louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00804921: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis in Intraocular Pressure (IOP) After Bevacizumab
Official title: Effectiveness of Oral Acetazolamide, Brimonidine Tartarate, and Anterior Chamber Paracentesis for Ocular Hypertension Control After Intravitreal Bevacizumab Injection: Preliminary Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Diabetic Retinopathy
Macular Degeneration
Keywords: bevacizumab
intra-ocular pressure
acetazolamide
anterior chamber paracentesis
brimonidine
macular edema secondary to diabetic retinopathy or macular degeneration
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-12-09
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Purpose: To evaluate the effects of anterior chamber paracentesis, brimonidine and oral acetazolamide to reduce intra-ocular pressure (IOP) variations after intravitreal bevacizumab injection (IVBV).

Methods: 47 patients scheduled for IVBV (1.5 mg / 0.06 ml) will be randomly assigned to a pre-treatment 1 hour before IVBV with either 250 mg oral acetazolamide (DIA, 9 eyes), anterior chamber paracentesis immediate after IVBV (PAR, 15 eyes), topic brimonidine tartarate 1 hour before IVBV (BRI, 14 eyes), or no pre-treatment IBVB (CTR, 9 eyes). IOP will be measured 90 minutes before injection (baseline), just before injection, and at 3, 10, 20 and 30 minutes after the procedure.


Eligibility criteria: Inclusion Criteria:

* macular edema

Exclusion Criteria:

* pulmonary chronic problems
* chronic renal failure
* intraocular inflammation
* drug or alcohol addiction

Primary outcomes:
measure: Intra-ocular pressure variation after intra-vitreous injection of bevacizumab
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: School of Medicine - Clinical Hospital
state: SP
Study officials:
References:
Clinical trial NCT00762021: Posterior Capsule Opacification (PCO) Evaluation of the AcrySof SN60AT Lens vs. SN60WF Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 104
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.


Eligibility criteria: Inclusion Criteria:

* patients with bilateral senile cataracts
* Age \> 50 years
* Fit for hospital follow ups
* Pupils dilating \> 6mm preoperatively
* Eyes expected to see 6/12 or better postoperatively

Exclusion Criteria:

* Diabetes
* On treatment for glaucoma
* Other ocular pathology
* Previous ocular surgery

Primary outcomes:
measure: Posterior Capsule Opacification (PCO)
timeFrame: 2 years after surgery
measure: 100% LogMAR Best Corrected Visual Acuity (BCVA)
timeFrame: 24 months after surgery
measure: 9% LogMAR Best Corrected Visual Acuity (BCVA)
timeFrame: 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01066221: Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile
Official title: Comparative Study of Enzyme Immunoassays:Techlab Toxins A&B, C Diff Quick Check for Glutamate Dehydrogenase (GDH);3 PCRs,and Cytotoxin Assay (CTA) for the Detection of Clostridium Difficile Toxin in Adult Stool Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile
Keywords: clostridium difficile
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: St. Joseph's Healthcare Hamilton
First posted: 2010-02-10
Enrollment: 470
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hamilton Regional Laboratory Medicine Program - patients with clostridium difficile

Brief summary: The purpose of this study is to establish which of the following tests perform best in diagnosing clostridium difficile. PCR, Enzyme Immunoassays (EIA) and C. difficile cytotoxin assay (CTA).

Detailed description: This comparative study will be carried out in the hospital microbiology laboratory of a tertiary academic health center, St. Joseph's Healthcare (SJH) affiliated with McMaster University, Hamilton, ON on 500 individual stool samples from patients greater than 12 months of age to determine an efficacy of distinction between current gold standard and other methods of testing for Clostridium difficile. This study is required to find a faster test for diagnosis of CDI in order to facilitate prompt treatment and reduce the complications of CDI. Identification of infected cases will lead to the enforcement of infection control measures and thereby prevent spread to other susceptible children. This is turn will reduce costs, length of stay, morbidity, and mortality from CDI if instituted correctly.

Eligibility criteria: Inclusion Criteria:

* Patients older than 12 months of age
* Having diarrhea

Exclusion Criteria:

* Inadequate volume of sample to perform all three diagnostic tests (less than 3mL
* Formed stools

Primary outcomes:
measure: To establish the performances of the three testing assays to see which one is the best.
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Christine Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05614921: External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy
Official title: Ultrasound Guided External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Erzurum City Hospital
name: Bursa City Hospital
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago.

Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged postoperative pain may cause early ambulation and delay performing deep breathing exercises.

Using regional anesthetic techniques results in less opioid use and better pain management. External oblique internal costal block; It is a new block that provides dermatomal sensory blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be used as part of multimodal analgesia in laparoscopic cases.

There is no study in the literature regarding the use of external oblique plane block in bariatric surgery yet.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Laparoscopic Obesity surgery

Exclusion Criteria:

* Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postextubation 0-24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
References:
citation: White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.
citation: Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.
Clinical trial NCT05071521: The Effectiveness of an Eating Disorders Prevention Program for Young Women in Saudi Arabia
Official title: The Effectiveness of a Dissonance-based Eating Disorders Prevention Programme for Saudi Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Symptom and Body Image Dissatisfaction
Lead sponsor: University of Sheffield
Sponsor class: OTHER
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2021-10-08
Enrollment: 92
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial is a randomized control trial about the effective of an eating disorders prevention programmer for young Saudi women.

The prevention program is title The Body Project. Participants will be Saudi undergraduates from Princess Nourah Bint Abdulrahman University. Sample size is 64 participants. They will be divided randomly to two groups, each group has 32 participants. The first group is the intervention group where the prevention program will be provided. The second group will be the control group where healthy eating education material will be provided. The outcomes will be measured with adapted tools to local culture at three points (pre, post and 3 month follow-up).


Eligibility criteria: Inclusion Criteria:

undergraduate Saudi female

Exclusion Criteria:

undergraduate Saudi female with eating disorders

Primary outcomes:
measure: Eating Disorder Examination-Questionnaire (EDE-Q, version 6.0).
timeFrame: 5 months
Secondary outcomes:
measure: Body Shape Questionnaire (BSQ-8C).
timeFrame: 5 months
measure: Brief Version of the Fear of Negative Evaluation Scale (BFNE).
timeFrame: 5 months
measure: Patient Health Questionnaire (PHQ-9).
timeFrame: 5 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Nourah Bint Abdulrahman University
Study officials:
References:
Clinical trial NCT04359121: COVID-19 and the Developement of Phobic Fears of Disease
Official title: COVID-19 and the Developement of Phobic Fears of Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID19
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: physicians, medical staff, general public, patients with psychiatric disorders

Brief summary: A lot of people suffer from phobias. Phobias concerning certain diseases are not rare. This study will examine whether the COVID-19 (Coronavirus Disease) crisis was able to rise phobias in people and if those with preexisting phobias or fears were more likely to develop a phobia concerning COVID. It will look at different subtypes - physicians, medical staff, general public (not medically affiliated) and patients with psychiatric disorders.


Eligibility criteria: Inclusion Criteria:

* Person gives written consent
* Persons between 18-90 years of age (men and women)
* No positive COVID infection known at time of first examination

Exclusion Criteria:

* Dementia, Delirium (not able to give consent)
* Not fulfilling the inclusion criteria
* COVID infection known at first examination point

Primary outcomes:
measure: Development of phobias
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Andreas Baranyi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300921: A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
Official title: A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A: 50mcg IV weekly Arm B: 12mcg PO daily
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) on pancreatic tumors in patients who are planned for surgical removal of their tumor. The study will also look at the safety of paricalcitol prior to surgery.


Eligibility criteria: Inclusion Criteria:

* Previously untreated, apparently resectable, adenocarcinoma of the pancreas at registration.
* Age greater than or equal to 18 years
* Medically fit for surgery in the opinion of the treating surgeon
* Ability to provide written informed consent

Exclusion Criteria:

- Patients who are currently pregnant, planning to become pregnant, or breast-feeding.

Note: women of childbearing potential must agree to use a medically accepted form of birth control including (condoms, diaphragms, cervical cap, an intra-uterine device (IUD), surgical sterility \[tubal ligation or a partner that has undergone a vasectomy\], or oral contraceptives). OR must agree to completely abstain from intercourse for two weeks before beginning study treatment, during participation in this study, and for 2 weeks after the final study treatment

* Patients with hypercalcemia (blood levels greater than 11.5 mg/dL). Note: In patients with GFR 30-60 mL/min by Cockroft-Gault, blood calcium levels must be 9.5 mg/dL or lower before starting paricalcitol.
* Serum creatinine \> 2.5 x ULN OR GFR \<30 mL/min by Cockroft-Gault formula . Patients who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01188421: Medications Development for Drug Abuse Disorders
Official title: Medications Development for Drug Abuse Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Opioid Related Disorders
Opioid Dependence
Opioid Addiction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.


Eligibility criteria: Inclusion/Exclusion Criteria:

* Participants in this study will be males and females between the ages of 18 and 60 years.
* Applicants must be opioid dependent based upon the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (SCID); in addition, they must have an opioid positive urine during the screening process (or have evidence of opioid withdrawal).
* They must be healthy, with no significant medical illnesses (e.g., insulin dependent diabetes), and without significant psychiatric illness (e.g., schizophrenia) besides their drug dependence.
* Females will have a pregnancy test prior to study enrollment, and if found to be pregnant will be excluded and referred to a substance abuse program for pregnant women (the Center for Addiction and Pregnancy) on the campus.
* Volunteers will also be excluded if they have pre-admission hypotension (due to the use of clonidine in the study).
* Applicants with a history of seizures (including substance-related seizures, such as alcohol withdrawal related) will be excluded.
* Alcohol and/or sedative dependence will be specific exclusionary criteria (given the small risk of seizures associated with tramadol use).
* Allergies to any of the study medications will be grounds for exclusion.

Primary outcomes:
measure: Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period.
timeFrame: 14 days total
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eric C. Strain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunn KE, Tompkins DA, Bigelow GE, Strain EC. Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):885-893. doi: 10.1001/jamapsychiatry.2017.1838.
Clinical trial NCT04707521: Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal Intubation
Official title: Application of Ship - Shaped Adhesive Tape Fixing in Patients Undergoing Tracheal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3M tape ship-shaped combined with strap fixing method
Primary purpose: OTHER

Brief summary: In order to evaluate the safety and value of the improved ship-shaped fixing on tracheal intubation patients and provide theoretical basis for clinical therapy, we conducted this research to compare the fixed effectiveness, complications, nursing workload and medical expenses about application of ship-shaped adhesive tape fixation on patient undergoing tracheal intubation.

Detailed description: the fixed effectiveness：Incidence of catheter displacement，Incidence of unplanned extubation.

complications：Incidence f skin damage，Oral care effect，Incidence of ventilator-associated pneumonia.

nursing workload:Oral care is time-consuming medical expenses :Material economic cost

Eligibility criteria: Inclusion Criteria:

* Patients with SICU intubation had been intubated for \<8h at the time of entry (the interval of oral care was 8h);
* Patients with brain diseases or septic shock caused by abdominal infection;
* There was no pulmonary infection before endotracheal intubation.
* Facial skin integrity;
* Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity;
* Informed consent is given by the family members and the informed consent is signed;
* No adhesive tape allergy.

Exclusion Criteria:

* Oral injury caused by suction;
* Endotracheal intubation time \< 48 h;
* In the experiment is not willing to carry on the experiment, quit voluntarily.

Primary outcomes:
measure: the fixed effectiveness of endotracheal intubation
timeFrame: 34 weeks
Secondary outcomes:
measure: Complications associated with endotracheal intubation fixation
timeFrame: 34 weeks
Other outcomes:
measure: Economic indicators
timeFrame: 34 weeks
measure: Nursing workload
timeFrame: 34 weeks
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05908721: Study of CM310 in Patients With Allergic Rhinitis
Official title: A Multicenter, Single Arm Phase II Clinical Study Evaluating the Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

Detailed description: Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-65.
* Understand the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs.
* Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310.
* Plan to participate in other studies during this clinical trial.
* With malignant or benign tumors of the nasal cavity.
* Other reasons the researcher believes that the subject is not suitable to participate in this study.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tong-Ren hospital
Study officials:
affiliation: Beijing Tong-Ren hospital
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
References: