our knowledge that systematically integrates screening, referral, and early intervention and treatment for perinatal depression and associated comorbidities within HV programs.

The specific aims are:

1. To develop an integrated model of perinatal depression care within HV programs. This integrated model ("SCRIPT") will incorporate screening, referral, and individualized prevention and treatment services.
2. To assess the feasibility of implementing the SCRIPT model with high fidelity in two HV programs. One HV program-DRUM Healthy Families-will use paraprofessionals as interventionists while the other program-M\&I Nursing-will use nurses and social workers as interventionists.
3. To determine the impact of the SCRIPT model on depressive symptoms and major depressive episodes.


Eligibility criteria: Inclusion Criteria:

* pregnant or child \< 6 months
* enrolled in Baltimore City home visiting program

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: DRUM Healthy Families
state: Maryland
city: Baltimore
country: United States
facility: Maternal and Infant Nursing Program
state: Maryland
Study officials:
References:
Clinical trial NCT06908109: This Study Will Evaluate the Effectiveness of a Simple Intervention Through a Classical Yankauer Oral Suction Tube, in Decreasing the Sedative Medication Doses Needed to Provide Effective Patient Sedation During Bronchoscopy, Along With Its Effect on Both Patient's and Bronchoscopist Satisfaction
Official title: Continuous Oral Suctioning During Flexible Bronchoscopy: Effect on Sedative Medication Needs and Both Endoscopist's and Patient's Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the effectiveness of a simple intervention through a classical Yankauer oral suction tube, a device known to have a proven safety profile in multiple healthcare settings, in decreasing the sedative and opioid medication doses needed to provide effective patient sedation during bronchoscopy, along with its effect on both patient's and bronchscopist's satisfaction throughout the procedure.


Eligibility criteria: Inclusion Criteria:

* 18 years or above
* inpatients or outpatients
* scheduled to have a flexible bronchoscopy for one of multiple indications based on their physician's assessment, including the presence of a lung mass or collapse, persistent pulmonary infiltrates, pulmonary infection in the setting of immunosuppression, hemoptysis, or other rare causes like chronic cough.
* patients provided a written informed consent.

Exclusion Criteria:

* patients with anatomic oro-pharyngeal abnormalities,
* critically ill patients
* uncooperative patients or inability to provide signed consent by the patient or their legal representative
* coagulopathy or bleeding diathesis
* severe obstructive airway disease
* recent myocardial infarction
* uncontrolled or poorly controlled asthma or chronic obstructive pulmonary disease (COPD)
* pregnancy.

Primary outcomes:
measure: Mean doses of Midazolam and Fentanyl
timeFrame: From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02048709: Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
Official title: A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists
* Age \> or = 18
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Life expectancy \> or = 12 weeks
* Adequate hematologic and organ function before initiation of GDC-0919
* For some patients only: Accessible lesions amenable to paired fresh tumor biopsies

Exclusion Criteria:

* Some prior cancer immunotherapies
* Untreated brain metastases
* Active or history of autoimmune disease

Primary outcomes:
measure: Percentage of patients with dose-limiting toxicities
timeFrame: 28 days
measure: Number of dose-limiting toxicities
timeFrame: 28 days
measure: Percentage of patients with adverse events
timeFrame: approximately 15 months
Secondary outcomes:
measure: Pharmacokinetics: Serum concentrations (Cmax/Steady State)
timeFrame: 21 days
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nayak-Kapoor A, Hao Z, Sadek R, Dobbins R, Marshall L, Vahanian NN, Jay Ramsey W, Kennedy E, Mautino MR, Link CJ, Lin RS, Royer-Joo S, Liang X, Salphati L, Morrissey KM, Mahrus S, McCall B, Pirzkall A, Munn DH, Janik JE, Khleif SN. Phase Ia study of the indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor navoximod (GDC-0919) in patients with recurrent advanced solid tumors. J Immunother Cancer. 2018 Jun 20;6(1):61. doi: 10.1186/s40425-018-0351-9.
Clinical trial NCT01231009: The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
Official title: The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Vestibular Neuritis
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.


Eligibility criteria: Inclusion Criteria:

* Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
* Horizontal-rotatory spontaneous nystagmus.

Exclusion Criteria:

* History of vestibular disfunction before the acute onset of symptoms
* Simultaneous Hearing loss
* Neurologic disorder
* Pregnancy or lactation
* History of psychiatric disorders
* History of glaucoma
* Diabetes
* Hypertension
* Contraindication in receiving corticosteroids

Primary outcomes:
measure: clinical recovery of vestibular function
timeFrame: 1 year
measure: Laboratory recovery of vestibular
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: 1st ENT Department, AHEPA University Hospital
Study officials:
References:
citation: Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.
Clinical trial NCT04964609: EmbracePlus SpO2 Accuracy Validation
Official title: Accuracy of Pulse Oximeters With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oximetry
Keywords: Oximetry
Wearable
SpO2
Lead sponsor: Empatica, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Empatica Srl
First posted: 2021-07-16
Enrollment: 14
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: OTHER

Brief summary: The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.


Eligibility criteria: Inclusion Criteria:

* The subject is male or female, aged ≥18 and \<50.
* The subject is in good general health with no evidence of any medical problems.
* The subject is fluent in both written and spoken English.
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* The subject is obese (BMI\>30).
* The subject has a known history of heart disease, lung disease, kidney or liver disease.
* Diagnosis of asthma, sleep apnea, or use of CPAP.
* Subject has diabetes.
* Subject has a clotting disorder.
* The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
* The subject has any other serious systemic illness.
* The subject is a current smoker.
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
* The subject has a history of fainting or vasovagal response.
* The subject has a history of sensitivity to local anesthesia.
* The subject has a diagnosis of Raynaud's disease.
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
* The subject is pregnant, lactating or trying to get pregnant.
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
* The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.

Primary outcomes:
measure: SpO2 Accuracy
timeFrame: Through study completion, 3 months average
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California
state: California
Study officials:
References:
Clinical trial NCT03391609: Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients
Official title: Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pre-Eclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output \[UOP\], creatinine and glomerular filtration rate \[GFR\]) in preeclamptic patient.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension \[systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg\] accompanied by proteinuria first detected after 20 weeks of gestation).
* Proteinuria is defined as at least 300 mg protein in 24 h urine collection \[or ≥1+ dipstick (30 mg/dl) in a single urine sample\] ).
* American Society of Anesthesiologists (ASA) physical status of II or III.
* age between 19 and 40 years

Exclusion Criteria:

* patient refusal to consent (obsolete).
* pre-existing neurological disease or psychic patients.
* history of cardiac and respiratory system failure.
* co-existing significant renal or liver disease.

Primary outcomes:
measure: postoperative analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: stress response
timeFrame: 24 hours postoperatively
measure: renal function
timeFrame: 24 hours postoperatively
measure: untoward events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute
Study officials:
References: