louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01245465: Profermin® in Active Ulcerative Colitis
Official title: Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Nordisk Rebalance A/S
Sponsor class: INDUSTRY
Collaborators: name: Hvidovre University Hospital
First posted: 2010-11-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.


Eligibility criteria: Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below 12.

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Exclusion Criteria:

Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-

Primary outcomes:
measure: Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
timeFrame: 24 weeks
Secondary outcomes:
measure: Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nordisk Rebalance A/S
name: Hans Israelsen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04098965: Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum
Official title: Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Disorders
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.

At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.


Eligibility criteria: Inclusion Criteria:

* Patients who have dysfunctions in the pelvic floor after childbirth
* Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
* Patients who do not have any medical alteration that does not indicate the treatment

Exclusion Criteria:

* Patients who do not have pelvic floor dysfunctions after childbirth
* Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
* Patients who have any medical changes that counter the treatment

Primary outcomes:
measure: change in VAS from the start to the end
timeFrame: in the begining, at thirth month, at sixth month and at the finish (one year later)
measure: Change in SF36 from de start to the end
timeFrame: in the begining, at thirth month, at sixth month and at the finish (one year later)
measure: Change in EPIQ from de start to the end
timeFrame: in the begining, at thirth month, at sixth month and at the finish (one year later)
measure: Change in OXFORD from the start to the end
timeFrame: in the begining, at thirth month, at sixth month and at the finish (one year later)
Secondary outcomes:
Other outcomes:
Locations:
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
state: Cantabria
Study officials:
References:
Clinical trial NCT03798665: A Real World Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Solid Tumors
Official title: A Prospective, Multicenter, Non-interventional Registry Study Evaluating the Clinical Application of PEG-rhG-CSF During Chemotherapy in Patients With Malignant Solid Tumors in Sichuan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neutropenia
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical College
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Age ≥ 18 years old;
2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
4. Subjects volunteered to participate in this clinical trial and signed informed consent.

Brief summary: Prospective, multicenter, non-interventional registration studies were used in this project . Eight hundreds patients with solid tumors who met the inclusion criteria in six hospitals in Sichuan Province, Sichuan Province, were selected from the first chemotherapy cycle using PEG-rhG-CSF (can be any chemotherapy cycle of the patient), and each subsequent chemotherapy cycle was recorded. The use of PEG-rhG-CSF and related patient outcomes until the end of chemotherapy. Analyze the clinical practice of using PEG-rhG-CSF in the real world.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old;
2. Diagnosed as a malignant solid tumor by histology and cytology, requiring chemotherapy patients;
3. The first use of PEG-rhG-CSF during the chemotherapy cycle (not limited to the first chemotherapy cycle, can be any chemotherapy cycle of the patient);
4. Subjects volunteered to participate in this clinical trial and signed informed consent.

Exclusion Criteria:

1. PEG-rhG-CSF was used in the current chemotherapy cycle;
2. Have received hematopoietic stem cell transplantation or bone marrow transplantation;
3. Other drug clinical trials are currently underway.

Primary outcomes:
measure: Dosage of PEG-rhG-CSF in chemotherapy
timeFrame: 1 YEAR
measure: Administration time of PEG-rhG-CSF in chemotherapy
timeFrame: 1 YEAR
measure: dosing frequency of PEG-rhG-CSF in chemotherapy
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Affiliated Hospital of North Sichuan Medical College
state: Sichuan
Study officials:
References:
Clinical trial NCT03456765: Fetal Kidney in Estimation of GA in Pregnancy
Official title: Fetal Kidney in Estimation of GA and Maturity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Age and Maturity
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-03-07
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant ladies with no medical disorders with pregnancy between 16 weeks and 40 weeks in a single living fetus

Brief summary: A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .

Detailed description: Several longitudinal studies have been performed in the western countries concerning sonographic measurement of fetal kidney length. Initially these were done for diagnosis of renal malformation in utero \& later on they were to find out the correlation between the fetal kidney length and the gestational age

Eligibility criteria: Inclusion Criteria:

1. Single fetus.
2. pregnant ladies. with no medical disorders
3. Fetal kidneys are normally seen

Exclusion Criteria:

* Medical disorders with pregnancy
* Renal anomalies
* Renal agesnesis

Primary outcomes:
measure: The number of participants who will have accurate GA calculated by Kidney parameters
timeFrame: within 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05844865: Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
Official title: Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peritoneal Carcinomatosis
Gastrointestinal Peritoneal Carcinomatosis
Keywords: Peritoneal Carcinomatosis
Gastrointestinal Peritoneal Carcinomatosis
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.


Eligibility criteria: Inclusion Criteria:

* Patients must have a GI tumor
* Must have planned standard of care surgical procedure
* Age ≥ 18 years.
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Pattens who are unable to comply with the study protocol

Primary outcomes:
measure: Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)
timeFrame: Up to 4 years
measure: Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)
timeFrame: Up to 4 years
measure: Progression-Free Survival (PFS) at 6 months
timeFrame: 6 months
measure: Overall Survival (OS)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center, University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Maheswari Senthil, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163865: A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents
Official title: A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Affective Disorders
Anxiety Disorders
Attention Deficit and Disruptive Behavior Disorders
Psychotic Disorders
Keywords: Boredom
Adolescent
Mental illness
Depression
Anxiety
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: The Alfred
First posted: 2005-09-14
Enrollment: 71
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents

Brief summary: The aim of the following pilot study is to examine boredom in a community sample of adolescents and a clinical sample of adolescents. This is important in order to examine differences among healthy adolescents and adolescents with mental illness.

Detailed description: Boredom has been recognized as a significant problem in a wide variety of areas. However, limited research has been focused on this construct (Vodanovich \& Watt, 1999). Research into boredom in adolescents is especially lacking in the psychological literature. This is surprising given that adolescence is a time marked by change, stress, and identity issues.

The aim of the following pilot study is to examine boredom in a community sample of adolescents and a clinical sample of adolescents. This is important in order to examine differences among healthy adolescents and adolescents with mental illness, such as depression, anxiety, and ADHD. This has implications for both prevention and intervention strategies and programs, such as the assessment and treatment of adolescents with mental illness. Hence, the results of this study will be important in providing an evidence-based practice in the treatment of mental illness in adolescents.

Participants will be asked to complete one survey, the Boredom Proneness Scale (Farmer \& Sundberg, 1986), and a demographic background form to measure gender, date of birth, country of birth, etc. The community sample of adolescents will be recruited from secondary schools in Victoria. The clinical sample of adolescents will be recruited from the Alfred Child and Adolescent Mental Health Service. It is envisaged that about 100 adolescents from each sample will be recruited to participate.

Eligibility criteria: Inclusion Criteria:

* 13-18 years of age
* has consenting guardian

Exclusion Criteria:

* unable to sufficiently understand self report measure
* IQ \< 70

Primary outcomes:
measure: Boredom proneness scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Child and Adolescent Mental Health Service
state: Victoria
Study officials:
affiliation: Alfred Hospital Bayside Health
name: Campbell R Thorpe, MBBS FRANZCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03307265: Impact of the Use of a Weighted Jacket on the Balance of Patients With a Balance Disorder.
Official title: Impact of the Use of a Weighted Jacket on the Balance (While Walking or Standing) of Patients With a Balance Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance; Distorted
Keywords: Weighted Jacket
Balance disorder
Equilibrium disorder
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to test whether wearing a weighted jacket can help improve the balance distortion of patients with neurologic pathologies.

The center of mass of the patient will be analyzed in order to determine the direction in which the imbalance is most important. Weights will be placed accordingly in a jacket in order to correct the imbalance. In the experimental group, weights will represent 1.5 to 2% of the patient body mass. In the control group, the investigators will use weights of 200 grams maximum, placed evenly on both sides of the jacket. Patients will wear the jacket for 2 consecutive hours.

After wearing the jacket for 2 hours, data similar to those recorded at the beginning of the experiment will be taken again, namely the determination of the center of mass and of the deviations caused by the imbalance.

A final series of tests will take place approximately one week after wearing the jacket, to determine if there are any residual effects.


Eligibility criteria: Inclusion Criteria:

* good level of French understanding
* be able to walk a minimum distance of 10 meters with or without rod/walker
* walk 10 meters in more than 12 seconds.
* have a diagnosis of Multiple Sclerosis, Parkinson's, or any other neurological pathology that could cause balance disorders
* be able to endure at least 2 hours of tests, interviews or medical care.
* score of more than 8 seconds at the time up and go (TUG), less than 24 points out of 28 in the Tinetti test

Exclusion Criteria:

* the patient underwent a period of exacerbation of his pathology in the last two months (especially for multiple sclerosis patients)
* chronic back pain
* poor eyesight (not be able to perform the tests)
* osteoporosis

Primary outcomes:
measure: Imbalance
timeFrame: Data measured after 2 hours of jacket utilisation
measure: Time Up and Go
timeFrame: Data measured after 2 hours of jacket utilisation
measure: Tinetti test
timeFrame: Data measured after 2 hours of jacket utilisation
measure: Berg balance scale
timeFrame: Data measured after 2 hours of jacket utilisation
Secondary outcomes:
measure: Imbalance
timeFrame: 1 week after jacket utilisation
measure: Time Up and Go
timeFrame: 1 week after jacket utilisation
measure: Tinetti test
timeFrame: 1 week after jacket utilisation
measure: Berg balance scale
timeFrame: 1 week after jacket utilisation
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: CHU Brugmann
Study officials:
References:
Clinical trial NCT01199965: Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers
Official title: An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Subjects
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2010-09-13
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.


Eligibility criteria: Major Inclusion Criteria:

1. Able to provide written informed consent
2. Male or Female subjects 18 to 45 years old
3. Female subjects who are practicing adequate contraception or who are sterile
4. Stable cardiac status
5. Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Major Exclusion Criteria:

1. Contraindication to dihydroergotamine mesylate (DHE)
2. Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
3. History of hemiplegic or basilar migraine
4. Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial

Primary outcomes:
measure: Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers
timeFrame: 48 hours
measure: AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Limited
Study officials:
References:
Clinical trial NCT00274365: Consultations in Psychiatry Through Videoconference
Official title: Consultations in Psychiatry Given to GP's Through Videoconference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Remote Consultation [L01.178.847.652.550]
Keywords: general practitioners, psychiatry, videoconference
Lead sponsor: Sha'ar Menashe Mental Health Center
Sponsor class: OTHER
Collaborators: name: Galil Center for Telemedicine and Medical Informatics
First posted: 2006-01-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Online consulatations through videoconference in the field of psychiatry given to general practitioners will reduce costs of medical treatment and improve service.

Detailed description: CLINICAL STATE, SATISFACTION AND COST EFFECTIVENESS WILL BE CHECKED DURING 1 YEAR OF ONLINE VIDEO CONFERENCE CONSULTATION TO GENERAL PRACTITIONERS. BPRS, HAMILTON ANXIETY AND DEPRESSION AND CGI SCALES WILL BE COMPLETED.COSTS OF MEDICATIONS, NUMBER OF VISITS, LAB AND OTHER EXAMINATIONS, HOSPITALIZATIONS, MISSING WORKING DAYS WILL BE EVALUATED.

Eligibility criteria: Inclusion Criteria:

Referral by general practitioner Age: \>18 - Speaking Hebrew or Russion

Exclusion Criteria:

CGI\>4 Dementia Drug or alcohol addiction -

Primary outcomes:
measure: Expenditures on medications
measure: No. of visits
measure: Loss of work days
measure: Expenditure on lab tests
measure: Satisfaction
measure: CGI
measure: Hamilton
measure: Somatisation
measure: GHQ11
measure: Q-LES-Q-18
measure: No. of consultations
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Regional clinic of General Health Services
Study officials:
affiliation: Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel
name: Ilan Modai, MD, MHA
role: STUDY_DIRECTOR
References: