louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02377999: Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
Official title: Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anogenital Warts
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 40
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: An exploratory open label, single treatment trial of anogenital warts with Picato® repeated up to 2 times with two weeks intervals.

Detailed description: The purpose of the present trial is to explore the safety, tolerability and efficacy when treating GW with Picato® 0.05% gel. The primary outcome measures will be related to safety and tolerability and consists of severity of any local reactions in the treated area; treatment-related adverse events (AEs) and serious AEs.

Eligibility criteria: Inclusion Criteria:

* 1. A clinical diagnosis of external anogenital/perianal warts with at least 2 warts and no more than 20 warts located in one or more of the following anatomic locations:

  1. In both sexes: inguinal, perineal, and perianal areas
  2. In men: penis shaft, scrotum, glans penis and foreskin
  3. In women: on the vulva
* 2. Subjects has a total wart areas of at least 10 mm2, but not more than 500 mm2
* 3. Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment

Exclusion Criteria:

* 1. Subject has received any topical and/or destructive treatments for external anogenital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrolment
* 2. Subject suffer from any of the following conditions:

  1. Known human immunodeficiency virus (HIV) infection
  2. An outbreak of herpes genitalis in the wart areas within 4 weeks prior to enrolment
  3. Has internal (rectal urethral, vaginal/cervical) warts that require or are undergoing treatment
  4. Has a dermatological disease (e.g. psoriasis) or skin condition in the wart areas
* 3. Subjects using systemic virostatic compounds or immunosuppressive medication within 30 days prior to enrollment
* 4. Prior quadrivalent HPV vaccination

Primary outcomes:
measure: Number of incidence and severity of Local Skin Reactions (LSR)
timeFrame: Measured two weeks after every treatment and final measurement 2 weeks after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00622999: Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery
Official title: Effects of Malnutrition on Colon Cancer Patients With Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Colon Cancer
Keywords: Malnutrition
Colon cancer
Colon surgery
Outcome
Complication rate
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing colorectal surgery with diagnosed malignity.

Brief summary: The prevalence of malnutrition in patients with colorectal cancer is recorded. We want to find out, if a malnourished patient has more complications after the elective surgery.

Detailed description: All patients attending elective colorectal surgery are screened for malnutrition in advance. Their length of stay in the hospital and the complications are recorded.

Eligibility criteria: Inclusion Criteria:

* Colorectal Carcinoma
* Elective surgery
* Informed consent

Exclusion Criteria:

* Survival \< 4 weeks

Primary outcomes:
measure: Complication rate
timeFrame: during stay
Secondary outcomes:
measure: Mortality
timeFrame: during stay
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital
Study officials:
affiliation: Kantonsspital Aarau, Switzerland
name: Stefan F Mühlebach, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05063799: Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
Official title: Pulmonary Rehabilitation After Pregnancy in COVID-19 Infection: A Case Report
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19 Pneumonia
Pulmonary Rehabilitation
Pregnancy
Keywords: COVID-19, pulmonary rehabilitation, pregnant
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-01
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The 33-month pregnant patient was followed in the gynecology service with the complaint of shortness of breath after receiving the covid positive diagnosis and was transferred to the intensive care unit due to acute respiratory failure. She was intubated in the intensive care unit and the baby was taken by cesarean section. Pulmonary rehabilitation steps to be applied to the patient with long-term intensive care hospitalization will be examined.

Detailed description: After the patient was admitted to the chest diseases service, pulmonary rehabilitation was started. The patient was evaluated before starting pulmonary rehabilitation.

Evaluation parameters; vital signs, shortness of breath, oxygen support, grip force and pinchmeter, fatigue, anxiety and depression, cognitive functions. The pulmonary rehabilitation program will be implemented every day during the hospitalization. The pulmonary rehabilitation program will consist of breathing exercises, strengthening training of upper and lower extremity, exercises in bed, mobilization and reducing oxygen support. The patient will be re-evaluated before discharge.Pulmonary rehabilitation after discharge will continue 2-3 days a week.The patient will be re-evaluated at the 3rd, 6th, 9th and 12th months.

Eligibility criteria: Inclusion Criteria:

-pregnant and covid patient

Exclusion Criteria:

Primary outcomes:
measure: finger muscle power
timeFrame: 15 second
measure: grip strength
timeFrame: 15 second
Secondary outcomes:
measure: Assessment of cognitive
timeFrame: 10 minutes
measure: Assessment of anxiety and depression
timeFrame: 10 minutes
measure: Assessment of fatigue
timeFrame: 10 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Halime Sinem Barutcu
Study officials:
References:
Clinical trial NCT06398899: Sugammadex v.s. Neostigmine/Glycopyrrolate
Official title: Sugammadex Compared With Neostigmine/Glycopyrrolate in Impact of Postoperative Urinary Retention for Head and Neck Surgery Patients With High Risk of Dysuria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Chronic Sinusitis
Chronic Otitis Media
Keywords: Sugammadex
anticholinergic drug
postoperative urinary retention
head and neck surgery
neostigmine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of study is to clarify the role of sugammadex in head and neck surgery patients with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer, to prevent postoperative urinary retention. The main question it aims to answer are:

* Anticholinergic agent interferes the postoperative urination
* Sugammadex does not interfere postoperative urination Sugammadex can be recommended for these patients with high risk in postoperative urinary retention in the future.

Detailed description: Investigators will evaluate the benefit of sugammadex in reducing postoperative urinary retention for these head and neck surgery patients with high-risk for dysuria. The definition of high-risk of dysuria is patient with a prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer.

Patients scheduled to undergo head and neck surgery within two hours of expected surgical time are enrolled. These patients are associated with high-risk of postoperative urinary retention, including prior history of urinary retention, benign prostatic hypertrophy, or a history of prostate cancer. They are randomly divided these patients into sugammadex group (S group) and neostigmine/glycopyrrolate group (Group N), sugammadex or neostigmine/glycopyrrolate are used during recovery period of anesthesia, to compare the incidences of postoperative urinary retention, nausea/vomiting, bradycardia, hypotension, and dry mouth in these patients after head and neck surgery. Sugammadex can be recommended for these high-risk patients in the future.

Eligibility criteria: Inclusion Criteria:

* head and neck surgery patients whose surgery is expected to take less than two hours
* prior history of postoperative urinary retention
* benign prostatic hypertrophy
* history of prostate cancer

Exclusion Criteria:

* refusal or inability to provide informed consent
* age younger than 18 years
* American Society of Anesthesiologists class more than III

Primary outcomes:
measure: postoperative urinary retention
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: PEILIN LN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03581799: Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children
Official title: Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Child
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.

Detailed description: Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.

Eligibility criteria: Inclusion Criteria:

* Age between 2 and 10 years
* Attending study site as an outpatient during the study period.
* Informed consent form for study participation signed by legal guardian
* Verbal assent to participation from child

Exclusion Criteria:

* Wearing dental braces
* Injuries or inflammatory disease affecting the oral cavity or throat
* Dysphagia
* Olfactory impairment
* Known renal impairment
* Known hypercalcaemia,
* Any known allergy against medications
* Ongoing antibiotic treatment at the time of the study
* Moderate-severe developmental delay as reported by the parents
* Parents/legal guardians are unlikely to reliably complete structured questionnaire because of significant language barriers
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study

Primary outcomes:
measure: Parent-reported palatability assessed by interview
timeFrame: Day 1
measure: Child-reported palatability (children aged 6-10 years only) assessed by interview
timeFrame: Day 1
Secondary outcomes:
measure: Observer-reported palatability assessed by questionnaire
timeFrame: Day 1
measure: In-situ disintegration behaviour of carrier tablet
timeFrame: Day 1
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: UKBB
Study officials:
affiliation: University of Basel Children's Hospital
name: Julia Bielicki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06921499: Va Meh Du: A Sports-based Mental Health Promotion Intervention for Karenni Refugees
Official title: Continuing and Expanding Va Meh Du, A Mental Health Promotion Program for Karenni Refugee Children and Emerging Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coping Skills
Social Connectedness
Psychological Well Being
Physical Activity
Keywords: mental health education
sports-based mental health
mental health intervention
refugee health
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 60
Sex: MALE
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if a soccer program focused on mental health positively impacts mental health in Karenni refugee young boys and men. The main questions it aims to answer are:

Does mental health education provided during a sports program improve mental health coping for Karenni refugee young boys and men? Does participation in a sports-program improve social connection for Karenni refugee young boys and men?

Researchers will compare those receiving mental health education to a comparison group to see if mental health education improves mental health coping skills.

Participants will:

Participate weekly soccer practices for 6 months Receive mental health education or comparison activities Answer questions about their health, such as their coping skills, social connection, and physical activity


Eligibility criteria: Inclusion Criteria:

* For child/minor participants: 8-16 years old, self-identifies as Karenni, self-identifies as a boy, speaks English, currently lives in Piedmont Triad area of NC, has parental consent, assents to participate
* For adult participants--18 years of age, self-identifies as Karenni, self-identifies as a man, speaks English and Karenni, currently lives in Piedmont Triad area of NC, consents to participate, anticipates missing no more than 2 practices

Exclusion Criteria:

* \[for adult participants only\]: Criminal record indicating potential harm to children (i.e., convicted of a violent or sexual crime, registration in the Sex Offender Registry, Responsible Individual List, or Child Maltreatment Registry) or are expected to miss more than 2 practices

Primary outcomes:
measure: Coping Skills
timeFrame: From enrollment to end of intervention at 6 months
measure: Social Connectedness
timeFrame: From enrollment to end of intervention at 6 months
Secondary outcomes:
measure: Psychological Well being
timeFrame: From enrollment to end of intervention at 6 months
measure: Physical Activity
timeFrame: From enrollment to end of intervention at 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Bamboo Roots
state: North Carolina
Study officials:
References:
Clinical trial NCT02712099: TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
Official title: TUI 3D in Diagnosis of Placenta Accreta: Comparison With Gray-scale and Color Doppler Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
* All patients will undergo the following :

  1. History taking
  2. Clinical examination.
  3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

Brief summary: The purpose of this study is to evaluate the potential of the 3 D TUI view in diagnosis of morbidly adherent placenta in comparison to 2D grayscale, color Doppler and intraoperative findings.

Detailed description: * This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.
* All patients will undergo the following :

  1. History taking
  2. Clinical examination.
  3. For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.

Eligibility criteria: Inclusion Criteria:

1. History of previous cesarean section or hysterotomy.
2. Placenta previa with its lower edge covering the scar of previous cesarean section
3. From 28 wks to Full term.

Exclusion Criteria:

1. Multiple pregnancies.
2. Medical disorder as diabetes mellitus, hypertension.
3. Obese patients. BMI \> 30
4. Intrauterine growth retardation.

Primary outcomes:
measure: Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography
timeFrame: 28 -36 weeks of gestation
measure: Abnormal Placental Lacunae by 2D Grayscale Ultrasonography
timeFrame: 28 -36 weeks of gestation
Secondary outcomes:
measure: Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography
timeFrame: 28 -36 weeks of gestation
measure: Abnormal Placental Lacunae by Power Doppler Ultrasonography
timeFrame: 28 -36 weeks of gestation
measure: Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)
timeFrame: 28 -36 weeks of gestation
measure: Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)
timeFrame: 28 -36 weeks of gestation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01495299: 24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glaucoma
Keywords: relationship
IOP fluctuations
glaucoma
cataract surgery
SENSIMED Triggerfish
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma patients scheduled to undergo cataract surgery.

Brief summary: The purpose of this study is to determine the relationship between intraocular pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This device has previously been investigated and shown to be safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

* Subject is able to comply with the study procedures

  * 18-80 years old
  * Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \> 22 mmHg at the screening visit and under ocular hypotensive treatment.
  * Subject has consented to be in the trial
  * Visual acuity of 20/200 or better
  * Presence of cataract requiring phacoemulsification with lens exchange
  * Ability to understand the character and individual consequences of the study
  * For women of childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects presenting with any of the following criteria will not be included in the trial:

  * Subjects with contraindications for wearing contact lenses
  * Severe dry eye syndrome
  * Keratoconus or other corneal abnormality
  * Conjunctival or intraocular inflammation
  * Eye surgery prior to and throughout the study.
  * Full frame metal glasses during SENSIMED Triggerfish® monitoring
  * Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
  * Pregnancy and lactation
  * Simultaneous participation in other clinical studies

Primary outcomes:
measure: 24-h IOP patterns
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References: