louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06308809: Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student
Official title: Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Behavior
Keywords: adolescent population
PNF training
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany.

Detailed description: The test steps and methods are as follows:

1. Before the test, arrange the subjects to be familiar with the lower limb stability test system and test environment, and master the test method.
2. The subject stands barefoot and one foot in the center of the center of gravity movement trajectory tester, with his hands placed on his sides naturally, and maintains his body balance for 30 seconds.
3. Record data of the test system.
4. The measurement was repeated three times with a time interval of 5min. Collect the test data of the center of gravity moving trajectory tester, including swing frequency, coordination coefficient and stability coefficient, and get the best results of the three tests. The smaller the oscillation frequency and coordination coefficient are within a certain range, the better the stability is. The greater the value of stability coefficient is within a certain range, the better the stability is.

Eligibility criteria: Inclusion Criteria:

1. Unilateral functional ankle instability;
2. Have not received formal rehabilitation treatment or informal rehabilitation treatment within the past month;
3. Voluntarily accept the treatment in this study and ensure to complete the training tasks arranged by the therapist;
4. Aged between 18 and 23 years old;

Exclusion Criteria:

1. Does not meet the above diagnostic criteria;
2. Ankle pain caused by infectious diseases;
3. suffering from severe neurological diseases;
4. Soft tissue damage near the ankle joint;
5. Other joints outside the ankle are unstable.

Primary outcomes:
measure: CAIT score
timeFrame: Baseline, post-test after 8 weeks
measure: Lower limb stability test
timeFrame: Baseline, post-test after 8 weeks
measure: Star offset balance test
timeFrame: Baseline, post-test after 8 weeks
measure: Muscle strength test
timeFrame: Baseline, post-test after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04933409: 3D Printed Donor Tooth Replica in Autotransplantation of Teeth
Official title: 3D Printed Donor Tooth Replica in Autotransplantation of Teeth. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decayed Teeth
Keywords: decayed teeth; autotransplantation; 3d printing
Lead sponsor: College of Medical Sciences Teaching Hospital. Nepal
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized controlled tria
Primary purpose: TREATMENT

Brief summary: 3D printed replicas of the donor tooth can reduce extraoral time during the autotransplantation of teeth, which can reduce dehydration and manipulation of periodontal tissue of the donor tooth, thus possibly increasing the success rate.

Detailed description: This technique of autotransplantation has been innovated using 3-dimensional (3D) imaging and rapid prototyping.The use of a 3D-printed replica of the donor tooth is thought to minimize the risk of iatrogenic damage to the actual donor tooth. Nevertheless, no large prospective and comparative studies are available to assess the outcomes using these 3D techniques. Therefore, this study aimed to compare 3D printed replicas in autotransplantation of teeth, compared to the conventional technique. The present study will evaluate the feasibility, clinical satisfied accuracy, and stability of a novel approach for computer-aided autotransplantation of teeth. This new approach facilitated the surgical procedure and might be a viable and predictable method for autotransplantation of teeth.

Application of printed 3D replicas of transplanted teeth facilitates surgical preparation of the recipient site, shortens the extra-alveolar time, and reduces the minimum the number of attempts of the donor tooth insertion at the prepared socket. Their use can significantly decrease the risk of damage to the root surface of a transplant, thus increasing the chance of success.

Eligibility criteria: Inclusion Criteria:

1. patient presenting with decayed first molars
2. autotransplantation of third molar at the recipient site

Exclusion Criteria:

1. Diabetic, pregnant patients
2. other autotransplantations (other than first molar recipient and third molar donor)

Primary outcomes:
measure: Number of teeth that fail
timeFrame: two weeks
measure: Operative time
timeFrame: 1 day
measure: Rate of Ankylosis (replacement resorption)
timeFrame: 6 months
measure: Rate of root resorption
timeFrame: 6 months
Secondary outcomes:
measure: Cost difference of the treatment
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01130909: A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
Official title: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Effect of a single dose on gamma-band qEEG
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 36
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

Detailed description: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo

Eligibility criteria: Inclusion Criteria:

* BMI 18-30 Non-smoker for at least 4 weeks

Exclusion Criteria:

* Any clinically relevant acute or chronic disease
* History of substance abuse Hypersensitivity to ketamine

Primary outcomes:
measure: qEEG assessed through the gamma bands
timeFrame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
Secondary outcomes:
measure: Pupil Size - to assess the relationship between qEEG and pupil size
timeFrame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h
measure: Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.
timeFrame: Day 1 of each treatment period at Predose, 1h, 3h, and 8h
measure: Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment
timeFrame: Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Albena Patroneva, MD
role: STUDY_DIRECTOR
affiliation: Forenap
name: Francine Santoro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
Clinical trial NCT02666209: Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Official title: Early Patient Access Single Named Patient Program for the Use of Ulocuplumab for the Treatment of Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma in Relapse
Multiple Myeloma
Keywords: Multiple Myeloma
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-01-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Participant that has been diagnosed with Relapsed/ Refractory Multiple Myeloma and are currently participating in a clinical trial which is closing. This research study is studying Ulocuplumab as a possible treatment. It's an expanded access from NCT01359657

Detailed description: This research study is an Expanded Access Trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available.

The purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab.

Participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. Ulocuplumab is supposed to kill myeloma cells.

Lenalidomide, which is also known as Revlimid® and Bortezomib, which is also known as Velcade®, are approved by the FDA for treatment of Multiple Myeloma. Dexamethasone, also known as Decadron®, is also approved by the FDA for other treatments. It is a type of steroid medication that fights inflammation.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent document
* Must be currently participating on protocol 11-240 (DFCI)/ CA 212-002(BMS), tolerating therapy, and still receiving benefit from treatment.

Exclusion Criteria:

* Prior exposure to Ulocuplumab other than in DFCI Protocol 11-240 (BMS protocol CA212-002) or any other any other CXCR4 inhibitor (small molecule within 14 days; antibody against CXCR4 within 10 weeks).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Irene M Ghobrial, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05411809: The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
Official title: The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stereotactic Body Radiation Therapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 180
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 ctDNA could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer.

Detailed description: This is a prospective study. The purpose of this study is to determine whether MRD could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer. The ctDNA was detected for early stage lung cancer patients before and after SBRT. If a high level of ctDNA was detected after SBRT, the patients were randomly divided into observation group and adjuvant treatment group.

Eligibility criteria: Inclusion Criteria:

1. Patients pathologically diagnosed as non-small cell lung cancer, and was early stage（AJCC 8th）;
2. Patients aged between 18 -80 years; with expected survival time\>3 months.
3. Patients with normal organ function within 30 days prior to treatment, the following criteria are met:

   1. blood routine examination criteria : i) hemoglobin (HB) ≥90g/L; ii) absolute neutrophil count (ANC) ≥1.5×10e9/L; iii) platelet (PLT) ≥80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; iii) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min;

Exclusion Criteria:

1. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
2. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication;
3. Patients with any other severe and/or uncontrolled disease;
4. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
5. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；

Primary outcomes:
measure: PFS
timeFrame: 3-year
Secondary outcomes:
measure: PFS
timeFrame: 5-year
measure: OS
timeFrame: 3-year
measure: OS
timeFrame: 5-year
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:
References:
Clinical trial NCT04884009: A Trial of SHR-1701 in Combination With and Without Famitinib Malate in Patients With Extensive Stage Small Cell Lung Cancer
Official title: An Open-label, Multicenter PhaseⅡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR-1701 in combination with or without famitinib
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form.
2. 18 to 75 years old, male or female.
3. Histologically or cytologically confirmed extensive stage small cell lung cancer（ED-SCLC）.
4. ECOG Performance Status of 0 or 1.
5. Adequate hematological, hepatic and renal function.
6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Untreated central nervous system metastases.
3. Cancerous meningitis (meningeal metastasis).
4. Uncontrolled pleural effusion, pericardial effusion or ascites.
5. Tumor infiltration into the great vessels on imaging;
6. Hemoptysis symptoms and maximum daily hemoptysis ≥ 2.5ml occurred within 1 month.
7. Uncontrolled tumor-related pain.
8. Malignancies other than SCLC within 5 years.
9. Systemic antitumor therapy was received 4 weeks prior to trial treatment.
10. History of autoimmune diseases.
11. Significant cardiovascular disease.
12. Inadequately controlled hypertension.
13. Known history of testing positive test for HIV or known AIDS.
14. Patients with active hepatitis B or hepatitis C
15. Severe infections within 4 weeks prior to trial treatment.
16. Active tuberculosis.

Primary outcomes:
measure: Objective response rate (ORR) based on RECIST 1.1 criteria
timeFrame: up to approximately 1 year.
Secondary outcomes:
measure: Progression free survival (PFS) based on RECIST 1.1 criteria
timeFrame: up to approximately 1 year.
measure: Disease control rate (DCR) based on RECIST 1.1 criteria
timeFrame: up to approximately 1 year.
measure: Duration of response (DoR)
timeFrame: up to approximately 1 year
measure: Overall survival (OS)
timeFrame: up to approximately 1 year
measure: AEs+ SAEs determined by NCI-CTCAE V5.0
timeFrame: Baseline until up to 90 days after end of treatment.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04362709: Study of Post-anesthesia Management in Patients Undergoing Neurosurgery
Official title: A Prospective Cohort Study of Post-anesthesia Management in Patients Undergoing Neurosurgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Neurosurgery
Complication
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients expected to returned to post-anesthesia care unit(PACU) after neurosurgical treatment in Beijing Tiantan hospital.

Brief summary: The postoperative complications of neurosurgery are various and complex, which brings heavy economic and social burden to families. Timely detection and early intervention can help reduce the incidence of adverse events and mortality. The main purpose of this study is to analyze the possible factors related to postoperative complications of Neurosurgery, so as to achieve the prospective prevention and treatment of postoperative complications of neurosurgery.


Eligibility criteria: Inclusion Criteria:

* Patients received neurosurgery in Beijing Tiantan hospital.

Exclusion Criteria:

* Preoperative severe cognitive dysfunction ；
* Refused to sign informed consent.

Primary outcomes:
measure: The incidence of postoperative complications in neurosurgery.
timeFrame: 5±2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TianTan Hospital
Study officials:
affiliation: Department of Anesthesiology, Beijing Tiantan Hospital
name: Yuming Peng, M.D., Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT00168909: Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)
Official title: Influence of Alfacalcidol on Falls in Elderly Postmenopausal, Alendronate-Treated, Osteopenic/Osteoporotic Women With High Risk of Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Osteopenia
Falls
Keywords: osteoporosis
frailty
falls
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 282
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.

primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)


Eligibility criteria: Inclusion Criteria:

* age \> 65 years
* postmenopausal women
* osteopenia/osteoporosis as defined by WHO criteria

Exclusion Criteria:

* Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
* Chronic inflammatory rheumatoid disease
* Arthritis with continuous pain and influence on locomotion
* Inflammatory or metabolic bone disease, excluding osteoporosis.
* Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
* 25-OH-Vitamin D3 \< 12 ng/ml (12 ng/ml = 30 mmol/L)
* Systemic corticosteroid treatments of more than one month within previous 12 months
* Intolerability for alfacalcidol
* Hypercalcaemia (\>2,7 mmol/l)
* Milk alkali syndrome
* Uncorrected, severe visual impairments
* Creatinin \> 2.5 mg/dl (\>220 µmol/L)

Primary outcomes:
measure: primary outcome: number of fallers (patients with at least one locomotor fall incl.mixed falls)
timeFrame: 3 years
Secondary outcomes:
measure: secondary outcome: number of falls (locomotor falls, incl.mixed falls), all falls/fallers, neuromuscular parameters, BMD, biochemical parameters of calcium and bone metabolism; cognition and moods; muscle biopsies
timeFrame: 3 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
city: Stuttgart
country: Germany
facility: Centre for Muscle and Bone Research, Aerpah-Kliniken Esslingen
Study officials:
affiliation: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, Germany
name: Dieter Felsenberg, Prof. Dr.
role: STUDY_CHAIR
References: