louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06453798: Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy
Official title: Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiculopathy, Cervical
Lead sponsor: Lingshan County second People's Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial was to investigate the effects of cervical spine exercises combined with nerve mobilization in patients with radiculopathy.

The main questions it aims to answer are:

1. Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.
2. Is there any difference between cervical spine operation combined with nerve mobilization and single method? The participants were patients with cervical radiculopathy and were divided into three groups in this study.

1. Experimental group: received cervical spine operation combined with nerve mobilization 2. Control group 1: cervical spine exercises were performed 3. Control group 2: received neuromobilization

Detailed description: After being informed of the risks, participants are required to sign an informed consent form. Eligible participants will be randomly assigned to cervical spine operation combined with nerve mobilizatio or cervical spine exercises or neuromobilization on a 1:1:1 ratio.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of CSR and have no other complications;
2. Age 18-65 years old, gender unlimited;
3. No other treatment for cervical spondylosis in the last 1 month;
4. No previous surgical treatment for cervical spondylosis;
5. Good compliance;
6. Good mental state, no history of mental illness;
7. Informed consent, and sign the informed consent.

Exclusion Criteria:

1. does not meet the diagnostic criteria;
2. Women during pregnancy;
3. severe stenosis of the foramen;
4. osteoporosis combined with spinal cord tumor, osteomyelitis;
5. infectious diseases, skin defects, allergies;
6. have serious heart, lung and other important organ dysfunction;
7. unable to cooperate.

Primary outcomes:
measure: Visual analogue scale
timeFrame: baseline and 4 weeks
measure: Range of motion
timeFrame: baseline and 4 weeks
measure: Muscle strength
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Tanaka Yasuhisa Cervical Spondylopathy Symptom Scale
timeFrame: baseline and 4 weeks
measure: neck disability index. The total score ranges from 0 (accessibility) to 50 (total paralysis), with higher scores indicating more severe dysfunction.
timeFrame: baseline and 4 weeks
measure: the medical outcomes study 36-item short-form health survey
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Qinzhou
country: China
facility: Lingshan County second People's Hospital
state: Guangxi
Study officials:
References:
Clinical trial NCT00282945: Beta Cell Function Tests Over Time In Patients With T2dm Randomized To Metformin Or Rosiglitazone
Official title: Analyzing Beta Cell Function Tests Over Time In Patients With Type 2 Diabetes Mellitus Randomized To Metformin Or Rosiglitazone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-27
Enrollment: 29
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether markers of b-cell function can predict changes in B-cell function over time in patients with type 2 diabetes mellitus (T2DM) randomized to treatment with metformin or rosiglitazone.

Detailed description: The study terminated on 17-Jul-07 due to concerns about long-term cardiovascular safety of Avandia and slow patient enrollment. There were no specific safety issues raised within the trial.

Eligibility criteria: Inclusion Criteria:

* Male or female with type diabetes mellitus (diagnosed via ADA criteria), newly diagnosed or treatment-naive (other than diet and exercise) and HbA1c range of 7 to 9%.
* 45-70 years of age.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies).

Primary outcomes:
measure: This study will examine whether biomarkers of B-cell function measured early in the study (1, 3, and/or 6 months) will predict long-term changes in B-cell function (as represented by HOMA-B).
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02912845: Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Official title: Post-marketing Study of KamRAB Administered as a Single Dose With Active Rabies Vaccine in Children Exposed to Rabies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies
Lead sponsor: Kamada, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kedrion S.p.A.
First posted: 2016-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to confirm the safety of KamRAB (Human Rabies Immunoglobulin) in children ages 0 months to \<17 years, when administered as part of post-Rabies Exposure Prophylaxis (PEP).


Eligibility criteria: Inclusion Criteria:

* Healthy children (male and female) ages 0 months to \<17 years.
* Have been exposed or possibly exposed to rabies.
* Are indicated to receive post-exposure prophylaxis (PEP) against rabies infection.
* Have documented informed consent from the child's parent(s) or legal guardian(s) and assent from the child if appropriate.

Exclusion Criteria:

* History of previous administration of rabies vaccine or human rabies immune globulin (HRIG)
* Rabies exposure or possible rabies exposure more than seven days prior to initiation of PEP, or timing of exposure unknown

Primary outcomes:
measure: Frequency and severity of local and systemic adverse events occurring within 14 days of KamRAB treatment
timeFrame: Within 14 days from treatment
measure: Frequency and severity of local and systemic SAEs occurring within 84 days of KamRAB treatment
timeFrame: Within 84 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: ACH
state: Arkansas
Study officials:
References:
Clinical trial NCT05745298: The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
Official title: The Use of Functional Electrical Stimulation in Conjunction With Respiratory Muscle Training to Improve Unaided Cough in Individuals With Acute Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute spinal cord injuries.


Eligibility criteria: Inclusion Criteria:

1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date \< 12 months prior to enrollment
2. Positive response to electrical stimulation through a palpable contraction
3. Fluent in written and spoken English

Exclusion Criteria:

1. Individuals who do not meet inclusion criteria
2. Prisoners
3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning \< VI
4. Individuals with open tracheostomy
5. Persons with pacemakers
6. Pregnant women
7. Persons with epilepsy
8. Open wounds or metal implants at site of electrode placement
9. Unresponsive to functional electrical stimulation
10. Current diagnosis or history of thoraco-abdomino-pelvic cancer

Primary outcomes:
measure: Percentage change in peak cough flow (PCF)
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
measure: Percentage change in peak expiratory flow
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
Secondary outcomes:
measure: Percentage change in forced expiratory volume in 1 second (FEV1)
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
measure: Percentage change in forced vital capacity (FVC)
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
measure: Percentage change in maximum inspiratory pressure (MIP)
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
measure: Percentage change in maximum expiratory pressure (MEP)
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
measure: Change in cough effectiveness as measured by Likert Scale
timeFrame: one week pre-intervention and up to 4 weeks post-intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Stephane Philippe-Ratway, MS, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218645: Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males
Official title: The Bioequivalence Between WE 941 OD Tablets (0.25mg as the Basis) and Brotizolam Conventional Tablets (Lendormin® Tablets, 0.25 mg as the Basis), Both Taken With Water, as a Single Administration in Healthy Adult Male Subjects (Open-labelled, 2-way Cross-over Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 35 years
* Weight between 50 and 80 kg
* Obesity level within the range of +/- 20% of the standard weight according to the Body Mass Index (BMI) method
* Judged as eligible as a study object following the screening test by the investigator
* Volunteers to participate in the study, who are capable of giving written informed consent

Exclusion Criteria:

* Known hypersensitivity to drugs
* History of drug or alcohol abuse
* Received other investigational drug within 4 months of the trial drug administration
* Had \> 400 mL of whole blood drawn within 3 months of the trial drug administration
* Had \> 400 mL of blood components drawn within 1 month of the trial drug administration
* Used any drug within 10 days of the trial drug administration
* Engaged in strenuous exercise within 5 days of the trial drug administration
* Consumed alcohol within 3 days of the trial drug administration
* Judged as ineligible for the study participation by the investigator for a reason other than above

Primary outcomes:
measure: AUC0-24h (Area under the plasma concentration-time from 0 to 24 hours)
timeFrame: up to 24 hours after drug administration
measure: Cmax (maximum plasma concentration)
timeFrame: up to 24 hours after drug administration
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 30 days
measure: tmax (time to maximum plasma concentration)
timeFrame: up to 24 hours after drug administration
measure: MRT (Mean residence time)
timeFrame: up to 24 hours after drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06550245: Babies' Brain Responses to Strangers
Official title: The Malleability of Social Group Understanding in Infancy and Early Childhood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infant Development
Lead sponsor: University of California Santa Cruz
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample from the larger Santa Cruz area

Brief summary: Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds.

Detailed description: The goal of this observational study is to learn how infants' brain activities, as captured by EEG, differ for familiar or unfamiliar racial group in typically developing infants. The main questions of the study are:

* Will infants show greater event-related desynchronization (i.e., more motor system activation), frontal theta synchronization (i.e., more attention), and more positive frontal alpha asymmetry (i.e., more approach motivation) to familiar than unfamiliar racial group?
* How does infants' exposure to racial diversity in their social network and neighborhoods relate to these EEG activities? Participants will visit a laboratory at the UC Santa Cruz campus for this study. Infants will put an EEG cap on and watch about 15 minutes of videos, in which people from different racial backgrounds do different actions (e.g., grabbing an object, saying hi and approaching closer, and playing peek-a-boo). Caregivers will be asked to fill out a demographic form and a social network survey.

Eligibility criteria: Inclusion Criteria:

* typically developing
* age 7 to 12 months
* at least 37 weeks gestation

Exclusion Criteria:

* any known developmental delays
* less than 37 weeks gestation

Primary outcomes:
measure: Mu event related desynchronization
timeFrame: Through study completion, an average of 10 years.
measure: Frontal theta synchronization
timeFrame: Through study completion, an average of 10 years.
measure: Frontal alpha asymmetry
timeFrame: Through study completion, an average of 10 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz
country: United States
facility: Social Science 2 Building
state: California
Study officials:
affiliation: University of California Santa Cruz
name: Hyesung Hwang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang HG, Debnath R, Meyer M, Salo VC, Fox NA, Woodward A. Neighborhood racial demographics predict infants' neural responses to people of different races. Dev Sci. 2021 Jul;24(4):e13070. doi: 10.1111/desc.13070. Epub 2020 Dec 16.
Clinical trial NCT03950245: Incretin Hormone Antagonism After Bariatric Surgery
Official title: Importance of Endogenous Glucagon-like Peptide-1 and Glucose-dependent Insulinotropic Polypeptide for Postprandial Glucose Metabolism After Roux-en-Y Gastric Bypass and Sleeve Gastrectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Keywords: glucagon-like peptide-1
glucose-dependent insulinotropic polypeptide
Roux-en-Y gastric bypass
sleeve gastrectomy
gastric bypass
bariatric surgery
glucose
diabetes
exendin(9-39)
GIP(3-30)
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.


Eligibility criteria: Inclusion Criteria, surgery groups:

* Age \> 18 years
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion

Inclusion Criteria, control group:

* Age \> 18 years
* no former RYGB- or SG operation
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1 mmol/l and no history of diabetes

Exclusion Criteria:

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations

Matching between groups

* Age
* Sex
* BMI at inclusion and for surgery groups also pre-surgery BMI

Primary outcomes:
measure: iAUC glucose
timeFrame: 240 minutes
Secondary outcomes:
measure: Beta-cell glucose sensitivity (β-GS)
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Dept. of Endocrinology, Hvidovre Hospital, Denmark
name: Kirstine N Bojsen-Møller, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Endocrinology, Hvidovre Hospital, Denmark
name: Morten G Hindsø, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206045: Evolution of the SURvival of Patients With SEzary Syndrome (SS) Over the 1998-2020 Period and Its Association With the Early Use of Therapeutic Monoclonal Antibodies
Official title: Evolution of the SURvival of Patients With SEzary Syndrome (SS) Over the 1998-2020 Period and Its Association With the Early Use of Therapeutic Monoclonal Antibodies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sezary Syndrome
Cutaneous T Lymphoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with Sézary syndrome diagnosed between 1998 and 2020

Brief summary: Sezary syndrome (SS) is a rare, aggressive and advanced form of cutaneous T lymphoma with a poor prognosis (5-year survival rate varying between 24% and 52%). The treatments are only suspensive with short-term remissions. For the past fifteen years, therapeutic approaches have been based on depleting monoclonal antibodies (anti-CD52, anti-CCR4, anti-KIR3DL2, anti-CD70), or antibody-drug conjugates (anti-CD30). But while the efficacy of mogamulizumab on progression-free survival was reported in the phase III study, no study on a large cohort has compared the current overall survival of patients with Sezary syndrome to that before the era of monoclonal antibodies. In this context, we propose to report a large series of patients with Sézary syndrome in order to compare the current survival of patients with that of the pre-monoclonal antibodies era (1998-2003).

The objective of this study is to assess the evolution of the overall survival of patients with Sezary syndrome since the early use of therapeutic monoclonal antibodies. The underlying hypothesis of this study is that the use of therapeutic monoclonal antibodies has improved the prognosis of these patients. Patients included in this retrospective study are patients with a Sezary syndrome diagnosed between 1998 and 2020.


Eligibility criteria: Inclusion Criteria:

1. Adult patients over 18 years of age
2. Patient with Sezary Syndrome diagnosed between 1998 and 2020

Exclusion Criteria:

1. Patient opposition to research
2. Patient under guardianship or curatorship, unable to express opposition

Primary outcomes:
measure: Overall Survival
timeFrame: at 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: at 10 years
measure: Overall survival
timeFrame: at 15 years
measure: Sezary syndrome specific survival
timeFrame: at 5 years
measure: Sezary syndrome specific survival
timeFrame: at 10 years
measure: Sezary syndrome specific survival
timeFrame: at 15 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis, Service de Dermatologie
Study officials:
References: