louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01484171: HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Official title: HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
idarubicin
Microtransplantation
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

1. Having signed informed consent
2. Diagnosis was based on the French-American-British (FAB) and WHO criteria.
3. Age ≥ 7 years old
4. Age \< 60 years old

Exclusion Criteria:

1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia

Primary outcomes:
measure: complete remission
timeFrame: one year
Secondary outcomes:
measure: disease-free survival
timeFrame: three years
measure: overall survival
timeFrame: three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Affiliated Hospital of the Chinese Academy of Military Medical Science
state: Beijing
Study officials:
affiliation: The Affiliated Hospital of the Chinese Academy of Military Medical Science
name: huisheng ai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01745978: Compare the Knob-tipped Knife With the Needle Knife in Difficult Biliary Cannulation
Official title: The Efficacy and Safety of Precut Papillotomy Using the Knob-tipped Knife and Needle Knife in Difficult Biliary Cannulation: a Randomized-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endoscopic Retrograde Cholangiopancreatography
Bile Duct Diseases
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to compare the efficacy and safety of the knob-tipped knife and needle knife for precut papillotomy in difficult common bile duct (CBD)cannulation.

Detailed description: Precut sphincterotomy is an alternative technique used to facilitate CBD cannulation following the failure of conventional bile duct cannulation. Needle knife papillotomy is the most widely practiced precut technique. However,Pre-cutting the papilla with a needle-knife is difficult, requiring experience and dexterity to control the axis and depth of the cut. Due to the increased rate of complications associated with this procedure, including pancreatitis, hemorrhage, and perforation, it was recommended to be performed only by experienced endoscopists.

The knob-tipped knife, a novel instrument utilizing a 2mm or 1.5mm cutting knife, is usually used for endoscopic submucosal dissection (ESD). Its knob-shaped tip and nonadjustable length make the knife less likely to slip and penetrate the tissue during the resection. Since the process of precut papillotomy is similar to ESD, the precutting procedure with the knob-tipped knife may be easier to be performed, as well as be safer. The efficacy and safety of this instrument in precut papillotomy have not been reported. We therefore assessed the efficacy and safety of the knob-tipped knife in precut papillotomy in difficult CBD cannulation.

Eligibility criteria: Inclusion Criteria:

* intact papilla and deep cannulation of the bile duct
* a standard wire-guided cannulation \>10 minutes, OR Pancreatic contrast injections ≥3, OR Pancreatic deep wire pass ≥5

Exclusion Criteria:

* ampullary tumors
* Billroth II or Roux-en-Y anatomy
* prior endoscopic sphincterotomy(EST) or biliary stent
* choledochoduodenal fistulae

Primary outcomes:
measure: Successful biliary cannulation rate after precut papillotomy
timeFrame: During endoscopic retrograde cholangiopancreatography (ERCP) procedure
Secondary outcomes:
measure: Biliary cannulation time after precut papillotomy
timeFrame: From precut papillotomy started to biliary cannulation achieved or abandoned
Other outcomes:
measure: The incidence of Early complications of endoscopic retrograde cholangiopancreatography(ERCP) including pancreatitis, hemorrhage, and perforation
timeFrame: 7 days after ERCP
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
Clinical trial NCT01535378: Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
Official title: Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorders
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with temporomandibular disorders

Brief summary: If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important. Treatment of patients presenting TMD is based on conservative and reversible therapeutics. The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.


Eligibility criteria: Inclusion Criteria:

* Male and female over 18,
* Patient who was informed about the protocol and who did not refuse to take part in the programme,
* Patient who suffers of dysfunctions of masticatory apparatus: myofascial pain, joint clicking or crepitations, disc deplacement with reduction, mandibular limitation and/or deviation,
* Patient who presents more or less obvious parafunctions, which are associated or not to other etiologies
* Patient consulting for the 1st time for TMD

Exclusion Criteria:

* Persons over 18 who are under legal protection (guardianship), persons who are deprived of their freedom,
* Patient who is already followed in the consultation of dysfunctions of masticatory apparatus and who is under treatment,
* Patient who is under treatment of occlusal splint (not in the framework of the consultation of TMD
* Patient with pains other than orofacial pains (cephalalgia, neuralgia, vascular algia of the face, migraine),
* Patient who needs a treatment other than a behavioural reeducation (pharmacological treatment, occlusal splint , addressed to another therapist, prosthetic treatment)

Primary outcomes:
measure: Assessment of pain based on the analogical visual scale
timeFrame: 1 year
Secondary outcomes:
measure: Amplitude of mouth opening, mandibular deviation, joint clicking or crepitations,disc deplacement with reduction
timeFrame: 1 year
measure: Assessment of behavioural reeducation
timeFrame: 1 year
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Brittany
Study officials:
affiliation: Rennes University Hospital
name: Dominique Chauvel-Lebret
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002178: A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Official title: A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Dosage Forms
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 375
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Detailed description: Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV RNA \>= 5000 copies/ml by Amplicor assay.
* Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Previous treatment with antiretrovirals.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dr Charles Farthing
state: California
city: Brookline
country: United States
facility: Community Research Initiative
state: Massachusetts
Study officials:
References:
citation: Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
Clinical trial NCT06692478: Benefits of Intrahospital Exercise Program in Pediatric HSCT
Official title: Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic Stem Cell Transplant
Pediatric Cancer
Deconditioning
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Arizona
First posted: 2024-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.


Eligibility criteria: Inclusion Criteria:

1. Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
2. Karnofsky (if ≥16 years) or Lansky (if \<16 years) score \>60 at enrollment and prior to each testing point
3. Parental/guardian permission (informed consent) and child assent prior to transplant.

Exclusion Criteria:

1. Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
2. Previous stem cell transplant in the last 6 months
3. Patients with grade 3 or greater sensory/motor neuropathy

Primary outcomes:
measure: Change from Baseline 6-minute walk test at 6 weeks discharge.
timeFrame: Average of 100 days post-transplant
measure: Change from Baseline Manual Muscle Testing at 6 weeks post discharge
timeFrame: Average of 100 days post-transplant
measure: WeeFIM
timeFrame: Average of 100 days post-transplant
Secondary outcomes:
measure: PROMISE Measures
timeFrame: Average of 100 days post transplant
measure: Time Out of Bed
timeFrame: through study completion, average of 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
References:
Clinical trial NCT02148978: Cystic Fibrosis Related Diabetes
Official title: DPP-IV Inhibition in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections and exocrine pancreatic insufficiency. The vast majority of patients with CF will develop pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.

The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, additional mechanisms may be involved. The investigators have recently shown that insulin secretion in patients with CF is significantly altered prior to the development of diabetes. This phenomenon is associated with reduced secretion of gut derived incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether due to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced secretion or due to rapid clearance of such peptides) may be a major underlying driver of altered glucose metabolism in such patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* No diabetes based on screening OGTT
* No C/I for use of the medications
* Normal kidney function
* Willing and able to participate

Exclusion Criteria:

* Use of anti-hyperglycemic medications
* Acute illness or infection at enrollment

Primary outcomes:
measure: glucose tolerance after treatment with Saxagliptin
timeFrame: The outcome will be measured at 2 timepoints. at baseline and 6 weeks after Saxagliptin treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Har Hazofim
Study officials:
affiliation: Hebrew University
name: Limor Marko, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Har Hazofim
name: Eitan Kerem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebrew University
name: Karen Hershkop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04965571: Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Official title: Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wilson Disease
Generalized Epilepsy
Keywords: Chinese
clinical features
generalized epilepsy
outcome
Wilson's disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 13
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: Each patient was diagnosed with WD by clinical evaluation and genetic screening. Patients were given small doses of antiepileptic drugs (AEDs), followed by copper-chelation therapy when the seizures stabilized.

Brief summary: Generalized epilepsy is rarely reported in patients with Wilson disease (WD) and lacks experience in clinical practice. We aim to provide better experience for the diagnosis and treatment for WD patients with epilepsy in the future.

Detailed description: A retrospective study was performed in 13 Chinese WD patients with generalized epilepsy. Each patient was diagnosed with WD by clinical evaluation and genetic screening. Patients were given small doses of antiepileptic drugs (AEDs), followed by copper-chelation therapy when the seizures stabilized. Clinical manifestations, brain imaging changes, and treatment and outcome after a long-term follow-up were analyzed.

Eligibility criteria: Inclusion Criteria:

* Each patient was diagnosed with WD by clinical evaluation and genetic screening and had ever experienced generalized epilepsy

Exclusion Criteria:

* Not WD \& without generalized epilepsy

Primary outcomes:
measure: Number of participants with treatment stop seizures attacks
timeFrame: 12 month
Secondary outcomes:
measure: Number of participants with treatment have improved brain MRI
timeFrame: 12 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01044771: Pilot Study of Raltegravir Switch to Resolve Tenofovir Induced Proteinuria
Official title: A Pilot Study to Evaluate the Effectiveness of a Tenofovir Raltegravir Switch in Resolving Tenofovir Induced Proteinuria in HIV Infected Individuals With Undetectable HIV Viral Loads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Proteinuria
Keywords: HIV
Human immunodeficiency virus
tenofovir
viread
truvada
proteinuria
Lead sponsor: Metropolis Medical
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-01-08
Enrollment: 20
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: The study is designed to evaluate the proportion of patients with tenofovir induced proteinuria that will resolve their proteinuria when the tenofovir containing nucleoside/nucleotide backbone is switched to a raltegravir backbone. Common HIV treatment regimens contain nucleoside/nucleotide combinations that may have long-term side effects including nephrotoxicity. Switching these backbones out for an integrase inhibitor based regimen has not been systematically evaluated.

Hypothesis: Proteinuria developing during treatment with tenofovir improves or resolves when tenofovir is switched out with raltegravir. Switching to a nuc- sparing regimen, containing raltegravir and a boosted protease inhibitor in patients without preexisting protease inhibitor mutations is safe and does not lead to virologic failure

Detailed description: As described in the brief summary, this is a pilot study to evaluate for improvements in proteinuria when switched off from Tenofovir

Eligibility criteria: Inclusion Criteria:

* Documented HIV infection
* Ability to comply to protocol requirements
* On stable HAART for minimum of 12 weeks
* Evidence of TDF induced proteinuria
* No evidence of prior Protease inhibitor failure
* Treatment-naïve to integrase inhibitors
* VL\<200 x 12 weeks (minimum of 2 viral load measurements)

Exclusion Criteria:

* Active Hepatitis B infection
* Proteinuria predating tenofovir use
* PRAMs on historic GT or PT
* Life expectancy less than 6 months
* Subjects with any ongoing AIDS defining illness
* Any condition which could compromise the safety of study subject
* Grade 3 or 4 lab abnormalities (excl. grade 3 bilirubin elevations)

Primary outcomes:
measure: Patients With Reduced or Resolved Proteinuria
timeFrame: 24 weeks
Secondary outcomes:
measure: Patients Without HIV Re-bound
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Metropolis Medical
name: Fritz Bredeek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06366971: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction
Official title: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Dysfunction
Keywords: flexibility
mobility
pain
proprioceptive neuromuscular facilitation
sacroiliac joint dysfunction
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD.


Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of SIJD
* Being between the ages of 18 and 40
* Volunteering to participate in the study

Exclusion Criteria:

* Having a history of any neurological, psychiatric and/or orthopedic disease
* Being pregnant or having a suspicion of pregnancy
* Having one or more of disc herniations, spondylosis, spondylolisthesis and/or similar lumbar pathologies that may cause low back pain
* Having a history of previous spine/hip/lower extremity surgery
* Having a history of active malignancy and/or infection
* Having a history of any injection and/or surgical procedure for the sacroiliac joint within the last 3 months

Primary outcomes:
measure: The Level of Low Back Pain
timeFrame: 6 weeks
measure: Mobility
timeFrame: 6 weeks
measure: Flexibility
timeFrame: 6 weeks
measure: Lumbar Range of Motion
timeFrame: 6 weeks
measure: Posture
timeFrame: 6 weeks
measure: Trunk Muscle Endurance
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas University
state: Kagıthane
Study officials:
References: