louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04381208: Medical Record, Physical and Neurological Data That Orient to the Diagnosis of Sacroiliac Joint Dysfunction
Official title: Datos de la Historia clínica y Del Examen físico y neurológico Que Orientan al diagnóstico de Dolor Originario en la articulación sacroilíaca
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sacroiliac Joint Somatic Dysfunction
Low Back Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario de Valencia
First posted: 2020-05-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being evaluated in the clinic for chronic low back pain or buttocks pain with or without radiation to the legs.

Brief summary: There are many patients coming daily to our office with the complaint of chronic lumbosacral pain radiating or not to the legs that need a proper diagnosis before any treatment is decided. The diagnosis, based mostly on radiological exams, carries a risk of failure to diagnose the sacroiliac joint as the cause of the pain. The study proposes that a quick interrogatory followed by a physical exam with the adequate provocative testing can raise the suspicion of the diagnosis that the pain is originating from the sacroiliac joint. Thereafter, a diagnostic sacroiliac joint block can be performed. The study aims to correlate findings from patient history and physical examination with eventual diagnosis.

Detailed description: This is a prospective cohort study of patients seeking care for chronic low back pain. All patients will undergo a detailed history and physical examination, followed by other indicated diagnostic testing. The analysis will correlate findings from patient history and physical examination testing with the eventual diagnosis. The goal of the study is to identify key historical and physical examination criteria that raise the suspicion for sacroiliac joint pain, which is commonly underdiagnosed. Failure to diagnose a health condition could lead to inappropriate surgery.

Eligibility criteria: Inclusion Criteria:

* Patient being evaluated in clinic for chronic low back or buttocks pain with or without radiation to the legs

Exclusion Criteria:

* Patient has already undergone surgery for the condition of interest
* Inflammatory condition
* Active cancer

Primary outcomes:
measure: Final diagnosis
timeFrame: 1-2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
References:
Clinical trial NCT01510808: The Affect of Orthodontic Treatment on the Periodontal Status of Patients With Aggressive Periodontitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aggressive Periodontitis
Keywords: aggressive periodontitis orthodontic stability
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with aggressive periodontitis in maintenance that had completed orthodontic treatment

Brief summary: Orthodontic Treatment will affect the periodontal status of periodontally treated Aggressive Periodontitis patients.


Eligibility criteria: Inclusion Criteria:

* patients with aggressive periodontitis in maintenance that had completed orthodontic treatment
* age 13-40
* with full records of periodontal treatment
* with full records of orthodontic treatment

Exclusion Criteria:

* smoking over 10 cigarets/day
* non controlled diabetes
* pregnancy
* alcohol consumption

Primary outcomes:
measure: periodontal pocket depth
timeFrame: one year
Secondary outcomes:
measure: PAR index
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Department of periodontology - Hadassah hospital
Study officials:
affiliation: Hadassa Medical Organization - department of periodontology
name: Tali Chackartchi, DMD
role: STUDY_DIRECTOR
References:
citation: Passanezi E, Janson M, Janson G, Sant'Anna AP, de Freitas MR, Henriques JF. Interdisciplinary treatment of localized juvenile periodontitis: a new perspective to an old problem. Am J Orthod Dentofacial Orthop. 2007 Feb;131(2):268-76. doi: 10.1016/j.ajodo.2005.03.025.
Clinical trial NCT01923155: Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision
Official title: Safety & Effectiveness of Nurse Performed Colonoscopies Under Supervision: A Randomized Controlled Study in Asia (NE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is no theoretical or practical reason why non-medical personnel such as nurses could not be trained to perform diagnostic colonoscopy with comparable proficiency as medical endoscopists. Nurse endoscopists have been widely accepted in the United Kingdom for the past 15 years as a valuable resource to cope with the increasing demand for endoscopic service, in particular diagnostic colonoscopy for colorectal screening. A pilot study performed in Hong Kong in 2008 has shown that endoscopy nurses can be trained to perform diagnostic endoscopy safely and reliably. This study aims to demonstrate that properly trained nurse endoscopists have a comparable proficiency in performing colonoscopy procedures as their medical counterparts.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects receiving screening colonoscopy
* 2. Age ≥ 18
* 3. Informed consent

Exclusion Criteria:

* 1. Subjects have undergone colonoscopy in the past 5 years
* 2. Patients with prior colorectal surgery
* 3. Subjects with a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial Adenomatous Polyposis or Familial non-polyposis syndrome
* 4. Pregnant or lactating women
* 5. Lack of consent

Primary outcomes:
measure: Adenoma detection rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Cecal intubation RATE
timeFrame: Up to 3 months
measure: Withdrawal time
timeFrame: Up to 3 months
measure: Complication rate
timeFrame: Up to 3 months
measure: Patients pain score
timeFrame: Up to 3 months
measure: Patients overall satisfactory score
timeFrame: Up to 3 months
measure: Cecal intubation TIME
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Tai Po
country: Hong Kong
facility: Combined Endoscopy Unit, Alice Ho Miu Ling Nethersole Hospital
Study officials:
References:
citation: Hui AJ, Lau JY, Lam PP, Chui AO, Fan AS, Lam TY, Tse YK, Tang RS, Ng SC, Wu JC, Ching JY, Wong MC, Chan FK, Sung J. Comparison of colonoscopic performance between medical and nurse endoscopists: a non-inferiority randomised controlled study in Asia. Gut. 2015 Jul;64(7):1058-62. doi: 10.1136/gutjnl-2013-306293. Epub 2014 Dec 18.
Clinical trial NCT00866255: Continuous Measurement of Intratracheal Pressure
Official title: Continuous Measurement of Intratracheal Pressure in Mechanically Ventilated Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Pressure
Keywords: endotracheal tube
endotracheal pressure
airway pressure
pressure drop
calculation
continuous calculation
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway pressure continuously measured at the proximal end of the ETT.


Eligibility criteria: Inclusion Criteria:

* Children \< 10 Years
* volume-controlled ventilation

Exclusion Criteria:

* refusal of written informed consent
* severe pulmonary diseases

Primary outcomes:
measure: tracheal pressure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
Study officials:
References:
citation: Guttmann J, Kessler V, Mols G, Hentschel R, Haberthur C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. doi: 10.1097/00003246-200004000-00018.
citation: Guttmann J, Eberhard L, Fabry B, Bertschmann W, Wolff G. Continuous calculation of intratracheal pressure in tracheally intubated patients. Anesthesiology. 1993 Sep;79(3):503-13. doi: 10.1097/00000542-199309000-00014.
citation: Spaeth J, Steinmann D, Kaltofen H, Guttmann J, Schumann S. The pressure drop across the endotracheal tube in mechanically ventilated pediatric patients. Paediatr Anaesth. 2015 Apr;25(4):413-20. doi: 10.1111/pan.12595. Epub 2014 Dec 10.
Clinical trial NCT04974255: Association of TTGA (Tissue Transglutaminase Antibody) and Histopathologic Findings in Thyroidectomy Patients
Official title: Does Gluten Sensitivity Play a Role in Development of Thyroiditis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Fibrosis
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-23
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Gluten sensitivity is the most common auto-immune disease associated with auto-immune thyroiditis. This association is through elevated anti-Tissue transglutaminase (Anti-tTG) levels both in Celiac disease and thyroiditis. In our study we tried to find if there is any correlation in between Anti-tTG and degree of fibrosis in thyroid tissue (Post-operative specimen).

Detailed description: Most common auto-immune disease associated with Celiac disease is autoimmune thyroiditis. This association in between Celiac disease and aout-immune thyroiditis is related with asymptomatic rise in anti-tTG levels. In our study, we planned to show that if there is any correlation of thyroiditis related fibrosis in thyroid tissue with anti-tTG IgA ( immune-globulin A) and IgG (immune-globulin G).

Eligibility criteria: Inclusion Criteria:

* Thyroiditis patients operated for any indication

Exclusion Criteria:

* Patients with known IgA deficiency

Primary outcomes:
measure: Amount of fibrosis in thyroid tissue and measured level of anti-tTG levels in serum
timeFrame: one day after operation
measure: Measurement of Anti-tTG levels in serum
timeFrame: one day after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: SBU Diskapi Yildirim Beyazit Training and Research Hospital
Study officials:
affiliation: Not Affliated
name: Gorkem Gundogan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03104855: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Official title: Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
vitamin d catabolism
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of this work is to provide the first comprehensive characterization of vitamin D metabolism in CF patients and promote novel hypotheses for subsequent studies.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Serum total 25(OH)D 10-50 ng/mL
* Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal CONTROL

Exclusion Criteria:

* Primary hyperparathyroidism
* Gastric bypass
* Tuberculosis or sarcoidosis
* Current pregnancy
* Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dL, serum albumin \<=3.5 g/dL, or PT \>= 4 seconds)
* History of kidney transplantation or end stage renal disease treated with dialysis
* Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
* Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
* Serum calcium \> 10.1 mg/dL
* Hemoglobin \< 9 g/dL

Primary outcomes:
measure: Metabolic Clearance of D6-25(OH)D3
timeFrame: 8 weeks
Secondary outcomes:
measure: AUC of D6-25(OH)D3
timeFrame: 8 weeks
measure: Terminal Half-life of D6-25(OH)D3
timeFrame: 8 weeks
measure: Volume of Distribution of D6-25(OH)D3
timeFrame: 8 weeks
Other outcomes:
measure: Metabolic Formation Clearance of D6-25(OH)D3 Metabolites
timeFrame: 8 weeks
measure: Serum Concentration of Calcium
timeFrame: 7 days
measure: Serum Concentration of Creatinine
timeFrame: 7 days
measure: Serum Concentration of AST
timeFrame: 7 days
measure: Serum Concentration of ALT
timeFrame: 7 days
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian de Boer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05829655: Measuring Acute Drug Demand in Humans
Official title: Measuring Acute Drug Demand in Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Opioid Use Disorder
Opioid Dependence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

Detailed description: This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the Johns Hopkins Bayview Medical Center. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years old
* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)
* Lifetime substance use history criterion \[blinded\]
* Medically cleared to take suvorexant and blinded study medications
* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

Exclusion Criteria:

* Pregnant or breast feeding
* Seeking opioid use treatment
* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff
* Known contraindications or allergies to suvorexant and/or the blinded study medications

Primary outcomes:
measure: Demand Intensity
timeFrame: Upon completion of experimental session (~8 hours post drug administration)
measure: Demand Elasticity
timeFrame: Upon completion of experimental session (~8 hours post drug administration)
measure: Cross-Price Elasticity
timeFrame: After Experimental Session 4
Secondary outcomes:
measure: Total Mean Sleep Time
timeFrame: Through study completion, up to two weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Justin Strickland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646055: AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
Official title: A Phase Ib/II Clinical Study of AK112 and Cadonilimab Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
2. ≥18 years old and ≤ 75 years (regardless of sex).
3. ECOG performance status 0-1
4. Life expectancy longer than 3 months.
5. Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal carcinoma (PDAC).
6. No prior systemic anti-tumor therapy for metastatic PDAC.
7. Adequate organ function.
8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Exclusion Criteria:

1. Histological or cytological diagnosis of other pathological types.
2. BRCA1/2 or PALB2 mutations.
3. Participating in another clinical research.
4. Active central nervous system (CNS) metastases.
5. Undergoing systemic antiangiogenic therapy.
6. Acute or subacute pancreatitis.
7. Other known malignancies within five years.
8. Active infection requiring systemic therapy.

Primary outcomes:
measure: Frequency of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 28days+28days
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Pharmacokinetics (PK)
timeFrame: Up to Cycle 12
measure: Anti-Drug Antibodies(ADAs)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of Response (DoR)
timeFrame: Up to approximately 2 years
measure: Time to Response (TTR)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.
state: Hubei
Study officials:
References:
Clinical trial NCT03596255: Clinical Estimation of Dental Anxiety
Official title: Clinical Estimation of Dental Anxiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ostergotland County Council, Sweden
First posted: 2018-07-23
Enrollment: 1230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden

Brief summary: Introduction: Dental anxiety (DA) is treatable and preventable when dental personnel correctly estimate the patient's level of DA. Objective: To evaluate dental personnel's ability to estimate DA.

Detailed description: Method: All public dental clinics in the region of Östergötland, Sweden, were asked to consecutively recruit adult patients returning for their annual examination. The patient rated DA using the Modified Dental Anxiety Scale (MDAS) and a Visual Analogue Scale of dental anxiety (DA-VAS). The patient also recorded gender, age, level of education and confidence in handling DA. After the examination, the dental personnel estimated the patient's level of DA (eDA) on a VAS. The examiner also recorded gender, age, profession, years of experience, country of education, interest in DA, special education concerning DA and confidence in ability to handle DA.

Eligibility criteria: Inclusion Criteria:

Adult patients returning for their annual examination on a public dental clinics in the region of Östergötland, Sweden during a two week period.

Exclusion Criteria:

inability to fill in the questionnaire

Primary outcomes:
measure: Estimated Dental anxiety on a 100mm VAS vs MDAS
timeFrame: through study completion, 2 weeks/clinic and a total of aproximatly 6 months
Secondary outcomes:
measure: The patients Dental Anxiety, measured whit the "Modified Dental Anxiety Scale"(MDAS)
timeFrame: through study completion, 2 weeks/clinic and a total of approximately 6 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Centrum för Orofacial Medicin, Torkelbergsgatan 11.
state: Östergötland
Study officials:
affiliation: Linköpings University, Sweden.
name: Mats Bågesund, Lecturer
role: STUDY_DIRECTOR
References: