louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04416022: Cervical Gland Area as a Predictor of Success of Labour Induction
Official title: Cervical Gland Area as a Predictor of Success of Labour Induction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Induced Vaginal Delivery
Keywords: Labour induction
Cervical glandular area
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are planned form labour induction

Brief summary: Women who fulfil the inclusion criteria and who are planned for labour induction will be recruited. Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process, and patient information and maternal and neonatal outcome will be documented following the delivery.

Detailed description: Patient consent to participate in the study will be retrieved following the medical decision of labor induction and the mode of induction and following the patient consent to the induction.

Bishop score, cervical length, and the presence of cervical glandular area (CGA) will be documented for every patient up to 12 hours prior to the induction process.

The method of induction, data regarding patient demographics, the progress of labor, and the maternal and neonatal outcome will be documented following the delivery.

Eligibility criteria: Inclusion Criteria:

* Singleton and twins' pregnancies
* Pregnancy 34-41 weeks of gestation
* Vertex presentation
* Induction methods (Oxytocin, prostaglandin 1 (PGE1), prostaglandin 2 (PGE2), double balloon catheter, rupture of memebrane (ROM)

Exclusion Criteria:

* Intrauterine fetal demise (IUFD)
* Contraindication to vaginal delivery
* Status post cervical cerclage
* Previous attempt of labor induction
* History of cervical surgery
* Active vaginal bleeding

Primary outcomes:
measure: Onset of active labour
timeFrame: Up to delivery
Secondary outcomes:
measure: Time from Induction to second stage
timeFrame: Up to delivery
measure: Time from Induction to delivery
timeFrame: Up to delivery
measure: Rate of vaginal delivery
timeFrame: Up to delivery
measure: Neonatal outcome - PH
timeFrame: Up to 10 minutes from delivery
measure: Neonatal outcome - APGAR (Apearance, Pulse, Grimace, Activity, Respiration score)
timeFrame: Up to 5 minutes from delivery
measure: Neonatal outcome - NICU (Neonatal Intensive Care Unit) admission
timeFrame: Up to 48 hours from delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04868422: Telemonitoring of CPAP Therapy in Sleep Apnea Patients
Official title: Wireless Telemonitoring of Nasal CPAP Therapy in Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
CPAP treatment
telemedicine
nursing time
patient satisfaction
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
First posted: 2021-05-03
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Ethics Committee approval was not required, since this study was part of our quality assurance procedure to revise the treatment protocol.
Primary purpose: TREATMENT

Brief summary: Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

Detailed description: Both patients and study nurses were unblinded for the wireless telemonitoring system (ResTraxx™Online, ResMed, Sydney, Australia). The module was attached to the S9 Elite™ (ResMed, Sydney, Australia) CPAP device, which transmitted compliance data every day automatically to the ResTraxx™ Online (ResMed, Sydney, Australia) data base. The treatment was considered successful when CPAP use was \>4 h/day, mask leak \<0.4 L/s, and AHI \<5/h during the last 6 days. Study nurses made the data check-ups daily during weekdays and if the criteria for successful CPAP therapy was not achieved during two consecutive nights the nurses adjusted the CPAP pressure remotely and called the patient to give further advice. Patients had also a control viist aftr one year.

Eligibility criteria: Inclusion Criteria:

* Adult patients with diagnosed obstructive sleep apnea

Exclusion Criteria:

* Not able to understand Finnish language
* Unable to co-operate

Primary outcomes:
measure: Nursing time
timeFrame: One year after the baseline
Secondary outcomes:
measure: Hours of CPAP use
timeFrame: One year after baseline
Other outcomes:
measure: Residual apnea-hypopnea index (AHI)
timeFrame: One year after baseline
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT03413722: Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus
Official title: Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors to Everolimus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: Kidney transplant
Cognitive function
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2018-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be patients undergoing kidney transplant at the University of Kansas Medical Center.

Brief summary: The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.


Eligibility criteria: Inclusion Criteria:

* English speaking
* able to sign informed consent
* able to arrange transportation to and from study site
* without acute stroke, concussion or traumatic brain injury
* without acute medical issues at the time of participation
* At least 12 weeks post Kidney transplant surgery

Exclusion Criteria:

* are claustrophobic or have other contra-indication for magnetic resonance imaging (MRI)
* have hearing or visual impairment
* are unable to read, write, speak or understand English
* have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
* taking Envarsus at the time of recruitment

Primary outcomes:
measure: Change in cognitive function
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
measure: Change in cerebral blood flow
timeFrame: Change from Baseline to Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Aditi Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04923022: Therapeutic Exercise and Vegan Diet on Pain and Quality of Life
Official title: The Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women With Chronic Idiopathic Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Idiopathic Neck Pain
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 45 sedentary volunteer female individuals whose age range is between 18-25 years and diagnosed with chronic idiopathic neck pain by a specialist physical therapy doctor will participate in the study. Participants will be randomly divided into three groups: vegan diet group (n=15), therapeutic exercise group (n=15) and control group (n=15). Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®). Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.The aim of this study is to compare the Effect of Therapeutic Exercise and Vegan Diet on Pain and Quality of Life in Young Women with Chronic Idiopathic Neck Pain.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-25,
* neck pain for at least 3 months,
* VAS score greater than 5

Exclusion Criteria:

* using regular analgesic,
* having had neck surgery,
* the presence of neurological or specific problems in the neck (vertebral fracture, inflammation, infection, etc.),
* cortisone use,
* pregnancy,
* serious chronic diseases,
* those with serious psychiatric disorders
* Individuals who received physical therapy within 3 months
* Antidepressant use

Primary outcomes:
measure: Body Mass Index
timeFrame: 1 minute
measure: Visual Analog Scale (VAS)
timeFrame: 2 minutes
measure: Neck Disability Index (NDI)
timeFrame: 10 minutes
measure: Short Form 36
timeFrame: 15 minutes
measure: Tampa Scale of Kinesiophobia (TSK-17)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT06215222: Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Official title: Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBS - Irritable Bowel Syndrome
Healthy
Functional Bloating
Functional Gastrointestinal Disorders
Keywords: microbiome
Small intestine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Subjects or those with clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)

Brief summary: We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.


Eligibility criteria: Inclusion Criteria:

* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
* American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
* Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)

Exclusion Criteria:

* History of any of the following:

  * Prior gastric or esophageal surgery, including lap banding or bariatric surgery
  * Bowel obstruction
  * Gastric outlet obstruction
  * Diverticulitis
  * Inflammatory bowel disease
  * Ileostomy or colostomy
  * Gastric or esophageal cancer
  * Achalasia
  * Esophageal diverticulum
* Active Dysphagia or Odynophagia
* Active medication use for any gastrointestinal conditions
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study

Primary outcomes:
measure: Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
timeFrame: 1-4 years
Secondary outcomes:
measure: Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules
timeFrame: 1-4 years
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Digestive Health Clinic
state: California
Study officials:
References:
Clinical trial NCT01617122: Evaluate Bacteriophage as a Useful Immunogen in Patients With Primary Immune Deficiency Diseases (PIDD)
Official title: To Evaluate Bacteriophage OX174 Antigen as a Useful Immunogen in Patients With Immune Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Immune Deficiency Diseases
Keywords: PID
PIDD
antibody deficiency
CVID
recurrent infections
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This protocol is designed to ascertain whether the bacteriophage 0X174 neoantigen is safe and effective as an antigen used in the evaluation of primary and secondary immune responses. Bacteriophage 0X174 is given intravenously 2 billion PFU/Kg of body weight; small blood specimens of 3-5 ml (about 1 teaspoon) are collected after 15 minutes, 7 days, 14 days, and 28 days. Blood is collected at intervals following the administration of the bacteriophage and the number of phage/ml is determined by the agar overlay method using suspension of E. coli C and serially diluted patient's serum. Phage-specific IgG and IgM are measured by neutralization assay. Capacity of switch from IgM to IgG is determined.


Eligibility criteria: Inclusion Criteria:

1. subject/parent or guardian willing to sign consent and adhere to study schedule
2. known or suspected primary immune deficiency

Exclusion Criteria:

1. pregnancy
2. breastfeeding
3. unwilling to sign consent or adhere to study schedule
4. \< 2 yrs of age or \> 85 yrs of age
5. previous reaction to vaccine

Primary outcomes:
measure: Evidence of capacity of switch from IgM to IgG.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: John W Sleasman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587022: Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors
Official title: Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Tumor
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant tumor spinal metastasis who received or will receive stereotactic radiotherapy, without preoperation.

Brief summary: The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.

Detailed description: The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1：The target bolume only includes local tumor. Group 2：The target bolume includes local tumor and adjacent vertebral area.

Eligibility criteria: Inclusion Criteria:

* Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
* Patients with sufficent pre-treatment imaging data
* Patients who can cooperate with imaging review and follow-up after radiotherapy.

Exclusion Criteria:

* Patients with an expected survival of less than 3 months;
* Patients with second-course radiotherapy;
* Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
* Patients with extensive spinal metastasis and no local therapeutic value

Primary outcomes:
measure: Disease Control Rate（DCR）
timeFrame: 2 years
measure: Pain relief rate
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of side effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hongqing Zhuang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05124522: A Health Action Process Approach Online Intervention for People With Multiple Sclerosis
Official title: Developing A Person-centered Internet-based Health Action Process Approach to Promoting Physical Activity in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Physical Activity
Internet-Based Intervention
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 60
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 implement the person-centered internet-based Health Action Process Approach to promoting physical activity in people with Multiple Sclerosis (i.e., eHAPA-MS online intervention) and assess the intervention's effectiveness and adherence.


Eligibility criteria: Inclusion Criteria:

* are 18 years old and above;
* any type of multiple sclerosis
* have not maintained 30 minutes of MVPA accumulated per day for 2 days of the week during the previous 6 months;
* be relapse-free for the past 30 days;
* show low risk for contraindications of physical activity indicated by no more than a single 'yes' response on the Physical Activity Readiness Questionnaire;
* be able to walk with or without an assistive device;
* are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period;
* have a reliable Internet access.

Exclusion Criteria:

* have a score \>14 for the leisure score index of the Godin Leisure-Time Exercise Questionnaire;
* No computer or mobile device access with the internet.
* Patient determined disease steps (PDDS) Score = 7 i.e., using a wheelchair or scooter most of the time, or PDDS Score = 8 being bedridden.
* Anyone living outside of the United States of America.
* Anyone who is unable to speak, read and write in English.
* not willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period.

Primary outcomes:
measure: The Health Action Process Approach Battery
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Chungyi Chiu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05526222: A Phase III Study of Jaktinib in Adults With Moderate and Severe Atopic Dermatitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Adult Patients With Moderate and Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 438
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: A multicenter, randomized, double-blind, placebo-controlled phase III clinical study of jaktinib hydrochloride tablets in the treatment of adult patients with moderate and severe atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* Have fully understood the test and voluntarily signed the informed consent;
* When signing the informed consent form, the age of male or female subjects must be ≥ 18 years old;
* The onset time of atopic dermatitis was at least 1 year at the time of screening, and the subjects met the Hanifin and Rajka criteria for atopic dermatitis at the time of screening;
* For women with reproductive ability and all male subjects, during the trial period and within 6 months after the discontinuation of the trial drug, they must maintain abstinence or contraception, including but not limited to physical and drug contraception.
* The subjects were able to communicate well and agreed to follow the study and follow-up procedures.

Exclusion Criteria:

* The investigator considers that any subjects are not suitable to participate in the trial.

Primary outcomes:
measure: The efficacy in the treatment of moderate and severe atopic dermatitis
timeFrame: 16 weeks
measure: The efficacy in the treatment of moderate and severe atopic dermatitis
timeFrame: 16 weeks
Secondary outcomes:
measure: The abnormal laboratory values and/or adverse events in the treatment of moderate and severe atopic dermatitis
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: 139 People's Middle Road
state: Hunan
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_DIRECTOR
References: