louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04308967: Central Sensitization in Knee Osteoarthritis
Official title: Effects of Balance Exercises on Central Sensitization in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Central Sensitisation
Keywords: central sensitisation
osteoarthritis
balance exercises
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 40
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 stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Therefore, central sensitization should be considered and treated in patients with osteoarthritis. Although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. The aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
* To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
* To be with a central sensitization score of over 40 according to the CSI,
* To be able to fill the scales and accept to participate in the study.

Exclusion Criteria:

* Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
* Having cognitive impairment,
* To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
* Having various diseases that may adversely affect performing balance exercises,

Primary outcomes:
measure: Central Sensitization Inventory (CSI)
timeFrame: Before intervention, change in CSI scores at sixth week, change in CSI scores at 3 months.
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Before intervention, change in BBS scores at sixth week, change in BBS scores at 3 months.
measure: Western Ontario ve McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Before intervention, change in WOMAC scores at sixth week, change in WOMAC scores at 3 months.
measure: Y Balance Test
timeFrame: Before intervention, change in Y balance test scores at sixth week, change in Y balance test scores at 3 months.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University, Faculty of Medicine, Physical Medicine and Rehabilitation Clinic
Study officials:
References:
Clinical trial NCT05105867: CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
Official title: A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Relapsed or Refractory B-cell Non-hodgkin Lymphoma
Lead sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sponsor class: OTHER
Collaborators: name: Gracell Biotechnologies (Shanghai) Co., Ltd.
name: Kunming Hope of Health Hospital
First posted: 2021-11-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

Detailed description: The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Eligibility criteria: Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
2. Expected survival time ≥12 weeks;
3. Adequate hematological, renal and liver function;
4. Subjects understand and voluntarily sign the informed consent form.

Key Exclusion Criteria:

1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
3. Active central nervous system (CNS) involvement by malignancy；
4. Active infection.

Primary outcomes:
measure: Dose Limiting Toxicities
timeFrame: Up to 4 weeks after CAR-T infusion
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: At 4,12,24 weeks after CAR-T infusion
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
state: Yunnan
Study officials:
affiliation: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
name: Sanbin Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01701167: Verification of the Quantitative Accuracy of the PET/CT System Imaging Chain
Official title: ROMAN (PCA-9000A) PET/CT System Verification
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Confirm PCA-9000A PET/CT System is Effective for Its Intended Use
Lead sponsor: Toshiba America Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients already scheduled for a FDG test.

Brief summary: The purpose of this study will evaluate new technologies that have been included in the new PCA-9000A PET/CT System.

Detailed description: Scope:

To evaluate the new technologies that have been included in the PCA-9000A PET/CT System, the study has the following 3 goals.

* Define and confirm all supported clinical protocols from Low-Dose CT, to PET acquisition and presentation.
* Verification of the quantitative accuracy of the imaging chain.
* Evaluate the performance and stability of the new system and its related quality control and calibration procedures.

Result (Expected):

The study is an essential step in assessing the quality of the hardware and software defining the new PCA-9000A PET/CT System. Several essential parameters for the acquisition, reconstruction, correction, filtering, and presentation will be estimated or adjusted during this period. The evaluation will confirm PCA-9000A PET/CT System is effective for its intended use.

Eligibility criteria: Inclusion:

* Patients already scheduled for an FDG test at SDMI
* 40 years and older
* Adult must be able to sign an informed consent form

Exclusion

* Patients not scheduled for an FDG test at SDMI
* 39 years or younger
* Pregnant adult female or plan to be pregnant
* Adult who is unable to sign the informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Steinberg Diagnostic Medical Imaging Centers
state: Nevada
Study officials:
References:
Clinical trial NCT05709067: Probiotics Effect on Mental Wellness
Official title: Probiotics Effect on Mental Wellness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Sun Genomics
First posted: 2023-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the effect of a probiotic strain on mental wellbeing in moderately stressed, healthy, adults in the general population. The main question it aims to answer is

• what is the impact of probiotic consumption on overall mental wellbeing? Participants will consume one probiotic or placebo capsule per day, answer a set of questionnaire (at 3 time points) and wear a wearable device for the total duration of the study.


Eligibility criteria: Inclusion Criteria:

* Adults aged between 18-60 years old
* Currently living in the US.
* Have access to a smart phone, internet and computer.
* Report moderate levels of perceived stress.

Exclusion Criteria:

* Are currently taking medication for depression or anxiety
* Have had antibiotics within the previous month
* Have an allergy to coconut

Primary outcomes:
measure: Change in Mental wellbeing
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Stress scores
timeFrame: 4 weeks
measure: Change in anxiety scores
timeFrame: 4 weeks
measure: Change in Depression scores
timeFrame: 4 weeks
measure: Change in Salivary cortisol
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sun Genomics, Inc.
state: California
Study officials:
affiliation: SunGenomics
name: Divya Nair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02531867: Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
Official title: A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) Treatment for Patients With Hypophosphatasia (HPP) in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypophosphatasia
Keywords: HPP
Bone Disease
Soft Bones
Low Alkaline Phosphatase
Genetic Metabolic Disorder
Alkaline Phosphatase
Rickets
Osteomalacia
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-25
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further information on the safety and efficacy of treatment with asfotase alfa.

Detailed description: The primary objective of this study was to collect data on the safety of repeated subcutaneous (SC) injections of asfotase alfa. There were no secondary objectives. Exploratory objectives related to the efficacy of asfotase alfa are not being reported.

Eligibility criteria: Inclusion Criteria:

1. Patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
2. Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol for asfotase alfa

Exclusion Criteria:

1. Patient has a documented form of rickets caused by a condition other than HPP, including, but not limited to, rickets caused by 25(OH) vitamin D deficiency
2. Patient has serum calcium and/or phosphorus levels below the normal range
3. Patient is pregnant or lactating
4. Patient received treatment with bisphosphonates within 2 years prior to the Screening visit
5. Patient has a documented sensitivity to any of the components of asfotase alfa
6. Patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation)
7. Patient has clinically significant other disease in the opinion of the Investigator, defined as any other non HPP-related condition for which the patient is considered medically unstable.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs)
timeFrame: Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical Monitor
name: Kenji Fujita, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00694967: A Randomized Trial of Cerclage Versus 17 α-Hydroxyprogesterone Caproate for Treatment of a Short Cervix
Official title: Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mid Trimester Cervical Shortening
Keywords: short cervix, cervical funneling, spontaneous preterm birth, cerclage, progesterone
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 92
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesized that weekly intramuscular injections of 17 hydroxyprogesterone caproate(17P) will reduce the number spontaneous preterm births prior to 35 weeks gestation when compared to cerclage therapy. The purpose of this study was to compare medical therapy with 17P to surgical therapy with transvaginal cerclage in patients with an ultrasound diagnosed short cervix and funnel in the mid-trimester.


Eligibility criteria: Inclusion Criteria:

* Ultrasonographic evidence of premature dilatation of the internal os
* Prolapse of the chorio-amniotic membranes into the endocervical canal
* Functional cervical length less than 25mm
* Exacerbation of these ultrasound findings with transfundal and/or suprapubic pressure

Exclusion Criteria:

* Any fetal chromosomal or structural anomaly
* Multiple gestation
* Known allergy to progesterone
* Ruptured membranes
* Vaginal bleeding
* Intra-amniotic infection (diagnosed clinically or by amniocentesis)
* Prolapse of endocervical membranes beyond the external cervical os
* Persistent uterine activity accompanied by cervical change
* Obstetrically indicated delivery.

Primary outcomes:
measure: The primary outcome was spontaneous preterm birth prior to 35 weeks gestation
timeFrame: 11/2003 - 12/2006
Secondary outcomes:
measure: Obstetrical complications
timeFrame: 11/2003 - 12/2006
measure: Neonatal morbidity & mortality
timeFrame: 11/2003 --12/2006
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Hospital
name: Orion Rust, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04805567: Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy
Official title: Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Polyp
Endocuff
Keywords: endocuff
tandem colonoscopy
Lead sponsor: Venizelio General Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Τhe study is a single center cohort study. Venizeleio General Hospital is a tertiary hospital and the population that will be selected would be residents of the island of Crete.

Brief summary: Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal.

The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.


Eligibility criteria: Inclusion Criteria:

* (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.

Exclusion Criteria:

* (i) age below 50 years; (ii) the presence of significant comorbidities (American Society of Anesthesiologists \[ASA\] score III or IV); (iv) recent abdominal surgery; (iv) inflammatory bowel disease; (v) colectomy; (vi) polyposis syndrome; (vii) the presence of acute, severe colitis or a known colonic stricture (viii) boston scale bowel preparation ≥6.

Primary outcomes:
measure: of Endocuff-assisted colonoscopy adenoma and polyp miss rate
timeFrame: up to 21 days after the colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04259567: Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination
Official title: Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Keywords: Cerebrovascular Autoregulation
Septic Shock
Cytokine
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 150
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 trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.


Eligibility criteria: Inclusion Criteria:

* septic shock
* acute renal failure with need for renal replacement therapy

Exclusion Criteria:

* pregnancy
* nursing
* impossibility to do transcranial Doppler ultrasound

Primary outcomes:
measure: Differences in the index of cerebrovascular autoregulation (Mx) between both groups
timeFrame: days 1 to 4 after diagnosis of septic shock
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-Univerity
Study officials:
References:
Clinical trial NCT00001240: Evaluating Patients With Abnormal Levels of Gastric Acid
Official title: Diagnostic Evaluation of Patients With Suspected Abnormalities of Gastric Secretion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achlorhydria
Gastrinoma
Zollinger Ellison Syndrome
Keywords: Stomach
Hypersecretion
Hyposecretion
Gastrinoma
Zollinger-Ellison Syndrome
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is used by the Digestive Diseases Branch to evaluate patients with suspected abnormalities in the secretion of gastric acid. The level of gastric acid is measured by analyzing the gastric juices of each individual patient. The gastric acid sample is obtained by a procedure known as nasogastric suctioning, where a thin plastic tube is passed from the nose to the stomach.

Depending on the patient's present condition further diagnostic testing may be required to achieve a diagnosis.

Detailed description: This study is an omnibus protocol used by the Digestive Diseases Branch to evaluate patients with suspected abnormalities of gastric acid secretion. Gastric acid secretion is measured by means of analysis of gastric juices obtained by nasogastric suction. Other clinically indicated diagnostic procedures are performed depending on the patient's clinical state in order to reach a diagnosis.

Eligibility criteria: Eligibility criteria not identified in the protocol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
state: Maryland
Study officials:
References:
citation: McArthur KE, Collen MJ, Maton PN, Cherner JA, Howard JM, Ciarleglio CA, Cornelius MJ, Jensen RT, Gardner JD. Omeprazole: effective, convenient therapy for Zollinger-Ellison syndrome. Gastroenterology. 1985 Apr;88(4):939-44. doi: 10.1016/s0016-5085(85)80011-1.
citation: Howard JM, Chremos AN, Collen MJ, McArthur KE, Cherner JA, Maton PN, Ciarleglio CA, Cornelius MJ, Gardner JD, Jensen RT. Famotidine, a new, potent, long-acting histamine H2-receptor antagonist: comparison with cimetidine and ranitidine in the treatment of Zollinger-Ellison syndrome. Gastroenterology. 1985 Apr;88(4):1026-33. doi: 10.1016/s0016-5085(85)80024-x.
citation: Vinayek R, Howard JM, Maton PN, Wank SA, Slaff JI, Gardner JD, Jensen RT. Famotidine in the therapy of gastric hypersecretory states. Am J Med. 1986 Oct 24;81(4B):49-59. doi: 10.1016/0002-9343(86)90600-5.
Clinical trial NCT04679740: Resorbable Magnesium Scaffolds Registry
Official title: RMS (Resorbable Magnesium Scaffolds) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Registry
Magmaris
Coronary Artery Disease
PCI
Resorbable Magnesium Scaffolds
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 1106
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: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions

Brief summary: The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).


Eligibility criteria: Inclusion Criteria:

* According to the IFU

Exclusion Criteria:

* According to the IFU

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Heart Center Segeberger Kliniken
city: Kempten
country: Germany
facility: Herz-und Gefäßzentrum Oberallgäu-Kempten
Study officials:
affiliation: Centro Cardiologico Monzino
name: Stefano Galli, MD
role: PRINCIPAL_INVESTIGATOR
References: