louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006195: Glucose Regulation During Risperidone and Olanzapine Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Janssen, LP
name: Washington University School of Medicine
First posted: 2000-09-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The overall purpose of this research is to look at how two of the most commonly prescribed newer antipsychotic medications, risperidone and olanzapine, affect substances in the body such as glucose and insulin. Undesirable changes in blood sugar control, or glucose regulation, and type 2 diabetes can occur more commonly in individuals with schizophrenia compared to healthy subjects and subjects with other psychiatric conditions. While abnormalities in glucose regulation were first reported in schizophrenia before the introduction of antipsychotic medications, antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Attention to the way that antipsychotic medications may affect glucose regulation has increased as doctors have become more concerned in general about disease- and drug-related medical complications, including weight gain during antipsychotic treatment.

Detailed description: This study will include 70 patients diagnosed with schizophrenia, taking either risperidone, olanzapine or haloperidol, and 20 healthy control subjects. Each subject will undergo a 4 hour glucose tolerance test. In addition, there will be a small project within the overall study to measure the effects of risperidone and olanzapine on glucose regulation as the individuals switch from their prior treatment with a conventional antipsychotic medication to either risperidone or olanzapine. Ten subjects will be studied on a typical neuroleptic at baseline then switched over a one week period to risperidone or olanzapine. The participants will be evaluated at 1 week, 4 weeks, and 12 weeks, prospectively. Each evaluation will consist of a 4 hour glucose tolerance test.

Eligibility criteria: Inclusion Criteria:

* meet DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
* able to give informed consent;
* no medication changes for 2 weeks prior to and during the period of study;
* currently taking olanzapine, risperidone, haloperidol or another typical antipsychotic

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT00362895: A Bioequivalence Study of Tobradex AF
Official title: A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 995
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 the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.


Eligibility criteria: Inclusion Criteria:

* 18 or older
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Concentration of dexamethasone in aqueous humor following a single topical ocular administration
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon for Trial Location(s)
state: Texas
Study officials:
References:
Clinical trial NCT06812195: Periprosthetic Plate Over Humeral Nail
Official title: Plate Over Humeral Nail in Deformity Correction of Femur in Adult Osteoporotic Bone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteopenia, Osteoporosis
Keywords: deformity
osteoporosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Under spinal anesthesia in supine position, lateral approach to the femur is used to do corrective osteotomies and introduction of humeral nail according to preoperative plan. After that, plate is applied to lateral border to the feoral shaft. Weight bearing is allowed after confirmation of union after 6 weeks. Regular visits every 3 months.
Primary purpose: TREATMENT

Brief summary: use of plate over humeral nail in deformity correction of femur in adult osteoporotic bone

Detailed description: small IM interlocking nail, such as humeral nail, could be used in femoral fixation in normal adolescent patients due to the advantages of the entry point lateral to tip of greater trochanter resulting in avoiding iatrogenic vascular injury and being the IM locking device with smaller diameter and shorter length than conventional femoral nail which was appropriate for small-sized adolescent femoral anatom

Eligibility criteria: Inclusion Criteria:

* Osteoporotic bone with femoral deformity.
* Osteogenesis imperfecta. --Vitamin D deficiency ricket

Exclusion Criteria:

* Uncooperative patient.

  -- Skeletally immature
* Not receiving medical treatment.
* Patient with history of allergy to drugs used in the study.
* Neuromuscular pathology, previous trauma, or surgery to the leg

Primary outcomes:
measure: Metal failure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hesham M Elbaseet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gordon JE, Khanna N, Luhmann SJ, Dobbs MB, Ortman MR, Schoenecker PL. Intramedullary nailing of femoral fractures in children through the lateral aspect of the greater trochanter using a modified rigid humeral intramedullary nail: preliminary results of a new technique in 15 children. J Orthop Trauma. 2004 Aug;18(7):416-22; discussion 423-4. doi: 10.1097/00005131-200408000-00004.
Clinical trial NCT02230995: Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
Official title: Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (25 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2014-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.


Eligibility criteria: Inclusion criteria:

- Healthy male and female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition.

Primary outcomes:
measure: AUC0-tz of Empagliflozin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
measure: AUC0-tz of Metformin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
measure: Cmax of Empagliflozin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
measure: Cmax of Metformin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Secondary outcomes:
measure: AUC0-infinity of Empagliflozin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
measure: AUC0-infinity of Metformin in Plasma
timeFrame: -1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration
Other outcomes:
Locations:
city: Biberach an der Riss
country: Germany
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT06692595: Digital PCR for Quantifying Periodontal Pathobionts
Official title: Digital PCR for Quantifying Periodontal Pathobionts: A Comparative Study With qPCR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study comprised of two subject groups. The first group consisted of 20 subjects with periodontitis, who had at least one probing site in each jaw quadrant with pocket depth (PPD) measuring \&gt; 4 mm and positive bleeding on probing (BOP). Periodontitis stage and grade were determined following the 2018 classification system.

The second group consisted of 20 volunteers without periodontal pathologies (healthy group), i.e. plaque index \&lt; 10% at baseline visit, absence of periodontal pockets measuring \&gt; 4 mm and no prior periodontal treatment.

Brief summary: Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.


Eligibility criteria: For inclusion, each subject had to be systemically healthy and aged 20 to 80 years. Subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. HIV/AIDS, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.

Primary outcomes:
measure: concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
Clinical trial NCT01326195: Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Official title: Dating Violence and HIV Prevention in Girls: Adapting Mental Health Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dating Violence
HIV Infections
Keywords: HIV Prevention
Dating Violence
Females
Romantic relationships
Adolescents
Sexuality
Underserved youth
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.

Detailed description: A growing body of research reveals that dating violence (DV) plays a significant role in adolescent girls' HIV risk. Dating violence has been associated with less condom use, younger age at first intercourse, having multiple sex partners and alcohol use prior to sexual encounters. Thus, prevention strategies that address dating violence and HIV risk may hold promise for reducing sexual risk behavior among a particularly at-risk population. In this study, a cognitive-behaviorally based intervention named "Skills to Manage Aggression in Relationships for Teens" (Date S.M.A.R.T.) is being developed and compared to a psychoeducational program for dating violence and HIV prevention. The program is being implemented with a sample of underserved youth, as economic disadvantage and minority status have been found to be related to increased rates of adolescent dating violence. A primary focus of the intervention is to address mental health problems (i.e. psychological distress and behavioral dysregulation) that underlie the development and maintenance of both dating violence and sexual risk behavior among adolescent girls.

Eligibility criteria: Inclusion Criteria:

* Adolescent must be English-speaking
* Adolescent must have a lifetime history of physical dating violence perpetration or victimization

Exclusion Criteria:

* Current enrollment in an intervention for dating violence or HIV prevention

Primary outcomes:
measure: Change in number (#) of unprotected sex acts
timeFrame: Baseline, 3 months, 6 months, 9 months
Secondary outcomes:
measure: Change in number of acts of dating violence perpetration and victimization
timeFrame: Baseline, 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Christie J. Rizzo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rizzo CJ, Joppa M, Barker D, Collibee C, Zlotnick C, Brown LK. Project Date SMART: a Dating Violence (DV) and Sexual Risk Prevention Program for Adolescent Girls with Prior DV Exposure. Prev Sci. 2018 May;19(4):416-426. doi: 10.1007/s11121-018-0871-z.
Clinical trial NCT03198195: Post-transplant Cyclophosphamide in Wiskott-Aldrich Syndrome
Official title: Post-transplant Cyclophosphamide for HLA-haploidentical Transplantation in Wiskott-Aldrich Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wiskott-Aldrich Syndrome
Lead sponsor: Capital Research Institute of Pediatrics
Sponsor class: OTHER_GOV
First posted: 2017-06-26
Enrollment: 5
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Wiskott-Aldrich Syndrome :

1. life-threatening bleeding
2. strong demand of parents

Brief summary: A protocol named as "CIP-2015" for patients with Wiskott-Aldrich Syndrome may reduce the rate of GvHD.

The details of the protocal followed with:

1. Conditioning regimen Busulfan 16 mg/kg in total, Fludarabine 160 mg/m2 in total.
2. GvHD Prophylaxis:

Rabbit antihuman thymocyte globulin 7.5 mg/kg post-transplant cyclophosphamide (CY) (50 mg/kg.d on days +3 and +4) Cyclosporine or tacrolimus, mycophenolate mofetil, on days +5

Detailed description: Patients were enrolled in CIP-2015 Protocol at the Capital Institute of Pediatrics (Beijing). The conditioning regimen consisted of fludarabine (40 mg/m2) from days -6 to -3, and Busulfan was administered intravenously for 4 days, from days -5 to -2，using dose targeting based on therapeutic drug monitoring. Thymoglobulin (Sanoﬁ, Cambridge, MA) 7.5 to 10 mg/kg (cumulative dose over 4 days) was administered over 4 days, from days -5 to -2. Bone marrow (BM) and PBSC were infused on day 0, followed by post-transplant CY (50 mg/kg/day, on days +3 and +4). To protect against hemorrhagic cystitis, MESNA (2-mercaptoethane sodium sulfonate) was administered at 150% of the CY dose. Post grafting immunosuppression with mycophenolate mofetil and tacrolimus commenced on day +5 and extended until days +28 and +84, respectively. Tacrolimus was tapered off by day +90 if there was no GVHD.

Eligibility criteria: Inclusion Criteria:

-Patients diagnosed with Wiskott-Aldrich Syndrome with indication of Hematopoietic stem cell transplantation

Exclusion Criteria:

* without indication of Hematopoietic stem cell transplantation

Primary outcomes:
measure: Rate of aGvHD
timeFrame: 3month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05981495: Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Official title: Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis, Pulmonary
Tuberculosis, Extrapulmonary
Tuberculosis Active
Lead sponsor: NanoPin Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fortrea
First posted: 2023-08-08
Enrollment: 460
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.

Brief summary: The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease.

The main question\[s\] it aims to answer are:

* How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?
* How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?

Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.


Eligibility criteria: Inclusion Criteria:

* Children and adults aged two years or older (including older adults that are 65+)
* Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years
* Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable)
* Clinical signs and symptoms typically associated with active TB disease including, but not limited to:

Cough for \> two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats

* Physician (or healthcare provider) suspicion of TB disease

Exclusion Criteria:

* Pregnancy (based on participant-provided information)
* Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures
* Critical illness needing immediate medical care
* Receipt of treatment for active TB or LTBI in the past 24 months

Primary outcomes:
measure: NanoDetect-TB result compared to sputum culture
timeFrame: Single visit for patient for blood draw.
Secondary outcomes:
measure: NanoDetect-TB result compared to AFB Smear and NAAT
timeFrame: Single visit for patient for blood draw.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02449395: Cross-sectional Study of Fibromyalgia
Official title: A Cross-sectional Study of Fibromyalgia in Beijing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital, Beijing China.

Brief summary: This study is designed to collect data on precipitating factors, diagnosis, morbidity, therapy, quality of life, and symptom severity, etc. informations in patients with fibromyalgia.

Detailed description: Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia outpatient service which is belonged to the Department of Rheumatism. Except collecting patients' demographic and social characteristic informations, rheumatologist also carry out a comprehensive evaluation including patient current history, current medication use, and tender point examination for a diagnosis or confirmation of fibromyalgia and treatment recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study will be conducted in Beijing, China.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for Fibromyalgia.

Exclusion Criteria:

* Don't fulfill any classification criterions for Fibromyalgia.

Primary outcomes:
measure: Fibromyalgia symptoms severity as measured by Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: up to 1 week
Secondary outcomes:
measure: QOL as measured by Short Form-36 Health Status Questionnaire (SF-36)
timeFrame: up to 1 week
measure: Pain scores as measured by Numerical rating scale (NRS)
timeFrame: up to 1 week
measure: Fatigue scores as measured by Multidimensional Assessment Fatigue (MAF)
timeFrame: up to 1 week
measure: Depression scores as measured by Beck depression inventory (BDI)
timeFrame: up to 1 week
measure: Stress scores as measured by Perceived Stress Scale (PSS)
timeFrame: up to 1 week
measure: Sleep scores as measured by Pittsburgh sleep quality index (PSQI)
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Juan Jiao, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References: