louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01159548: Efficacy of Low Dose Promethazine for Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ambulatory Gynecological Laparoscopic Procedures
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: There has been an increase in ambulatory surgical procedures performed across Canada; ambulatory procedures account for almost 70% of all surgeries. Postoperative nausea and vomiting (PONV) and pain are the most frequently reported adverse events by patients prior to discharge after ambulatory surgery. The incidence can be as high as 70 to 80% in high-risk patients.

PONV is a cause of morbidity particularly in gynecological procedures and the incidence of patients experiencing PONV is as high as 58-75%. Apart from delayed recovery, the occurrence of PONV has been linked to gastric aspiration, psychological distress and wound dehiscence. The occurrence of PONV delays patient discharge and further more is a leading cause of unexpected admission after ambulatory anesthesia

Promethazine, is an antiemetic medication that has been widely used over the last 50 years, and although effective at reducing PONV, it tends to cause sedation. In this study, we are trying to determine if a smaller dose of promethazine, in addition to the standard treatment for post-surgical nausea and vomiting, will be more beneficial than the standard treatment on its own.

It is hypothesized that the use of low dose promethazine (3 mg) as part of a multimodal antiemetic regimen will be efficacious in preventing PONV without the sedative effects of promethazine.


Eligibility criteria: Inclusion Criteria:

1. Patient is between 18 - 60 yrs of age

2 Patient's health is graded as class I-III according to the American Society of Anesthesiologists physical status classification.

3. The patient has 2 or more of the following risk factors:

* Female
* Non-smoker
* History of PONV/motion sickness
* Use of post-operative opioids (current surgery)

  4. Undergoing ambulatory gynecological laparoscopic procedures of at least 30 minutes duration

Exclusion Criteria:

* preexisting nausea, vomiting or retching, gastric outlet or intestinal obstruction
* clinical evidence of a difficult airway
* obesity (body mass index \> 40 kg m-2)
* scheduled to receive propofol for anesthesia maintenance
* current pregnancy
* psychiatric illness
* clinically significant major organic disease
* preoperative QTc interval \> 440 ms on electrocardiogram
* known hypersensitivity to promethazine, granisetron, ondansetron or other 5 HT3-receptor antagonists

Primary outcomes:
measure: Absence of emetic episode for 24 h in the postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Jean Kronberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172848: Mastery, Social Support and Depression of Patients With Major Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study was to discuss the relation of mastery, social support and depression in patients with depressive disorder. Cross-sectional quantitive study and purposive sampling method were designed. Data collection and analysis was conducted through structural questionnaires (including demographics, social support scale, mastery scale, CESD scale) at a medical center in Taipei. Results showed that patients with depression whose degree of depression was negative correlated with mastery and social support, and mastery was positive correlated with social support. Regression statistics results showed that mastery, social support, age, loss of jobs can predict degree of depression up to 60 percent. The mastery was strongest independent predictable factor to degree of depression, and had partial or total mediate effects to age, loss of jobs, financial condition, and social support. The result of this study suggested that clinically the care of patients with depression should focus on their confidence in mastery and provide strategies to promote their confidence in mastery, which can effectively reduce the degree of depression of those patients.


Eligibility criteria: Inclusion Criteria:

* patients with depression

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ping-Chuan,Hsiung
Study officials:
affiliation: Department of Nursing, National Taiwan Umiversity
name: Ping-Chuan Hsiung, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT03701048: Rectus Musle Reapproximation During Cesarean Section
Official title: Intraoperative and Postoperative Results of Rectus Musle Reapproximation During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: During Cesarean section in Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Detailed description: Pfannenstiel incision will be done under general or spinal anesthesia. The abdomen will be opened and fetus and placenta will be delivered. Then the abdomen will be closed. In Group 1 rectus muscle will be closed with interrupted sutures. In group 2 rectus muscle will not be closed. Postoperative pain scores, distance between the rectus muscles and bowel functions will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old women undergoing cesarean section

Exclusion Criteria:

* grandmultiparas

Primary outcomes:
measure: Postoperative pain: Visual Analog Score
timeFrame: 24 hours after the procedure
measure: Postoperative interrectus distance
timeFrame: 6 weeks after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSRTH
Study officials:
affiliation: KSSTRH
name: Berna Aslan A Çetin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyell DJ, Naqvi M, Wong A, Urban R, Carvalho B. Rectus Muscle Reapproximation at Cesarean Delivery and Postoperative Pain: A Randomized Controlled Trial. Surg J (N Y). 2017 Aug 11;3(3):e128-e133. doi: 10.1055/s-0037-1604074. eCollection 2017 Jul.
Clinical trial NCT04273048: The MOM TO BE Study
Official title: A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 14
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research will last up to 12 weeks. The participant will attend two research study visits and will be asked to donate oocytes and follicular fluid to the study team during their oocyte retrieval procedures. They will be randomized (like flipping a coin) to either a standard of care group or an intervention group. If they are in the intervention group, they will also be asked to follow a Mediterranean diet (all meals will be shipped to their home weekly) and exercise at least 3 times a week at a gym or at their house. If they are in the control group, they will follow the normal fertility clinic procedures.
Primary purpose: OTHER

Brief summary: This research study is about the effects of diet and exercise in women undergoing fertility treatment.

Detailed description: This study will randomize women who are undergoing fertility treatment and put them either in an intervention group or standard care. This study should help us learn if diet and exercise changes oocytes gene expression and follicular fluid content.

Eligibility criteria: Inclusion Criteria:

* BMI 25 - 45 kg/m2
* ≥ 21 years of age

Exclusion Criteria:

* Pre-existing conditions (e.g. sexual transmitted diseases) that will affect the outcomes of the study as determined by the principal investigator
* Current use of recreational drugs, tobacco, or alcohol
* Food allergies, intolerances or preferences which would interfere with compliance to the meal plan
* Contraindications to exercise
* Already meeting the physical activity guidelines (150 min moderate activity/week or 75 minutes of vigorous activity/week with resistance exercise on 2 or more days/week).

Primary outcomes:
measure: Oocyte gene expression profile
timeFrame: 8-12 weeks
measure: Follicular fluid content
timeFrame: 8-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
citation: Fawcett K, Martinez A, Crimmins M, Sims C, Borsheim E, Andres A. Effect of a dietary and exercise intervention in women with overweight and obesity undergoing fertility treatments: protocol for a randomized controlled trial. BMC Nutr. 2021 Aug 17;7(1):51. doi: 10.1186/s40795-021-00454-y.
Clinical trial NCT01069848: Feasibility Study of the Vedera KXS for Treatment of Keratoconus
Official title: Feasibility Study of the Vedera KXS for Treatment of Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 23
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this investigation is to evaluate the feasibility, safety and efficacy of the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or glasses.


Eligibility criteria: Inclusion Criteria:

1. 14 years of age or older
2. Presence of central or inferior steepening on the Pentacam map
3. Axial topography consistent with keratoconus
4. I-S ratio \> 1.5 on the Pentacam map or topography map
5. BSCVA worse than 20/20 (\<53 letters on ETDRS chart)
6. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
7. Signed written informed consent
8. Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

1. Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
2. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
3. Corneal pachymetry \<400 microns at diameter to be treated.
4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

   1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
   2. Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
5. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
6. Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
7. Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.

Primary outcomes:
measure: The reduction in Kmax (by keratometry) of >1 D
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beyoglu Eye Hospital
Study officials:
References:
Clinical trial NCT03534648: Evaluation of Pharmacokinetic Drug Drug Interaction Between PF-05221304 And PF-06865571 In Healthy Adult Subjects
Official title: A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Drug drug interaction study between PF-05221304 and PF-06865571

Detailed description: A Phase 1, Open Label, Two-cohort, Non-randomized Fixed Sequence Study To Evaluate The Pharmacokinetic Drug Drug Interaction Between Pf-05221304 And Pf-06865571 In Healthy Adult Subjects

Eligibility criteria: Inclusion criteria:

1. Healthy female subjects of nonchildbearing potential and/or male subjects.
2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
2. Any condition possibly affecting drug absorption.
3. A positive urine drug test.
4. Screening supine BP 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
5. Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec.

   -

Primary outcomes:
measure: Arm 1: PF-05221304 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Day 7, 0-12 hours and Day 14 0-12 hours
measure: Arm 1: PF-05221304 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
timeFrame: Day 7, 0-12 hours and Day 14 0-12 hours
measure: Arm 2: PF-06865571 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
timeFrame: Day 7, 0-12 hours and Day 14 0-12 hours
measure: Arm 2: PF-06865571 Maximum observed concentration from Time Zero to End if Dosing Interval (Cmax)
timeFrame: Day 7, 0-12 hours and Day 14 0-12 hours
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Screening up to 28 days after last dose of study medication
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05632848: Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients
Official title: The Efficacy and Safety of Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients: A Single-armed, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: Chidamide plus Zimberelimab
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 47
Sex: FEMALE
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: The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.

Detailed description: This is a phase II, single center, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. This study plans to recruit 47 subjects.

Eligibility criteria: Inclusion Criteria:

* Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis.
* At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Fail first-line or above anti-tumor treatment.
* Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
* Compliance with the study protocol.
* Have provided written and signed informed consent.
* Minimum life expectancy 16 weeks.

Exclusion Criteria:

* Pregnant or breast feeding.
* Uncontrolled medical problems.
* Evidence of active acute or chronic infection.
* Hepatic, renal, cardiac, or bone marrow dysfunction.
* Concurrent malignancy or history of other malignancy within the last five years.
* Known severe hypersensitivity to Chidamide or Zimberelimab
* Patients were unable or unwilling to comply with program requirements.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 18 months
Secondary outcomes:
measure: Clinical benefit rate (CBR)
timeFrame: 18 months
measure: Progression Free Survival (PFS)
timeFrame: 24 months
measure: Overall Survival (OS)
timeFrame: 30 months
measure: Occurrence and severity of AEs
timeFrame: 30 months
Other outcomes:
measure: Biomarkers related to efficacy
timeFrame: 24 months
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University, Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-yu Yuan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05290948: Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Official title: Comparison of Combined Intravitreal Bevacizumab and Oral Acetazolamide Versus Intravitreal Bevacizumab Alone for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, which will be performed as a randomized clinical trial, all patients with macular edema with central involvement (central macular thickness greater than 300 μm) and corrected vision less than or equal to 20/40 and better than 20/400 were included in the study. After a thorough eye examination, people are randomly divided into two groups. The first group was treated with intravitreal injection of Bevacizumab in three injections one month apart with receiving oral Acetazolamide tablets of 250 mg twice a day, and the second group was treated with intravitreal injection of Bevacizumab for three Loads are spaced one month apart. Ophthalmologic examinations and corrected visual acuity, as well as macular thickness examination, are repeated with Spectral-domain Optical coherence tomography (SD-OCT) at the beginning of treatment and at the end of the first, second, and third months. At the end of the study, the rate of changes in visual acuity and macular thickness in the eyes in the two groups will be compared and will be statistically analyzed.


Eligibility criteria: Inclusion Criteria:

* 20 / 400≤ Best Corrected Visual Acuity ≤20 / 40
* Central macular thickness \<300 μm
* The onset of the disease is less than three years
* No other eye diseases that affect the evaluation and process of this study.

Exclusion Criteria:

* It is not possible to provide informed consent.
* Patients who are prohibited from taking oral acetazolamide (renal failure, hepatic failure, history of allergies)
* Other eye diseases that affect the evaluation and process of this study. Including diabetes retinopathy
* History of retinal laser photocoagulation

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 3 months
Secondary outcomes:
measure: Central macular thickness
timeFrame: 3 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research center
Study officials:
References:
Clinical trial NCT03275948: Effects of Whole Grain Rye on Metabolic Risk Markers and Mood
Official title: Effects of Whole Grain on Cognitive Performance and Mood, and the Relationships to Cardiometabolic Risk Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disorders and Cognitive Decline
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate, in healthy middle age subjects, effects of whole grain rye on cognitive functions, mood, and cardiovasculair risk markers


Eligibility criteria: Inclusion Criteria:

* healthy
* BMI 19-28
* plasma glucose \< 6.1 mmol/L
* non smooker

Exclusion Criteria:

* known metabolic diseases
* known gastrointestinal disorders
* known cognitive decline.

Primary outcomes:
measure: cognitive performance
timeFrame: postprandial 0-180 min after breakfast
Secondary outcomes:
measure: glucose tolerance
timeFrame: 0-180 min after breakfast
Other outcomes:
Locations:
Study officials:
References:
citation: Sandberg JC, Bjorck IME, Nilsson AC. Impact of rye-based evening meals on cognitive functions, mood and cardiometabolic risk factors: a randomized controlled study in healthy middle-aged subjects. Nutr J. 2018 Nov 6;17(1):102. doi: 10.1186/s12937-018-0412-4.