louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03853811: Customized Orthosis for Children With Clubfoot
Official title: Customized Orthosis for Children With Clubfoot Following Ponseti Casting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Congenital Talipes Equinovarus
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 3
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mitchell shoe during bracing, following Ponseti casting. The investigators hypothesize that following Ponseti casting, the implementation of customized AFOs with Ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with Mitchell shoes.


Eligibility criteria: Inclusion Criteria:

* less than 12 months old (no age minimum)
* no neuromuscular disease involved
* treated by Ponseti casting
* idiopathic bilateral or unilateral clubfoot
* no other congenital foot deformity
* no previous open surgeries to treat the deformity

Exclusion Criteria:

* patients with prior surgical treatment
* not treated by Ponseti casting
* an underlying syndrome
* neurological disorder

Primary outcomes:
measure: Assessment of Functional Outcomes of Bracing Treatment Using Dimeglio Scores
timeFrame: Collected when visit where cast is applied, visit when cast is removed, then at 2 weeks, 12 weeks, 24 weeks of bracing
measure: Time Spent in Brace to Assess Brace Compliance
timeFrame: 24 weeks (from start of bracing treatment)
measure: Assessing Treatment Factors that Impact Brace Compliance with Parental Questionnaires
timeFrame: 24 weeks (from start of bracing treatment)
Secondary outcomes:
measure: Assessing Demographic Factors that Impact Brace Compliance with Parental Questionnaire
timeFrame: 24 weeks (from start of bracing treatment)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Scott Van Valin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05849311: Phase I Trial of Envafolimab for Healthy Male Subjects
Official title: A Randomized, Double-blind, Single-dose, Parallel Controlled Phase I Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Envafolimab in Healthy Male Subjects Before and After the Manufacturing Process Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male
Lead sponsor: 3D Medicines
Sponsor class: INDUSTRY
First posted: 2023-05-08
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.


Eligibility criteria: Inclusion Criteria:

1. Be able to fully read, understand, and sign the informed consent form;
2. Male subjects aged 18-45 years
3. Clinical examinations in the screening period are normal or abnormal without clinical significance;
4. A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;
5. Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.

Exclusion Criteria:

1. Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure \< 90 mmHg/ diastolic blood pressure \< 60 mmHg, pulse \> 100 beats /min or \< 50 beats /min at screening or baseline examination;
2. QT interval (QTcF) ≥450;
3. Estimated glomerular filtration rate eGFR \< 90 ml/min/1.73m2;
4. Thyroid function beyond the normal range;
5. ALT \> ULN Or AST \> ULN;
6. Prior treatment with a PD-1/L1 inhibitor;
7. Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration;
8. Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration;
9. Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.

Primary outcomes:
measure: AUC0-t
timeFrame: From pre-dose to day 85
measure: Cmax
timeFrame: From pre-dose to day 85
Secondary outcomes:
measure: AUC0-infinity
timeFrame: From pre-dose to day 85
measure: Tmax
timeFrame: From pre-dose to day 85
measure: CL
timeFrame: From pre-dose to day 85
measure: λz
timeFrame: From pre-dose to day 85
measure: t1/2
timeFrame: From pre-dose to day 85
measure: Vd
timeFrame: From pre-dose to day 85
measure: Safety and tolerance
timeFrame: From pre-dose to day 85
measure: Immunogenicity assessment
timeFrame: From pre-dose to day 85
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Gaobo Boren Hosipital
state: Beijing
Study officials:
affiliation: Beijing Goboard Boren Hospital
name: Qing He
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220311: A Study to Confirm the Efficacy and Safety of Fludarabine Phosphate Administered in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Official title: A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic Lymphocytic Leukemia Patients With Anemia and/or Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (CLL) patients with anemia and/or thrombocytopenia.

Detailed description: As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.

Eligibility criteria: Inclusion Criteria:

* Patients with histologically or cytologically confirmed CLL
* Patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal
* Patients who have not received cancer chemotherapy or radiotherapy

Exclusion Criteria:

* Patients with apparent infections (including viral infections)
* Patients with serious complications (heart, liver, or kidney disease, etc.)
* Patients with a serious bleeding tendency (e.g., DIC)
* Patients with serious CNS symptoms
* Patients with fever \>= 38°C (excluding tumor fever)
* Patients with interstitial pneumonia or pulmonary fibrosis
* Patients with active multiple cancers
* Patients receiving other investigational products within 6 months before registration in this study
* Patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives)
* Women who are pregnant, of childbearing potential, or lactating

Primary outcomes:
measure: Response rate of final overall evaluation up to 6 treatment cycles (at about 6 months)
timeFrame: Up to 6 treatment cycles (at about 6 months)
Secondary outcomes:
measure: Response rate for measurable lesions / evaluable lesions / peripheral blood findings / bone marrow findings
timeFrame: Up to 6 treatment cycles (at about 6 months)
measure: Duration of response and change of peripheral blood findings
timeFrame: End of study
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06547411: Effects of Different Anesthesia Machine Modalities on Bariatric Surgery Patients: a Prospective Randomized Controlled Study
Official title: Effects of Different Ventilation Modes on Intracranial Pressure and Carbon Dioxide Partial Pressure During Bariatric Surgery: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilation
Bariatric Surgery
Intracranial Pressure
Carbon Dioxide
Lead sponsor: Inner Mongolia University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Inner Mongolia Baogang Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
First posted: 2024-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the clinical significance and value of the PRVC ventilation mode in Bariatric Surgery Patients. The main questions it aims to answer are：

* Do different ventilation patterns affect intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
* Does PRVC mode reduce intracranial pressure and partial pressure of carbon dioxide in bariatric surgery patients?
* Whether intracranial pressure can be quickly measured by monitoring a patient's optic nerve sheath diameter (ONSD)？ Researchers randomized bariatric surgery patients into PC, VC, and PRVC groups for comparison, looking at breathing mechanics, PaCO2, and ICP.

Participants will:

* take PC mode ventilation, VC mode ventilation, and PRVC mode ventilation
* monitor Respiratory mechanics, PaCO2, and ONSD


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective bariatric surgery.
* Age between 16 and 65 years.
* Continuous weight gain for more than 5 years with a BMI ≥ 35.
* ASA-PS (American Society of Anesthesiologists Physical Status) categorization of Grade II or III.

Exclusion Criteria:

* Patients who were dependent on alcohol or opioids.
* Patients with severe mental or intellectual disabilities.
* Patients with severe ocular conditions, such as ocular trauma, optic nerve tumors, or those wearing ocular prostheses.

Primary outcomes:
measure: optic nerve sheath diameter [ONSD]
timeFrame: 1 year
measure: carbon dioxide partial pressure
timeFrame: 1 year
measure: mean airway pressure (PAWM)
timeFrame: 1 year
measure: peak airway pressure (PAP)
timeFrame: 1 year
measure: esophageal pressure (PES)
timeFrame: 1 year
measure: tidal volume (TV)
timeFrame: 1 year
measure: mean arterial pressure (MAP)
timeFrame: 1 year
measure: heart rate (HR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baotou
country: China
facility: Inner Mongolia Baogang Hospital
state: Inner Mongolia
Study officials:
References:
Clinical trial NCT05303428: Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals
Official title: Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and cognitive brain signaling using structured tasks. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, all ethnicities, who understand and speak English.

Exclusion Criteria:

1. Claustrophobia (scanning environment may be uncomfortable).
2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
3. Contraindications to CT: pregnancy
4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)
5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
6. History of head injury resulting in loss of consciousness for \>10 minutes.
7. History of alcohol or drug dependence (through self-report).

Primary outcomes:
measure: fMRI Signals - Cognition
timeFrame: Participant study duration, approximately 3 weeks.
Secondary outcomes:
measure: Executive function task performance
timeFrame: Participant study duration, approximately 3 weeks.
Other outcomes:
measure: Assess for changes in physiological measures
timeFrame: Participant study duration, approximately 3 weeks.
Locations:
Study officials:
References:
Clinical trial NCT01005628: Bortezomib (Velcade) - Regulatory Post Marketing Surveillance (PMS)
Official title: Velcade - Regulatory Post Marketing Surveillance (PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Bortezomib postmarketing surveillance
Korea bortezomib PMS
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 1121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma in Korea

Brief summary: After the KFDA (Korea Food and Drug Administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade).

Detailed description: After the KFDA approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the Health Authority in 6 years. In this Observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (Velcade). We will collect the response rate according to the EMBT (European Group for Blood and Marrow Transplant; a non-profit organization based in the Netherlands that promotes the transplantation of haemopoietic stem cells from all donor sources and donor types and related basic and clinical research, education, standardization, quality control, and accreditation for transplant procedures) or IMWG (the International Myeloma Working Group) criteria and the adverse events to assess the efficacy and safety. Observational Study - No investigational drug administered

Eligibility criteria: Inclusion Criteria:

* Patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma

Exclusion Criteria:

* Patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity
* Patients with severe hepatic impairment
* Pregnant women

Primary outcomes:
measure: The data on AE (Adverse event) incidence, such as whether AEs occurred, types of AEs, and incidence of AEs by type
timeFrame: every cycles or every 3 weeks
Secondary outcomes:
measure: The overall response rate (complete remission rate+partal remission rate) will be measured according to the EBMT or IMWG criteria.
timeFrame: every cycle or every 3 weeks and end of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04224428: Role of Fexofenadine in Diabetic Kidney Disease
Official title: Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Kidney Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 60
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: TREATMENT

Brief summary: * This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus.
* Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt.

This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following

* Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months
* Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months

The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after six months of treatment


Eligibility criteria: Inclusion Criteria:

* Males or females aged ≥ 18 years
* Confirmed diagnosis of Type 2 diabetes mellitus at least 6 months prior to screening
* Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) \>30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
* Hemoglobin A1c \> 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion Criteria:

* Type 1 diabetes mellitus
* Severe renal impairment (eGFR\< 30 mL/min/1.73 m2 at screening)
* Pregnant or lactating women
* Chronic heart failure
* Malignancy
* Inflammatory or autoimmune disease
* History of kidney disease other than diabetic nephropathy

Primary outcomes:
measure: Percent change in urinary albumin creatinine ratio (UACR)
timeFrame: After 6 months
Secondary outcomes:
measure: Urinary cyclophilin A
timeFrame: After 6 months
measure: Urinary monocyte chemoattractant protein-1 (MCP-1)
timeFrame: After 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Pharmacy, Tanta University
Study officials:
References:
Clinical trial NCT06595628: Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair
Official title: Comparative Study of Modified Guarnieri-Desarda Technique Versus Lichtenstein Technique in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: Inguinal Hernia
Hernia Repair
Guarnieri Technique
Desarda Technique
Lichtenstein Hernioplasty
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study follows a parallel assignment model. Patients are randomly assigned to one of two groups: the Lichtenstein mesh-based repair group (L group) or the combined modified Guarnieri-Desarda tissue-based repair group (C group). The interventions are performed independently in each group, with outcomes compared between the two. There is no blinding in this study, and both the participants and the surgeons know which procedure is being performed (open-label study). The primary focus is on comparing the effectiveness and safety of the two surgical techniques.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the surgical outcome of both Lichnichtien tension free mesh hernioplasty of inguinal hernia and the combined modified Guarnieri Desarda technique in terms of postoperative pain, post operative complications (seroma, hematoma, wound infection), chronic inguinodenia, early recurrence and assessment of testicular vascularity and size by application of a testicular duplex and ultrasound.


Eligibility criteria: Inclusion Criteria:

* Adult male patients aged 18 years or older.
* Patients diagnosed with non-complicated inguinal hernia (both direct and indirect).
* Patients able to provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with complicated hernias (e.g., inflamed, obstructed, or strangulated hernias).
* Patients with a recurrent inguinal hernia.
* Patients with weak or thin external oblique aponeurosis (intraoperative findings).
* Patients with a history of prior surgery in the inguinal region.
* Patients who refuse to participate in the study.

Primary outcomes:
measure: Postoperative Pain Assessment
timeFrame: At 2 weeks, 1 month, 3 months, and 6 months post-surgery.
Secondary outcomes:
measure: Incidence of Postoperative Complications
timeFrame: At 2 weeks, 1 month, and 3 months post-surgery.
measure: Hernia Recurrence Rate
timeFrame: At 6 months and 1 year post-surgery.
measure: Testicular Vascularity
timeFrame: At 3 months post-surgery.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy
Study officials:
affiliation: Kasr El Aini Hospital
name: Fadi F. Khalil, MSc
role: PRINCIPAL_INVESTIGATOR
References: