louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06099860: Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction
Official title: Therapeutic Impact of Kinesio Taping Along With Balance Training in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction:A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Lead sponsor: Najran University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aimed to determine the impacts of KT and balance exercises in patients with CLBP of SIJ dysfunction.

Detailed description: The study will be based on a two-arm parallel group randomized control design. thirty participants of CLBP of SIJ Dysfunction will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into two groups A and B. Experimental group A will receive the hot pack, Stretching exercise, and Kinesio taping along with balance training (KBT), and group B will receive the hot pack, Stretching exercise, and Balance training (BT) exercise

Eligibility criteria: Inclusion Criteria:

* Subjects having chronic (\>3 months) non-specific low back pain (NSLBP) of sacroiliac joint (SIJ) origin
* Age 20-50 years.
* Presence of pain exacerbated as a result of bending laterally or backward.
* Positive results on at least 2 of the pain-provocation tests \[FABER, Posterior shear, and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests) .

Exclusion Criteria:

* past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months.
* lower extremity musculoskeletal disorders.

  .localized spinal pathology, congenital anomalies of hip, pelvis or spine that limits mobility -systematic arthropathy, neuropathy or metabolic disorder
* Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
* pregnancy.

Primary outcomes:
measure: Pain Intensity
timeFrame: 6 Weeks
measure: Functional disability
timeFrame: 6 Weeks
measure: Balance
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Integral University Hospital
state: Uttar Pradesh
Study officials:
affiliation: Najran University
name: Hashim Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06541860: DAratumumab and REvlimid REfractory MM
Official title: Salvage Regimens in Multiple Myeloma Patients Double Refractory to Lenalidomide and MoAbs: Evidence From Real World Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.

Brief summary: Retrospective and prospective multicenter observational study on patients with relapsed and refractory multiple myeloma after anti-CD38 MoAb therapy and IMIDS treated with onlabel regimens.


Eligibility criteria: Inclusion Criteria:

Phase I

* Patients with RRMM after therapy with anti-CD38 MoAb plus IMIDS started on therapy with PVD scheme
* Patients aged ≥ 18 years
* Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

Phase II

* Patients with RRMM after first-line therapy with anti-CD38 MoAb plus IMIDS started on therapy with on-label schemes
* Patients aged ≥ 18 years
* Patients able to understand and voluntarily sign an informed consent and be willing to consent to the review of clinical data

Exclusion Criteria:

* Patients not willing to consent to review of clinical data

Primary outcomes:
measure: To explore the efficacy and tolerability of different combinations, particularly the PVD regimen, in the emerging context of RRMM after anti-CD38 MoAb plus IMIDS therapy.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Irccs San Matteo Pavia
state: PV
Study officials:
References:
Clinical trial NCT06599060: Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
Official title: Prosthesis Use Experience And Satisfaction Of Unılateral Transtibial Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transtibial Amputation - Unilateral
Keywords: transtibial amputees
prosthesis satisfaction
prosthesis experience
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Information on patients who had undergone unilateral transtibial prosthesis placement in previous years was obtained from the patient records of the Nesa Prosthetics Orthotics Production and Application Center.

Brief summary: This study aimed to investigate the experience and satisfaction of unilateral transtibial amputees with prostheses. This study included 31 unilateral transtibial amputees aged 18-75 years. The Prosthesis Satisfaction Questionnaire (PSQ) and Trinity Amputation and Prosthesis Experience Scale (TAPES) were used to measure prosthesis satisfaction. Data analyses were performed using SPSS for Windows version 24.0 program. No significant data were found when the SATPRO scale scores were compared with general information. The TAPES activity restriction scale scores were lower in women than in men (p\&lt;0.05). When the causes of amputation were compared, the mean scores of the TAPES activity restriction, TAPES athletic restriction, and TAPES social restriction subscales were higher in amputees with vascular causes than in those with traumatic and other causes (p\&lt;0.05). Satisfaction with TAPES prosthesis weight was lower in vascular amputees than in traumatic and other amputees (P \&lt;0.05). The TAPES restriction compliance score was higher in the vascular amputee group than in the traumatic and other cause groups (p\&lt;0.05). There was no difference in the TAPES and SATPRO scores according to the different types of prostheses used by the amputees (p\&gt;0.05). Researchers believe that the cause of amputation and cosmetic limitations affect prosthesis satisfaction and are also important for prosthesis adaptation and socialization for users.


Eligibility criteria: Inclusion Criteria:

* between 18-75
* unilateral below knee amputation
* volunteer to participate
* have been using a transtibial prosthesis for at least one year
* can read and understand Turkish.

Exclusion Criteria:

* muscle strength and sensory loss in the intact extremity that may affect ambulation
* upper limb amputees
* congenital amputees
* bilateral amputees
* mentally disabled
* with neurological disease

Primary outcomes:
measure: Trinity Amputation and Prosthetic Experience Scales (TAPES)
timeFrame: 0-1 years
Secondary outcomes:
measure: Satisfaction with the Prosthesis (SATPRO) Questionnaire
timeFrame: 0-1 years
Other outcomes:
Locations:
city: Beykoz
country: Turkey
facility: Medipol University
state: Istanbul
Study officials:
References:
Clinical trial NCT04155060: The Prognostic Value of Lactate is Different Among Septic Patients
Official title: The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Diabetes Mellitus
Keywords: hyperlactatemia
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .

Brief summary: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.

Detailed description: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients.

Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis.

DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.

Eligibility criteria: Inclusion Criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis.

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Exclusion Criteria:congenital metabolic and psychiatric diseases and clinical data deficiency.

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Primary outcomes:
measure: The primary outcome was 28-day mortality
timeFrame: up to at least 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
References:
Clinical trial NCT06632860: A Dual-targeting Tracer TATE-RGD for the Diagnosis of SSTR- and RGD- Positive Tumors
Official title: a Novel Dual-Targeting Molecular Probe TATE-RGD for the Diagnostic Integration of SSTR2 and αvβ3 Positive Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Iodine-resistant Thyroid Cancer
Meningioma
NETs
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The US FDA approved a targeted somatostatin receptor 2 imaging agent, 68Ga-DOTATATE, in 2016. It has higher uptake in small cell lung cancer, pulmonary carcinoid, and medullary thyroid cancer. Integrin αvβ3 is highly expressed in some tumor cells and new blood vessels, making it an ideal target for targeted diagnosis and treatment of tumors and tumor vessels.68Ga-labeled DOTA-TATE-RGD is a new type of tumor-specific imaging agent developed by researchers based on the above foundation, which is used for targeted diagnosis and internal radiation therapy for patients with SSTR2 and αvβ3 positive tumors.

Detailed description: This research has conducted extensive studies on the treatment of neuroendocrine tumors with 177Lu-EB-TATE and the treatment of FAP-expressing tumors with 177Lu-EB-FAPI. The same protocol had demonstrated 68Ga-TATE-RGD showed an increasing TBR, suggesting the tracer kinetic advantage of TATE-RGD. Compared to the single-target tracer DOTATATE, the dual-target TATE-RGD probe has a clear advantage in detecting NETs liver metastases, and it can be explored for potential therapeutic uses in future studies and used for related companion diagnostics in targeted radiolabeling therapy (RLT), which has been published in the 1st-impact factor journal European Journal of Nuclear Medicine and Medical Imaging (IF: 9.6), performing a small-dose diagnostic PET imaging with the same tracer.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed various cancer patients;
* 68Ga-TATE-RGD and 18F-FDG PET/CT within a week;
* signed written consent.

Exclusion Criteria:

* known allergy against TATE-RGD;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Tumor detection rate
timeFrame: through study completion, an average of half-year
Secondary outcomes:
measure: standardized uptake value (SUV) of tumor
timeFrame: through study completion, an average of half-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04690660: Swiss Postpartum Hypertension Cohort
Official title: Swiss Postpartum Hypertension Cohort (Swiss-PPHT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postpartum Hypertension (PPHT)
Keywords: Pregnancy Induced Hypertension (PIH)
Home Blood Pressure Monitoring (HBPM)
Office Blood Pressure Monitoring (OBPM)
Automated Office Blood Pressure Measurement (AOBPM)
Gestational Hypertension
HekaHealth Self-Measured Blood Pressure (SMBP) App
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will take place at the Hypertension Clinic of the Medical Outpatient Department at the University Hospital Basel and the Department of Obstetrics and Gynaecology at the University Hospital Basel. Participants will be consecutively screened and recruited by the treating physicians and the Hypertension Team of the Hypertension Clinic.

Brief summary: This open label, prospective observational, single-center registry is to study short-, intermediate-and long-term course of postpartum hypertension and predictors/risk factors associated with long term cardiovascular and renal risk.

Current disease management strategies will be evaluated.


Eligibility criteria: Inclusion Criteria:

* all women with hypertensive disorders of pregnancy
* postpartum hypertension (blood pressure measurements of systolic ≥140 and/or diastolic ≥ 90mmHg or antihypertensive therapy within the first 14 days after delivery)
* women with preexisting hypertension or
* women on antihypertensive medication

Exclusion Criteria:

* delivery \> 14 days
* lack of consent to participate in the study, language barriers or lack of general understanding

Primary outcomes:
measure: Frequency of persistent hypertension defined by 24 hours BP measurement
timeFrame: through study completion, an average of 5 years
measure: Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)
timeFrame: through study completion, an average of 5 years
measure: Frequency of microalbuminuria
timeFrame: through study completion, an average of 5 years
measure: Frequency of damage to the retina of the eyes (retinopathy)
timeFrame: through study completion, an average of 5 years
measure: Signs of hypertensive heart disease
timeFrame: up to 24 months
measure: Frequency of dyslipidemia
timeFrame: through study completion, an average of 5 years
measure: Frequency of prediabetes/diabetes
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Medical Outpatient Department and Hypertension Clinic, University Hospital Basel
Study officials:
affiliation: Medical Outpatient Department and Hypertension Clinic, University Hospital BaselUni
name: Thenral Socrates, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950260: Early Levothyroxine Post Radioactive Iodine
Official title: Prevention of Overt Hypothyroidism Following Radioactive Iodine Therapy for Graves' Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Graves' Disease
Keywords: Graves' disease
Radioactive iodine
Hypothyroidism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will try to answer the question of whether early treatment with levothyroxine at 4 weeks after radioactive iodine for Graves'disease will prevent overt hypothyroidism (low thyroid hormone levels).


Eligibility criteria: Inclusion criteria:

-all adult patients (ages 18-70 years) with Graves' Disease (GD) who will receive radioactive iodine (RAI) ablation of the thyroid gland for treatment of GD

Exclusion criteria:

* clinically manifest Graves' ophthalmopathy (GO)
* recent (\<1 yr.) history of arrhythmias or any history of ventricular arrhythmias
* preexistent cardiomyopathy
* malnutrition
* psychiatric history that could get worse if patient remains persistently hyperthyroid
* unlikely to return for the planned follow-up visits
* unlikely to comply with the blood drawing schedule
* unlikely to complete the hypothyroid-Health Related Quality of Life (HDQL) and Thyroid Specific (TSQ) questionnaires

Primary outcomes:
measure: Number of Participants With Overt Hypothyroidism
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Hypothyroid-Health Related Quality of Life
timeFrame: 4 weeks, 8 weeks
measure: Change in Thyroid Specific Quality of Life
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Marius Stan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423560: Pulmonary Fibrosis After Severe COVID-19 Pneumonia
Official title: Evaluation of Pulmonary Fibrosis After Severe Interstitial Pneumonia Due to COVID-19 (SARS-CoV-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
COVID-19
Keywords: COVID-19
Pulmonary fibrosis
ARDS
Computed tomography
pulmonary function test
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized for sever COVID-19 pneumonia and successively discharge and with a 1-year follow-up

Brief summary: Patients discharged after hospitalization for COVID-19 pneumonia were retrospectively selected by radiologically established criteria that at admission presented at chest computed tomography (CT) (i) normal lung parenchyma \<50% of total lung volume; and/or (ii) area of lung consolidation \> 10%. All At discharge and after 9 months, all subjects underwent cardiological evaluation, echocardiogram, pulmonary function tests (PFT) both atby 3 and by 12 months after discharge. Chest CT was performed by 12 months after discharge and chest CT. Specifically, the magnitude of pulmonary involvement between baseline and follow-up was considered the primary endpoint of this study. Secondary endpoints of the study were results of respiratory function testing, echocardiographic parametersparameters, and persistence of symptoms.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Hospitalization for severe COVID-19 pneumonia
* Computed tomography during index hospitalization that showed: (i) normale lung parenchyma \< 50% of total lung volume and/or (ii) parenchymal consolidation \> 10%
* Cardiological and pneumological visit, echocardiography and pulmonary function test at 3 and 12 months from hospital discharge
* Computed tomography by 12 months from hospital discharge

Exclusion Criteria:

* Age \< 18
* Absence of previously cited test.

Primary outcomes:
measure: The magnitude of pulmonary involvement
timeFrame: 12 months
Secondary outcomes:
measure: results of respiratory function testing
timeFrame: 12 months
measure: echocardiographic parameters
timeFrame: 12 months
measure: persistence of symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele
state: Lombardia
Study officials:
affiliation: IRCCS San Raffaele
name: Gabriele Fragasso, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00147160: Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents
Official title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 87
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents


Eligibility criteria: Inclusion Criteria:

* Age from 4th birthday and younger than 21st birthday
* Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours
* Measurable and evaluable disease by the imaging criteria (MRI)
* Patient not previously treated by either of the two drugs

Exclusion Criteria:

* Malignant brain stem tumours are excluded

Primary outcomes:
measure: Radiological response after two courses of Temozolomide-Cisplatinum
Secondary outcomes:
measure: Progression-free survival
measure: Health status and quality of life
measure: Toxicity
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave-Roussy
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jacques Grill, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: