louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01429493: Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases
Official title: Biological Image Guided Antalgic Stereotactic Body Radiotherapy of Bone Metastases: a Randomized Phase II/III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bone Metastases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Painful bone metastasis of solid tumors
* Pain score minimum of 2 on a scale of 10
* A maximum number of painful bone metastases: 3 or more
* Life expectancy \> 3 months
* Age minimum 18 years old
* Signed informed consent

Exclusion Criteria:

* Tumor histology (renal cell and melanoma vs. other solid tumors)
* VAS pain score (\<5 vs. 6-10).
* Bisphosphonate use (yes vs. no)
* Opioid analgesics (yes vs. no)
* Corticosteroid use (yes vs. no)
* Spine vs non-spine localisation

Primary outcomes:
measure: Level of pain response 1 month after radiotherapy
timeFrame: 1 month after radiotherapy
Secondary outcomes:
measure: Quality of life 1 month after radiotherapy.
timeFrame: 1 Month after radiotherapy
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124293: Incidence/Magnitude-Haemorrhagic Progression-Cerebral Contusions and Identification (ID) of Safety Issues After Traumatic Brain Injury
Official title: A Multi Centre Observational Study to Evaluate the Incidence and Magnitude of Haemorrhagic Progression of Cerebral Contusions and the Identification of Important Safety Issues Following Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Bleeding Disorder
Trauma
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-07-27
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were selected from a speciality practice group (Neurosurgery practices with a focus on head trauma. Subjects will have had a mild-to-moderate head injury and require hospitalization.

Brief summary: This study is conducted in North America. The purpose of this study is to evaluate the occurrence and severity of bleeding in brain injury and to identify important safety issues following traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* Ages Eligible for Study: 18 Years - 85 Years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00800293: Randomized Study to Compare the Bioavailability of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Official title: Bioequivalence of Two Augmented Betamethasone Dipropionate 0.05% Topical Creams
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: bioequivalence
betamethasone dipropionate
Bioequivalency
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Community Volunteers

Brief summary: The purpose of this study was to compare the relative vasoconstrictive effects of test and reference topical augmented betamethasone dipropionate augmented 0.05% cream in healthy, female subjects.


Eligibility criteria: Inclusion Criteria:

* Non-tobacco-using female subjects, 18 to 50 years of age
* Demonstrated blanching response to Reference Drug (augmented betamethasone dipropionate) Cream 0.05%
* Weight within + or - 20% from normal for height and weight for body frame
* Good health as determined by lack of clinically significant abnormalities in medical history and clinical assessment, as judged by the Investigator
* Signed and dated informed consent form which meets all criteria of current FDA regulations

Exclusion Criteria:

* History of allergy to systemic or topical corticosteroids
* Presence of any skin condition or coloration that would interfere with the placement of test sites or the response or assessment of skin blanching
* Presence of medical condition requiring regular treatment with prescription drugs
* Drug or alcohol addiction requiring treatment in the past 12 months prior to dosing
* Use of any dermatological drug therapy on the flexor surface of the forearms within 30 days of dosing
* Use of any tobacco products in the 30 days prior to study dosing
* Receipt of any drugs as part of a research study within 30 days prior to study dosing
* Pregnant or lactating

Primary outcomes:
measure: Vasoconstriction will be measured by the degree of skin blanching observed after treatment removal using a ChromaMeter.
timeFrame: Over the course of one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05324293: To Evaluate the Safety, Tolerability and Efficacy in Male and Female with AGA Treated with HMI-115 Over a 24-week Treatment Period
Official title: An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female with Androgenetic Alopecia Treated with HMI-115 Over a 24-Week Treatment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: Hope Medicine (Nanjing) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and 5. Female subjects who meet Sinclair scales 2-4.

Exclusion Criteria:

1. Subject with clinical diagnosis of non-AGA
2. Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
3. Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
4. Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
5. Subject has clinically significantly abnormal laboratory tests at Screening
6. Known hypersensitivity to any of the IMP ingredients
7. Any other conditions in the investigator's opinion that prevent the subject from participating

Primary outcomes:
measure: TAHC(target area hair count) of non-vellus
timeFrame: From baseline to Week 24
Secondary outcomes:
measure: TAHC of non-vellus
timeFrame: From baseline to Week 6, 12, 18, and 36
measure: TAHW(target area hair width) of non-vellus hair
timeFrame: From baseline to Week 6, 12, 18, 24, and 36
measure: Investigator Global Assessment (IGA)
timeFrame: Week 6, 12, 18, 24, and 36
measure: Subject self-Assessment (SSA)
timeFrame: Week 6, 12, 18, 24, and 36
measure: Hair growth questionnaire assessment (HGQA)
timeFrame: Week 6, 12, 18, 24, and 36
Other outcomes:
Locations:
city: Melbourne E.
country: Australia
facility: Dr Rodney Sinclair Pty Ltd, trading as Sinclair Dermatology
state: Victoria
Study officials:
References:
Clinical trial NCT04310293: Novel Therapy for Poor Responders Management
Official title: Novel Therapy for Poor Responders Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poor Ovarian Response
Keywords: IVF
POOR RESPONDERS
GROWTH HORMONE
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \<41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of the Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before

Detailed description: Unfortunately for some infertile women, gonadotrophin administration results in a desultory ovarian response. While this is commonly due to diminished ovarian reserve, as indicated by advanced age and/or elevated basal day 3 FSH concentrations, a subset of these patients are \<41 years old and have normal FSH concentrations.

To overcome this problem several strategies have been reported, with limited success.

With approval of our Board, 100 women with a history of previous poor response to vigorous gonadotrophin stimulation. All with AFC ≤3, AMH;≤0.5 and they give only ≤3 oocytes in their previous cycles will be included in this study using this new protocol: clomiphene citrate 150 for 7 days starting on DAY2, associated with HMG 300 IU \& Groth hormone 8 units in alternating days (i.e.; HMG on D2,4,6,8 while GH on D3,5,7,9) then folliculomonitoring will be started on D9, then Antagonist may be added till triggering then will see the response compared to their own ovarian response before in their previous trials

Eligibility criteria: Inclusion Criteria:

* All with AFC ≤3,
* AMH;≤0.5
* and they give only ≤3 oocytes in their previous cycles

Exclusion Criteria:

-

Primary outcomes:
measure: NUMBER OF OOCYTES
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Al-BARAKA FERTILITY HOSPITAL
Study officials:
References:
Clinical trial NCT02335593: Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients
Official title: Evaluation of the Effect of Zinc Supplementation on the Health Status of Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: Hemodialysis patients
Zinc
Anemia
Oxidative stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: National Institute of Urology and Nephrology
First posted: 2015-01-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effect of Zinc supplementation on health status of hemodialysis patients through measurement of the following before and after Zinc administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also, Evaluation of quality of life of hemodialysis patients before and after Zinc administration using Fatigue severity scale questionnaire.


Eligibility criteria: Inclusion Criteria:

* Under regular hemodialysis for at least 6 months.
* Clinically stable condition as outpatients.
* Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).

Exclusion Criteria:

* Patients taking any antioxidant supplements including vitamin E, Omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study.
* Patients receiving Al hydroxide phosphate binders.
* Hospitalization in the previous month before the onset of the trial, or having active infection.
* Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.

Primary outcomes:
measure: Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)
timeFrame: three months
Secondary outcomes:
measure: Effect on Oxidative stress (Measurement of Malondialdehyde, Total antioxidant capacity, Nitric oxide and Superoxide dismutase)
timeFrame: three months
measure: Effect on Inflammatory status. (Measurement of C-Reactive protein and Interleukin-6)
timeFrame: three months
measure: Effect on Fatigue (Fatigue Sevrity Scale)
timeFrame: three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Institute of Urology and Nephrology
state: El Matareya
Study officials:
affiliation: Ain Shams University
name: Rasha R. El-kady, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04601493: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
Official title: PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Opioid Use
Opioid Abuse
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-10-23
Enrollment: 631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 43 Primary Care Clinics will be randomized to be in one of 4 arms: 1) Care as usual, 2) Choice architecture nudge, 3) Prescription Drug Monitoring Program (PMP) Integration \& nudge, 4) Choice architecture nudge + PMP Integration \& nudge
Primary purpose: PREVENTION

Brief summary: The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.

Detailed description: To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.

The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.

Eligibility criteria: Inclusion Criteria:

- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics

Exclusion Criteria:

- Primary care providers who work less than 20% full time equivalent (FTE)

Primary outcomes:
measure: Opioid Prescription Rate
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Non-Opioid Treatment Prescription
timeFrame: 12 months
measure: Opioid Prescription Length
timeFrame: 12 months
measure: Opioid Prescription MME
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ezra Golberstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294593: Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome
Official title: One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Down Syndrome
Keywords: Down syndrome
folinic acid therapy
cognitive functions
Lead sponsor: Institut Jerome Lejeune
Sponsor class: OTHER
Collaborators: name: Fondation Jérôme Lejeune
First posted: 2006-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.


Eligibility criteria: Inclusion Criteria:

* Down syndrome without mosaicism
* age 3 to 30 months
* weight over 4 kg
* possible assessment by the revised Brunet-Lezine scale

Exclusion Criteria:

* history of leukemia
* West syndrome or non-stable epilepsy
* non-stable thyroxin treatment

Primary outcomes:
measure: Score on a psychomotor development scale after a 6 and 12 months treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Jerome Lejeune
Study officials:
affiliation: Institut Jerome Lejeune
name: Henri Blehaut, M.D.
role: STUDY_DIRECTOR
affiliation: Institut Jerome Lejeune
name: Clotilde Mircher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botez MI, Botez T, Leveille J, Bielmann P, Cadotte M. Neuropsychological correlates of folic acid deficiency: facts and hypotheses. In: Botez MI, Reynolds EH, eds. Folic acid in neurology, psychiatry and internal medicine. New York, Raven Press, 1979:435-461.
citation: Lejeune J. [Pathogenesis of mental impairment in trisomy 21]. Ann Genet. 1991;34(2):55-64. French.
citation: Blehaut H, Mircher C, Ravel A, Conte M, de Portzamparc V, Poret G, de Kermadec FH, Rethore MO, Sturtz FG. Effect of leucovorin (folinic acid) on the developmental quotient of children with Down's syndrome (trisomy 21) and influence of thyroid status. PLoS One. 2010 Jan 11;5(1):e8394. doi: 10.1371/journal.pone.0008394.
Clinical trial NCT02668393: Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Official title: An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.


Eligibility criteria: Inclusion criteria:

-Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible).

First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

* ECOG inferior or equal to 1 at screening.
* Further inclusion criteria apply

Exclusion criteria:

* Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
* Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
* Further exclusion criteria apply.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel
timeFrame: First treatment cycle, the first 28 days following the start of trial medication.
measure: Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle
timeFrame: First treatment cycle, the first 28 days following the start of trial medication.
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: HOP d'Angers
city: Besançon
country: France
facility: HOP Jean Minjoz
city: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Halle/Saale
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: