louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04655768: Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Official title: Prospective Randomized Comparison of Conservative and Opertaive Treatment of Radius Fractures in Elderly Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Disorder
Keywords: radius fracture, clinical outcome
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Elderly Patients often suffer from radius fracture. Treatment options are conservative and operative. Aim of the stdy is to find out if there are diffrences in Patient's satisfaction depending on the different treatment.

A randomized prospective trial is palnned

Detailed description: Patients of 70 years and more of age who suffer from C1 or C2 radius fracture are randomized treated by conservative treatment and operative treatment.

Primary aim is PRWE, secondary ROM as well as power and DASH score.

Eligibility criteria: Inclusion Criteria:

* Radius Fractures C1-C2
* age over 70

Exclusion Criteria:

* demetia
* collateral damages
* age \< 70

Primary outcomes:
measure: Patient Related Wrist Evaulation
timeFrame: 12-24 months post intervention
Secondary outcomes:
measure: ROM
timeFrame: 12-24 months post intervention
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: Kepler University Hospital Linz
name: Stefan M Froschauer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01218568: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Official title: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* Age 18-80
* Hepatic encephalopathy grade II-IV
* Informed consent

Exclusion Criteria:

1. Degenerative CNS disease or major psychiatric illness
2. Serum creatinine \> 1.5 mg/dl
3. Active alcohol intake \<4 weeks prior to present episode
4. Others metabolic encephalopathies
5. Hepatocellular Carcinoma
6. Severe comorbidity such as CHF, Pulmonary disease, Neurological \& Psychiatric problems impairing quality of life

Primary outcomes:
measure: Reversal of hepatic encephalopathy
timeFrame: 10 days
Secondary outcomes:
measure: Death
timeFrame: 10 days
measure: duration of hospital stay
timeFrame: 10 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
References:
Clinical trial NCT03232268: HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
Official title: HLA-mismatched Microtransplantation Without Immunosuppressive Treatment in Patients With Myeloid Hemopathies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Keywords: Microtransplantation
Myeloid Hemopathy
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 25
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: This study aims at evaluating the safety of an approach based on HLA-mismatched Microtransplantation without immunosuppressive treatment in patients With myeloid hemopathies who are ineligible to conventional allograft


Eligibility criteria: Inclusion Criteria:

* Age\> or = 65 years with a myeloid hemopathy in Complete Remission or Complete remission with incomplete hematological recovery or Age\<65 years with an ineligibility to allograft (contraindication to conditioning)
* HLA-partially matched family donors
* Affiliated to(or beneficiary of) the Social Security
* Informed consent signed

Exclusion Criteria:

* AML3
* Previous Hematopoietic Stem Cell TRansplantation
* Uncontrolled infection -PS\>3 -Other progressive cancer
* Psychiatric disease
* Vulnerable person or unable to provide informed consent
* Emergency
* Unable to comply with required study follow up

Primary outcomes:
measure: Occurrence of acute Graft versus Host disease after a HLA-mismatched transplantation without an immunosuppressive treatment
timeFrame: 100 days after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches du Rhône
Study officials:
References:
Clinical trial NCT06493968: Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy
Official title: Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accrete Spectrum Disorders Undergoing Cesarean Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta Spectrum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Pregnancy of singleton living fetus
* Previous one or more cesarean sections
* Gestational age: \> 32 weeks
* The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
* Preoperative hemoglobin more than 10 gm/dl
* Cases with PAS that will undergoing CS Hysterectomy

Exclusion Criteria:

* Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.....
* Any known or reported hypersensitivity to the used medication.
* All cases with spontaneous placental separation at laparotomy.
* All patients undergoing conservative management of PAS.
* All cases which necessitate emergency termination.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: during operation
Secondary outcomes:
measure: operative time
timeFrame: during operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00373568: Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
Official title: Miltefosine (42 Days) for Mucosal Leishmaniasisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leishmaniasis
Keywords: mucosal
miltefosine
Lead sponsor: AB Foundation
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis

Detailed description: Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi

Eligibility criteria: Inclusion Criteria:

* Mucosal leishmaniasis

Exclusion Criteria:

* No comcomitant disease as judged by laboratory and clinical parameters

Primary outcomes:
measure: efficacy
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
city: Palos Blancos
country: Bolivia
facility: Palos Blancos
Study officials:
affiliation: CIBIC
name: Jaime Soto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01499368: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Official title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Esophagitis
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 495
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the healing rate and safety of Lafutidine in erosive esophagitis


Eligibility criteria: Inclusion Criteria:

* Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

* Gastric or duodenal ulcers (excluding ulcer scars)
* Concurrent presence of Barrett's esophagus
* A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
* Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety

Primary outcomes:
measure: Recovery Rates of Reflux Esophagitis
timeFrame: 8 weeks
Secondary outcomes:
measure: The Proportion of Days Without 'Cardinal Symptom'
timeFrame: 4 or 8 week
measure: The Proportion of Daytimes Without 'Cardinal Symptom'
timeFrame: 4 or 8 week
measure: The Proportion of Nighttimes Without 'Cardinal Symptom'
timeFrame: 4 or 8 week
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Ansan Hospital
name: Sang Woo Lee
role: STUDY_CHAIR
References:
Clinical trial NCT02244268: Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia
Official title: Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 3629
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices

Brief summary: The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information

Exclusion Criteria:

No exclusion criteria is defined, prescribing information is to be considered

Primary outcomes:
measure: Change in obstructive BPH symptoms
timeFrame: up to 12 weeks
measure: Change in irritative BPH symptoms
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in Residual Urine volume
timeFrame: up to 12 weeks
measure: Number of patients with adverse events
timeFrame: up to 12 weeks
measure: Assessment of the number of days on sick leave
timeFrame: up to 12 weeks
measure: Global assessment of efficacy by investigator on a 4-point scale
timeFrame: after 12 weeks
measure: Change in Quality-of-Life Index
timeFrame: up to 12 weeks
measure: Global assessment of tolerability by investigator on a 4-point scale
timeFrame: after 12 weeks
measure: Changes in urinary flow rate
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03511768: A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Official title: A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Neoplasm
Keywords: 18F-AlF-NOTA-octreotide
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).

Detailed description: 18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Eligibility criteria: Inclusion Criteria:

1. Histologically and/or clinically confirmed and/or suspicious of NEN.
2. Signed informed consent.

Exclusion Criteria:

1. Claustrophobia (unable to accept PET/CT scanning)
2. Pregnant or breast-feeding

Primary outcomes:
measure: 18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
timeFrame: 12 months
Secondary outcomes:
measure: 18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of PET Center,Xiangya Hospital,Central South University
state: Hunan
Study officials:
affiliation: Department of PET Center,Xiangya Hospital, Central South University
name: Tingting Long, MD,Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laverman P, McBride WJ, Sharkey RM, Eek A, Joosten L, Oyen WJ, Goldenberg DM, Boerman OC. A novel facile method of labeling octreotide with (18)F-fluorine. J Nucl Med. 2010 Mar;51(3):454-61. doi: 10.2967/jnumed.109.066902. Epub 2010 Feb 11.
Clinical trial NCT05412368: Enhancing Referrals to Child and Adolescent Mental Health Services: EnCAMHS
Official title: Enhancing CAMHS Referrals: EnCAMHS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Lead sponsor: Greater Manchester Mental Health NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
name: Manchester University NHS Foundation Trust
name: Pennine Care NHS Foundation Trust
name: Northumberland, Tyne and Wear NHS Foundation Trust
name: MQ Mental Health
name: Anna Freud National Centre for Children and Families
name: McPin Foundation
name: 42nd Street
First posted: 2022-06-09
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone aged 16 and above who has been involved in the CAMHS referral pathway

Brief summary: Our aim is to find low-cost and widely reusable mechanisms to reduce inappropriate referrals. Our key objectives are:

Engage with key stakeholders to identify problems with making appropriate referrals Analyse CAMHS referral data to understand and identify problems (quantitatively) Identify requirements for sustainable solutions Explore with key stakeholders how we can improve the referral process Identify how the best proposed solutions could be embedded within routine CAMHS referral pathways

Detailed description: The Investigators shall conduct a series of focus groups with key stakeholders involved in the referral to CAMHS process; children and young people (CYP), parents/carers, key referrers, CAMHS professionals in order to better understand the challenges that exist with the current referral process. Following this, the Investigators will conduct further focus groups with the key stakeholders above, in which they will suggest sustainable solutions to the problems that have been identified.

The Investigators shall then identify how the propose solutions can be embedded into routine CAMHS referral pathways.

Eligibility criteria: Inclusion Criteria:

* Aged 16 years and above
* have experience of CAMHS referral pathway

Exclusion Criteria:

* younger than 16 years

Primary outcomes:
measure: Solutions to enhance the referral process for CAMHS
timeFrame: By end of study - within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
References:
Clinical trial NCT06024668: Simulated Walking With Multiplexing Prism for Field Expansion in Monocular Vision
Official title: Monocular Visual Confusion for Field Expansion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: One Eye Blindness
Blind Left Eye
Blind Right Eye
Keywords: Simulated Walking
Collision
Field Expansion
One eye blindness
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-09-06
Enrollment: 1
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individuals with Acquired Monocular Vision/ Blindness in One Eye
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators will test the efficacy of the prism in improving the detection of colliding pedestrians during a simulated walking task.


Eligibility criteria: Inclusion Criteria:

* No medical health issues such as seizures, motor movements problem
* Loss of vision in one eye (less than 20/200) for \>1 year
* Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
* No visual field defect in the seeing eye (nasal field of at least \>45degree)

Exclusion Criteria:

* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
* Any person with a history (such as pacemaker use or photosensitive epilepsy)
* Any person with motor movements problem (e.g., unable to use extremities)

Primary outcomes:
measure: Mean response time to detect colliding pedestrian
timeFrame: Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period
Secondary outcomes:
measure: Pedestrian Detection Rate
timeFrame: Approximately 3 sessions, up to 3 hours for each session, any time within 4 month period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute
name: Eli Peli, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JH, Castle R, Kurukuti NM, Manda S, Peli E. Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. Transl Vis Sci Technol. 2020 Jul 23;9(8):35. doi: 10.1167/tvst.9.8.35. eCollection 2020 Jul.
citation: Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.
citation: Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.
Clinical trial NCT05357768: Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
Official title: Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Undifferentiated Round Cell Sarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and femalke patient without limit of age with a diagnosis of undifferentiated round cell sarcomas treated from 01 January 1983 and all new cases referring to each participant site.

Brief summary: Experimental study with biological material : case series review of clinical and histological data

Detailed description: This is a multicenter retrospective and prospective study that will analyze all cases with a diagnosis of Undifferentiated round cell sarcomas from 01 January 1983 and all new cases referring to each participant site.

Eligibility criteria: Inclusion Criteria:

* Patients with undifferentiated round cell sarcomas treated from 01 January 1983 and all new patients will be included.
* Clinical and outcome information available.
* Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis/frozen tissue representative of the tumor available.

Exclusion Criteria:

* Diagnosis different from undifferentiated round cell sarcomas
* Patient with no clinical or outcome information available

Primary outcomes:
measure: event free survival
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCs Istituto Ortopedico Rizzoli
state: BO
Study officials:
References: