louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02585570: Effect of Phenylephrine During Shoulder Arthroscopic Surgery
Official title: Effect of Phenylephrine Infusion for Preventing Hypotension During Shoulder Arthroscopic Surgery in the Beach Chair Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Shoulder
Anesthesia
Keywords: shoulder
phenylephrine
hypotension
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether phenylephrine infusion are effective in the prevention of hypotension after changing position to beach chair position during general anesthesia for shoulder arthroscopic surgery.

Investigators hypothesized that by increasing arterial blood pressure with phenylephrine infusion, incidence of hypotension would be decreased.

Detailed description: The beach chair position is associated with hypotension, risk of cerebral hypoperfusion, and cerebral injury. Sixty-six patients undergoing elective shoulder arthroscopic surgery are randomized to receive either phenylephrine low dose (0.5 mcg/kg/hr), phenylephrine high dose (1.0 mcg/kg/min), or normal saline 5 minute before being placed in the beach chair position.

General anesthesia is induced with propofol, remifentanil and rocuronium (0.6 mg/kg) and the trachea intubated. Anesthesia is maintained with sevoflurane and remifentanil targeting for a BIS value 40-60. After hemodynamic stabilization, patients received on infusion of either phenylephrine high dose (1.0 mcg/kg/min), phenylephrine low dose (0.5 mcg/kg/hr) or normal saline 5 minute before being placed in the beach chair position. Following 15 minutes of infusion study drugs, measurements of mean arterial blood pressure and cardiac function (stroke volume variation, stroke volume index, and cardiac index) using Vigileo/Flotrac system were made.

Eligibility criteria: Inclusion Criteria:

* shoulder arthroscopic surgery undergone beach chair position

Exclusion Criteria:

* History of cerebrovascular event,
* significant cardiac disease (New York Heart Association symptoms class ≥ 3)
* uncontrolled hypertensive patients.
* American society of anesthesiologist class 4,5

Primary outcomes:
measure: Incidence of hypotension
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae paik hospital, inje university
Study officials:
affiliation: Haeundae paik hospital, inje university
name: Ki Hwa Lee, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soeding PF, Hoy S, Hoy G, Evans M, Royse CF. Effect of phenylephrine on the haemodynamic state and cerebral oxygen saturation during anaesthesia in the upright position. Br J Anaesth. 2013 Aug;111(2):229-34. doi: 10.1093/bja/aet024. Epub 2013 Mar 21.
Clinical trial NCT06320470: MIVetsCan: Can-Coach Trial (Phase 1)
Official title: MIVetsCan: Cannabis Coaching for Veteran Pain Management Trial (Phase 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Veteran
Cannabis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan, State of, Licensing and Regulatory Affairs
First posted: 2024-03-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of the MIVetsCan Can-Coach Trial is to pilot and modify a trial of four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

Detailed description: All study interactions will be done virtually and recruitment data is exploratory.

Eligibility criteria: Inclusion Criteria:

* United States Veteran
* Experiencing chronic pain (pain lasting 3 or more months)
* Worst pain of ≥3 out of 10 using a 0-10 Numeric Rating Scale (NRS)
* Are planning or currently using cannabidiol (CBD) or cannabis products for pain management
* Able to read and speak English sufficiently to allow for informed consent and active participation in the educational intervention sessions
* Willingness to attend all study visits (conducted virtually)
* Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)

Exclusion Criteria:

* Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)
* Participant states participant is pregnant
* Current diagnosis or past history of a psychotic disorder (schizophrenia spectrum, except substance/medication -induced or due to another condition)
* Current diagnosis or past history of bipolar disorder
* Unable to attend study visits
* Risk for eminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members
* Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Primary outcomes:
measure: Patient Global Impression of Change (PGIC) score
timeFrame: Week 14
Secondary outcomes:
measure: Average satisfaction level of the cannabis coaching overall assessed from a single survey question on satisfaction.
timeFrame: Following intervention, up to approximately Week 14
measure: Average helpfulness level of the cannabis coaching assessed from a single survey question on cannabis coaching.
timeFrame: Following intervention, up to approximately Week 14
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kevin Boehnke, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03375970: Establishing the Collaborative Care Model of Traditional Chinese Medicine and Western Medicine-Pediatric Atopic Dermatitis
Official title: Establishing the Collaborative Care Model of TCM and Western Medicine-Pediatric Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Taiwan, there are many patients suffer from pediatric atopic dermatitis. Because of the clinical characteristic of repetitive and scratchy, which will affect the patients' quality of life and lead to the medical heavy budget. TCM may play an important role in this disease and help patient to improved their health. In this project, we aim to establish a Collaborative Care Model of TCM and Western Medicine, to achieve the multiple goal in clinical treatment, research and medical training. By establishing a collaborative care model, including the Chinese medicine doctor and Western medicine doctor, nurses, pharmacists and case managers, to cooperative satisfy the patient needed in the medical service, to improve the clinical presentation, patients'quality of life, and reduce exposure to corticosteroid. Besides, we can also build a training environment and reduce medical cost in long term purpose. Furthermore, by establishing a collaborative care model, we can provide a medical education and training opportunity to educate the medical student and clinician the necessary knowledge of pediatric atopic dermatitis by caring patients and learning from clinical case. According to the above training program, we not only aim to strengthen the competitiveness of Chinese medicine doctor in Taiwan, but also make the Western medicine doctors comprehend the TCM characteristic and may find out the even more opportunity to cooperate in clinical practice. To make this collaborative care model as a beginning milestone of cooperation between Chinese medicine and Western medicine.


Eligibility criteria: Inclusion Criteria:

* age 0-18
* meets the Hanifin and Rajka diagnostic criteria
* SCORAD score ≧ 25

Exclusion Criteria:

* Drug abuse
* Pregnent or lactating women
* Mental or behavioral abnormalities
* Allergic to the ingredients of the test regimen
* Any potentially life-threatening disease or dysfunctional organ system l

Primary outcomes:
measure: Scoring Atopic Dermatitis (SCORAD) score
timeFrame: week 4
Secondary outcomes:
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: week 4
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT01451970: Dietary Fatty Acid Composition and Obesity-related Metabolic Abnormalities
Official title: Assessing the Effects of Two Diets Enriched in Either Saturated or Unsaturated Fatty Acids to Determine the Cellular and Molecular Mechanisms in Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight/Obese Women
Keywords: high fat diet treatment
insulin sensitivity
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Robert C. Atkins Foundation
First posted: 2011-10-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Individuals have a significant capacity to adapt to different environments by changing their core metabolic pathways. This adaptation is especially important in regards to diet. Epidemiological research over the last several decades have shown that diets high in saturated fats have a greater ability to cause insulin resistance and the 'metabolic syndrome' while diets low in saturated fats (or a so called 'Mediterranean Diet), reduces the risk for cardiovascular disease. In humans, experimental diets high in unsaturated fats, as compared to high carbohydrate or high saturated fat diets, result in increased insulin sensitivity and improved lipid profiles.

In this application, the investigators propose to systematically assess the effects of two diets enriched in either saturated or unsaturated fatty acids and determine the cellular and molecular mechanisms of the apparent increase in insulin sensitivity. The investigators hypothesize that individuals will 'adapt' to the different diets and the investigators will be able to generate predictive alterations in gene expression and metabolites that underlie the alterations in metabolism. In parallel, the investigators will test the ability of these different diets to affect the release of gastrointestinal hormones that may be critical to modulation of appetite.


Eligibility criteria: Inclusion Criteria:

* Premenopausal females with BMI range of 25-32 kg/m2

Exclusion Criteria:

* Evidence of metabolic or cardiovascular disease, Fasting plasma glucose concentration \> 125mg/dl, Abnormal EKG, Hyperlipidemia (plasma triglyceride concentration \> 150mg/dl), Pregnancy, Hematocrit \<34%

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 2-3 hours
Secondary outcomes:
measure: Resting Metabolic Rate
timeFrame: 20-30 min
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Clincal Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580970: Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury
Official title: A Phase II Study to Prevent Radiation-Induced Rectal Injury With Lovastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
radiation therapy
lovastatin
rectal injury
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Hunter Holmes Mcguire Veteran Affairs Medical Center
First posted: 2007-12-27
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Detailed description: Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
* Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
* Age at least 18 years
* Karnofsky Performance Status (KPS) ≥ 70
* No history of prior radiotherapy to the prostate or rectum
* History of prior malignancy, if likely to live at least 4 years, is acceptable.
* No evidence of distant metastases
* Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
* Creatine kinase \< 5 times upper normal limit
* Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
* transaminases \< 3 times upper normal limit

Exclusion Criteria:

* Planned abdomino-perineal resection after radiotherapy
* Contraindication to an HMG-coA-reductase inhibitor
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Currently taking an inhibitor of cytochrome P450 3A4
* Active liver or muscle disease

Primary outcomes:
measure: Percentage of Participants With Physician Reported Rectal Toxicity ≥ Grade 2 During the First 2 Years of Radiation Treatment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veterans Administration Medical Center
state: Virginia
city: Richmond
country: United States
facility: Massey Cancer Center/Virginia Commonwealth University
state: Virginia
city: Richmond
country: United States
facility: Southside Regional Medical Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Mitchell S. Anscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05448170: Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)
Official title: Linerixibat Compassionate Use for Cholestatic Pruritus in Adult Patients With Primary Biliary Cholangitis
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pruritus
Keywords: Linerixibat
Individual Patient Compassionate Use
Primary Biliary Cholangitis
Ileal bile acid transporter (IBAT) inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-07-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have cholestatic pruritus associated with PBC who are deemed at high risk of a significant clinical event as a result of their pruritus and for whom all available pharmaceutical treatment options for cholestatic pruritus have been unsuccessful or are considered to not be appropriate.


Eligibility criteria: Inclusion Criteria:

* Participants with cholestatic pruritus associated to PBC identified by their healthcare provider as being at high risk of a significant clinical event as a result of their pruritus.
* Male and female \>= 18 years of age.
* Participants for whom all available pharmaceutical treatments for cholestatic pruritus in PBC have been unsuccessful or are considered to not be appropriate.
* Contraceptive/Barrier Requirements (applicable for female participants only): A female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

  1. Is not a woman of childbearing potential (WOCBP) OR
  2. Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat.

Exclusion Criteria:

* Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy).
* Use of obeticholic acid or other IBAT inhibitor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06393270: 5-year Clinical Follow-up of Restorative Materials
Official title: 5-year Clinical Follow-up of Bulk-fill Restorative Materials in Class II Restorations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Class II Dental Caries
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Seventy-nine patients (50 females, 29 males) between the ages of 18 and 53, and 192 restorations meeting the criteria were included in the study.

Brief summary: Materials to be used as permanent filling materials in Class II restorations are still an essential field of study. This study aims to evaluate the 5-year clinical performance of Class II restorations performed with different bulk-fill restorative materials.

The study was planned as an observational clinical trial. In the study, Class II restorations performed with Tetric Bulk Fill (TBF) and Filtek Bulk Fill (FBF) composites and Equia Forte Fil (EF) will be evaluated. Fifty-one patients and 119 restorations will be included in the study. Restorations will be assessed in terms of modified United States Public Health Service (USPHS) criteria during the 5th year. Cochran Q, Pearson chi-square, and Fisher-Freeman-Halton tests will be used for statistical analysis.


Eligibility criteria: Inclusion Criteria:

* Patients who were;

  1. older than 18 years old
  2. had good general health and oral hygiene
  3. had interface restorations of similar size in their premolars and molars
  4. were able to attend control appointments were included The teeth were determined as follows;

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  1. in contact with the opposing tooth
  2. exposed to normal occlusal forces on the dentition
  3. restoration width not exceeding 1⁄2 of the intercuspal distance
  4. normal response to vitality tests without periodontal pathology

Exclusion Criteria:

* Patients with;

  1. poor oral hygiene
  2. those with active periodontal disease
  3. those with severe bruxism
  4. pregnant and lactating women
  5. endodontically treated teeth were excluded from the study

Primary outcomes:
measure: Retention
timeFrame: 5th year.
measure: Color Match
timeFrame: 5th year.
measure: Marginal Adaptation
timeFrame: 5th year.
measure: Marginal Discoloration
timeFrame: 5th year.
measure: Secondary Caries
timeFrame: 5th year.
measure: Surface Texture
timeFrame: 5th year.
measure: Anatomical Form
timeFrame: 5th year.
measure: Postoperative Sensitivity
timeFrame: 5th year.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry
Study officials:
References:
Clinical trial NCT06766370: The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome
Official title: The Application of Multimodal Ultrasound Imaging in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: ultrasound
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study primarily utilizes ultrasound multimodal imaging to observe the changes in multiple parameter indicators before and after the treatment of nerve hydrodissection combined with transverse carpal ligament release in patients clinically diagnosed with mild to moderate Carpal Tunnel Syndrome.

Brief summary: The aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of Carpal Tunnel Syndrome.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years;
2. Presence of sensory abnormalities and motor dysfunction in the median nerve distribution area;
3. Positive Tinel's sign or Phalen's test;
4. Neurophysiological examination consistent with mild to moderate Carpal Tunnel Syndrome.-

Exclusion Criteria:

1. Severe Carpal Tunnel Syndrome;
2. Concurrent rheumatic, metabolic, systemic, or other systemic diseases;
3. Concurrent cervical spondylosis or other peripheral neuropathies;
4. Wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions;
5. Concurrent malignant tumors or severe cardiopulmonary diseases;
6. History of previous wrist surgery or injections;
7. Pregnancy;
8. Allergy to corticosteroids or local anesthetics.-

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire ，BCTQ
timeFrame: 1,3,6,12 months
Secondary outcomes:
measure: the patient's sensory nerve conduction velocity (SNCV)
timeFrame: 3,6,12months
measure: the patient's distal motor latency (DML).
timeFrame: 3,6,12months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06922370: The Osteoarticular Manifestations in Patients With Gitelman Syndrome
Official title: The Osteoarticular Manifestations in Patients With Gitelman Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gitelman Syndrome
CPPD - Calcium Pyrophosphate Deposition Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients clinically and genetically confirmed with Gitelman Syndrome

Brief summary: Patients with clinically and genetically confirmed Gitelman Syndrome are screened for CPPD, and the clinical and radiographic manifestations are collected and analyzed.

Detailed description: Patients with clinically and genetically confirmed Gitelman Syndrome are screened for calcium pyrophosphate deposition, and the clinical data and radiographic manifestations are collected and analyzed to investigate the osteoarticular features in patients with Gitelman Syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients confirmed with Gitelman Syndrome

Exclusion Criteria:

* Patients with other confounding situations such as Bartter Syndrome, hyperparathyroidism

Primary outcomes:
measure: The presence of chondrocalcinosis
timeFrame: From the enrollment to the performance of the CPPD screen
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital, Zhejiang University School of medicine
state: Zhejiang
Study officials:
References: