louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01173965: Endometrial Ablation With Non-hysteroscopic Methods
Official title: Treatment of Dysfunctional Uterine Bleeding With Second Generation Ablation Devices: Microwaves (MEA®) vs Bipolar Impedance Control System (Novasure®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dysfunctional Uterine Bleeding
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 66
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endometrial ablation in women with dysfunctional uterine bleeding using second generation ablation devices is a common widespread therapeutic approach. This study aims to prove that amenorrhoea rates using Novasure are higher than those observed in microwave endometrial ablation, one year following intervention.


Eligibility criteria: Inclusion Criteria:

* Women presenting with dysfunctional uterine bleeding having completed their family planning(no wish for further childbearing)

Exclusion Criteria:

* Endometrial pathology
* FSH \> 20 day 2 -day 3 of the cycle
* Clotting Disorders
* Thyroid Dysfunction

Primary outcomes:
measure: Amenorrhoea rates one year after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: First Dept. Of ObGyn, Medical School Aristotle University of Thessaloniki, Papageorgiou Hospital
city: Thessaloniki
country: Greece
facility: First Dept. of ObGyn, Medical School, Aristotle University of Thessaloniki, Papageorgiou Hospital
Study officials:
References:
Clinical trial NCT04711265: Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Official title: A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HPV Vaccine
HPV Infection
HIV-1-infection
Keywords: HPV Vaccine, HIV infection, Adolescents, Africa
Lead sponsor: Kenya Medical Research Institute
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Merck Sharp & Dohme LLC
First posted: 2021-01-15
Enrollment: 176
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected boys and girls who had received 3 doses of QHPV vaccine

Brief summary: Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.

Detailed description: We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.

Eligibility criteria: Inclusion Criteria:

* receipt of 3 doses of QHPV vaccine
* participated in primary immunogenicity study
* consent/assent with parental consent for participants age \<18 years
* willing to continue extended follow up for 36 months

Exclusion Criteria:

* decline consent

Primary outcomes:
measure: Human Papillomavirus Antibody Titers
timeFrame: 48 months
Secondary outcomes:
measure: HIV RNA viral load
timeFrame: 48 months
measure: CD 4 cell count
timeFrame: 48 months
Other outcomes:
Locations:
city: Thika
country: Kenya
facility: Partners in Health Research and Development
state: Kiambu
Study officials:
References:
Clinical trial NCT02944565: Daratumumab in Treating Patients With Multiple Myeloma
Official title: Daratumumab Infusion Acceleration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plasma Cell Myeloma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 28
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: This phase II trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab.

II. Estimate the time savings versus (vs) predicted infusion time.

OUTLINE:

Patients receive daratumumab intravenously (IV) over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients must have received \>= 2 daratumumab infusions and be scheduled to receive another dose
* All races and ethnic groups are eligible for this study
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results
* Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug
* Prisoner

Primary outcomes:
measure: Total Daratumumab Infusion Time
timeFrame: Up to 6 months
Secondary outcomes:
measure: Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 6 months
measure: Infusion-related Reactions (IRR)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Craig Hofmeister, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05323565: Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries
Official title: A Comparative Study Between the Use of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Post-operative Pain Relief in Patients Undergoing Lower Open Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.

Detailed description: A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

Eligibility criteria: Inclusion Criteria:

Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.

Exclusion Criteria:

* Infection at site of injection.
* Patient refusal.
* Psychiatric or physical illness that lead to inability to cooperate, speak or read.
* Abdominal operations under spinal anesthesia.
* History or evidence of coagulopathy.
* Known allergies to drugs used .
* Preexisting neurological disorders.

Primary outcomes:
measure: 1st time for rescue analgesia
timeFrame: first 24 hours post-operatively
Secondary outcomes:
measure: Pain score- Visual Analogue Score (VAS)
timeFrame: First 24 hours post-operatively.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University, Faculty of medicine
Study officials:
affiliation: Ain Shams University, Faculty of medecine
name: Yasser Sayed, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05619666: Acute Rehabilitation in Patients With COVID-19 Pneumonia
Official title: Acute Rehabilitation in Patients With COVID-19 Pneumonia a Single Center Experience From a Developing Country
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Rehabilitation
Physical Medicine
Keywords: Acute rehabilitation
COVID-19 pneumonia
Lead sponsor: Institut za Rehabilitaciju Sokobanjska Beograd
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: COVID-19 can have different clinical manifestations including myalgia, arthralgia, neurological, cardiac, psychological and other manifestations.These patients are at greater risk of developing consequences of prolonged bed rest. Therefore physical medicine and rehabilitation could have an important role in the multidisciplinary treatment of these issues. Early respiratory and neuromuscular rehabilitation is necessary to improve functional physical limitations, performance, muscle strength, endurance as well as cognitive and emotional domains. Some studies proposed that rehabilitation protocols in the inpatient setting include early mobilisation, strength and endurance training with the aim of reducing weakness and dependency. This Study aimed to detect the effects of rehabilitation in patients with Covid-19 who were admitted in temporary Covid hospital in Serbia. Furthermore, to emphasize the importance of functional assessment of the patients, in identifying their problems and selections of priorities in planning the best therapeutic protocol.


Eligibility criteria: Inclusion Criteria:

* Positive pharyngeal or nasal swab for SARS CoV-2, 3) SP O2\> 94% on admission, 4) body temperature under 37.5 5) Clinical stability defined by ability to perform bedside active mobilization without a reduction of oxygen saturation (SpO2) below 92%;

Exclusion Criteria:

* 1) SP o2 \< 94% on admission, 2) Moderate and severe heart failure (grade III and IV, NY heart Association), 3) Paresis or plegia as a result of CVI or neurodegenerative disease, 4) Impaired cognitive status.

Primary outcomes:
measure: functional outcome of activity of daily living
timeFrame: up to three weeks
measure: functional outcome of cardiovascular and respiratory system
timeFrame: up to three weeks
measure: functional outcome for assesing dyspnea
timeFrame: up to three weeks
measure: functional outcome of mobility
timeFrame: up to three weeks
measure: functional outcome of lower limbs strength
timeFrame: up to three weeks
measure: functional outcome of static balance
timeFrame: up to three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Tamara Filipovic
city: Belgrade
country: Serbia
facility: Institute for Rehabilitation
Study officials:
References:
Clinical trial NCT02290366: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
Official title: Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Brachytherapy, using Cesium 131
Primary purpose: TREATMENT

Brief summary: The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) \<10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Clinical stage T1c-T2aN0M0
* Gleason score \<= 3+3=6
* prostate specific antigen (PSA) \<10 ng/ml
* \<= 2 cores positive out of a minimum of 12 cores sampled

Primary outcomes:
measure: biochemical disease free survival
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Mercy
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01012466: The Physical Effects of Pain Catastrophizing in Labor
Official title: The Physical Effects of Pain Catastrophizing on Normal Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
birth
labor
labor pain
catastrophizing
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nulliparous women attending the prenatal clinic at Oregon Health \& Science University

Brief summary: The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.

Detailed description: Subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. Chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.

Eligibility criteria: Inclusion Criteria:

* At least 20 weeks of pregnancy
* Nulliparous
* Singleton pregnancy
* Low risk pregnancy

Exclusion Criteria:

* Primiparous and multiparous women
* Women who request cesarean delivery
* Women who are pregnant with twins
* Women who plan induction
* Women who deliver before 37 weeks
* Women enrolled in the "Centering Pregnancy" program at the Family Birth Center
* High risk pregnancies
* Severe mental illness that impairs cognition or function
* Suicidal ideation
* Women who do not speak English or Spanish

Primary outcomes:
measure: Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms)
timeFrame: Immediate postpartum
Secondary outcomes:
measure: Relationship between pain catastrophizing and reported pain in labor
timeFrame: 1 day postpartum and 4-8 weeks postpartum
measure: Relationship between pain catastrophizing and satisfaction with birth experience and care
timeFrame: 1 day postpartum and 4-8 weeks postpartum
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800966: A Brief Intervention Programme for TID
Official title: A Leaflet-based Programme for Tobacco Industry Denormalisation - a Brief Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitudes Towards Tobacco Industry
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 1069
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. The questionnaires will be mixed in a way that two adjacent questionnaires are always different. The intervention leaflets will contain information for tobacco industry denormalisation. The control leaflets will contain information for tobacco control policy in Hong Kong. The study aims to test the effect of a leaflet-based intervention on primary school students' attitudes towards tobacco industry.


Eligibility criteria: Inclusion Criteria:

* Parents and children should all understand Chinese

Exclusion Criteria:

-

Primary outcomes:
measure: Attitudes towards tobacco industry in children
timeFrame: 1 month
Secondary outcomes:
measure: Intention to smoke cigarettes in children
timeFrame: 1 month
measure: Intention to use e-cigarettes in children
timeFrame: 1 month
measure: Tobacco control policy support in children
timeFrame: 1 month
measure: Attitude towards smoking in children
timeFrame: 1 month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Local primary schools
Study officials:
affiliation: The University of Hong Kong
name: Sai Yin Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05185466: Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses
Official title: The Effect of Nurse-Supported Self Management Programme on the Sustained Attention and Sleep Quality of the Nurses Working at Night Shift
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Quality
Attention
Nurses
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the effect of the nurse-supported self-management program on the sustained attention and sleep quality of night shift nurses. The self-management program consists of training and incentives for night shift nurses to gain healthy eating habits and improve their sleep health.


Eligibility criteria: Inclusion Criteria:

* Nurses working in shifts
* Those between the ages of 18-65
* Those who agree to participate in the study.

Exclusion Criteria:

* Pregnant and having suspicion of pregnancy
* Having vision and hearing problems
* Having diagnosed sleep disorder
* Having a chronic disease that will prevent participation in the study
* Having a diagnosed mental health problem

Primary outcomes:
measure: Sustained Attention
timeFrame: First Month
measure: Sleep Quality
timeFrame: First Month
measure: Sleepiness
timeFrame: First Month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul / Turkey
Study officials:
affiliation: T.C. Üsküdar Üniversitesi
name: Merve Çolak, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05227066: Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Official title: Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ataxic Cerebral Palsy
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is


Eligibility criteria: Inclusion Criteria:

* ataxic cerebral palsy aged 7-13 years

Exclusion Criteria:

* any musculoskeletal conditions that affect balance previous surgeries that affecting balance

Primary outcomes:
measure: Change in overall stability index
timeFrame: baseline and after 3 months of intervention.
Secondary outcomes:
measure: antero-posterior stability index
timeFrame: baseline and after 3 months of intervention.
measure: mediolateral stability index
timeFrame: baseline and after 3 months of intervention.
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta University for Science and Technology
state: Dakahelia
Study officials:
affiliation: Professor of physical therapy
name: Hala I. Kassem, Professor
role: STUDY_DIRECTOR
References: