louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01780207: Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
Official title: Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2013-01-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed moderate to severe OSA
* Age \> 17 years
* Written informed consent for study participation.

Exclusion Criteria:

* Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction)
* Patients with central sleep apnea syndrome
* Patients with other causes of pulmonary hypertension
* Intracardiac shunt other than via PFO
* Severe valvular heart disease
* Abnormal left ventricular (LV) systolic function (ejection fraction \<50%)
* Obesity with BMI \> 40
* Contraindication to TOE
* Severe pulmonary arterial hypertension (mean pulmonary artery pressure \> 45 mmHg)

Primary outcomes:
measure: Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up)
timeFrame: 0, 3 months
Secondary outcomes:
measure: Systemic vascular assessment
timeFrame: 0, 3 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
References:
citation: Rimoldi SF, Ott S, Rexhaj E, de Marchi SF, Allemann Y, Gugger M, Scherrer U, Seiler C. Patent Foramen Ovale Closure in Obstructive Sleep Apnea Improves Blood Pressure and Cardiovascular Function. Hypertension. 2015 Nov;66(5):1050-7. doi: 10.1161/HYPERTENSIONAHA.115.06303. Epub 2015 Sep 21.
Clinical trial NCT06705907: Improving Academic and Social Functioning in Middle-Schoolers With Autism
Official title: Improving Academic and Social Functioning in Middle-Schoolers With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: social skills
executive functions
academic achievement
middle school
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-11-26
Enrollment: 224
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism
* No intellectual disability
* Problems with organization, materials management, and planning and prioritization
* Problems with social skills
* Fully included in middle school
* Stable medication and behavioral treatment regime

Exclusion Criteria:

* Home schooled
* Severe co-occurring psychopathology (e.g., aggression, suicidal)
* Non English-speaking

Primary outcomes:
measure: Behavior Rating Inventory of Executive Functioning, 2nd Edition
timeFrame: From enrollment to the end of treatment at 8 weeks.
measure: Homework Problems Checklist
timeFrame: From enrollment to end of treatment at 8 weeks.
measure: Academic Performance Rating Scale
timeFrame: From enrollment to end of treatment at 8 weeks.
Secondary outcomes:
measure: Children's Organizational Skills Scale
timeFrame: From enrollment to the end of treatment at 8 weeks.
measure: Weekly Calendar Planning Activity
timeFrame: From enrollment to the end of treatment at 8 weeks.
measure: Social Skills Assessment (TRIAD)
timeFrame: From enrollment to the end of treatment at 8 weeks.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Leanne Tamm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Amie Duncan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06939907: Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract
Official title: Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract:
        A Prospective, Multi-Center, Single-Arm, Open-Label, Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Gastrointestinal Bleeding
Diverticular Bleeding
Lead sponsor: Next Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical Trial to Evaluate the Efficacy and Safety of Nexpowder™ for Diverticular Bleeding in the Lower Gastrointestinal Tract


Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years or older at the time of screening
* Patients diagnosed with diverticular bleeding

Exclusion Criteria:

* Patients diagnosed with upper gastrointestinal bleeding

Primary outcomes:
measure: Rebleeding rate
timeFrame: 30 days post treatment
Secondary outcomes:
measure: Hemostasis rate
timeFrame: Immediately after the procedure
measure: Rebleeding rate
timeFrame: 7 days post treatment
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Sejong
country: Korea, Republic of
facility: Sejong Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Kyunghee University Hospital
city: Yangsan
country: Korea, Republic of
facility: Yangsan Busan National University Hospital
Study officials:
References:
Clinical trial NCT00473707: Active Versus Expectant Management of the Third Stage of Labor
Official title: A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Third stage of labor
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 218
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

Detailed description: Postpartum hemorrhage is the leading cause of maternal mortality worldwide. During the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. Controversy remains as to the optimal method of delivering the placenta. Two predominant, yet very different, strategies have emerged. Expectant management is most commonly used in the United States. This includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. Then uterotonic agents are administered,usually oxytocin. This is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. This is the predominant practice in the United Kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine.

Comparison: Active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation
* Cephalic presentation
* \>37 weeks gestation
* \>16 years of age

Exclusion Criteria:

* Multiple gestation
* Breech presentation
* Blood dyscrasias
* Multiparous females Para \>5
* Placenta previa
* Patients on anticoagulants
* Previous history of postpartum hemorrhage
* IUFD
* Non-reassuring fetal heart rate pattern

Primary outcomes:
measure: Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater
timeFrame: reported immediately after delivery
Secondary outcomes:
measure: Mean change in hematocrit from before delivery to the first postpartum day
timeFrame: 24 hours
measure: Rate of maternal blood transfusion
timeFrame: 48 hours
measure: Duration of the third stage of labor
timeFrame: 60 minutes
measure: Incidence of retained placenta
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Danielle E Castagnola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04508907: A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
Official title: Pilot Study for the Use of Shortened Preemptive Therapy with Glecaprevir/pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung And/or Pancreas) of Hepatitis C Viremic Donors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Hepatitis C
Kidney Transplant; Complications
Heart Transplant Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 200
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 study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.


Eligibility criteria: Inclusion criteria:

* Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
* Willing to accept and consent for accepting hepatitis C positive graft

Exclusion criteria:

* Existing chronic liver disease (liver cirrhosis)
* Concomitant infection with HIV or Chronic hepatitis B
* Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
* Pregnancy (Pregnant patients do not undergo solid organ transplants)

Primary outcomes:
measure: Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
timeFrame: 3 months
measure: Graft and patient survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Bashar A Aqel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810407: Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients
Official title: Special Investigation For Non-hiv Patients Of Mycobutin (Regulatory Post Marketing Commitment Plan).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Non-tuberculous Mycobacterial Diseases (Including MAC Disease)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 628
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0061006 prescribes the Mycobutin®).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Mycobutin®.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 1 year
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: 1 year
measure: Number of Participants With Treatment-Related Adverse Events by Diagnosis
timeFrame: 1 year
measure: Number of Participants With Treatment-Related Adverse Events by Gender
timeFrame: 1 year
measure: Number of Participants With Treatment-Related Adverse Events by Age
timeFrame: 1 year
measure: Clinical Efficacy Rate
timeFrame: 1 year
measure: Clinical Efficacy Rate by Diagnosis
timeFrame: 1 year
measure: Clinical Efficacy Rate by Gender
timeFrame: 1 year
measure: Clinical Efficacy Rate by Age
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04391907: Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient
Official title: Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

Detailed description: IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.

Eligibility criteria: Inclusion Criteria:

1. A patient at the age of 21 cataract surgery
2. A patient has the visual potential of 20/25 or better in each eye after cataract removal
3. Dry eye patient by meibomian gland dysfunction
4. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Eye damage, active eye infection
2. Uncontrolled health problem
3. Wear contact lens within one month
4. Allergic reactions of fluorescein sodium or ophtalmic anesthetic
5. Eye surgery and trauma in the last six months
6. Eye disease, structural abnormality
7. If there is a cause of vision loss other than cataracts
8. Under 20/25 expect vision
9. Under the age of 20 years of age
10. Pregnant woman and lactating woman
11. Medical conditions in which IPL is contraindicated

Primary outcomes:
measure: TBUT
timeFrame: 3 months
measure: meibomian gland function score
timeFrame: 3 months
Secondary outcomes:
measure: OSDI
timeFrame: 3 months
measure: Corneal staining score
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Tae-Young Chung, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04512807: AMH and Pregnancy Outcome in IVF
Official title: Low Anti-mullerian Hormone and Pregnancy Outcome in IVF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMH
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 650
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low or very low AMH

Brief summary: Anti-Mu¨llerian hormone (AMH) is an established marker of ovarian reserve (La Marca et al., 2010; Nelson et al., 2009) and predicts both high and low responses in ovarian stimulation cycles (Eldar-Geva et al., 2005; Nardo et al., 2009; Nelson et al., 2007). Presently, AMH helps clinicians counsel patients prior to IVF treatment (La Marca et al., 2011), despite the fact that it fails to predict who will become pregnant (Lamazou et al., 2011; Riggs et al., 2011). It has been demonstrated that poor responders can achieve both pregnancy and live birth (Weghofer et al., 2011). There are few studies regarding extremely low AMH concentrations and live births (Fraisse et al., 2008; Tocci et al., 2009; Weghofer et al., 2011) and they present either a small number of patients or limited data describing the groups of investigated patients. Another factor affecting pregnancy rates is endometriosis, a chronic gynaecological disease characterized by the presence of functional endometrial tissue outside the uterine cavity (Koninckx et al., 1991). Many studies have reported that pregnancy rates are lower in women with endometriosis than in controls (Gupta et al., 2008; Koninckx et al., 1991 Pellicer et al., 2000). Lower AMH serum concentrations are associated with endometriosis severity (Shebl et al., 2006). The primary objective of the present study was to assess the clinical pregnancy rates in women with extremely low AMH concentrations with respect to age.


Eligibility criteria: Inclusion Criteria:

Women ≥22 years age AMH is 0.5 and less Body mass index- 18.5-30 kg/m 2 The normal uterine cavity on ultrasound scan At least one good quality embryo present for transfer Women willing to comply with the clinical study protocol

Exclusion Criteria:

* Women ≥ 45 years age
* AMH \>0.5
* Uterine abnormalities that can compromise the IRs (e.g., endometrial polyp, fibroids, hydrosalpinx, and adenomyosis)
* Endocrine dysfunction or organ dysfunction such as liver or kidney failure.

Primary outcomes:
measure: pregnancy test
timeFrame: 2 weeks
measure: clinical pregnancy rate
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04225507: Technology-Supported Treatment of Sleep Apnea in Prediabetes
Official title: Technology-Supported Treatment of Sleep Apnea in Prediabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea
PreDiabetes
Overweight or Obesity
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-01-13
Enrollment: 174
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the efficacy of intensive lifestyle interventions in prediabetes, the incidence of diabetes is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications in this high-risk population. Sleep apnea is a highly common condition in prediabetes, but it has been mostly ignored and undertreated in current practice. The proposed study will be the first to assess whether adding CPAP (continuous positive air pressure) treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in high-risk individuals with prediabetes.

Detailed description: This is a 6-month randomized controlled, parallel group trial with two arms. After baseline, the subjects will be randomized to lifestyle intervention alone (lifestyle group) or lifestyle plus CPAP intervention (lifestyle plus CPAP group). The same metabolic and cardiovascular assessments will be performed at baseline and after 6-months of intervention.

The lifestyle group will aim to achieve a weight loss through diet and exercise. The lifestyle plus CPAP group will additionally receive CPAP treatment. All subjects will use a custom smartphone app to track weight loss and/or CPAP goals and will receive weekly coaching phone calls to maximize treatment adherence.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Prediabetes
* Sleep apnea

Exclusion Criteria:

* Diabetic
* enrolled in a formal weight loss program
* Any underlying disease likely to limit life span and/or increase risk of interventions

Primary outcomes:
measure: Change from baseline 2-hour glucose levels at 6 months
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Change from baseline morning blood pressure at 6 months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Esra Tasali, MD
role: PRINCIPAL_INVESTIGATOR
References: