louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06713018: Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fracture of Neck of Femur
Keywords: orthopedic intelligent navigation system
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 300
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 goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.

Participants will:

* Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
* Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Patients diagnosed with femoral neck fracture;
3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion Criteria:

1. Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
2. The patient is known to have a history of allergy to one or more implanted materials;
3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
4. Active infection of the hip joint or other parts of the body is determined by the investigator;
5. Diagnosed as metabolic bone disease, radiation bone disease, etc.;
6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
9. Other conditions deemed unsuitable for inclusion by the investigator.

Primary outcomes:
measure: Perspective frequency
timeFrame: 1 day
Secondary outcomes:
measure: Neck shaft angle
timeFrame: 1 year
measure: Guide needle implantation effect
timeFrame: 1 day
measure: Fluoroscopy times of needle implantation
timeFrame: 1 day
measure: Operation time
timeFrame: 1 day
measure: Operative blood loss
timeFrame: 1 day
measure: Fracture union
timeFrame: 1 year
measure: Zarit Burden Interview score
timeFrame: 1 year
measure: Harris score
timeFrame: 1 year
measure: SF-36 score
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT02612818: Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
Official title: Prevention of Adhesions During Celioscopy for Endometriosis. Impact of the Use of Anti-adhesion Treatment on Clinical Signs and Fertility at One Year
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis, Adhesive
Keywords: coelioscopy
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 364
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subsequent patients of procreation age having undergone a cœlioscopy for endometriosis, for whom a spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately, and meeting all of the selection criteria will be included in the study.

Brief summary: Thus is a longitudinal, prospective, multicentric observational study performed in mainland France, among a sample of gynaecology surgeons practising at endometriosis "expert" centres.

The aim of this study is to describe, under real treatment conditions in patients suffering from endometriosis, the impact of the use of anti-adhesion treatment during celioscopy surgery on the development of clinical signs in the patients and their fertility at one year.


Eligibility criteria: Inclusion Criteria:

* Adult patients of procreation age and who have undergone treatment for endometriosis through celioscopic surgery.
* Patients for whom spontaneous pregnancy is possible, whether or not they wish to become pregnant immediately.
* Patients accepting and able to update a questionnaire in French.
* Informed patients who agree to computerised processing of their medical data and their right of access and rectification.

Exclusion Criteria:

* Patients for whom a medical assistance programme for procreation (IVF, artificial insemination) is currently in progress.
* Patients presenting with an absolute or relative contra-indication for use of an anti-adhesion agent (severe allergic antecedents etc).
* Patients not wishing to become pregnant.
* Patients participating or having participated during the previous month in a gynaecological clinical trial.

Primary outcomes:
measure: Change on the clinical signs
timeFrame: At 2 months and one year after the baseline visit (i.e. celioscopy)
measure: Fertility
timeFrame: One year after the baseline visit (i.e. celioscopy)
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: Nordic Pharma
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02550418: Budesonide 9 mg Capsules in Active UC
Official title: Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis


Eligibility criteria: Inclusion Criteria:

* Signed informed consent,
* Men or women aged 18 to 75 years,
* Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
* Established disease,

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
* Toxic megacolon or fulminant colitis,
* Colon resection,
* Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
* Malabsorption syndromes,
* Celiac disease,
* Bleeding hemorrhoids,
* Active peptic ulcer disease
* Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
* Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
* Any severe infectious disease (e.g., tuberculosis, AIDS),
* Severe co-morbidity substantially reducing life expectancy,
* History of colorectal cancer,
* History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma

Primary outcomes:
measure: Rate of clinical remission at final/withdrawal visit
timeFrame: 8 weeks treatment
Secondary outcomes:
measure: Rate of endoscopic remission/improvement at final/withdrawal visit
timeFrame: 8 weeks treatment
measure: Number of stools / bloody stools per week
timeFrame: 8 weeks treatment
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Klaus Fellermann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7.
Clinical trial NCT06822218: High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
Official title: High Tone Power Therapy Versus Transcutanuoselectrical Nerve Stimulation on Polyneuropathic Pain in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabete Mellitus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the results of this study may provide an easy non pharmacological modality for dealing with diabetic polyneuropathic pain. Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of diabetic polyneuropathy. In Addition, increased knowledge of the influence of High tone power therapy on neuropathic pain

Detailed description: This study will be carried out on sixty diabetic male patients with polyneuropathy with ages 50-60 years . Patient will be randomly assigned to two grouos. group A will include 30 type 2 diabetic patients with diabetic polyneuropathy. Theses patients will receive High tone power therapy with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced for 3 times per week, for 3 months for 30 minutes every session.

Group B :

This group will include 30 type 2 diabetic patients with diabetic neuropathy. These patients will receive TENS with applied frequencies range from 2 to 120 Hz. for 3 times per week for 30 minutes every session during 3 months of intervention.

Eligibility criteria: Inclusion Criteria:

* The patient selection will be according to the following criteria:

  1. Sixty male patients are diagnosed with diabetic polyneuropathy their ages will be ranged from 50-60 years old.
  2. All patients are ambulant independently.
  3. All patients are under full medical control
  4. HbA1c is ranged from 6.5 : 7 %.
  5. Patients has diabetes more than 10 years.

Exclusion Criteria:

* The participants will be excluded if they meet one of the following criteria:

  1. Psychiatric disorders or seizures.
  2. Visual and auditory impairment or tremors influencing balance.
  3. Other neuromuscular disorders.
  4. Foot deformities and ulcers.
  5. Lower limb operations.
  6. Feverish systemic infection
  7. cardiac pacemaker.

Primary outcomes:
measure: Neuropathic pain by DN4 (Douleur Neuropathique en 4 Questions) Questions)
timeFrame: up to 12 weeks
measure: Pain pressure threshold algometer
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Glyclated Haemoglobin Level (HbA1c)
timeFrame: up to 12 weeks
measure: life disability
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Om Elmasryeen Genral Hospital
Study officials:
References:
Clinical trial NCT06680141: The Effect of Virtual Reality Glasses Used Before Cesarean Section
Official title: The Effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of Virtual Reality Glasses Used Before Cesarean Section on Surgical Fear and Anxiety

Detailed description: Hypotheses 01; there was no difference between the Surgical Fear and Anxiety score of the Virtual Reality Glasses group and the control group.

The study will be carried out in two different groups. The practice will start with meeting the women whom will go to cesarean section in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Glasses Group; the intervention will be given glasses before the surgery and will be shown a video (30 minutes) of the 9-month fetal development process. Among the women who were admitted for a planned caesarean section, those who met the criteria would first be given the Informed Consent Form and a data collection form including sociodemographic characteristics, surgical fear scale, Spielberg State-Trait Anxiety Scale, and then randomization would be applied.

control group; the first surgical fear scale, anxiety scores will be recorded. After cesarean section anxiety scores will be recorded.

Eligibility criteria: Inclusion Criteria:

* Will undergo a cesarean section for the first time,
* Are over the age of 18,
* Have no diagnosed mental illness,
* Have no diagnosed physical illness in themselves or their baby,
* Volunteer to participate in the study

Exclusion Criteria:

* Have previously undergone a cesarean section,
* Are under the age of 18,
* Have a diagnosed mental illness,
* Have a diagnosed physical illness in themselves or their baby, Do not volunteer to participate in the study. -

Primary outcomes:
measure: Spielberger State Anxiety Scale
timeFrame: 30 minutes
measure: Surgical Fear Scale (SFS):
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Emine KOÇ, Asst.Prof
role: STUDY_CHAIR
affiliation: Ondokuz Mayıs University
name: Nazlı Baltacı, Asst.Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03322241: Increase Surveillance for Wellness Decisions, Also to Determine Targeted Risk-reducing and Preventative Strategies
Official title: Medical Provider Experience and Assessment On Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing Wellness Lab Tests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overall Wellness
Lead sponsor: Data Collection Analysis Business Management
Sponsor class: OTHER
Collaborators: name: PAS Research Services
First posted: 2017-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current standard operating procedures for providers

Brief summary: Healthcare Decisions Post-Testing On Risk Reducing, and Preventative Strategies Utilizing Wellness Lab Tests

Detailed description: The general design of this study is collecting data and reviewing the Principal Investigators' Standard Operating Procedures on wellness testing and changes made to their specific SOP.

Eligibility criteria: Inclusion Criteria:

* Must be a Medical Practitioner

  * Medical Doctor (MD)
  * Doctor of Osteopathic (DO)
  * Physician Assistant (PA)
  * Advanced Practice Registered Nurse (APRN)
  * Nurse Practitioner (NP)
* Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion Criteria:

* Government-funded insurance data cannot be included in the study.

Primary outcomes:
measure: Provider Structures and Processes
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Land O' Lakes
country: United States
facility: DCABM
state: Florida
Study officials:
References:
Clinical trial NCT06076941: Effect Of Oral And Dental Health Education In Pregnant Women
Official title: Effects of Education on Oral and Dental Health Behaviors and Knowledge Levels of Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Prengnancy
oral and dental health
Education
knowledge and behavior
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels. With the power analysis, α = 0.05, β = 0.20, 1-β = 0.80, a total of 60 pregnant women, 30 in the experimental group and 30 in the control group were included (the power of the test was found as p = 0.8056).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study was conducted as a randomized controlled experimental study to determine the effect of the education given to pregnant women on their oral and dental health behaviors and knowledge levels.

Detailed description: In line with these results, it is recommended that midwives should determine the behaviors and knowledge levels of pregnant women regarding oral and dental health within the scope of primary health care services, provide trainings to increase their knowledge and awareness on the subject, refer them to treatment in the presence of problems, and expand these services within the health system.

Eligibility criteria: Inclusion Criteria:

* Being in the first trimester of pregnancy
* Being 19-44 years old,
* Being able to read and write turkish,
* Being a healthy pregnant woman who agrees to participate in the study

Exclusion Criteria:

* Having a risky pregnancy,
* Can't speak or understand Turkish
* Women with intellectual disability
* Serious mental disorders will be excluded from the study.

Primary outcomes:
measure: Form for Assessment of Knowledge Levels of Pregnant Women Regarding Oral and Dental Health
timeFrame: up to 24 weeks
measure: Form for Assessment of Oral and Dental Health Behaviors of Pregnant Women
timeFrame: up to 24 weeks
measure: Pregnant Women's Education Satisfaction Evaluation Form
timeFrame: up to 24 weeks
measure: Descriptive Information Form
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarsus
country: Turkey
facility: Tarsus University
state: Takbaş
Study officials:
affiliation: Cumhuriyet University
name: Özlem DURAN AKSOY
role: STUDY_DIRECTOR
References:
Clinical trial NCT02988141: EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
Official title: A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonsmall Cell Lung Cancer
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2016-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EGFR mutation positive patients with paired tissue and blood samples

Brief summary: A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC

Detailed description: Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Male or female patients aged 18 years and older.
* Histological confirmation of stage IIIB/IV NSCLC.
* Documented EGFR mutation positive .
* WHO Performance Status 0, 1 or 2

Exclusion Criteria:

* Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
* Previous (within 6 months) or current treatment with AZD9291.

Primary outcomes:
measure: The biomarker profile of EGFR-TKI resistance
timeFrame: Baseline
Secondary outcomes:
measure: The concordance, sensitivity and specificity in paired blood and tissue samples
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: China
name: Jian Xing HE, MD
role: PRINCIPAL_INVESTIGATOR
References: