louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00687414: Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders
Official title: Evaluation of Formin Gene Status and Expression in Myeloproliferative and Myelodysplastic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Disorder
MDS
AML
Keywords: gene expression
gene sequencing
gene encoding
MPD
MDS
AML
mDia
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
name: Community Foundation for Southeast Michigan (JP McCarthy Fund)
First posted: 2008-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Aim of the study is to analyze the expression of genes and sequences encoding the human mammalian diaphanous (mDia) related formin proteins to test the hypothesis that defects in the mDia expression or function might drive the pathophysiology of myelodysplastic syndrome, acute myeloid leukemia and other myeloproliferative diseases.

Detailed description: Leukocytes and myeloid lineage cells from these specimens will be assayed for expression of DRF genes using standard molecular biological approaches to measure mRNA levels. Extracted DNA will be analyzed for mutations that affect expressions or function using direct sequencing techniques.

Alternatively, expression of DRF gene products (mDia proteins) will be assessed using specific antibodies and flow cytometry. Molecular findings resulting from these assays will be correlated with clinical information recorded in specimen logbook.

Eligibility criteria: Inclusion Criteria:

* 18 and over
* Male
* Female
* Diagnosed with MDS, MPD and AML

Exclusion Criteria:

* Under the age of 18
* Received bone marrow transplant

Control Group Criteria:

inclusion:

* healthy men and women
* ≥ 55 years of age

exclusion:

* history of hematological condition
* history of cancer

Primary outcomes:
measure: to determine if defective DRF1 expression or mDia1 function may contribute to myeloid malignancies and point to mDia1 as an attractive therapeutic target in MDS and MPS
timeFrame: within a year
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: St Mary's Health Care
state: Michigan
city: Grand Rapids
country: United States
facility: Van Andel Research Institute
state: Michigan
Study officials:
affiliation: Van Andel Research Institute
name: Arthur S Alberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756314: Contraceptive Counseling Following an Abortion
Official title: Effectiveness of Contraceptive Counseling of Women Following an Abortion in Recife, Brasil: a Randomized Controlled Intervention Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Abortion Care
Keywords: Ambulatory Care Facilities
abortion care
contraception
counseling
outpatient clinic
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2008-09-22
Enrollment: 246
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether contraceptive counseling is effective on acceptance and use of methods in women following an abortion.

Detailed description: Contraceptive counseling is considered an essential component of post abortion care (PAC) programmes and it is recommended to prevent unintended pregnancies and unsafe, repeated abortions. Indeed, most maternal deaths related to unsafe abortions could be prevented by expanding and improving family planning provision.

Eligibility criteria: Inclusion Criteria:

* Within the first 10 days (plus or minus 5 days) after an abortion
* Live in Recife or whereabouts in Recife(Brazil)

Exclusion Criteria:

* Clinical diagnosis of Gestational Trophoblastic Disease
* Women HIV positive
* Psychiatric pathology

Primary outcomes:
measure: Contraceptive Acceptability and Use of Contraceptives During the 6-month Follow-up
timeFrame: after the contraceptive counseling and during the 6-month follow
measure: Correct Use of the Method
timeFrame: within the first 6 months after intervention
measure: Chosen Contraceptive Method After Counseling
timeFrame: after the contraceptive counseling
Secondary outcomes:
measure: Pregnancies Among All Women
timeFrame: within the first six months after intervention
measure: Satisfaction With the Used Contraceptive Method
timeFrame: During the 6-month Follow-up
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: IMIP - Instituto Materno Infantil Prof Fernando Figueira
state: Pernambuco
Study officials:
affiliation: IMIP
name: Ariani I Souza, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04734314: Efficacy of Vojta on Balance and Quality of Life in Subject With CNLBP
Official title: Effect of Vojta on Balance and Quality of Life in Subject With Chronic Non-spacific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Non-Specific Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: . To investigate the effect of Vojta method on static balance ,dynamic balance, quality of life in patients with chronic non - specific low back pain

Detailed description: This randomized controlled trial is to investigate the effect of Vojta method on balance and quality of life in patients with chronic non-specific low back pain.

Forty patients (male and female) complaining of chronic non -specific low back pain was recruited to share in this study

. The recruited patients were randomly recruited into two groups; group A (control group) and group B (study group).

Group A: received conventional treatment of back pain which included; TENS 20 min and hot packs 10 min .The total treatment session is 30 min three session per week for four weeks Group B: received conventional treatment of back pain in addition to Vojta method. The total treatment session is 40 min.

Patient in both groups performed 10 sessions, 3 session per week

Eligibility criteria: Inclusion Criteria:

1. Patients with chronic non -specific low back pain for more than 3 months.
2. Their age ranged between 18-35 years old
3. Both sexes were recruited in this study.
4. Their BMI ranged between 18-25 kg/m2

Exclusion Criteria:

1- Patients with previous spinal surgery 2. Patients who have radiological diagnosis of spondylolysis or spondylolisthesis.

3. Patient with neurological disease . 4. Chest problems 5. Systematic disease

Primary outcomes:
measure: static and dynamic balance
timeFrame: one month
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mti University
Study officials:
References:
Clinical trial NCT02406014: Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
Official title: Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis (AK)
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 502
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: This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.

Detailed description: All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.

Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:

* Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
* Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.

Eligibility criteria: Inclusion Criteria:

1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
2. Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp

Exclusion Criteria:

1. Location of the selected treatment area:

* on the periorbital skin
* on the perioral skin/around the nostrils
* within 5 cm of an incompletely healed wound
* within 10 cm of a suspected BCC or SCC or other neoplasia

Primary outcomes:
measure: Complete clearance of all AKs
timeFrame: 11 Months
Secondary outcomes:
measure: Complete clearance of all AKs at Week 17
timeFrame: 11 Months
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Gemain, Weber & Craninic
Study officials:
affiliation: St. Josef-Hospital im Katholischen Klinikum Bochum
name: Eggert Stockfleth, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.
Clinical trial NCT06499714: HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase
Official title: HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase: A Prospective Cohort Study at 3600 m
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Mountain Sickness
Keywords: Women
Hypoxia
Prevention
Acetazolamide
Altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: University Hospital Heidelberg
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2024-07-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, non-smoking, premenopausal women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).

Brief summary: Prospective cohort study investigating the menstrual cycle phase (MCP)-dependent incidence of acute mountain sickness (AMS) in women travelling to 3600 m.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal, eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides

Primary outcomes:
measure: Acute Mountain Sickness (AMS) Incidence, LLS 2018
timeFrame: Day 1 to 3 at 3600 m
Secondary outcomes:
measure: Acute Mountain Sickness (AMS) Incidence, LLS 1993
timeFrame: Day 1 to 3 at 3600 m
measure: Acute Mountain Sickness (AMS) Severity, LLS 2018
timeFrame: Day 1 to 3 at 3600 m
measure: Acute Mountain Sickness (AMS) Severity, LLS 1993
timeFrame: Day 1 to 3 at 3600 m
measure: Arterial blood gases
timeFrame: Day 2 at 760 m and day 2 at 3600 m
measure: Hypoxic ventilatory response
timeFrame: Day 2 at 760 m
measure: Perceived pain visualization
timeFrame: Day 1 to 3 at 3600 m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Michael Furian, Prof. Dr.
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant Sooronbaev, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04804995: Investigating the Frequency and Phenotype of Headaches Associated With Fasting During the Month of Ramadan.
Official title: Headache in Ramadan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy participants and migraine patients.

Brief summary: Headaches are more common in the month of Ramadan in patients who already suffer from migraine. The object of the present study is investigate the frequency in the Ramadan month .


Eligibility criteria: Inclusion Criteria:

* age 18-60 years.
* expectation of fasting for at least 21 of 30 days during the month of Ramadan.
* understand and answer the questionnaire sent out in Danish.

Exclusion Criteria:

* non-compliance with the headache calendar (defined as non-registration of at least 21 days per 30 days).

Primary outcomes:
measure: Headache frequency
timeFrame: Daily headache diary in three months.
measure: Headache frequency
timeFrame: Daily headache diary in three months.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Faisal Mohammad Amin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690895: Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy
Official title: Long-term Outcome of AIDS-related Primary Central Nervous System Lymphoma Treated With High Dose Methotrexate and Combined Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Nervous System Lymphoma
AIDS Related Lymphoma
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-10-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated for AIDS-related primary central nervous system lymphoma in Fondation Rothschild (Paris, France) between january1996 and december 2014

Brief summary: This study aims at describing survival rates over time (Kaplan-Meier estimator) in patients suffering from AIDS-related primary central nervous system lymphoma who were diagnosed from 1996 to 2014 and treated with infusions of high-dose methotrexate and combined antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* HIV infection
* AIDS-related primary central nervous system lymphoma
* treated with at least one infusion of methotrexate and combine antiretroviral therapy

Exclusion Criteria:

* prior non-Hodgkin lymphoma

Primary outcomes:
measure: Median duration of survival after diagnosis of lymphoma (years)
timeFrame: At the time of systematic files review (jan 2014) - average follow-up 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
References:
Clinical trial NCT06605495: Using Dry Eye As a Disease Model, Investigators Demonstrated the Optimal Selection of Individualized Clinical Interventions and the Superiority of Dynamic Treatment Discrimination in Chinese Medicine.
Official title: Demonstration Clinical Study of Dry Eye Disease Advantage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease (DED)
Lead sponsor: Ineye Hospital of Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, investigators will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.


Eligibility criteria: Inclusion Criteria:

* Be 18-75 years of age and of any gender
* Meets Western diagnostic criteria for dry eye
* Formed consent and signed the Informed Consent Form

Exclusion Criteria:

* Those who are unable to perform a dry eye examination due to various factors
* Patients with severe diseases of the liver or renal system, or infectious eye diseases
* Those who are allergic to the medications used in this study
* Women who are pregnant or breastfeeding Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.

Primary outcomes:
measure: Chinese Medical Evidence Scale
timeFrame: From enrollment to end of 6-week treatment
measure: Ocular Surface Disease Index
timeFrame: From enrollment to end of 6-week treatment
measure: Fluorescein Breakup Time
timeFrame: From enrollment to end of 6-week treatment
Secondary outcomes:
measure: Schirmer Ⅰ test
timeFrame: From enrollment to end of 6-week treatment
measure: Height of the River of Tears
timeFrame: From enrollment to end of 6-week treatment
measure: fluorescent staining of the cornea
timeFrame: From enrollment to end of 6-week treatment
measure: Classification of blepharoplasty deficiency
timeFrame: From enrollment to end of 6-week treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06478095: Preoperative Visual Aids on Glaucoma Surgical Patients
Official title: Preoperative Visual Aids on Patients With Low Educational Backgrounds Undergoing Glaucoma Filtration Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Glaucoma Medications
Keywords: Preoperative visit;glaucoma;filtering surgery
Lead sponsor: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Shantou University Medical College
First posted: 2024-06-27
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.

Detailed description: A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.

Eligibility criteria: Inclusion Criteria:

* Adult inpatients with age ≥18 years
* Illiterate or with ≤ 9 years of compulsory education
* Indications for filtering surgery

Exclusion Criteria:

* Mental illness
* Cognitive impairment

Primary outcomes:
measure: Anxiety levels, pain scores, blood pressure, and pulse rates
timeFrame: 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
state: Guangdong
Study officials:
affiliation: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
name: Chukai Huang, PhD
role: STUDY_DIRECTOR
References: