louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06621680: Effect of Connective Tissue Massage on Premenstrual Syndrome
Official title: Effect of Connective Tissue Massage on Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premenstrual Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 50
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of connective tissue massage on premenstrual syndrome.

Detailed description: Premenstrual syndrome is a collection of emotional, physiological and behavioral symptoms that develop around the end of the luteal phase and fade away with or after mensturation.

The physiological effects of connective tissue massage (CTM) are both local and general. Local effects include release of histamine from mast cells which leads to a triple response, local swelling and arteriolar dilatation mediated by local axon reflexes. The increased blood flow to the region assists resolution of subacute or chronic inflammation and reduces pain by removing nocigenic chemicals from the tissues. The mechanical distortions produced by CTM strokes help to mobilize connective tissue and improve function.

Few studies have investigated the effect of the CTM on premenstrual syndrome in adolescent females. So this study will be conducted to add new information about the effect of connective tissue massage on premenstrual syndrome, which may help adolescent females suffering from this syndrome in decreasing their symptoms, thus adding new information to the field of physical therapy.

Eligibility criteria: Inclusion Criteria:

* Virgin adolescent females diagnosed with premenstrual syndrome.
* Their age will be ranged from 17-25 years (3 years post puberty).
* Their body mass index (BMI) will be less than 30 kg/m2 .
* All are of regular menstrual cycles.
* All of them suffering from moderate and severe PMS.

Exclusion Criteria:

Participants will be excluded from this study if they have

* Any pathological finding in the pelvic cavity as polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
* Irregular menstruation.
* Any history of gynecological intervention.
* Open wounds, weak/broken bones or fractures.

Primary outcomes:
measure: Pain intensity
timeFrame: 3 months
measure: Premenstrual syndrome severity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Enas Nabil Georgy
Study officials:
affiliation: Cairo University
name: Azza B Kassab, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00172380: Phase II Study of Docetaxel Plus CDDP for NSCLC Stage III
Official title: Phase II Study Evaluating Docetaxel and CDDP as Neoadjuvant Chemotherapy Prior to Surgery, Followed by Adjuvant Docetaxel Plus CDDP in Chemonaive Patients With NSCLC Stage III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the overall response rate to docetaxel plus CDDP as neoadjuvant chemotherapy prior to surgery, followed by adjuvant docetaxel plus CDDP in chemonaive patients NSCLC Stage IIIa and IIIb.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC, respectable NSCLC stage IIIa T1-2 N2 or or unresectable stage IIIb 2.KPS\>70% 3.Hb\>10g/dl,ANC\>2.0x109/L,Plt.\>100x109/L4.T-bil.\<1xULN,creatinine\<1xULN,creatinine clearance \>60 ml/min,GPT/GOT\<2.5xULN,ALP\<5xULN

Exclusion Criteria:

* 1.Brain meta.2..Prior surgery,R/T, C/t or immunotherapy for NSCLC

Primary outcomes:
measure: overall response rate
timeFrame: every cycle during 2nd-6th cycles
Secondary outcomes:
measure: resectability
timeFrame: resectability after treatment
measure: progression free survival
timeFrame: progression free survival after 1 year
measure: overall survival
timeFrame: overall survival at 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Internal Medicine, National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University hospital
name: Chong-Jen Yu, M.D,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084980: Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
Official title: A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Minimal Change Disease
Keywords: minimal change disease
tacrolimus
corticosteroid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

Detailed description: A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

Eligibility criteria: Inclusion Criteria:

* from 18yrs to 80 yrs , man and women
* Minimal change disease is diagnosed by kidney biopsy
* On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0
* On screening, the patient shows that the serum albumin is below 3.0g/dL
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take tacrolimus or cyclosporin for 1 month
* If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day
* steroid dependent or steroid resistant or frequent relapse case
* uncontrolled hypertension
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to tacrolimus or macrolide
* acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL

Primary outcomes:
measure: remission of proteinuria
timeFrame: 12 weeks
Secondary outcomes:
measure: time to remission, relapse rate, response failure rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06790680: GITMO AML/MDS-Relapse Registry Study
Official title: Managment of Acute Myeloid Leukemia and Myelodysplastic Patients Relapsing After Allogenic Stem Cell Transplantation: Results of the GITMO AML/MDS-relapse Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukaemia
Myelodysplastic Syndrome
Lead sponsor: Gruppo Italiano Trapianto di Midollo Osseo
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 859
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute myeloid leukemia and myelodysplasia relapsed after allotransplantation and who received salvage therapy.

Brief summary: The proposal arises from the increasingly pressing need to have a program of therapy for the prevention of relapse after allogeneic transplantation in patients with acute myeloid leukemia or myelodysplasia, especially if they undergo transplantation with positive minimal residual disease. These therapeutic approaches include molecular target drugs (for example, FLT-3 inhibitors when this gene lesion is present) or apoptosis inducers in combination with hypomethylating agents (for example, the combination of venetoclax and azacitidine or decitabine) or adoptive immunotherapy (for example, with infusion of donor lymphocytes).

To date, most of these therapeutic approaches are used in the phase of hematological relapse of the disease; less often they are used in the phase of persistence of minimal residual disease at the molecular level or in the phase of loss of molecular chimerism on CD34+ cells, also due to the prescribing constraints of the competent authorities (AIFA). It is believed that the collection of the Italian experience can provide important information on the use of different therapeutic platforms, in different settings. This information could be the starting point for the design of prospective and multicenter studies to be proposed in the near future.


Eligibility criteria: Inclusion Criteria:

* All patients with AML and MDS who underwent allo-SCT from 2015 to 2021, who relapsed and received salvage therapy for the relapse.

Exclusion Criteria:

* Patients with a diagnosis other than AML and MDS transplanted in the same period.

Primary outcomes:
measure: Primary Outcome
timeFrame: Through study completion, an avarage 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: Through study completion, an avarage 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: GITMO
Study officials:
References:
Clinical trial NCT03492580: A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
Official title: Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Cardiovascular Diseases
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 714582
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease over a 4-year period 1 April 2013 and 15 May 2017 will be observed.

Brief summary: The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.


Eligibility criteria: Inclusion Criteria:

* First exposure to the particular drug(s) in database (index date)
* Exposure start is between 1 April 2013 and 15 May 2017
* At least 365 days of continuous observation time prior to index
* At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)

For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date

Exclusion Criteria:

- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study

Primary outcomes:
measure: Number of Hospitalizations for Heart Failure
timeFrame: Approximately 4-years
measure: Number of Participants with Below Knee Lower Extremity Amputation Events
timeFrame: Approximately 4-years
Secondary outcomes:
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen Investigative Site
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06535880: Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas As Well As Subnuclei of the Spinal Trigeminal Nucleus
Official title: Brainstem Mapping of Nociceptive and Non-nociceptive Trigeminal Input and Its Functional Connectivty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Disorders
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 40
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
Primary purpose: BASIC_SCIENCE

Brief summary: In previous studies clustering of the three branches of the trigeminal nerve in brainstem were shown, cerebellum and periaqueductal gray. To further evaluate higher cortical structures, which were not covered by our previous field of view (FOV) and to further investigate the identified 'subnuclei' of the spinal trigeminal nucleus, here the aim is to scan the whole brain as well as the brainstem and the upper spinal cord during trigeminal nociceptive as well as non-nociceptive electrical stimulation of all three branches of the trigeminal nerve (and the arm as a somatic control site) during acquisition of BOLD-fMRI in humans.

Detailed description: Preprocessing and processing of the MR data will follow our previous publications (Mehnert et al 2023, Mehnert et al 2024)

Eligibility criteria: Inclusion Criteria:

* healthy
* suitable fo MRI

Exclusion Criteria:

* headache disease
* psychological disorder
* pregnancy
* all exclusion criteria necessary for imaging in a 3 T MRI scanner

Primary outcomes:
measure: Statistical Parametric Maps calculated from the fMRI data on brainstem level
timeFrame: only 1 visit
measure: Statistical Parametric Maps calculated from the fMRI data of higher cortical brain structures
timeFrame: only 1 visit
Secondary outcomes:
measure: Functional connectivty between insula and spinal trigeminal cortex
timeFrame: only 1 visit
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: Mehnert J, Basedau H, Sturm LM, Nielsen T, Jensen RH, May A. Functional brainstem representations of the human trigeminal cervical complex. Cephalalgia. 2023 May;43(5):3331024231174862. doi: 10.1177/03331024231174862.
citation: Basedau H, May A, Mehnert J. Cerebellar somatotopy of the trigemino-cervical complex during nociception. Eur J Pain. 2024 May;28(5):719-728. doi: 10.1002/ejp.2212. Epub 2023 Nov 28.
citation: Mehnert J, Tinnermann A, Basedau H, May A. Functional representation of trigeminal nociceptive input in the human periaqueductal gray. Sci Adv. 2024 Mar 22;10(12):eadj8213. doi: 10.1126/sciadv.adj8213. Epub 2024 Mar 20.
Clinical trial NCT06139380: Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
Official title: Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Intranasal Ketamine
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 84
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-group parallel double blind randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.

Detailed description: Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.

Eligibility criteria: Inclusion Criteria:

• Children who need to undergo procedural sedation and analgesia

Exclusion Criteria:

* Weight over 33 Kg
* No Consent from parents/patient
* Needs immediate procedure due to patient's condition
* Growth/mental retardation
* Sensory deficit at the site of intramuscular injection

Primary outcomes:
measure: Intramuscular injection pain
timeFrame: immediately after Intramuscular injection
Secondary outcomes:
measure: Hospital stay duration
timeFrame: 1 hours on average
measure: Adverse effects
timeFrame: 1 hours on average
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: IKHC
Study officials:
References:
Clinical trial NCT03297580: Itch and Clinacal Caracteristics in Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pruritus
Systemic Sclerosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 61
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: All patients with a systemic sclerosis followed in the University Hospital of Brest

Brief summary: Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).


Eligibility criteria: Inclusion Criteria:

* aged more than 18 years
* followed for systemic sclerosis since 2000, in the departments of dermatology, rheumatology, internal médicine or pneumology at the University Hospital of Brest.

Exclusion Criteria:

* lower than 18 years
* refusal to participate

Primary outcomes:
measure: Pruritus
timeFrame: Day 1 (questionnaire sent to patient)
Secondary outcomes:
measure: Characteristics of the systemic sclerosis
timeFrame: Day 1 (questionnaire sent to patient)
measure: Brest questionnaire
timeFrame: Day 1 (questionnaire sent to patient)
measure: 5-D itch scale
timeFrame: Day 1 (questionnaire sent to patient)
measure: ItchyQol scale
timeFrame: Day 1 (questionnaire sent to patient)
measure: Characteristics of the systemic sclerosis
timeFrame: Day 1 (questionnaire sent to patient)
measure: Characteristics of the systemic sclerosis
timeFrame: Day 1 (questionnaire sent to patient)
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04237480: Influence of Kidney Performance and Magnesium on Formation of (OH)2-vitamin D3
Official title: Influence of Kidney Performance and Magnesium on the Biomarkers of Vitamin D
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydroxylase Deficiency
Keywords: vitamin D
1-alpha hydroxylase
magnesium
renal insufficiency
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: no restriction

Brief summary: Retrospective database analysis. The target values are the serum values of 25(OH)D, of 1,25(OH)2D, of magnesium and creatinine as well as age and sex of the patients. The laboratory values of the years 2017 and 2018 are included. There are no additional measurements on patients.

Detailed description: The laboratory values of the years 2017 and 2018 are included. All laboratory results to be evaluated originate from Medics Labor in Bern. We expect about 50'000 data sets. It is impossible for the study team to draw conclusions about the patients or the senders.

Eligibility criteria: Inclusion Criteria:

* all data sets available

Exclusion Criteria:

* a declaration from the patient that his laboratory values may not be included in an evaluation.

Primary outcomes:
measure: correlation of serum values of 1,25(OH)2 vitamin D with estimated glomerular filtration rate
timeFrame: 2017 - 2018
measure: correlation of serum values of 1,25(OH)2 vitamin D with magnesium
timeFrame: 2017 - 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00213980: Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
Official title: Bone Mineral Density Effects of Zoledronate in Postmenopausal Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: bone mineral density
postmenopausal women
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 68
Sex: FEMALE
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 two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer.

Detailed description: This is a two arm, double-blind randomized study looking at the effect of zoledronate, a bisphosphonate, on the bone mineral density (BMD) of postmenopausal women with breast cancer. An approved bisphosphonate, alendronate, is of benefit in patients with osteoporosis, however, this agent has a roughly 30% incidence of gastrointestinal symptoms and up to 50% of patients may take the drug improperly, compromising absorption and potentially efficacy. Zoledronate is a heterocyclic imidazole third generation bisphosphonate, which is administered intravenously (IV) and has little toxicity. Zoledronate is more potent than alendronate, and because of its route of administration it does not have the problems of poor oral bioavailability and non-compliance.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women, Stage III or axillary node positive
* Currently disease free of breast cancer and other invasive malignancies at the time of registration
* No concurrent use of bisphosphonates

Exclusion Criteria:

* Metastatic disease

Primary outcomes:
measure: Change in Bone Mineral Density (BMD) From Baseline to 1 Year
timeFrame: Up to 1 year
Secondary outcomes:
measure: Rates of Metastases
timeFrame: Up to 1 year
measure: Overall Survival
timeFrame: Up to 10 years
measure: Clinical Toxicity of ZA
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Daniel Mulkerin, MD
role: PRINCIPAL_INVESTIGATOR
References: