louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06037499: System Accuracy of 14 Blood Glucose Monitoring Systems
Official title: Leistungsbewertungsprüfung Der Systemgenauigkeit, Von 14 Blutglukose Monitoring Systemen in Anlehnung an ISO 15197:2015
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The system accuracy of 14 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 over thr courese of 24 months


Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Blood glucose measurement using BGMS
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
References:
Clinical trial NCT04899999: Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents
Official title: Graphic Messages to Prevent E-Cigarette Use Among Latino and African American Adolescents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-05-25
Enrollment: 362
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine if graphic messages prevent future vaping use among African American and Latino adolescents. The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping among African American and Latino adolescents.


Eligibility criteria: Inclusion Criteria:

* self-identify as African American/Black and/or Hispanic/Latino
* know how to read and speak English and/or Spanish
* have never used e-cigarettes
* have access to a device that will be able to connect to the online survey

Exclusion Criteria:

* not identifying as African American/Black and/or Hispanic/Latino
* using e-cigarettes

Primary outcomes:
measure: change in percent of participants who are not susceptible to future vaping
timeFrame: baseline to post intervention, approximately 1 day
measure: Mean change in susceptibility score
timeFrame: baseline to post intervention, approximately 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02803099: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay ,UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRLSHF(Self History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06041399: The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Official title: The Effect of Related Blood Markers on Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetic Peripheral Neuropathy
electromyography
blood parameters
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this observational study is to explore the relationship between related blood indicators and diabetic peripheral neuropathy.

Detailed description: This is a multi-center(about five), randomized, double-blind, placebo-controlled clinical trial with over 1000 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers and electromyography. All participants provided their written informed consent to participate in this study.The study protocol was approved by the Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University(KY-2022-R009).

Eligibility criteria: Inclusion Criteria:

* patients who had undergone nerve conduction examination by electromyography(EMG).

Exclusion Criteria:

* pregnancy and lactation; chronic liver disease, kidney disease, arrhythmias, malignant diseases, severe respiratory diseases, heart failure, and acute infections;
* patients with alcohol abuse; history of Autoimmune liver disease, liver disease or abnormal liver function at baseline;
* parathyroid diseases (including hyperthyroidism and hypothyroidism);
* pancreatitis, pancreatectomy or any transplant;
* patients with malignancy and any serious concomitant disease limit the existence of life expectancy

Primary outcomes:
measure: the severity of diabetic peripheral neuropathy
timeFrame: From admission to discharge, up to 1 week
measure: the presence of diabetic peripheral neuropathy
timeFrame: From admission to discharge, up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06271642: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators
Official title: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anxiety
Keywords: vibrating device
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* English speaking
* Hearing intact

Exclusion Criteria:

* History of chronic pain or acute pain syndromes
* Currently has nausea
* Has hearing loss
* Is pregnant
* Is currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications

Primary outcomes:
measure: Mechanical Pain Threshold
timeFrame: immediately after intervention
Secondary outcomes:
measure: Mechanical pain sensitivity
timeFrame: immediately after intervention
measure: Anxiety scores
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Parkard Children's Hospital
state: California
Study officials:
References:
Clinical trial NCT06834542: Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors
Official title: Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Adult Gynecological Tumors
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 26
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: This study is an early exploration clinical study with one arm. The study consists of two stages, namely the dose escalation stage and the dose extension stage:


Eligibility criteria: Inclusion Criteria:

1. The Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
2. The physical fitness status score of the ECOG is 0 or 1
3. At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

1. The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
2. Arterial/venous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
3. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
5. Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin)

Primary outcomes:
measure: Objective Response Rate
timeFrame: 3 years
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
measure: Progression-Free Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medcine, Renji Hospital Ethica Committee
state: Shanghai
Study officials:
References:
Clinical trial NCT02976142: The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer
Official title: Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer, Metastatic
Keywords: gastric cancer, metastatic
positive wash cytology
neoadjuvant intraperitoneal immunotherapy
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 150
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: The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.


Eligibility criteria: Inclusion Criteria:

* ECOG 0-2
* Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition)
* Histological forms: gastric adenocarcinoma and signet ring cancer
* Blood characteristics (creatinine \<150 mg/l, total bilirubin \< 50 mkmol/l, neutrophils \< 1500/mkl, hemoglobin \>90 g/l, thrombocytes \> 100000/mkl)

Exclusion Criteria:

* Clinically apparent distant metastasis (besides free cancer cells)
* Synchronic or metachronic malignant tumors
* Previous systemic or surgical or combined therapy for gastric cancer
* Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding)
* Adhesions in abdominal cavity
* Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.

Primary outcomes:
measure: Overall 2-year survival
timeFrame: 2 years
Secondary outcomes:
measure: Portability of the systemic therapy methods
timeFrame: 6,9,12,24 months
measure: Mortality
timeFrame: 24 months
measure: Downstaging tumor
timeFrame: 2 years
measure: Morbidity
timeFrame: 30 days
measure: Quality of life
timeFrame: 6, 12, 18, 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Moscow Clinical Scientific Center
name: Nikolay Semenov
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Clinical Scientific Center
name: Boris Pomortsev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03553342: Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Official title: Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Recurrent Paralysis of Vocal Cords
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 156
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: Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.

The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for simple total thyroidectomy or lobo-isthmectomy
* Patients over eighteen years old
* Free subject, whitout tutorship or curatorship or subordination
* Informed consent and signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
* Patients with preoperative recurrent paralysis
* Patients with hypersensitivity to prednisolone or any of the excipients.
* Patients with contraindication to use Solupred
* Patients with anti-inflammatory of acetylsalicylic acid
* Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)

Primary outcomes:
measure: Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
References:
Clinical trial NCT04482842: Gene-guided Warfarin for Anticoagulation Therapy
Official title: Gene-guided Warfarin for Anticoagulation Therapy in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the effect of warfarin gene polymorphism on the effectiveness and safety of anticoagulant therapy in patients with acute ischemic stroke, and clarify the correlation between genetic testing and compliance rate of INR value. It will illustrate the significance of gene-guided warfarin for administered dose to anticoagulation therapy in patients with acute ischemic stroke. Then it will establish and verify a warfarin stable dose prediction model suitable for such patients, and provide basis for the personalized medication regimen of warfarin in patients with acute ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Patients with acute ischemic stroke aged ≥18 years (cardiogenic cerebral embolism patients)
* Clinicians judge that long-term oral anticoagulation with warfarin is required
* No anticoagulation treatment in the past 10 days
* Agree to participate in this project

Exclusion Criteria:

* Patients who had a tendency to bleed when taking warfarin
* High-risk groups using warfarin anticoagulation

Primary outcomes:
measure: Stroke recurrence rate, compliance rate of INR value
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00799942: Open-lable Extension Study on Safety and Efficacy of Neramexane to Treat Congenital and Acquired Nystagmus
Official title: Long-term Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nystagmus, Congenital
Nystagmus, Acquired
Multiple Sclerosis
Keywords: Nystagmus, congenital idiopathic
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the long-term safety, tolerability and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN). In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included.


Eligibility criteria: Inclusion Criteria:

* patients who has succesfully completed the lead-in study MRZ 92579-0707/1

Exclusion Criteria:

* Occurence of any major treatment-emergent adverse event or condition during the previous protocol (MRZ 92579-0707/1)

Primary outcomes:
measure: Long-term safety, Visual acuity
timeFrame: Baseline, week 4, month 3, 6, 9, 12, 18, 24, 30, 36 and follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester, Leicester Royal Infirmary, Ophthalmology Group
Study officials:
References: