louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05012241: The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
Official title: The Reliability of the Nine Hole Peg Test in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Motor Activity
Keywords: occupational therapy
fine motor skills
Nine Hole Peg Test
inter-rater reliability
variability
multiple sclerosis
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech patients with multiple sclerosis

Brief summary: The main aim of the project is to establish inter-rater reliability, internal variability and variability of results got in two different ways of the Nine Hole Peg Test administered according to the new Czech extended version manual in patients with multiple sclerosis.

Detailed description: At least 30 patients with multiple sclerosis will be tested by Nine Hole Peg Test according to new Czech manual for this test. The testing will take place in one session. Video of patients' performance will be obtained.

The inter-rater reliability, internal variability and variability of results got in two different ways will be established.

Eligibility criteria: Inclusion Criteria:

* outpatients with clinically definite multiple sclerosis
* Czech language as a mother tongue
* age from 20 to 65 years
* clinically stable disease (more than 30 days since the last attack of the disease)
* Expanded Disability Status Scale (EDSS) score between 1.5-8.0

Exclusion Criteria:

* inability to complete the test attempt of the Nine Hole Peg Test
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to complete complete testing
* failure to sign Informed consent for the patient and Consent to the collection and processing of personal data during the study at the General University Hospital in Prague

Primary outcomes:
measure: results from the Nine Hole Peg Test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Center for Demyelinating Disease (MS center), Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital in Prague
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
Clinical trial NCT04778241: Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding
Official title: Effects of Mini Implant Facilitated Micro-osteoperforations on the Alignment of Mandibular Anterior Crowding: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Position Anomalies
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 32
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the present study is to evaluate the the efficacy of micro-osteoperforation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth

Detailed description: Primarily the present study is designed to evaluate the efficacy of micro-osteoperation (MOPs) perfomed by mini-implant (MI) screw In improving alignment of mandibular anterior teeth. Additionally, the possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.

Subjects and Methods: Orthodontic patients aged 17-25 years old, non-extraction treatment with lower anterior crowding of 4-6 mm using Little's irregularity index. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment will be tested using t-test, while root resorption and pain perception will be tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P\<0.05).

Eligibility criteria: Inclusion Criteria:

1. Age range between 17-25years
2. Non-extraction treatment in the mandibular arch
3. Presence of full complement of dentition from first molar to first molar
4. Mandibular anterior irregularity index between 4-6 mm
5. Patient with healthy periodontium and no attachment loss of \>2 mm

Exclusion Criteria:

1. Previous orthodontic treatment
2. Presence of primary or missing permanent teeth in the mandibular anterior area
3. Medical problems that affect tooth movement.

Primary outcomes:
measure: Alignment efficiency
timeFrame: 4 weeks
measure: Alignment efficiency
timeFrame: 8 weeks
measure: Alignment efficiency
timeFrame: 12 weeks
Secondary outcomes:
measure: The amount of Root resorption
timeFrame: 12 weeks
measure: Pain perception
timeFrame: first 7 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentisry-University of Baghdad
Study officials:
affiliation: University of Baghdad
name: Mushriq Abid, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Attar A, Nissan L, Almuzian M, Abid M. Effect of mini-implant facilitated micro-osteoperforations on the alignment of mandibular anterior crowding: A randomised controlled clinical trial. J Orthod. 2022 Dec;49(4):379-387. doi: 10.1177/14653125221099038. Epub 2022 May 15.
Clinical trial NCT04138641: Dutch Cangrelor Registry
Official title: Dutch Cangrelor Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI - ST Elevation Myocardial Infarction
NSTEMI - Non-ST Segment Elevation MI
Coronary Artery Disease
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing (primary) PCI

Brief summary: Cangrelor is a fast and directly acting platelet aggregation inhibitor. It is potentially indicated for several types of patients who are undergoing PCI. A nationwide cangrelor registry has up until now not been performed and with the introduction of cangrelor in the Netherlands its efficacy and safety will be determined.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* One of the following criteria:
* Patients naïve for P2Y12 inhibition undergoing PCI
* Patients with suboptimal P2Y12 inhibition undergoing PCI (patients who vomited after P2Y12 loading, out of hospital cardiac arrest (OHCA) patients with restoration of spontaneous circulation (ROSC), patients loaded with P2Y12 inhibitors though platelet inhibition still insufficient (\<2 hours after oral loading dose)
* (N)STEMI patients loaded with P2Y12 inhibitors with large thrombus burden (thrombus grade 4 or 5) on initial coronary angiography (CAG) and undergoing primary PCI with expected insufficient P2Y12 inhibition

Exclusion Criteria:

* Patients on current/chronic treatment with P2Y12 inhibitors
* Patients (pre) treated with a GPI
* Patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
* hypersensitivity or allergy to and known contra-indication for aspirin, clopidogrel, ticagrelor or cangrelor
* history of major clinical bleeding or known coagulopathy
* active bleeding
* history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
* known severe liver dysfunction
* Patients that received any organ transplant or are on a waiting list for any organ transplant
* Patients undergoing dialysis
* Pregnant or lactating female
* Patients currently participating in another investigational drug or device study

Primary outcomes:
measure: NACE
timeFrame: 48 hours
Secondary outcomes:
measure: NACE 30 days
timeFrame: 30 days
measure: All individual endpoints in-hospital
timeFrame: In-hospital, mostly up to 72 hours.
measure: All individual endpoints at 30-days
timeFrame: 30 days
measure: TIMI 3 flow post PCI based on angiographic results
timeFrame: post-PCI, mostly up to 1 hour
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: R.S. Hermanides
state: Overijssel
Study officials:
References:
Clinical trial NCT00767741: Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Official title: Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
post prandial glucose level
insulin
pharmacokinetics
pharmacodynamics
Lead sponsor: Insuline Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement


Eligibility criteria: Inclusion Criteria:

1. Participant age between 18- 65 years old
2. Type I or Type II diabetes
3. HbA1c 6-12%
4. Does not suffer from sever hypertension, kidney, liver or heart disease
5. Does not suffer from active Ischemic heart disease
6. Is willing to sign the consent form

Exclusion Criteria:

1. Participants age \< 18 or \> 65
2. Pregnancy
3. Breast feeding women
4. Un-controlled diabetes, HbA1c values \> 12% range
5. Suffers from active Ischemic heart disease
6. Alcohol addiction
7. Is not prepared to signed the informed consent

Primary outcomes:
measure: Insulin blood level with and with out the intervention
timeFrame: at the end of every daily study
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical center
state: Other
Study officials:
References:
Clinical trial NCT05940441: A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
Official title: A Prospective Exploratory Clinical Study of Metronomic Capecitabine as Adjuvant Therapy in Locoregionally Advanced Hypopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: to Explore Whether the Adjuvant Therapy of Metronomic Capecitabine Could Improve the Disease-free Survival of Locoregionally Advanced Hypopharyngeal Carcinoma
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy )

Brief summary: To explore whether the adjuvant therapy of metronomic capecitabine could improve the disease-free survival of locoregionally advanced hypopharyngeal carcinoma (stage IV：T4N0-1M0，anyTN2-3M0).


Eligibility criteria: Inclusion Criteria:

* 1. Age between 18 and 65 years old. 2. Histologically confirmed hypopharyngeal carcinoma, staged as IV (T4N0-1M0，anyTN2-3M0) (as defined by the 8th AJCC edition), Complete the recommended standard treatment (curative chemoradiotherapy, or radical surgery + postoperative chemo/radiotherapy ).

  3. No clinical evidence of persistent locoregional disease or distant metastases after definitive chemoradiotherapy.

  4. Within 8 weeks after completion of the last radiation dose. 5. Performance status of ECOG grade 0 or 1. 6. Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9 /L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min).

  7. Patients must be appraised of the investigational nature of the study and provide written informed consent.

Exclusion Criteria:

* 1.Patients who were known to be intolerable or allergic to capecitabine. 2. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

  3. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control).

  4. With esophagus cancer. 5. Pregnancy or lactation. 6. Other conditions that are not eligible for enrollment.

Primary outcomes:
measure: disease-free survival
timeFrame: 2023.7-2025.7
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital, Fudan University
Study officials:
References:
Clinical trial NCT05394441: Health and Quality of Life of ITMO University's Students, Faculty and Staff
Official title: Selected Health and Quality of Life Indicators Among ITMO University Students, Faculty and Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: students
faculty
academia
university
Lead sponsor: ITMO University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 830
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students, faculty and staff from ITMO University

Brief summary: This study assess various indicators of physical and mental health, quality of life, well-being and satisfaction among students, faculty and staff of ITMO University. Participants are invited to join the study via informational web-site. Several quality of life indicators are obtained via surveys and some blood samples are taken to assess health condition.

Detailed description: Students, faculty and staff from ITMO University are invited to participate in health examination on the campus. Surveys, such as EQ-5D-5L, K10+OHQ29, PSQI and others, assess different aspects of quality of life related to health. Also participants are asked to undergo several measurements by the interviewer (waist, hips, height, weight and others). Moreover blood samples are taken from the participants and lipidogram, cholesterol and glycohemoglobin are checked.

Eligibility criteria: Inclusion Criteria:

* student, faculty or staff from ITMO University
* participants, who signed informed consent and consent for data gathering
* participants, who signed consent to enroll in following surveys and health check-ups

Exclusion Criteria:

* participants younger than 16 years old
* participants with acute conditions distorting quality of life assessment
* participants, who did not sign informed consent and consent for data gathering - participants, who did not sign consent to enroll in following surveys and health check-ups

Primary outcomes:
measure: Cholesterol
timeFrame: 30 days
measure: Lipidogram
timeFrame: 30 days
measure: Glycohemoglobin
timeFrame: 30 days
measure: Distress
timeFrame: 30 days
measure: Psychological well-being
timeFrame: 30 days
measure: Health status and quality of life
timeFrame: 30 days
measure: Nicotine dependence
timeFrame: 30 days
measure: Diabetes risk score
timeFrame: 30 days
measure: Sleep quality and disturbances.
timeFrame: 30 days
measure: Physical activity
timeFrame: 30 days
measure: Emotional eating, external eating, and restrained eating behavior
timeFrame: 30 days
measure: Alcohol use
timeFrame: 30 days
measure: Ischemic heart disease prediction
timeFrame: 30 days
measure: Retinopathy
timeFrame: 30 days
measure: Ocular fundus condition
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: ITMO University
Study officials:
References:
Clinical trial NCT06347419: Body Awareness and Spinal Stability in Scoliosis
Official title: Examining the Relationship Between Body Awareness and Spinal Stability in Individuals With Scoliosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Scoliosis Idiopathic
Keywords: Body Awareness
Spinal Stability
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with idiopathic scoliosis by a specialist physician at Gazi University Hospital, Deparment of Orthopedics and Traumatology will be included in the study.

Brief summary: Thirty volunteer patients diagnosed with scoliosis by a specialist physician at Gazi University Hospital Orthopedics and Traumatology Department and subsequently referred to Gazi University Physiotherapy and Rehabilitation Department for exercise training will be included in the study. The lumbar Pressure Measurement Test with Stabilizer and Rotation Stability Tests will be utilized to evaluate the spinal stability of the patients. Body awareness will be assessed using the Body Awareness Survey, comprising 18 questions. All assessments will be conducted at the Orthopedic Rehabilitation Clinic within the relevant department.

The results obtained from this study will elucidate the relationship between body awareness and spinal stability in individuals with scoliosis.

Detailed description: The data obtained from the study will be analyzed using the Statistical Package for the Social Sciences (SPSS) software (IBM Corp., Armonk, NY, USA). Results will be presented as Mean ± Standard Deviation (X ± SD), percentage (%), or median with interquartile range (IQR), depending on their distribution normality. Data conforming to a normal distribution will be compared using the Independent Samples Student's t-test, while those not conforming will be analyzed using the Mann-Whitney U test. The relationship between variables will be assessed using the Spearman Correlation Test. A significance level of p \< 0.05 will be utilized to determine statistical significance.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic scoliosis by an orthopedist
* The Cobb angle measured on the standard scoliosis radiograph should fall within the range of 10°-45°.

Exclusion Criteria:

* Presence of any orthopedic or neurological disease affecting trunk and extremity mobility, excluding scoliosis.
* History of previous spine or orthopedic surgery.

Primary outcomes:
measure: Spinal stability
timeFrame: Initial examination
measure: Rotary Stability
timeFrame: Initial examination
measure: Body Awareness
timeFrame: Initial examination
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
Study officials:
affiliation: Gazi University
name: Zeynep Hazar, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485819: Optimal Embryonic Stage for Transfer in Poor Responders
Official title: Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poor Response to Ovulation Induction
Infertility, Female
Keywords: Poor responders
Embryo transfer
Cancellation rate
Implantation rate
Live birth rate
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt

Brief summary: A Prospective cohort study including couples with poor responder females who undergoing ICSI

Detailed description: Purpose:

To determine the optimal embryonic stage for transfer in poor responders.

Method:

Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical data were recorded and then analyzed using SPSS (version 23) statistical software.

Eligibility criteria: Inclusion Criteria:

* poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
* couples whose planning to do fresh transfer
* male partners have normal semen parameters according to WHO 2010.

Exclusion Criteria:

* sperm or oocyte donation
* gestational carriers

Primary outcomes:
measure: Live birth rate
timeFrame: delivery of healthy neonate after 37 weeks of pregnancy
measure: Implantation rate
timeFrame: 6 weeks of pregnancy
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: after 6 weeks of embryonic transfer
measure: Cancellation rate
timeFrame: 5:6 days of ICSI
measure: Fertilization rate
timeFrame: 16:19 hours after intracytoplasmic injection(ICSI)
measure: Cleavage rate
timeFrame: 72 hours after ICSI
measure: High quality day 3 embryos
timeFrame: 72 hours after ICSI
measure: Blast rate
timeFrame: 5:6 days of ICSI
measure: High quality blast rate
timeFrame: 5:6 days of ICSI
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin fertility center
Study officials:
affiliation: Ganin Fertility Center
name: Manar Hozyen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Amira Hassan, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Elkhader, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki
role: STUDY_CHAIR
References: