louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03434704: Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole
Official title: A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Antifungal Prophylaxis With Posaconazole.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Transplant-Related Hematologic Malignancy
Leukemia, Acute
Myelodysplastic Syndromes
Graft Vs Host Disease
Fungal Infection
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole.

The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of myelodysplastic syndromes or acute leukemia
* Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR) with absence of a 10/10 Human Leukocyte Antigens (HLA) matched unrelated donor
* Age \>18
* Unavailability of a HLA-matched related donor (MRD)
* Performance status : Eastern Cooperative Oncology Group (ECOG) \<3
* Written and signed informed consent
* Life expectancy not severely limited by concomitant illness.

Exclusion Criteria:

* Women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), vasectomised partner on treatment and for at least 6 months thereafter.
* Pregnant or nursing (lactating) women.
* Known allergies, hypersensitivity, or intolerance to any experimental drugs.
* Any active, uncontrolled infection.

Primary outcomes:
measure: Graft-versus-host disease-free, relapse-free survival (GRFS)
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy of antifungal prophylaxis strategy
timeFrame: 85 days after transplantation
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
Study officials:
References:
Clinical trial NCT05162404: Video Education to Improve Rural Cancer Care Delivery
Official title: Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: The Hope Foundation for Cancer Research
First posted: 2021-12-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to understand if a video-based education program delivered on a tablet device will improve care coordination experiences for patients with cancer living in rural areas.


Eligibility criteria: Inclusion Criteria:

* Patients must have a newly diagnosed Stage I, II, or III disease at the time of enrollment.
* Patients to be treated with adjuvant chemotherapy or recent initiation of (within 1 month of starting) adjuvant chemotherapy.
* Patients with a history of previous malignancy treated with chemotherapy within the last 3 years are not eligible, as their perceptions of care coordination may be impacted by their previous treatment.
* Patients must be ≥ 18 years of age.
* Patients must be able to read, write, and speak English. Study materials and telephone calls are only available in English.
* Patients must be residents of Hawaii, Kauai, or Maui counties
* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Primary outcomes:
measure: Changes in rural patients' perceptions of cancer care coordination as assessed by the Care Coordination Instrument at 4-6 months post-intervention.
timeFrame: 6 months
Secondary outcomes:
measure: Rural patient satisfaction with video education materials as assessed by semi-structured telephone interview.
timeFrame: 6 months
measure: To examine patient demographic and clinical information collected from the background questionnaire as potential correlates of patients' perceptions of cancer care coordination at post-intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
Study officials:
References:
Clinical trial NCT02542904: Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Disease Recurrence
Crohns Disease
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.

Detailed description: Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups.

All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease limited to the distal ileum and/or right colon

Exclusion Criteria:

* Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion

Primary outcomes:
measure: postoperative endoscopic recurrence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01215604: Involvement of Translation Initiation Factors in the Immune Response in the Elderly
Official title: Characterization of the Involvement of Translation Initiation Factors in the Immune Response to Acute Infection in the Elderly and Very Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elderly Patient
Infection
Keywords: elderly patients
acute infection
translation initiation factors
eIF4E
eIF4G
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient aged \>65 years admitted to internal medicine or geriatric departments due to acute infection with fever and leukocytosis.

Brief summary: The investigators propose that the translation initiation factors eIF4E and eIF4GI may be involved in resolution of acute inflammation (regardless of age). Furthermore, the investigators suggest that differences in translation initiation factors state of activation may contribute to inflammation. Finally, the investigators hypothesize that differences in translation initiation factors state of activation may underlie the immune compromised state of the very elderly affording additional explanation for the heightened morbidity from infection in this group.

In the current study the investigators aim to test these hypotheses by measuring the levels of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly (85yrs\<) patients hospitalized at Meir hospital for acute infection and after their recovery (detailed in study design).


Eligibility criteria: Inclusion Criteria:

* elderly patients (65\<)
* hospitalized for acute infection (fever 38c\<, leukocytosis)

Exclusion Criteria:

* patients with dementia who can not sign informed consent of institutional Helsinki committee
* patient with active cancer with active chemotherapy treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Sava
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Rachel Heffez Ayzenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00382304: A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Official title: A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudomembranous Colitis
Clostridium Difficile Diarrhea
Antibiotic-Associated Diarrhea
Keywords: Clostridium difficile-associated diarrhea
C. difficile
CDAD
Clostridium difficile
Clostridium difficile Disease
Clostridium Enterocolitis
Antibiotic-Associated Colitis
Infectious diarrhea
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria:

* \> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
* Patient not considered sufficiently stable clinically to complete the study period

Primary outcomes:
measure: The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Secondary outcomes:
measure: Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
Other outcomes:
Locations:
city: Edmonton
country: Canada
state: Alberta
city: Nanaimo
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Ottowa
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06182904: Management of Pilon Fractures With Versus Without Fibula Fixation
Official title: Management of Pilon Fractures With Versus Without Fibula Fixation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pilon Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Management of pilon fractures with versus withot fibula fixation: prospective controlled study

Brief summary: Management of pilon fractures with versus without fibula fixation

Detailed description: Comparing results with or without fibular fixation in :

* Rate of bone union .
* Functional return ( clinical outcomes)
* Alignment of lower limb.

Eligibility criteria: Inclusion Criteria:

* patients with metaphyseal non rotational pilon or distal tibia : age ( 18 _ 65 )
* No skin troubles
* No infections
* Non-dibetic patients.

Exclusion Criteria:

* Patients who will not complete their follow up.
* Skin troubles
* Infections

Primary outcomes:
measure: Fracture healing and bone union
timeFrame: Baseline
Secondary outcomes:
measure: Incidece and rate of complications
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02593604: Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
Official title: Quality of Life After Wide Surgical Excision in Patients With Hidradenitis Suppurativa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hidradenitis Suppurativa
Wide Excision
Keywords: Hidradenitis suppurativa
Wide excision
Quality of Life
Sexual Function
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Fachklinik Hornheide an der Universität Münster
First posted: 2015-11-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hidradenitis suppurativa that were treated in 2013 in Fachklinik Hornheide, Germany, by wide excision of their infected skin areas.

Brief summary: Patients undergoing wide surgical excision of their hidradenitis suppurativa areas are asked by telephone about their quality of life by standard questionnaires (WHOQOL-BREF, DLQI, Skindex, MHF, FLQA-d) and their sexual function (FSFI, IIEF).


Eligibility criteria: Inclusion Criteria:

* Hidradenitis suppurativa that was wide excised in 2013 in Fachklinik Hornheide
* Agreed to retrospective analysis and questionnaires

Exclusion Criteria:

* Non-compliance

Primary outcomes:
measure: Quality of Life (WHOQOL-BREF)
timeFrame: 2 years postop
measure: Quality of Life (DLQI)
timeFrame: 2 years postop
measure: Quality of Life (FLQA-d)
timeFrame: 2 years postop
measure: Quality of Life (Skindex)
timeFrame: 2 years postop
Secondary outcomes:
measure: Sexual Function
timeFrame: 2 years postop
measure: Demographic Parameters
timeFrame: 2 years postop
measure: Smoking
timeFrame: 2 years postop
measure: Weight and height
timeFrame: 2 years postop
measure: Wound assessment
timeFrame: 2 years postop
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: University of Schleswig-Holstein, Campus Lübeck, Germany
name: Tobias Kisch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03901404: Myomectomy Operation and Fundus Incision, Energy Modalities and Methods of Extraction
Official title: Used During Myomectomy Operation; Comparison of Fundus Incision, Energy Modalities and Methods of Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myoma;Uterus
Surgery
Keywords: Myomectomy
Fundus Incision
Energy Modalities
Methods of Extraction
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated with the diagnosis of myoma uteri

Brief summary: Myomectomy operation due to myoma uteri is an operation that can cause serious blood loss. For some anatomical reasons, fundal myomas were removed, while a group of investigators recommended the initiation of a longitudinal incision and some surgeons preferred a transverse incision. the authors aim to show some surgical differences, intraoperative blood loss, and difficulties and ease of removal of myoma in patients with these approaches without consensus. It is also noted that the incision made with the same energy modality is recorded; The effect of energy modality on blood loss and surgical comfort will be examined. Different approaches are used for laparoscopic surgical operations in order to remove myoma from the abdomen. It can be removed from the vagina by colpotomy and can also be minimized in the abdomen by a morselator. In particular, patients with vaginal myoma removed, such as complaints of postoperative dyspareunia will be followed. In this way, the investigators aim to evaluate the methods which have not yet gained clarity in the literature or have not proven superiority to each other.


Eligibility criteria: Inclusion Criteria:

- Patients operated with the diagnosis of myoma uteri

Exclusion Criteria:

* Cardiopulmonary diseases such as cardiac insufficiency, myocardial infarction, unstable angina, acute or new vascular thrombosis, asthma or pulmonary obstructive disease;
* Patients with long-term Trendelenburg contraindications;
* Previous pelvic or abdominal radiation therapy; or those with inadequate bone marrow, kidney and hepatic function;
* Gynecological malignancies.
* Those who received preoperative medication due to myoma uteri

Primary outcomes:
measure: Fundus Incision
timeFrame: 3 months
measure: Energy Modalities
timeFrame: 3 months
measure: Methods of Extraction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT02034604: Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neurogenic Lower Urinary Tract Dysfunction
Keywords: Naftopidil
safety
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 194
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 20 years old and above (upper limit of age: 80 years old)
2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)
3. a+b

   1. IPSS ≥ 12 and QoL ≥ 3
   2. Maximum Flow Rate \<15 mL/s (Voiding volume) ≥ 120mL)
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)
2. In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2
3. In female, the history of anti-incontinence operation.
4. Patients with cancer of any type including cancer of the prostate or bladder
5. Patients with urethral stricture or bladder neck contracture

Primary outcomes:
measure: Changes in patients' symptom questionnaires
timeFrame: from baseline to 8 weeks of treatment
Secondary outcomes:
measure: Changes in uroflow parameters
timeFrame: from baseline to 8 weeks of treatment
measure: Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.
timeFrame: from baseline to 8 weeks of treatment
measure: Benefit, Satisfaction, and Willingness to Continue (BSW) questions
timeFrame: 8 weeks after treatment
measure: Score of global response assessment for Korean, GRA-K
timeFrame: 8 weeks after treatment
measure: Treatment satisfaction question, TSQ
timeFrame: 8 weeks after treatment
measure: safety evaluation : incidence and severity of adverse events
timeFrame: up to 8 weeks
measure: change in each domain scores of IPSS
timeFrame: up to 8 weeks
measure: change in number of urinary frequency, nocturia
timeFrame: up to 8weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: