louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00529880: Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: Cooperative Study Group A for Hematology
Sponsor class: NETWORK
First posted: 2007-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
* The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Detailed description: * A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
* G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
* For the patients who achieve a complete remission, consolidation therapy will be given as follows:

  * Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
  * In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
  * In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).

Eligibility criteria: Inclusion Criteria:

* Failure to achieve CR after initial induction chemotherapy
* Any relapse, regardless of the frequency and time of relapse from first CR
* Relapse after hematopoietic cell transplantation, allogeneic or autologous.
* Multiple relapses, extramedullary relapse(s)

Exclusion Criteria:

* Inadequate hepatic,renal,cardiac function
* Psychiatric disorder or mental deficiency
* CNS involvement of leukemic blasts

Primary outcomes:
measure: Complete remission rate, duration of complete remission, toxicities
Secondary outcomes:
measure: progression-free survival, overall survival
Other outcomes:
Locations:
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
Study officials:
affiliation: Ulsan University Hospital, ROK
name: Hawk Kim, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05855980: Toe Amputations in Patients With Diabetes
Official title: Toe Amputations in Patients With Diabetes - the Effect of Leaving a Wound Open or Closing on Healing and Ambulation After Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Infections
Amputation
Keywords: Diabetic foot
Infection
Amputation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 102
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 study is a randomized controlled trial (RCT) to evaluate outcome after toe amputation due to diabetic foot infection. Aim of this RCT is to evaluate wound healing and functional outcome based, whether wound is closed or left open. As a part of this study, emerging technology of thermal imaging is evaluated as a possible tool to predict complication after amputation.

Detailed description: Patients with diabetes undergoing toe amputation due to infection, are recruited for this study. Based on randomization, wound is either closed or left open during the amputation procedure. If primary closure is not possible (e.g. deep abscess) and patient is randomized to closed group, delayed closure is performed when feasible. Patients are followed up in outpatient clinic 3 month after amputation. Primary outcome is wound healing that is evaluated during follow ups in the outpatient clinic. Functional outcome is evaluated with PROM questionnaires preoperatively and during the follow up.

Eligibility criteria: Inclusion Criteria:

* Toe amputation due to diabetic foot infection

Exclusion Criteria:

* Deep foot infection
* Sepsis
* No clinical infection (amputation due to trauma, deformity or uninfected necrosis)

Primary outcomes:
measure: Wound healed
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 3 months
measure: Functional outcome: 15D
timeFrame: 3 months
measure: Functional outcome: TESS
timeFrame: 3 months
measure: Functional outcome: FHSQ
timeFrame: 3 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Miska Vuorlaakso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01476280: Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting
Official title: A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: antiemetics
ramosetron
palonosetron
PONV(postoperative nausea and vomiting)
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.


Eligibility criteria: Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting for 48 hours after surgery
timeFrame: for 48 hours after surgery
Secondary outcomes:
measure: severity of nausea for 48 hours after surgery
timeFrame: for 48 hours after surgery
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Soo Kyoung Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05432180: Human Milk Nutrients and Infants' Health Outcomes in South China
Official title: Human Milk Nutrients and Infants' Health Outcomes in South China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children of this study will be recruited from lactating women provided human milk samples before.

Brief summary: The purpose of this study is to investigate the associations between human milk nutrients and infants' health outcomes in China.

Detailed description: Human milk components are beneficial to the growth and development of infants, such as phospholipids, gangliosides, sialic acids, choline, oligosaccharide and so on. However, studies on the associations between human milk components and infants' outcomes are limited. Therefore, this study is designed to investigate the relationship between Chinese human milk components and the growth and development of infants.

Eligibility criteria: Inclusion Criteria:

* age 4-5 years
* healthy children
* breastfeeding between 0 to 400 days of age
* human milk components in human milk being determined
* sign informed consent

Exclusion Criteria:

* children with severe chronic diseases, such as tumor, severe digestive diseases, kidney diseases
* gestational diabetes, hypertension and other metabolic diseases
* children with mental system diseases
* children with congenital and genetic diseases
* children with infectious diseases, eg, upper respiratory tract infection or diarrhea
* antibiotic or other drugs influencing intestinal flora being taken within 45 days
* Withdraw withdraw informed consent serious violation of the scheme no longer meet the research criteria because of health factors or accidents

Primary outcomes:
measure: The growth of children
timeFrame: 18 month
measure: The cognitive development of children
timeFrame: 18 month
measure: Gut microbiota
timeFrame: 6 month
Secondary outcomes:
measure: General demographic materials
timeFrame: 14 month
measure: Dietary and lifestyle information
timeFrame: 3 month
measure: Behavior problems
timeFrame: 18 month
measure: Allergic assessment
timeFrame: 18 month
measure: Sleep assessment
timeFrame: 18 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huilian Zhu, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02225080: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
Official title: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dura Mater Nick Cut or Tear
Surgery
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neurgosurgery service in Hospital

Brief summary: The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.


Eligibility criteria: Inclusion Criteria:

* Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Exclusion Criteria:

* Patient who does not agree to allow collection of his/her medical data

Primary outcomes:
measure: Patient's Outcome
timeFrame: Day 30
Secondary outcomes:
measure: Occurence of Adverse Event
timeFrame: first 72 hours post-op
measure: Occurence of Adverse Event
timeFrame: between days 4-14
measure: Occurence of Adverse Event
timeFrame: Between days 15-30
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisière
city: Berlin
country: Germany
facility: die Charité - Universitätsmedizin Berlin
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
Study officials:
References:
Clinical trial NCT01876680: The Effects of Two Different Home-exercise Programmes on Women Suffering Long Term Neck/Shoulder Muscle Pain
Official title: The Effects (Pain, Function, Biochemistry and Psychological Factors) of Two Different Home-exercise Programmes on Women Suffering Long Term Nack/Shoulder Muscle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: chronic
neck
shoulder
exercise
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2013-06-12
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of specific neck/shoulder muscle exercises on pain, function, biochemistry and psychological factors in women suffering chronic neck/shoulder pain.


Eligibility criteria: Inclusion Criteria:

* female
* 20-60
* long term neck/shoulder muscle pain
* willing to exercise

Exclusion Criteria:

* widespread pain
* pregnancy
* major trauma in medical history
* tendonitis in upper extremities
* neurological causes of the pain
* inflammatory and hormonal disorders

Primary outcomes:
measure: Pain
timeFrame: Before training, 4-6 months and after one year of training.
measure: Function
timeFrame: Before training, 4-6 months and after one year of training.
Secondary outcomes:
measure: Muscle biochemistry
timeFrame: Before training, 4-6 months follow-up and 12 months follow-up
measure: Psychological factors
timeFrame: Before training, 4-6 months follow-up and 12 months follow-up
measure: Pain sensitivity
timeFrame: Before training, 4-6 months follow-up and 12 months follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Faculty of Health Sciences, Linköping University
state: Östergötland
Study officials:
affiliation: rehabilitation medicine, Faculty of Health Sciences, Linköping University, SE 581 85, Linköping, Sweden
name: Britt Larsson, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghafouri N, Ghafouri B, Fowler CJ, Larsson B, Turkina MV, Karlsson L, Gerdle B. Effects of two different specific neck exercise interventions on palmitoylethanolamide and stearoylethanolamide concentrations in the interstitium of the trapezius muscle in women with chronic neck shoulder pain. Pain Med. 2014 Aug;15(8):1379-89. doi: 10.1111/pme.12486. Epub 2014 Jul 4.
citation: Karlsson L, Takala EP, Gerdle B, Larsson B. Evaluation of pain and function after two home exercise programs in a clinical trial on women with chronic neck pain - with special emphasises on completers and responders. BMC Musculoskelet Disord. 2014 Jan 8;15:6. doi: 10.1186/1471-2474-15-6.
Clinical trial NCT01961180: The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
Official title: The Effect of Cipralex in Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: Quality of Life
Adrenal hyper activity
Glucose metabolism
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.

Detailed description: We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).

PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes.

Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.

We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI \>25 and \<50
* Age \< 50
* PCOS

Exclusion Criteria:

* Epilepsia
* use of metformin or oral anticonceptives
* pregnancy/breastfeeding

Primary outcomes:
measure: Quality of Life
timeFrame: 14 weeks
Secondary outcomes:
measure: Level of cortisone in 24 hour urine sample
timeFrame: June 2013 to October 2015
Other outcomes:
measure: Glucose metabolism
timeFrame: June 2013 to October 2015
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Marianne MD Andersen, sponsor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254280: Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial
Official title: Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light and Paring Versus Paring Alone - a Randomized Controlled Trial With Blinded Response Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Warts
Keywords: Warts
Intense pulsed light
RCT
Recalcitrant hand and foot warts
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-11-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of treatment with Intense Pulsed Light and paring versus paring alone.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Recalcitrant warts
* No previous IPL treatment of warts

Exclusion Criteria:

* Immunosuppressive treatment
* Patients suffering from HIV, diabetes or other immunosuppressive diseases
* Pregnancy
* Previous IPL treatment
* Patients with a tendency to prodyce keloids or hypertrophic scars
* Mosaic and flat warts
* Lack of informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, MD, PhD, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520480: Pathological Subtrochanteric Fractures in 194 Patients
Official title: Pathological Subtrochanteric Fractures in 194 Patients. A Comparison of Outcome After Surgical Treatment of Pathological and Non-pathological Fractures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subtrochanteric Femur Fractures
Keywords: survival after surgery
Pathological Subtrochanteric Fractures
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 281
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological subtrochanteric femur fractures.

Brief summary: In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.

Detailed description: The Scandinavian Sarcoma Group (SSG) has initiated a Skeletal Metastasis Register in 1999. The Register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. Data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. Information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. Moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the Karnofsky performance score are recorded.

We will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009.

The Stockholm Hip Fracture Group provides data on the reference group. During 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in Stockholm were included in a prospective cohort study. The regional ethical review board located at the Karolinska Institutet approved the study (DNR 206/02).

The aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. We want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.

Eligibility criteria: Inclusion Criteria:

* All patients with pathological subtrochanteric femur fractures register in the Scandinavian Sarcoma Group Register

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: