louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00347841: Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost
Official title: Efficacy of Bimatoprost 0.03% in Patients Who Are Low-Responders to Latanoprost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the IOP-lowering efficacy of bimatoprost 0.03% in patients found to be low-responders to latanoprost therapy.


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age

  * Documented low-responder to latanoprost therapy as delineated in the outline above.
  * Diagnosis of open-angle glaucoma or ocular hypertension
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted)
  * History of intraocular surgery within the last 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Noecker
state: Pennsylvania
Study officials:
affiliation: UPMC Eye Center
name: Robert Noecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02130141: The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure
Official title: The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: cocoa
dark chocolate
hypertension
blood pressure monitoring, ambulatory
flavanols
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Fazer Group
First posted: 2014-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.


Eligibility criteria: Inclusion Criteria:

* age 25-65 years
* resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
* BMI 25.0- 29.9

Exclusion Criteria:

* smoking
* regular medication for hypertension, cardiovascular disease, diabetes or asthma

Primary outcomes:
measure: Changes in systolic and diastolic blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Ambulatory blood pressure
timeFrame: 8 weeks
measure: Blood lipids, inflammation markers, plasma levels of cocoa polyphenols
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
state: Helsingin Yliopisto
city: Helsinki
country: Finland
facility: Institute of Clinical Medicine
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Mikael Fogelholm, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koli R, Kohler K, Tonteri E, Peltonen J, Tikkanen H, Fogelholm M. Dark chocolate and reduced snack consumption in mildly hypertensive adults: an intervention study. Nutr J. 2015 Aug 22;14:84. doi: 10.1186/s12937-015-0075-3.
Clinical trial NCT03785041: Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Official title: Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain After Knee Arthroscop
Keywords: Tramadol
Intra-articular injection
Preemptive
post-arthroscopy pain
Levobupivacaine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 220
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: Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy

Detailed description: 220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25 % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain sensation. Duration till request of rescue analgesia and number of requests were recorded. Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa Satisfaction with Anesthesia Scale.

Eligibility criteria: Inclusion Criteria:

* Patient physical status according to American Society of Anesthesiology (ASA) classes I-II
* Patients free of general diseases prohibiting the use of local anesthesia.

Exclusion Criteria:

* Patients had allergy for local anesthetics or to tramadol
* Patients have psychological or neurological disorders inducing difficulty for evaluation of pain scoring.

Primary outcomes:
measure: Pain control
timeFrame: Pain assessment for 12 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT05347641: Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma
Official title: A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore PFS, ORR (CR/CRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy


Eligibility criteria: Inclusion Criteria:

* For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016
* Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions
* PS score was 0\~4 according to ECOG

Exclusion Criteria:

* Organs or lymph nodes outside the central nervous system are involved
* Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)
* Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription
* Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)
* A severe acute or chronic infection requiring systemic treatment
* The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study

Primary outcomes:
measure: 2-year PFS rate of PCNSL patients treated with penpulimab combined with RMA
timeFrame: 2 years
Secondary outcomes:
measure: ORR, 2-year OS rate and safety of penpurlimab combined with RMA in first-line treatment of PCNSL patients
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04415541: Psychodynamic Psychotherapy for Psychosis
Official title: Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: American Psychoanalytic Association
First posted: 2020-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The broad goals of our pilot study are to (1) determine whether psychodynamic psychotherapy for psychosis (PPfP), relative to treatment as usual (TaU), can maintain or augment clinical and functional benefits for patients who have achieved initial recovery in our coordinated specialty care (CSC) early psychosis treatment program; (2) to conduct novel empirical study of how various psychodynamic factors may inform candidate selection, mediate therapeutic effects, and influence relational aspects of the therapy; and (3) to conduct a detailed study of how features of therapist and patient speech and behavior influence therapeutic outcomes, therapeutic alliance alliance, and relational process. This registration focuses on the first goal.


Eligibility criteria: Inclusion Criteria:

* completed the 2-3 year Coordinated Specialty Care (CSC) program
* judged by present provider to be in an intermediate or advanced phase of recovery
* had first episode of psychosis within the 3 years prior to enrollment

Exclusion Criteria:

* established diagnosis of primary affective disorder, psychosis secondary to substance use or a medical illness
* inability to communicate in English
* eligibility for Department of Developmental Services
* legally mandated to enter treatment.

Primary outcomes:
measure: Overall Symptom Severity
timeFrame: From enrollment up to 5 years from enrollment.
measure: Overall Functioning - Social
timeFrame: From enrollment up to 5 years from enrollment.
measure: Overall Functioning - Role
timeFrame: From enrollment up to 5 years from enrollment.
Secondary outcomes:
measure: Symptom Severity (Positive Symptoms)
timeFrame: From enrollment up to 5 years from enrollment.
measure: Symptom Severity (Negative Symptoms)
timeFrame: From enrollment up to 5 years from enrollment.
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Keith Gallagher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870219: Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy
Official title: The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Electroconvulsive Therapy
Keywords: sevoflurane
ketamine
QT interval
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and Tp-e interval during in patients with major depression.

Detailed description: Patients enrolled in the study are randomly allocated by computer-generated random numbers to receive either sevoflurane or ketamine for their initial ECT session. They subsequently receive an alternative study drug in their next session, continuing to alternate between drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus is delivered, In group K, ketamine are given to 1mg/kg ıv bolus.

Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively).The QT interval and Tp-e interval are measured by one author, who was unaware of group allocation.

Eligibility criteria: Inclusion Criteria:

* Unpremedicated
* American Society of Anesthesiologists (ASA) I-II the patients
* Major depressions patients scheduled for ECT sessions

Exclusion Criteria:

* pregnant
* with permanent pacemakers,
* diabetes mellitus,
* atrial fibrillation,
* electrolyte imbalance,
* patients taking antiarrhythmics and β-blockers.

Primary outcomes:
measure: Evaluation Of QT interval
timeFrame: 10 minutes
Secondary outcomes:
measure: Evaluation of Tp-e interval
timeFrame: 10 minutes
measure: Seizure durations
timeFrame: 120 seconds
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Ozal Medical Center
Study officials:
affiliation: Associated Prof Dr
name: Feray Erdil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erdil F, Demirbilek S, Begec Z, Ozturk E, Ersoy MO. Effects of propofol or etomidate on QT interval during electroconvulsive therapy. J ECT. 2009 Sep;25(3):174-7. doi: 10.1097/YCT.0b013e3181903fa5.
Clinical trial NCT04379219: Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy
Official title: Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cesarean Scar Pregnancy
Keywords: cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 56
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez \& Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).

Detailed description: This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy

Eligibility criteria: Inclusion Criteria:•

* Gestational age before 13 w
* Past history of 1 or more CS
* Presence of GS implanted on cesareans scar

Exclusion Criteria:

* Presence of severe vaginal bleeding (emergency)
* Previous history of uterine surgery other than CS
* The whole mass is interior and the bulge is more in the cavity
* Bleeding disorder
* Patient not candidate for methotrexate (Positive fetal heart pulsation,
* Patient refuse to participate in the study

Primary outcomes:
measure: Estimated blood loss intraoperative
timeFrame: intraoperative blood loss
Secondary outcomes:
measure: need further management
timeFrame: 1 month
measure: • Rate of urological injury
timeFrame: immediatly and 1 week post operative
measure: • Rate of readmission, relaparotomy
timeFrame: with in 1 month
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahliya
Study officials:
affiliation: Mansoura University
name: Maher Elgaly
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05514119: A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
Official title: Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Liver Transplant
Keywords: Ischemic Cholangiography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).

Detailed description: In this prospective pilot study, we aim to evaluate 1) the tolerability and safety, 2) the efficacy of 12 weeks once-daily fenofibrate in reducing IC incidence after DCD liver transplantation, 3) assess the association between serum markers of cholestasis and development of IC.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT).
* At least one serum alkaline phosphatase level \>2.5x upper limit of normal between post-LT days 21-60 (inclusive).

Exclusion criteria:

* LT performed for primary sclerosing cholangitis or primary biliary cholangitis.
* Untreated hepatic artery compromise (e.g thrombosis, stenosis)
* Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT
* Renal dysfunction defined as baseline glomerular filtration rate \< 30 ml/min.
* Previously known intolerance or allergy to fenofibrate.
* Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment.

Primary outcomes:
measure: Tolerability of fenofibrate
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety of fenofibrate
timeFrame: 12 weeks
measure: Safety of fenofibrate
timeFrame: 12 weeks
measure: Safety of fenofibrate
timeFrame: Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment
measure: Safety of fenofibrate
timeFrame: 4 weeks after end of treatment
measure: Efficacy of fenofibrate
timeFrame: 12 weeks
measure: Serum biomarker association with development of IC
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Channa Jayasekera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109519: Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture
Official title: A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis User
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients in this study will be divided into two equal groups Group I (control): patients who would be delivered mandibular implant overdenture using conventional locator attachments.

Group II (study): patients who would be delivered mandibular implant overdenture using Locator RTX attachments
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments


Eligibility criteria: Inclusion Criteria:

* 1. All selected patients have two implants placed in the mandibular interforaminal region.

  2. All selected patients have a healthy mucosa and with no clinical complications.

  3. All patients are cooperative and approve the proposed treatment protocol

Exclusion Criteria:

* 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure

Primary outcomes:
measure: crestal cone loss
timeFrame: three years
measure: prosthetic complications
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University ,Faculty of dentistry
Study officials:
References: