louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00256971: Balance in Patients After Surgery for Torn Meniscus
Official title: Functioning Balance in Patients After Surgery for Torn Meniscus: Meniscectomy vs Meniscal Repair; A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Torn Menisci
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Time perspective: PROSPECTIVE

Brief summary: The important role of the menisci in knee function and in preserving knee health has been shown in several studies. Additionally to principal functions of load transmission and shock absorption, meniscus contributes to knee joint proprioception and probably also to joint stability.Study about affect of meniscus injury on balance posture has not previously been published.Surgical practice is increasingly aimed at minimal resection of injured tissue, preserving a stable meniscal remnant with as much function as possible.The purpose of this study is to determine whether menisci surgery have any effects on relatively new postural control measures, in correlation with functional balance assessment. The second purpose is to establish the affect of different types of menisci surgery on balance impairment (meniscectomy vs tear repair), in correlation with a long-term outcome.


Eligibility criteria: Inclusion Criteria:

* Participants have to be healthy people
* 18-40 years old
* After a traumatic event of only one knee

Exclusion Criteria:

* Previous knee surgery
* OA per arthroscopy
* Neurological problem
* Any other orthopedic problem of lower limbs
* Systemic arthritic condition (RA, SLE etc.)
* Severe cognitive problem with restricted consent
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem,
country: Israel
facility: Hadassah Medical Organization,
Study officials:
affiliation: Hadassah Medical Organization IRB
name: isabella schwartz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723471: Impact of a Collaborative Program of Physical Activity of Newly-diagnosed Cancer Patients
Official title: Impact of a Collaborative Program of Customized, Adaptive and Supervised Physical Activity on Adherence, Fitness, Quality of Life and Resilience of Newly-diagnosed Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Adaptative physical activity
Cancer
Quality of Life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: During the last twenty years, the cancer overall incidence has been increasing in europe and developed countries, while diagnostic and therapeutic progress have contributes to a reduction in mortality. Currently, almost 4 million people are treated or followed for cancer in France. The physical, psychological and social after-effects are significant.

Adaptated physical activity plays an important role in the rehabilitation process. Overall, meta-analyses carried-out with most frequent cancers demonstrate that physical activity practiced would allow an improvement in quality of life, tolerance to anticancer treatments and survival.

Detailed description: This is a multicenter, two-arm parallel-group randomizes (in a 1:1 ratio), open-label, controlled intervention clinical trial of the comparison of long term adherence to physical activity between an adaptative, customized and collaborative exercise program and standard exercise prescription in patients with newly diagnosed cancer.

Eligibility criteria: Inclusion Criteria:

* newly-diagnosed cancer patient
* able to start a program of physical activity within the first year follow diagnosis
* performance status between 0 to 2

Exclusion Criteria:

* uncontrolled cardiovascular disease
* peripheral neuropathy grade 3-4 with risk of falling
* bone metastasis with risk of bone fracture
* platelets \<100X109/L
* hemoglobin \<8g/dL
* patient under legal protection

Primary outcomes:
measure: Number of physical activity session
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
city: Toulouse
country: France
facility: Stéphanie MOTTON
Study officials:
affiliation: University Hospital, Toulouse
name: Stéphanie MOTTON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00812071: Phase 1B Study of RiVax, a Vaccine to Prevent the Toxic Effects of Ricin
Official title: Phase 1 Study of the Safety and Immunogenicity of RiVax With Alum in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2008-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Dose escalation study: 3 dose groups. 5 patients in each dose group, then 15 more patients in "best" group. 3 vaccinations in volunteers, at 0 6 and 16 weeks.

Detailed description: Final report was submitted to Dr. Karen Russell at FDA, Rockville on September 26, 2012.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers aged 18-31, m or f

Exclusion Criteria:

* immunodeficiency
* pregnant
* chronic disease
* parental IgG
* abnormal labs
* drug use
* hiv
* hep c
* hep b

Primary outcomes:
measure: assess the safety of 3 dose levels
timeFrame: one year
Secondary outcomes:
measure: determine the immunogenicity of the 3 dose levels
timeFrame: one year
Other outcomes:
Locations:
city: Chesapeake
country: United States
facility: Hampton Roads Center For Clinical Research
state: Virginia
Study officials:
affiliation: Lubin Clinic
name: Lubin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06125171: Tucidinostat Plus Apatinib for Advanced Osteosarcoma
Official title: A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteosarcoma
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 46
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥10 years, ≤ 75 years;
2. Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ；
3. Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide;
4. Eastern Collaborative Oncology Group (ECOG) 0\~2；
5. Tumor size is measurable according to RECIST1.1 criteria；
6. Adequate organ function；
7. Life expectancy is more than 3 months；
8. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors;
2. Urine protein≥ ++;
3. FBG\>10mmol/L;
4. Uncontrolled blodd pressure (ystolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg);
5. Known active CNS metastases and/or carcinomatous meningitis;
6. Not able to take medicine orally;
7. Coagulant function abnormality (PT\>16s, APTT\> 43s, TT\>21s, FIB）\<2g/L);
8. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease;
9. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.

Primary outcomes:
measure: 6-month progression-free survival rate
timeFrame: 6 months
Secondary outcomes:
measure: Progression-free survival(PFS)
timeFrame: 2 years
measure: Objective Response Rate（ORR）
timeFrame: 2 years
measure: Disease Control Rate （DCR）
timeFrame: 2 years
measure: Overall survival(OS)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00042471: Evaluation of the Bioavailability of Pramlintide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.


Eligibility criteria: Inclusion Criteria:

* HbA1c value between 6-12%
* BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2
* Consistent insulin regimen for 2 months prior to screening

Primary outcomes:
measure: Effect of varying needle length on bioavailability of Pramlintide
timeFrame: approximately 6days but not to exceed 14days
Secondary outcomes:
measure: Effect of varying needle length on safety and tolerability of Pramlintide
timeFrame: Approximately 6 days not to exceed 14days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
References:
Clinical trial NCT04653571: CASPR2 Encephalitis Initial Symptoms
Official title: Defining the Initial Clinical Symptoms and Characterizing Those Leading to the Discovery of CASPR2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CASPR2-Antibody
Encephalitis Autoimmune
Paraneoplastic Syndromes
Keywords: antibody ; auto-immune encephalitis ; paraneoplastic syndrome ; CASPR2
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 48
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: Patients with a CASPR2 antibody-associated auto-immune encephalitis

Brief summary: Auto-immune encephalitides involve auto-antibodies targeting the central nervous system, and particularly the synapse and its structure, such as protein CASPR2.

CASPR2 antibody-associated auto-immune encephalitides lead to an inflammation of the limbic system and generate focal temporal seizures and cognitive impairment. Most patients are initially hospitalized because of the temporal seizures (Joubert et al., JAMA Neurology 2016). However, many already show at that time cognitive impairment, which has failed to elicit the appropriate investigations, therefore delaying the diagnosis.

The study will hence investigate precisely the initial, sometimes neglected, clinical symptoms and those leading to the diagnosis, in the cohort of patients suffering from a CASPR2 antibody-associated encephalitis, from the French reference center on paraneoplastic neurological diseases and autoimmune encephalitis.

This way, the study aims to delineate the symptoms that should trigger suspicions of a CASPR2 antibody-associated encephalitis


Eligibility criteria: Inclusion Criteria:

* Positive CASPR2-Ab in serum and/or CSF tested by immunohistochemistry on mouse brain slices and confirmed by cell-based assay (CBA) of HEK293 cells expressing CASPR2.
* Diagnosis and follow-up in France
* From 18 to unlimited age

Exclusion Criteria:

* Patients CASPR2-IgG negative in serum and CSF
* Foreign follow-up

Primary outcomes:
measure: Initial cognitive impairment or clinical presentation of first epileptic seizures.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neuro-Oncologie, Hôpital Neurologique Pierre Wertheimer
Study officials:
affiliation: Service de neuro-oncologie, Hôpital neurologique
name: Jérôme HONNORAT, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02049671: Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypopituitary Adults
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypopituitary adults

Brief summary: Large population studies of hypopituitary adults (patients with pituitary gland failure) on conventional hormone replacement, but not growth hormone, have an approximate two fold increase in death rate (mortality). The vast majority of this excess mortality relates to vascular disease. While it is possible that overreplacement with steroids, underreplacement with thyroid hormones and sex hormone deficiency contribute, there are increasing data to support a role for GH in the cause of the excess vascular risk. Although a number of surrogates of vascular risk are described in patients with GH deficiency (GHD), how these translate mechanistically into atherothrombotic (blockage of the arteries) disease has not been fully elucidated.

This proposed study will analyse both traditional (body composition, serum lipids, handling of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular risk/disease. In addition the study will examine 24hr blood pressure, arterial wall thickness, clot structure and function, as well as platelet action. Measurements will be performed at baseline and will be reassessed after patients have been on a stable dose of GH replacement for at least three months.

The results of the study will characterise risk factors for vascular disease, and take this a step further to elucidate how these changes translate mechanistically in to vascular damage.


Eligibility criteria: Inclusion Criteria:

* Able to give written consent
* Adults with confirmed GHD (Insulin stimulation test \<3ug/L)
* Other hormone replacement therapy stable for at least three months

Exclusion Criteria:

* active malignancy
* an acute vascular event within three months of the study
* any therapy other than hormone replacement
* serum creatinine \>120 micromol/l
* abnormal LFTs (ALT\>3 fold upper limit of normal)

Primary outcomes:
measure: Turbidity analysis.
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT00886171: Effects of Social Skills and Physical Activity Training on Recreational Activities in Youth
Official title: Effects of Social Skills and Physical Activity Training on Recreational Activities in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Skills
Physical Activity
Keywords: social skills
physical activity
peer relationships
childhood obesity
changes in physical activity
changes in social involvement
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 35
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of social skills training on adolescents physical activity levels. For one week at the beginning and end of the study teens will wear a BioTrainer to measure their activity levels and also wear a pager to communicate the types of activities they are doing throughout the day. For 8 weeks participants will be randomized into one of two groups, a social skills training group or a physical activity group.

The investigators predict that both groups will experience an increase in physical activity and social involvement (decrease time spent alone).


Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 12-14
* Youth who encounter problematic relationships with their peers

Exclusion Criteria:

* Youth should have no psychopathology, developmental disabilities, or asthma that would limit participation
* Youth should have no cold or upper respiratory distress or a condition that could influence their activities
* Youth should not be taking medications that could affect their level of activity

Primary outcomes:
measure: physical activity levels
timeFrame: pre and post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah J Salvy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04216771: Comparing the Consolidation Regimens of IDA With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone for Elderly AML Patients
Official title: Randomized Comparison of Consolidation Treatment in Elderly Patients With Acute Myeloid Leukemia: Idarubicin (IDA) Combined With Intermediate-dose Cytarabine Versus Intermediate-dose Cytarabine Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: AML in Remission
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates Idarubicin (IDA) in combination with the intermediate-dose cytarabine, compared with intermediate-dose cytarabine alone, as a consolidation treatment for elderly AML in first remission.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed de novo AML who achieved complete remission (CR), including CRi and CRp after a maximum number of 2 cycles of induction chemotherapy.
* Histologically or morphologically confirmed diagnosis of AML except for AML M3 (acute promyelocytic leukemia)
* No contraindication to anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \< 50%
* Age ≥ 60 years and \< 75 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up

Exclusion Criteria:

* Relapsed or refractory AML
* Patients with acute promyelocytic leukemia (APL)
* Patients with secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)
* Severe pshyciatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment
* Subjects for which allogeneic HSCT is planned in CR1
* Known allergic or hypersensitivity to idarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

Primary outcomes:
measure: Relapse free survival
timeFrame: 2 years
Secondary outcomes:
measure: Toxicities
timeFrame: enitire study course until 2 years
measure: Minimum Residual Disease
timeFrame: 6, 9, 12,18 and 24 months
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT06012071: Two-piece Zirconia Implants With Two Various Platforms
Official title: Comparison of Two-piece Zirconia Implants With Tissue-level and Bone-level Platform: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Edentulous Alveolar Ridge
Keywords: dental implants
zirconia
two-piece
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 24 patients with missing premolar teeth and healed sockets will be recruited. They will be randomized into two groups to supplied with tissue-level (n=12) or bone-level (n=12) 10-mm long 4-mm wide zirconia implants. Primary and secondary stabilities will be measured with International Stability Quotient (ISQ) device. After 3 months, ceramic crowns will be supplied. Implant survival rates and parameters in relation to periimplant soft-tissues and bone health and anatomy will be recorded and evaluated after 1, 3 and 5 years.


Eligibility criteria: Inclusion Criteria:

* Single missing maxillary premolar
* Occlusal stability
* Good oral hygiene
* Good general health

Exclusion Criteria:

* Oral mucosa pathology
* Dental caries
* Active periodontitis (non-treated)
* Systemic diseases and conditions that affect healing or immune capacity

Primary outcomes:
measure: Crestal bone loss (mm)
timeFrame: baseline, 1-year, 3-years, 5 years
Secondary outcomes:
measure: Probing depth (mm)
timeFrame: baseline, 1-year, 3-years, 5 years
measure: Bleeding on probing (BOP)
timeFrame: baseline, 1-year, 3-years, 5 years
measure: Volumetric tissue change
timeFrame: 1-year, 3-years, 5 years
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
affiliation: faculty of medicine
name: Rok Gašperšič, PhD
role: PRINCIPAL_INVESTIGATOR
References: