louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05351944: Dialectical Behavioral Therapy Skills for Impulsive Aggression
Official title: Dialectical Behavioral Therapy Skills for Impulsive Aggression in Children Diagnosed with Attention Deficit Hyperactivity Disorder At Alexandria University Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impulsive Aggression
ADHD
Executive Dysfunction
Keywords: DBT
aggression
ADHD
biomarkers
executive functions
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 66
Sex: MALE
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control clinical trial
Primary purpose: TREATMENT

Brief summary: This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.


Eligibility criteria: Inclusion Criteria:

* Patients from 6 to 13-year-old.
* Patients diagnosed with ADHD and presented with impulsive aggression.
* Commitment to therapy from the child and the parent.
* Written consent of all the children parents.
* Male gender.
* Drug naïve or stopped medications for at least one month.

Exclusion Criteria:

* Patients younger than 6 years of age as it's the starting age for DBT-C.
* Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent.
* Patients diagnosed with drug abuse.
* Patients with severe sensory impairment or intellectual disability.
* Drug induced aggression as levetiracetam, topiramate and benzodiazepines.
* Patients diagnosed with Autism spectrum disorder or psychotic disorders.

Primary outcomes:
measure: Impulsive aggression severity
timeFrame: Change from Baseline at 12 month
measure: Biomarkers of aggression 1
timeFrame: Change from Baseline 12 month
measure: Biomarkers of aggression 2
timeFrame: Change from Baseline 12 month
measure: Biomarkers of aggression 3
timeFrame: Change from Baseline 12 month
Secondary outcomes:
measure: Executive dysfunctions severity
timeFrame: Change from Baseline 12 month
measure: ADHD symptom severity
timeFrame: Change from Baseline 12 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
affiliation: Alexandria University
name: aya maged, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593744: Thyroid Dysfunction Induced by Anti-PD-1 Therapy in Patients With Advanced Carcinoma
Official title: Study on the Correlation Between Thyroid Dysfunction Induced by Anti PD-1 Therapy and Prognosis in Patients With Advanced Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with advanced carcinoma who received anti-PD-1 therapy at East Branch of Qilu Hospital of Shandong University

Brief summary: In this study, we monitored patients with advanced malignant tumors who received anti-PD-1 therapy to observe the characteristic of anti-PD-1 therapy-induced thyroid dysfunction and its correlation with prognosis.


Eligibility criteria: Inclusion Criteria:

* Eighteen years or older
* Confirmed diagnosis of malignancy
* Received anti-PD-1 therapy

Exclusion Criteria:

* Thyroid malignancy or history of thyroid malignancy
* Thyroid dysfunction before anti-PD-1 therapies
* Previous ICIs treatment
* Less than 2 cycles of anti-PD-1 treatment
* No thyroid function monitoring during treatment
* Known pituitary disease
* Pregnancy.

Primary outcomes:
measure: Progression-free survival
timeFrame: Through study completion, an average of 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT01977144: Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Official title: Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Single Embryo Transfer
Double Embryo Transfer
CCS (Comprehensive Chromosome Screening)
Aneuploidy
Low Responders
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS) on patients with low ovarian reserve in an effort to improve success during in vitro fertilization and decrease the time to successful pregnancy.

Detailed description: Patients will undergo a stimulated IVF cycle culminating with an ultrasound guided egg retrieval procedure and either a fresh or frozen embryo transfer as clinically appropriate and without regard to study. All embryology laboratory procedures will be conducted per routine. Once the embryo(s) have reached the blastocyst stage of development patients will be randomized into either the study group or the control group. The SOLAIRE Trial is "blinded" which means neither patients nor the RMANJ study doctor/staff will know to which group the embryos were randomized. The study group will have their embryo(s) biopsied for CCS on day 5, if appropriate, for a fresh day 6 embryo transfer. The control group will not have CCS testing performed on their embryo(s) and may proceed with a fresh or frozen embryo transfer as clinically appropriate. The maximum amount of embryos that can be transferred is two per RMANJ protocol. All post-transfer care and pregnancy monitoring will be identical and per routine protocol regardless of study participation.

Eligibility criteria: Inclusion Criteria:

* Age of female partner \< 43 y/o AMH \< 1.1 OR BAFC \< 8 (within previous year) Male must have \>100,000 motile sperm BMI \< 32

Exclusion Criteria:

* Diagnosis of endometrial insufficiency Use of oocyte donor/gestational carriers Use of surgical sperm or DNA Banking Communicating hydosalpinges (HSG) Single gene disorders or sex selection Participation in another study

Primary outcomes:
measure: Delivery rate
timeFrame: 2 years
Secondary outcomes:
measure: pregnancy rate per ET
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD, HCLD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
Clinical trial NCT01514344: Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
Official title: Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
Keywords: OAL
MALT
conjunctiva
indolent
CD20+
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 20
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: Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Detailed description: Preliminary data suggest intralesional rituximab is able to revert resistance to systemic rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of autologous serum seems to exhibit a synergistic effect on tumor regression. These two main aspects will be assessed in this trial.

Eligibility criteria: Inclusion Criteria:

* histological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma
* conjunctival localization alone (1EA stage; mono- or bilateral)
* at least one measurable lesion
* age \>/= 18 years
* ECOG-PS \</=3
* HIV 1-2 negativity
* at least one previous treatment (antibiotic or rituximab)

Exclusion Criteria:

* concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
* known allergy to rituximab
* systemic symptoms
* concurrent diagnosis of pemphigus
* postsurgical conjunctival scars

Primary outcomes:
measure: assessment of safety
timeFrame: During experimental treatment (within 7 months from trial registration)
Secondary outcomes:
measure: assessment of activity
timeFrame: at the end of experimental treatment (at 7th month from trial registration)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Study officials:
affiliation: San Raffaele Scientific Institute, Milano, Italy
name: Andrés JM Ferreri, MD
role: STUDY_CHAIR
References:
citation: Ferreri AJM, Sassone M, Miserocchi E, Govi S, Cecchetti C, Corti ME, Mappa S, Arcaini L, Zaja F, Todeschini G, Mannina D, Calimeri T, Perrone S, Ponzoni M, Modorati G. Treatment of MALT lymphoma of the conjunctiva with intralesional rituximab supplemented with autologous serum. Blood Adv. 2020 Mar 24;4(6):1013-1019. doi: 10.1182/bloodadvances.2020001459.
Clinical trial NCT05674344: Calibration and Validation of the Masimo Temperature Device in Febrile Patients
Official title: Calibration and Validation of the Masimo Rad-G With Temperature Device in Febrile Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 170
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to test the performance of the Masimo noninvasive temperature device in patients with fever. The main question it aims to answer is whether the Masimo temperature device is comparable to standard methods of taking temperature such as inserting a probe under the tongue or using a forehead thermometer.

Participants will be asked to sit still while rounds of measurements are taken using the Masimo temperature device and the reference temperature device. Researchers will compare the measurements taken with the Masimo device with the measurements taken with the reference device.

Detailed description: Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05787782, NCT05674344, and NCT05779397)

Eligibility criteria: Inclusion Criteria:

* Patients age ≥ 1year old
* Febrile at time of enrollment: ≥ 99.5oF/37.5oC for patients ages 1-5 years; ≥ 100.4oF/38oC for patients older than 5 years old.
* English- or Spanish-speaking patient or parent/LAR

Exclusion Criteria:

* Patients deemed not suitable for the study at the discretion of the investigator
* Patients who are rated as a 1 or 2 Emergency Severity Index

Primary outcomes:
measure: Accuracy of Masimo RAD-GT Temperature Measurments
timeFrame: 15-30 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Site 1
state: California
Study officials:
References:
Clinical trial NCT03742544: Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Official title: Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Dyslipidemias
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-11-15
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of Korea, in real-world practice

Brief summary: Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)

Detailed description: Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.

Eligibility criteria: Inclusion Criteria:

* The patient who is first prescribed and administered Telostop plus Tab.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* The patients to the "Do not administer to the next patient" section of the approved instructions for use

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical practice
timeFrame: 24 weeks
Secondary outcomes:
measure: The change from baseline to week 24 in the LDL cholesterol
timeFrame: 24 weeks
measure: The change from baseline to week 24 in the blood pressure
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06516744: A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
Official title: A Single Group Study to Evaluate the Efficacy of Bye Bye Bloat Capsules in Relieving Bloating and Promoting Healthy Digestion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Health
Digestion
Keywords: Gastrointestinal Symptoms
Hormonal Bloating
Capsule Supplement
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This virtual single-group study aims to evaluate the efficacy of Bye Bye Bloat Capsules in relieving hormonal and food-related bloating and promoting healthy digestion. The study will last 4 weeks, involving 40 female participants aged 18+ who will take two capsules after meals and during times of bloating. Measurements and questionnaires will be completed at Baseline, first use, Week 2, and Week 4.


Eligibility criteria: Inclusion Criteria:

* Women aged 18+
* Self-reported concerns with bloating after eating
* Issues with hormonal bloating
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid using digestive health remedies and other oral supplements during the study

Exclusion Criteria:

* Pre-existing chronic conditions preventing adherence to the protocol
* Undergoing procedures related to digestive health
* Started new medications or supplements targeting digestive health in the past 3 months
* Severe allergic reactions requiring an Epi-Pen
* Pregnant, breastfeeding, or attempting to conceive
* Unwilling to follow the study protocol
* Recent surgeries or planned surgeries during the study
* Diagnosed gastrointestinal disorders
* Recent changes in hormonal birth control use

Primary outcomes:
measure: Reduction in Bloating
timeFrame: Baseline, first use, Week 2, and Week 4
Secondary outcomes:
measure: Improvement in Digestion and Mental Well-being
timeFrame: Baseline, first use, Week 2, and Week 4
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT02130544: Acute Pain Management Following Video-assisted Thoracoscopic Surgery: Comparison of Lobectomy and Wedge Resection
Official title: Acute Pain Management Following Video-assisted Thoracoscopic Surgery: Comparison of Lobectomy and Wedge Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pain
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected patients are from the hospital patients who are arranged to have video-assisted thoracoscopic surgery for lobectomy or wedge resection

Brief summary: Viedo-assisted thoracoscopic surgery(VATS) have became popular in recent years. There is no golden rule of postoperative analgesia for VATS. Compared with lobectomy, wedge resection preserves better pulmonary function and is suitable for elder patients and patients who could not afford to have lobectomy. In addition to surgery time、recovery time and hospital stay, wound incisions and organization damages are different,too. Will patients also have different response to pain control after these two surgery? The retrospective study is to compared the differences of postoperative pain management between VATS lobectomy and wedge resection.


Eligibility criteria: Inclusion Criteria:

1. Age \>= 20
2. Using intravenous patient-controlled analgesia for postoperative analgesia
3. ASA physical status classification I-III

Exclusion Criteria:

1. Staying in intensive care unit after surgery
2. Emergency surgery
3. Pregnancy
4. Other surgery incisions which are not used for the video-assisted thoracoscopic surgery
5. Patients never use intravenous patient-controlled analgesia after surgery

Primary outcomes:
measure: Postoperative pain scale
timeFrame: postoperative day 1 to day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ya-Jung Cheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04742244: Lemon Verbena Extract Oxidative Stress and Muscle Damage
Official title: Evaluation of the Efficacy of Supplementation With Lemon Verbena Extract in Improving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Injury
Muscle Soreness
Keywords: DOMS,
Lemon verbena
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, investigators investigated whether supplementation with lemon verbena extract (LVE) could improve muscle damage and biochemical indicators after exhaustive exercise challenge. Based on maximum jump heights, 60 subjects (30 males and 30 females) were equally divided into a placebo group (0 mg/human/day) and an LVE supplement group (400 mg/human/day), with gender-equal distribution. All subjects started supplementation 10 days before exhaustive exercise and continued it until all tests were completed. Before the intervention, after the exhaustive exercise, and on the following 3 days, the participants underwent 12-minute Cooper running/walking; blood collection; assessments of pain, muscle stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic strength tests.


Eligibility criteria: Inclusion Criteria:

* health
* Must be able to swallow tablets

Exclusion Criteria:

* non-smokers
* no musculoskeletal
* medical
* metabolic disease
* women not on the reproductive cycle
* high blood pressure, asthma
* skeletal neuromuscular injuries in the upper or lower extremities

Primary outcomes:
measure: inflammation of IL-6 level
timeFrame: 10 days
measure: Clinical Biochemistry of CK level
timeFrame: 10 days
measure: Stress hormones 8-Hydroxy-2'-Deoxyguanosine (8-OHdG) in Urine
timeFrame: 10 days
measure: Assessment of muscle stiffness
timeFrame: 10 days
measure: Visual Analogue Scale (VAS) evaluation
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: National Taiwan Sport University
Study officials:
affiliation: PI
name: Chi-Chang Huang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee MC, Hsu YJ, Ho CS, Chang CH, Liu CW, Huang CC, Chiang WD. Evaluation of the Efficacy of Supplementation with Planox(R) Lemon Verbena Extract in Improving Oxidative Stress and Muscle Damage: A Randomized Double-Blind Controlled Trial. Int J Med Sci. 2021 May 3;18(12):2641-2652. doi: 10.7150/ijms.60726. eCollection 2021.