louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05863273: Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）
Official title: Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients With Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Apremilast
Otazla
Real World Study
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
First posted: 2023-05-18
Enrollment: 360
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: Chinese patients with moderate to severe plaque psoriasis

Brief summary: This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。


Eligibility criteria: Inclusion Criteria:

* Males or females, ≥ 18 years of age at the time of signing the informed consent document；
* Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6；
* Subject is a candidate for phototherapy and/or systemic therapy
* Patients who wish to be treated with Apremilast and sign the informed consent

Exclusion Criteria:

* Allergy to Apremilast or any component of the study drug；
* Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout；
* Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)；
* History of substance abuse, suicide attempts, or mental illness；
* Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period；
* Pustular type, erythroderma type and other psoriasis patients；
* Other circumstances that investigators don't consider appropriate to include.

Primary outcomes:
measure: DLQI or PASI improvement
timeFrame: 16 week
Secondary outcomes:
measure: PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS
timeFrame: 16 week
measure: DLQI improvement
timeFrame: 2 week
measure: DLQI improvement
timeFrame: 6 week
measure: DLQI improvement
timeFrame: 10 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Shenyang
country: China
facility: the First Hospital of China Medical University
Study officials:
affiliation: First Hospital of China Medical University
name: Xinghua Gao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05425173: Limbs Range of Motion Exercises Along With Chest Physical Therapy After Correction of Congenital Heart Diseases in ICU
Official title: Effect of Limbs Range of Motion Exercises Along With Chest Physical Therapy on Cardiopulmonary Parameters After Correction of Congenital Heart Diseases in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 20
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To determine the effect of limb ROMs along with chest Physical therapy on cardiopulmonary parameters after correction of congenital heart diseases in ICU
2. To determine the response of Inotropic drug in relation to Limb ROMs after Correction of Congenital heart diseases in ICU


Eligibility criteria: Inclusion Criteria:

* Patients below the age 5 years old that underwent congenital heart surgery.

Exclusion Criteria:

* Contraindications for exercise, mental retardation, unstable hemodynamics

Primary outcomes:
measure: Heart Rate
timeFrame: Upto 10 days
measure: Respiration Rate
timeFrame: Upto 10 days
measure: Systolic Blood Pressure
timeFrame: Upto 10 days
measure: Diastolic Blood Pressure
timeFrame: Upto 10 days
measure: Partial pressure of oxygen
timeFrame: Upto 10 days
measure: Partial Pressure of carbon dioxide
timeFrame: Upto 10 days
measure: Arterial blood gas (ABG) parameter like potential of hydrogen (PH)
timeFrame: Upto 10 days
measure: Arterial blood gas parameter like bicarbonate(HCO3).
timeFrame: Upto 10 days
measure: Oxygen saturation
timeFrame: Upto 10 days
measure: Ejection fraction
timeFrame: Upto 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: Khyber PkahtoonKhwa
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06463873: Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
Official title: A Pilot Study of OmniGraft in Simultaneous Pancreas Kidney Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplant; Complications
Pancreas Disease
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Eurofins Lancaster Laboratories
First posted: 2024-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Simultaneous kidney pancreas transplant who are treated at the Miami Transplant Institute

Brief summary: The purpose of this research is learn about how OmniGraf works in kidney pancreas transplant patients. Also, to analyze the performance characteristics of OmniGrafTM (TruGraf Gene Expression Profiling (GEP) and T Cell Receptor Alpha Constant (TRAC) dd-cfDNA) in a population of simultaneous kidney pancreas transplants as a part of routine surveillance, as well as a part of the workup for patients clinically suspected to have rejection of the kidney and/or pancreas.


Eligibility criteria: Inclusion Criteria:

1. Male or female adult (≥18 years old) with a history of simultaneous pancreas kidney transplant between 3 months and 1 year prior to enrollment (cohort 1) or at the time of presentation for "for-cause" biopsy
2. Adults able to consent
3. Bladder or enteric drained
4. Type 1 or Type 2 DM

Exclusion Criteria:

1. Recipient of an organ transplant other than a simultaneous pancreas kidney transplant
2. Known to be pregnant
3. Known to be infected with Human Immunodeficiency Virus with actively replicating HIV virus
4. Active BK viremia with \>100,000 copies or biopsy proven BK nephropathy
5. Participation in other biomarker studies
6. Pancreas transplant alone
7. Re-transplantation, unless both organs have been removed prior to or at the time of the retransplant procedure.

Primary outcomes:
measure: Number of participants that underwent SPK transplant
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Transplant Institute 1801 NW 9th Ave
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Mariella Ortigosa-Goggins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755073: Pulmonary Artery Doppler in Preeclamptic Mothers
Official title: Fetal Pulmonary Artery Doppler in Mothers with Preeclampsia for Detecting Neonatal Respiratory Distress
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Artery Doppler
Keywords: Pulmonary Doppler
Preeclampsia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman with preeclampsia

Brief summary: Evaluation of Pulmonary artery Doppler parameters in fetuses of mothers with severe preeclampsia

Detailed description: Preclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE.

Preeclampsia affects about 5% of pregnancies and hypertensive disorders of pregnancy cause over 60,000 maternal fatalities each year around the world .The decision to deliver a woman with severe pre-eclampsia that is far from the term \[mid-trimester\] is difficult for the obstetrician.In most cases of highly premature pre-eclamptic gestation, certain institutions propose continuing pregnancy until one of the following occurs development of fetal lung maturity, development of fetal or maternal discomfort, or accomplishment of gestational age of 34 to 36-week of gestation .

Numerous tests have been developed in an attempt to identify if fetal lung maturation has reached a level sufficient to prevent the development of fetal RDS. These tests are based on four core themes: biochemical testing for active surfactant components, biophysical testing for surfactant functionality, physical testing of amniotic fluid opacity, and ultrasound examination of the fetuses and their tissues . Neonatal RDS has been predicted using fetal pulmonary artery Doppler. Kim and colleagues discovered that a high PAT/ET was linked to newborn RDS .The development of RDS in preterm newborns is linked to an increased acceleration time to ejection time \[AT/ET\] ratio in the fetal pulmonary artery .

Eligibility criteria: Inclusion Criteria:

* preeclampsia patients Pregnant 28 -37 weeks

Exclusion Criteria:

* fetal death Congenital fetal anomalies Fetal Cardiac arrhythmia

Primary outcomes:
measure: Pulmonary Doppler resistance index
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
References:
Clinical trial NCT04711473: Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
Official title: Choice Architecture and Mailed Colorectal Cancer Screening Outreach in a Community Health Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: screening
prevention
colonoscopy
stool testing
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2021-01-15
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 3-arm randomized trial aimed at increasing rates of participation in colorectal cancer (CRC) screening by outreach to patients' homes using choice architecture informed by behavioral science principles.

Detailed description: The investigators will evaluate the effectiveness of mailed outreach with choice between colonoscopy and FIT, and FIT alone, as compared to colonoscopy alone in increasing CRC screening rates.

Eligibility criteria: Inclusion Criteria:

1. At least 1 visit with CHDC in the past 2 years
2. Not up to date on CRC screening (no evidence of colonoscopy in the last 10 years, sigmoidoscopy in the last 5 years, or stool testing in the past 12 months)

Exclusion Criteria:

1. History of CRC or polyps
2. Significant family history of CRC
3. History of Inflammatory Bowel Disease or Ulcerative Colitis
4. History of colectomy
5. History of metastatic cancer
6. Current use of Medication Assisted Therapy (MAT)

Primary outcomes:
measure: Colorectal Cancer Screening Completion
timeFrame: 6 months from initial outreach
Secondary outcomes:
measure: Choice of Colorectal Cancer Screening Test
timeFrame: 6 months from initial outreach
Other outcomes:
Locations:
city: Pottstown
country: United States
facility: Community Health and Dental Care
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04637373: Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss
Official title: Hysteroscopy Assisted Suction Curettage for Early Pregnancy Loss: Does it Reduce Retained Products of Conception and Postoperative Intrauterine Adhesions?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retained Products of Conception
Intrauterine Adhesion
Keywords: intrauterine adhesions
Hysteroscopy
Retained Products of Conception
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-11-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This prospective descriptive study is taking place in a single university affiliated medical center.
Primary purpose: PREVENTION

Brief summary: Retained products of conception (RPOC) and intrauterine adhesions (IUA) may occur following suction curettage for early miscarriage and cause secondary infertility, recurrent pregnancy loss and pregnancy complications. The aim of this study is to investigate whether adding hysteroscopy to suction curettage reduces the rates of RPOC and IUA.

Detailed description: This is a descriptive, prospective study. Women aged 18-40 years admitted for surgical evacuation in cases of early missed abortion in a single university affiliated medical center are being recruited. All procedures performed under general anesthesia following cervical ripening with vaginal Misoprostol.

Before the evacuation, a diagnostic hysteroscopy was performed to identify the pregnancy's implantation wall. Subsequently, ultrasound guided suction and curettage directed to the implantation wall is done. Finally, the uterine cavity is evaluated by hysteroscopy for RPOC. Participants are scheduled for follow-up diagnostic office hysteroscopy 2 months after termination of pregnancy for assessment of IUA and RPOC. However, due to restrictions on elective surgical procedures brought on by the Covid-19 pandemic, the follow-up hysteroscopy examination was postponed until 5 to 6 months after termination of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-40 years who were admitted to the gynecology emergency department at our institution with early miscarriage up to 12 weeks and 6 days of gestation, and choose surgical evacuation over medical treatment

Exclusion Criteria:

* incomplete and complete abortions, gestational age\>13 weeks of gestation, suspected molar pregnancy and patients' contraindications for general anesthesia.

Primary outcomes:
measure: the occurrence of Retained products of conception following suction curettage.
timeFrame: at the end of suction curettage procedure
Secondary outcomes:
measure: the occurrence of intra uterine adhesions following targeted suction curettage
timeFrame: on follow-up office hysteroscopy, 5-6 months after the primary procedure
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
Study officials:
References:
Clinical trial NCT06387173: Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer
Official title: Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Stage Breast Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 2
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 cryoablation for breast cancer

Brief summary: This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To obtain observational real-life data of patients who choose this non-conventional treatment and to follow their outcomes.

OUTLINE: This is an observational study.

Patients have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cryoablation for breast cancer

Primary outcomes:
measure: Prospectively track patients who undergo cryoablation for breast cancer and record post-treatment related events.
timeFrame: five years from last participant enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Nimmi S Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05650073: A Study of Soundscapes for Patient Wellbeing
Official title: Impact of Immersive Soundscapes in Outpatient Procedure Rooms on Patient Wellbeing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 100
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the impact of immersive soundscape on patient pain, stress, anxiety, heart rate and blood pressure during an outpatient vascular surgery procedure.

Detailed description: Adult (≥18-years-old) patients having outpatient vascular surgery procedures who elect to participate in the study will be randomized to Control/ Intervention. For Control Subjects: procedure will be performed in the procedure room with no immersive soundscape. For Intervention Subjects procedure will be performed in the procedure room with immersive soundscape.

Eligibility criteria: Inclusion Criteria:

- English-speaking adults

Exclusion Criteria:

* Patients needing an English interpreter
* Patients who lack the capacity to provide consent.

Primary outcomes:
measure: Change in Self-Report Visual Analog Pain Score
timeFrame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
measure: Change in Self-Report Visual Analog Anxiety Score
timeFrame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
measure: Change in Self-Report Visual Analog Stress Score
timeFrame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
measure: Change in Heart Rate
timeFrame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
measure: Change in Blood Pressure
timeFrame: Baseline, before procedure commences, after injection of anesthetic, and end of procedure, approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Ellen Meltzer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01922973: Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
Official title: Effect of Fasting on Ghrelin and Growth Hormone in Healthy Young and Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: ghrelin
growth hormone
aging
normal volunteers
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal volunteers

Brief summary: The overall objective of this study is to determine the extent to which circulating ghrelin levels (total and bioactive ghrelin) are regulated by nutritional state and age.

Detailed description: Normal volunteers: young and older men and women studied under fed and fasting (total 62.5h) conditions, frequent blood sampling for ghrelin and other related hormones

Eligibility criteria: Inclusion Criteria:

Healthy young (ages 18-30) and older (ages \> 60) men and women with a body mass index (BMI) of \<35 kg/m2. Young and older subjects will be matched for BMI.

Exclusion Criteria:

1. A history of coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP \>180 systolic or \>100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis): abnormal screening laboratory tests. This information will be obtained through the use of screening labs, history and physical exam and the medical record. See the GCRC protocol for details of the labs.
2. Hematocrit \< 41% men, \< 38% women
3. History of daily tobacco use within past 3 months
4. Chronic alcohol abuse
5. Recent weight change of \> 10 pounds in last 3 months
6. Strenuous exercise for average of more than 60 min/day
7. Investigational drug within past 6 weeks
8. Any history of major psychosis, severe depression, anorexia nervosa
9. Transmeridian travel within 2 weeks prior to or during study -

Primary outcomes:
measure: Ghrelin concentration
timeFrame: 24-h mean
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Michael O Thorner, MD
role: PRINCIPAL_INVESTIGATOR
References: