louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02424721: Sepsis Assessment in Belgian Emergency Rooms
Official title: Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sepsis
Shock, Septic
Severe Sepsis
Lead sponsor: Axis Shield Diagnostics Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-23
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: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Emergency Department with suspected infection

Brief summary: To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

Detailed description: Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.

Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.

The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age,
* Suspected infection (temperature \>38C or clinical evidence of infection),
* intention by clinician to start antibiotics

Exclusion Criteria:

* None

Primary outcomes:
measure: Validation of use of HBP in evaluation of patients with suspected infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Clinique St Anne St Remy
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Charleroi
country: Belgium
facility: Hopital Civil de Charleroi
city: La Louviere
country: Belgium
facility: CHU Tivoli
Study officials:
affiliation: Erasme University Hospital
name: Jean-Louis Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04845321: VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers
Official title: Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Venatorx Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2021-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

Detailed description: In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight \>50 kg (110 lbs)
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
2. History of severe allergic or anaphylactic reaction
3. Abnormal ECG or history of clinically significant abnormal rhythm disorder
4. Positive alcohol, drug, or tobacco use/test

Primary outcomes:
measure: Part 1: Number of subjects with adverse events
timeFrame: Up to 8 days after last administration of study drug
measure: Part 2: Number of subjects with adverse events
timeFrame: Up to 8 days after last administration of study drug
Secondary outcomes:
measure: Part 1: AUC0-tau
timeFrame: Days 1-6 (Days 1-12 for fasted/fed cohort)
measure: Part 1: Cmax
timeFrame: Days 1-6 (Days 1-12 for fasted/fed cohort)
measure: Part 1: tmax
timeFrame: Days 1-6 (Days 1-12 for fasted/fed cohort)
measure: Part 1: AUCinf
timeFrame: Days 1-6 (Days 1-12 for fasted/fed cohort)
measure: Part 1: t1/2
timeFrame: Days 1-6 (Days 1-12 for fasted/fed cohort)
measure: Part 2: AUC0-tau
timeFrame: Day 1 and Following Last Dose on Day 14
measure: Part 2: Cmax
timeFrame: Day 1 and Following Last Dose on Day 14
measure: Part 2: tmax
timeFrame: Day 1 and Following Last Dose on Day 14
measure: Part 2: t1/2
timeFrame: Following Last Dose on Day 14
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
References:
Clinical trial NCT00174421: Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
Official title: Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age


Eligibility criteria: Inclusion Criteria:

* Participation in the 90-080 study

Exclusion Criteria:

* Any severe, acute or chronic disease
* Any other identifiable reason for short stature

Primary outcomes:
measure: Final height, compared to the expected familial target height
Secondary outcomes:
measure: Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01778621: Effect of Acupuncture on Anti Mullerian Hormone and Assisted Reproduction Outcome in PCOS Patients Undergoing IVF
Official title: Acupuncture Treatment Versus Non-acupuncture During IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Keywords: Acupuncture
AMH
PCOS
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
First posted: 2013-01-29
Enrollment: 102
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acupuncture at follicular phase of the cycle may improve the pregnancy rate. This study aims to compare assisted reproduction outcome between two groups of PCOS patients underwent IVF, one group received acupuncture and other group without acupuncture.

Detailed description: Follicular phase acupuncture applied for PCOS patients underwent IVF to evaluate the effect of acupuncture on anti-mullerian hormone (AMH) and the effect on assisted reproduction outcome. It applied at certain acupoints according to the principles of traditional Chinese medicine.

Eligibility criteria: Inclusion Criteria::

* PCOS patients with patent one or two fallopian tubes, normal uterine cavity and partners with normal semen parameters.
* infertility
* 20-40 years
* IVF treatment -

Exclusion Criteria:

* patients with disorders that have the similar clinical presentation
* closed both tubes
* abnormal semen parameters
* intracytoplasmic sperm injection (ICSI)

Primary outcomes:
measure: Clinical pregnancy rate.
timeFrame: 13 months
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 15 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Assisted Reproduction Center, Department of Obstetrics and Gynecology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Assisted Reproduction Center, Union Hospital
name: Ying Gao, Ph.D., M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01929421: A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Keywords: colorectal cancer
gemcitabine
S-1
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer


Eligibility criteria: Inclusion Criteria:

* non resectable colorectal adenocarcinoma.
* disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
* estimated life expectancy of more than 3 months.
* ECOG status 2 or lower

Exclusion Criteria:

* other tumor type than adenoarcinoma.
* presence or history of CNS metastasis.
* evidence of gastrointestinal bleeding.

Primary outcomes:
measure: Response rate
timeFrame: 1year
Secondary outcomes:
measure: overall survival
timeFrame: 1year
measure: number of participants with adverse events
timeFrame: 1year
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
References:
Clinical trial NCT05146921: Gut Health and Probiotics in Parkinson's (SymPD)
Official title: Gut Health and Probiotics in Parkinson's (SymPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Current literature suggests that the gut microbiota is altered in patients with Parkinson's disease (PD) and might play a role in the clinical presentation and pathogenesis of this condition. The latter has driven the interest in investigating the use of gut microbiota-modulating interventions, such as probiotics, as possible novel therapeutic strategies for PD. Symprove is a food supplement working as an oral active probiotic which unlike many commercially available probiotics can reach the intestine and has been shown to be beneficial for gut health in gastrointestinal disorders.To date, no research has explored the possible effects of the intake of Symprove in PD. This is an exploratory study with a randomised, double-blind, placebo-controlled design investigating the effects of a 12-week probiotic intervention (Symprove) on gut and general health in 60 patients with PD and constipation.


Eligibility criteria: Inclusion Criteria:

* Age of 18 and upwards
* Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society clinical diagnostic criteria
* Hoehn Yarh stage II-IV
* Diagnosis of constipation according to the ROME IV criteria and ≤ than 3 complete bowel movements per week

Exclusion Criteria:

* Diagnosis or suspicion of other causes for parkinsonism
* Advanced-stage therapies (deep brain stimulation, intrajejunal levodopa infusion, and apomorphine subcutaneous infusion)
* Any inflammatory bowel disease or diseases of the colon
* Previous surgery on the gastrointestinal tract
* History of laxative abuse
* Ongoing artificial nutrition
* Regular use of probiotics
* Previous intolerance and/or adverse reactions to probiotics
* Previous use of Symprove
* Recent or current use of any antibiotics (within 4 weeks before the start of the study)
* Swallowing issues interfering with the safety intake of the probiotic/placebo
* Pregnancy or lactation
* Major systemic disease
* Any condition interfering with the ability to give the informed consent
* Enrolment in another simultaneous investigational trial

Primary outcomes:
measure: Gut microbiota of study population
timeFrame: Baseline
measure: Changes of gut microbiota following probiotic intervention and their association with changes in Parkinson's symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Blood
timeFrame: 12 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London
name: K Ray Chaudhuri, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098864: Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.
Official title: Transcranial Magnetic Stimulation of the Prefrontal Cortex: Effects on Risky Decision Making and Temporal Discounting.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Decision Making
Keywords: Behavior
Impulsivity
Transcranial Magnetic Stimulation
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2010-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objective of this study is to examine the effects of magnetic stimulation on the prefrontal cortex. We plan to use low frequency, repeated transcranial magnetic stimulation (1 Hz rTMS) to temporarily inhibit activity in the prefrontal cortex and measure the resulting effect on two decision-making tasks. The prefrontal cortex is thought to mediate or control cognitive functions like decision-making, planning, memory, and inhibit impulsive behavior.Previous research has indicated that rTMS over the right dorsal lateral prefrontal cortex will lead to preferences for riskier alternatives. Our hypothesis is that rTMS over the right DLPFC will lead to greater preference for the riskier alternative and greater temporal discounting.


Eligibility criteria: Inclusion Criteria:

* Healthy participants willing to give informed consent to participate
* complete the Transcranial magnetic stimulation Adult Safety Screen
* have a MRI scan
* wear ear plugs during rTMS
* receive rTMS over the designated course of days
* complete cognitive assessments and decision making tasks.
* return for post-testing on all tasks after completing all rTMS sessions

Exclusion Criteria:

* Diagnosed neurological and/or psychiatric disorders requiring hospitalization or medication
* pregnancy or the possibility of pregnancy at the time of consent
* a history of tinnitus
* metal implants in head or neck or a pacemaker
* poorly-controlled migraines
* a history of head injury, stroke, previous brain neurosurgery, or loss of consciousness due to head injury lasting greater than 10 minutes
* a personal or family history of epilepsy or seizures

Primary outcomes:
measure: The k metric of a hyperbolic function for delayed discounting
timeFrame: 12-18 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universtiy of Arkansas for Medical Sciences
name: Mark S Mennemeier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05365464: HOPE Trial hCG or Progesterone Effect on Recurrent Pregnancy Loss
Official title: hCG or Progesterone Effect on Unexplained Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Recurrent Pregnancy Loss Without Current Pregnancy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Up to half of all cases of recurrent pregnancy loss are unexplained (uRPL). Evidence points towards endometriosis and progesterone resistance as an underlying cause of uRPL. Previous non-RCT studies have suggested the luteal hCG provides a useful treatment for uRPL. We propose performing a randomized controlled trial to compare mid-luteal hCG with oral progesterone to prevent early pregnancy losses. the endpoint will be ongoing pregnancy and live birth rates. Equal numbers of patients will be randomized to each group.

Detailed description: Fifty (50) patients with unexplained recurrent pregnancy loss, defined as 2 or more losses. Workup will exclude structural, genetic, hormonal, and anti-phospholipid syndrome-related causes of RPL. Women with unexplained RPL will be randomized to receive a mid-luteal injection of ovidril (250 ug) 1 week after ovulation vs prometrium (200 mg qhs) starting 4 days after ovulation. If pregnant, prometrium will be continued until 8 weeks of pregnancy. If pregnancy does not occur, subjects will be allowed to repeat this protocol for up to 3 cycles. Outcomes will be listed as "not pregnant", "biochemical pregnancy", "miscarriage" or "ongoing pregnancy" for each cycle. Endpoints of pregnant cycles will be compared for pregnancy rate, miscarriage rate, ongoing pregnancy rate and live birth rate.

Eligibility criteria: Inclusion Criteria:

* 2 first trimester losses
* unexplained recurrent pregnancy loss

Exclusion Criteria:

* Antiphospholipid syndrome
* uterine septum
* Asherman's syndrome
* Paternal or maternal genetic abnormalities (i.e. balanced translocation)
* Endocrine causes of RPL (thyroid, diabetes, hyperprolactinemia)

Primary outcomes:
measure: Miscarriage
timeFrame: 4 to 11 weeks
measure: Ongoing pregnancy
timeFrame: 8 weeks
Secondary outcomes:
measure: Live birth rate
timeFrame: 40 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03629964: Study to Develop Head Stabilizer for Use During Brain Radiation Therapy
Official title: Real-Time Head Position Stabilization of Patients Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Diseases
Brain Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (SRS). SRS is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. This study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. The investigators would like to first see how the experimental device works in whole brain radiation.


Eligibility criteria: Adults undergoing whole brain radiation cancer treatment at the University of Chicago Medicine.

Primary outcomes:
measure: Access feasibility of the use of an experimental head stabilizer device
timeFrame: During radiation treatment (5-10 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Rodney Wiersma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108302: Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
Official title: Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: uterotonic
oxytocin
randomized trial
India
community
hemorrhage
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
name: PATH
name: Bill and Melinda Gates Foundation
First posted: 2010-04-21
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.


Eligibility criteria: Inclusion Criteria:

* gestational age \>=28 wks at enrollment
* anticipate spontaneous vaginal delivery
* hemoglobin \>=8 gm/dl
* delivery at home, sub-center, or primary health center
* delivery attended by Auxilliary Nurse Midwife

Exclusion Criteria:

* previous caesarean-section
* scheduled for caesarean-section
* antepartum bleeding during current pregnancy
* blood pressure \>140mm of Hg systolic and \>90mm of Hg diastolic
* in active labor at time of recruitment
* high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery

Primary outcomes:
measure: postpartum hemorrhage
timeFrame: after delivery of baby
Secondary outcomes:
measure: Oxytocin use before delivery
timeFrame: labor and delivery
measure: stillbirth
timeFrame: pregnancy
measure: neonatal death
timeFrame: first month of life
measure: need for neonatal resuscitation
timeFrame: 0-6 hours after birth
Other outcomes:
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
state: Karnataka
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Cynthia Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: JN Medical College, Belgaum, India
name: Shivaprasad Goudar, MD
role: PRINCIPAL_INVESTIGATOR
References: