louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06900010: A Study to Evaluate CM336 in Adults with Autoimmune Bullous Disease
Official title: An Open-label, Dose Escalation Phase Ⅰ/Ⅱ Study to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Autoimmune Bullous Disease
Lead sponsor: Shandong First Medical University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 30
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: to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Moderate to Severe Autoimmune Bullous Disease


Eligibility criteria: Inclusion Criteria:

* 1. Confirmed diagnosis of autoimmune bullous disease；
* 2. Age ≥18 years, regardless of gender；
* 3. Voluntarily signed informed consent form, with understanding of the study's nature, purpose, procedures, and willingness to comply with trial requirements.

Exclusion Criteria:

* 1. History of clinically significant diseases that, in the investigator's judgment, may pose safety risks to the subject during participation；
* 2. Prior treatment with anti-B-cell maturation antigen (BCMA) therapy；
* 3. History of allergic reactions to humanized monoclonal antibodies or known allergy to any component of CM336；
* 4. Any other condition deemed by the investigator to render the subject unsuitable for study participation.

Primary outcomes:
measure: To evaluate the efficacy after CM336 treatment
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Dermatology Hospital Affiliated to Shandong First Medical University
Study officials:
affiliation: Dermatology Hospital affiliated to Shandong First Medical University
name: Furen Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00145210: Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans
Official title: A Double-Blind, Randomized, Placebo- and Active-Controlled, Forced Titration Study Evaluating the Effects of Nebivolol on Blood Pressure and Heart Rate in African American Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Nebivolol
Lead sponsor: Mylan Bertek Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 630
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 this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.

Detailed description: Despite the established benefits of beta-blockers, their use is limited by their side effect profile and by a perception of reduced efficacy in certain populations such as African Americans (Amudha, 2003). This is a double-blind, randomized, placebo and active-controlled, multi-center, parallel group, forced titration study. Patients will be stratified across all treatment arms by age, gender, and diabetes status (history of diabetes mellitus vs no history of diabetes mellitus). The study consists of 3 periods: screening run-in, double-blind, randomized, forced titration and double-blind, washout period (only for patients who complete the double-blind, forced titration period and who are not participating in the long-term follow-up study). After a 14-28 day, single-blind, placebo controlled, run-in period, which includes washout (if applicable), eligible patients will be randomized to one of 3 treatment regimens for approximately 12 weeks.

This study will test the safety and efficacy of Nebivolol in the treatment of African American patients with hypertension.

Eligibility criteria: Inclusion Criteria:

* African Americans with stage 1-2 hypertension

Exclusion Criteria:

* Recent myocardial infarction or stroke
* Contraindications to beta-blocker therapy or stopping prior antihypertensive therapy

Primary outcomes:
measure: Blood pressure
measure: Heart Rate
Secondary outcomes:
measure: Safety and tolerability
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Mylan Pharmaceuticals Inc.
state: West Virginia
Study officials:
affiliation: Mylan Pharmaceuticals Inc
name: Betty S. Riggs, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02671110: A Trial Comparing Two Approaches to Weight Loss
Official title: A Randomized Trial Comparing Two Approaches to Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: weight loss treatment
Obesity
Lead sponsor: Bowling Green State University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the recently developed Transforming Your Life (TYL) weight loss program to the Diabetes Prevention Program (DPP), considered the "Gold Standard" in behavioral weight loss treatment.

Detailed description: Weight loss programs evidence considerable variability in treatment outcomes and weight regain is common, signaling the need for the refinement of effective treatments. This study compared the recently developed Transforming Your Life (TYL) program to the Diabetes Prevention Program (DPP), considered the "Gold Standard" in behavioral weight loss treatment.

Eligibility criteria: Inclusion Criteria

1. overweight/obese (body mass index\>27 kg/m2)
2. free from serious medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
3. had not undergone bariatric surgery
4. able to provide medical clearance from their physician.

Exclusion Criteria

1. evidence of medical conditions that would complicate participation in the intervention via adherence or mobility (e.g., serious heart disease or musculoskeletal problems that would interfere with moderate exercise)
2. had undergone bariatric surgery,

Primary outcomes:
measure: Weight Loss
timeFrame: 10 months
Secondary outcomes:
measure: Caloric Intake
timeFrame: 4 months
measure: Energy expenditure
timeFrame: 4 months
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Bowling Green State University
state: Ohio
Study officials:
References:
Clinical trial NCT03677310: Effects of 3% Sodium Chloride on Post-operative Dysphagia Following Anterior Cervical Spine Surgery
Official title: The Effects of 3% Sodium Chloride on Post-operative Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: a Prospective, Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Dysphagia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There is no effective treatment for post-operative dysphagia. Thus crossover is not expected.
Primary purpose: PREVENTION

Brief summary: Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.

Detailed description: Based on a priori analysis the investigators will need 100 subjects in a placebo arm (normal saline) and 100 subjects in a treatment arm (3% sodium chloride), for a total of 200 patients. This study will be conducted on healthy subjects with normal renal function undergoing anterior cervical discectomy and fusion for degenerative indications only. Subjects will be randomized to the treatment or placebo arm (which will be double blinded). Subjects in the treatment arm will begin to receive intravenous 3% sodium chloride before the incision is made. The solution will be given at a rate of 10 cc/hour over a period of 24 hours. Baseline, post-operative, and delayed post-operative dysphagia surveys will be administered either in person or by telephone. The investigators hope to decrease the incidence and severity of post-operative dysphagia.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications

Exclusion Criteria:

* history of cervical trauma
* baseline dysphagia
* age less than 18 years old
* history of previous anterior neck surgery
* Creatinine clearance less than 30
* Creatinine greater than 1.0
* baseline sodium greater than 145
* patients with known electrolyte abnormalities
* congestive heart failure

Primary outcomes:
measure: Post-operative dysphagia
timeFrame: Change in dysphagia scores will be assessed from pre-operative baseline value to: post-operative day one value, 2 week value, 6 week value, and 12 week value.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri Hospital
name: Tomoko Tanaka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06452810: A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area
Official title: A Clinical Trial to Evaluate the Effects of a Skin Balm on the Appearance of the Eye Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Keywords: Eye Balm
Periorbital area
Dermatology
Lead sponsor: Sahajan
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-06-11
Enrollment: 35
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study Type:

Interventional (Clinical Trial)

Estimated Enrollment:

35 participants

Allocation:

Non-randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment
Primary purpose: OTHER

Brief summary: This virtual single-group clinical trial aims to evaluate the effects of the Sahajan Golden Glow Balm on the health and appearance of the skin in the periorbital area over a period of 6 weeks. Participants will apply the product twice daily and complete questionnaires at various intervals. Photos for expert skin grading will be taken at Baseline and Week 6.

Detailed description: The study will investigate the impact of Sahajan Golden Glow Balm on skin health, particularly focusing on fine lines, wrinkles, dark circles, and dry eyes. It involves 35 female participants aged 35 and above, who will use the product for 6 weeks and complete periodic questionnaires and provide photos for dermatological assessment.

Eligibility criteria: Inclusion Criteria:

* Concerns with the appearance of skin in the periorbital area
* Willing to maintain the same skincare routine for the study duration
* Must own a smartphone or digital camera for photos

Exclusion Criteria:

* Medical conditions affecting skin health
* Use of medications or products that could affect skin health
* Pregnancy or breastfeeding
* Participation in another clinical study

Primary outcomes:
measure: Changes in the Health and Appearance of the Skin in the Periorbital Area
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Changes in Participants' Perception of the Appearance of the Skin in the Periorbital Area
timeFrame: Baseline, Day 1, Week 2, Week 4, and Week 6
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT02283710: The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
Official title: The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatty Liver
Keywords: Pentoxifylline
Aminotransferase
Steatohepatitis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 120
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: This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.

Detailed description: This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility criteria: Inclusion Criteria:

Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
* heart disease (ischemic or congestive),
* hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
* renal disease (serum creatinine concentration of \> 1.5 mg/dl),
* any severe systemic co-morbidities, neoplasm,
* using any hepatotoxic medication during the past 3 months,
* pregnant or lactating women.

Primary outcomes:
measure: Change from baseline serum alanine aminotransferase at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline serum aspartate aminotransferase at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Gastroenterology clinic, Sina Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Raika Jamali, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964210: Protecting Young Special Risk Females From Cervical Cancer Through Human Papilloma Virus (HPV) Vaccination
Official title: Prospective Non Controlled Study of Immunogenicity of Human Papilloma Virus (HPV) Vaccine in Groups at Special Risk of Poor Vaccine Result
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: Juvenile Idiopathic Arthritis
Inflammatory Bowel Disease
Acute Lymphoblastic Leukemia
Chronic Renal Disease
Solid Organ Transplant
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Brockhoff Foundation Australia
name: Shepherd Foundation Australia
First posted: 2009-08-24
Enrollment: 240
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A research project is currently being undertaken looking at Human Papilloma Virus (HPV) vaccination in special risk groups. It aims to see if young women with a chronic illness respond well to the HPV vaccine or whether they may require additional doses to ensure protective immunity. The four valent HPV vaccine protects against HPV types 16 \& 18, cervical cancer and HPV types 6 \& 11, anogenital warts.

The six special risk groups include:

Paediatric Rheumatological Disease Inflammatory Bowel Disease Acute Lymphoblastic Leukaemia Solid Organ Transplant Recipients (kidney and liver) Chronic Renal Disease Bone Marrow Transplants This immunity is measured by antibody levels of the HPV types, which requires a single blood test one month after the final dose of HPV vaccine.

This is compared to healthy controls using antibody response to HPV vaccine. This will assess directly whether these special risk groups respond as well to the HPV vaccine.


Eligibility criteria: Inclusion Criteria:

* Females aged 12-26 years
* Have been diagnosed by a specialist with one of the six chronic medical conditions described:

  1. Paediatric Rheumatological Disease
  2. Inflammatory Bowel Disease
  3. Acute Lymphoblastic Leukaemia
  4. Solid Organ Transplant Recipients (kidney and liver)
  5. Chronic Renal Disease
  6. Bone Marrow Transplant

Exclusion Criteria:

* Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis

Primary outcomes:
measure: Determine the HPV vaccine immunogenicity in females 12-26 years with six special risk groups at one month post the third and final HPV vaccination. Blood analysis taken at one month post third and final HPV vaccine to assess immunogenicity.
timeFrame: One Month post HPV vaccination
Secondary outcomes:
measure: Describe the safety of the HPV vaccine in the six study groups using self reports and liaison with treating sub specialist team.
timeFrame: One month post third HPV vaccination
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Childrens Hospital
state: Victoria
Study officials:
affiliation: NHMRC CCRE in Childhood and Adolescent Immunisation
name: Jim Buttery
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04098510: Concentration of MitoQ in Human Skeletal Muscle
Official title: Concentration of Mitoquinone Mesylate in Skeletal Muscle After a Single Oral Dose of MitoQ
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Mitochondria-targeted antioxidant
Skeletal muscle biopsies
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine mitoquinone mesylate concentration levels in skeletal muscle samples obtained after intake of an acute oral dose of MitoQ.


Eligibility criteria: Inclusion Criteria:

* Healthy,
* Male
* 18-40 years of age

Exclusion Criteria:

* Previous use of MitoQ or CoQ-10 within 30 days of screening appointment
* Ongoing use of MitoQ
* Smoking
* Ongoing treatment with medications
* Disease deemed by the MD to infer a risk to participate in the trial

Primary outcomes:
measure: Muscle mitoquinone mesylate concentration
timeFrame: Before oral administration of MitoQ
measure: Muscle mitoquinone mesylate concentration
timeFrame: 1 hours after oral administration of MitoQ
measure: Muscle mitoquinone mesylate concentration
timeFrame: 3 hours after oral administration of MitoQ
measure: Muscle mitoquinone mesylate concentration
timeFrame: 5 hours after oral administration of MitoQ
Secondary outcomes:
measure: Blood mitoquinone mesylate concentration
timeFrame: Before as well as 0.5, 1, 1.5, 2, 3, 4 and 5 hours after oral administration of MitoQ
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT06907810: Study of Lipid Mediators in Chronic Postoperative Pain - LICP
Official title: Study of Lipid Mediators in Chronic Postoperative Pain Following Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Postoperative Pain
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2025-04-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This interventional prospective study aims firstly to investigate variations in lipid levels in blood samples and their potential relationship with the duration and/or intensity of post-operative pain. Secondly, it aims to investigate the activation of peripheral blood mononuclear cells and neutrophils in patient blood samples. The study will enrol women aged 18 years or older who have been newly diagnosed with primary invasive or non-invasive breast cancer requiring surgical removal of the tumour, with or without axillary surgery.

The main objectives of the study are To assess whether there is an association between circulating levels of lipid mediators and chronicity (\> 3 months) of postoperative pain after breast cancer surgery.

To assess whether circulating levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.

To assess the existence of an association between resected tissue levels of lipid mediators and chronicity of postoperative pain in breast cancer surgery.

To assess whether tissue levels of lipid mediators can predict chronicity of postoperative pain in breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Women older than 18 years
* Newly diagnosed primary invasive or non-invasive breast cancer, requiring surgical excision of the tumor, with or without axillary surgery
* Able to give informed consent

Exclusion Criteria:

* Men
* Women aged less than 18 years
* Pregnant women
* History of major psychiatric disorders
* Previous breast or axillary surgery, recurrent disease or detectable metastatic disease at the time of diagnosis
* Unable to give informed consent

Primary outcomes:
measure: Pain intensity
timeFrame: Throughout the study, an average of 2 years
measure: Pain duration
timeFrame: Throughout the study, an average of 2 years
measure: Lipid Mediator Levels in Blood
timeFrame: Throughout the study, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc (UCLouvain)
Study officials:
affiliation: Université Catholique de Louvain
name: Mireille Alhouayek, PhD
role: PRINCIPAL_INVESTIGATOR
References: