louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01145274: A Pilot Study for Pharmacokinetic/Pharmacodynamic (PK/PD) Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
Official title: A Pilot Study for PK/PD Parameter of Allopurinol and Its Metabolite-oxypurinol After Once-daily Allopurinol in Chronic Kidney Disease Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Keywords: allopurinol
chronic kidney diseae
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic kidney disease ( estimated GFR 30-60 ml/min )

Brief summary: To know the blood level of allopurinol in chronic kidney disease (CKD) patient.

Detailed description: After the result of this pilot study, we can prescribe the optimal dose of allopurinol in CKD patient.

Eligibility criteria: Inclusion Criteria:

* from 18yrs to 80yrs , man and women
* the patient who are taking allopurinol
* On screening, the patient shows that the level of protein/creatinine ratio is over 3.0
* On screening, the patient shows that MDRD GFR \>= 30 ml/min and \<= 60 ml/min
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take medication that have an effect on renal function
* the patient have experience to take cyclosporin within 3month
* At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP \<= 100 mmHg or \>=160 mmHg and DBP \<=60 mmHg \>=100 mmHg, or Heart rate \< 40 beats/min or \> 90 beats/min
* uncontrolled hypertension
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to allopurinol
* acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
* serum albumin \< 3.5 mg/dL or \> 5mg/dL
* urinary retension, prostatic hyperplasia
* the patient show gout attack on taking allopurinol
* the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
* the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
* the patient who had taken part in the other study within 3months
* the patient who had gotten blood transfusion
* pregnant, breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00821574: Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
Official title: Project to Promote the Evaluation of the Cardiovascular Risk in the Clinical Practice and to Evaluate Its Evolution Following the Implementation of a Preventive Multifactorial Strategy Aimed to Reduce the Total Risk Level (SCORE Algorithm), in Subjects Suffering From Metabolic Syndrome and With a Risk Level ≥5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Dyslypidaemia
Keywords: Hypertension, dyslipidemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of a multi factorial preventive scheme of action (including fluvastatin and valsartan) to reduce the overall risk level in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Age between 40 - 65 years
* Diagnosed metabolic syndrome
* Risk of cardiovascular death ≥ 5% (according to SCORE)
* Written informed consent

Exclusion Criteria:

* Women not in menopause or not using efficient contraception
* Known hypersensitivity to study drugs
* History of ischemic heart disease

Primary outcomes:
measure: Change in global risk from baseline to 3 and 9 months, as evaluated by the SCORE algorithm
timeFrame: 9 months
Secondary outcomes:
measure: Change from baseline after 3 and 9 months in the individual risk factors (e.g. blood pressure, lipid variables)
timeFrame: 9 month
measure: Proportion of patients with controlled glycemia
timeFrame: 9 months
measure: Percentage of patients no longer classifiable as having metabolic syndrome
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: ASL Terni 4, Narni (TR) - Italy
name: Alessandro Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambrosioni E, Cicero AF, Parretti D, Filippi A, Rossi A, Peruzzi E, Borghi C. Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting. High Blood Press Cardiovasc Prev. 2008 Apr;15(2):37-45. doi: 10.2165/00151642-200815020-00001. Epub 2013 Jan 3.
Clinical trial NCT03650374: Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity
Official title: Effects of Contralateral Strength Training on Postoperative Strength Deficits in the Immobilized Lower Extremity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus; Detachment, Current Injury
Keywords: Meniscus root tear
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-28
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: This is a prospective, randomized controlled trial that will enroll patients undergoing unilateral meniscal root repair or meniscus transplant. The objective of this study is to determine if immediate postoperative strength training of the contralateral (non-surgical) lower extremity reduces postoperative loss of strength in an immobilized lower extremity.

After the completion of surgery, patients will be randomized to either the experimental treatment (Group 1) or control group (Group II)for postoperative rehabilitation.

Detailed description: Group I will receive knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation. The experimental strength training will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.

Eligibility criteria: Inclusion Criteria:

* Patient is indicated for meniscal root repair
* Patient is indicated for meniscus transplant
* Patient is at least 18 years of age
* Patient is expected to survive at least 1 year beyond surgery
* Patient has intact lower extremities bilaterally
* Patient is willing to participate by complying with pre-and post-operative visit requirements
* Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

* Lower extremity musculoskeletal defects
* Systemic neuromuscular disorders
* Failure to complete pre-operative BIDOEX strength assessment
* Failure to complete pre-operative self-assessment score intake forms

Primary outcomes:
measure: KOOS
timeFrame: 6 Weeks, 3 Months, 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Guillem Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457674: Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)
Official title: Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Alcohol Use Disorder
Keywords: Cognitive Behavioral Therapy
Sleep Hygiene
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.


Eligibility criteria: Inclusion Criteria:

* Meet probable Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Alcohol Use Disorder with ≤12 weeks of abstinence
* Planned enrollment into an abstinence-based treatment program
* Meet probable DSM-5 criteria for chronic insomnia, confirmed with sleep diary
* Ability to travel to Ann Arbor for sleep laboratory assessments
* Access to a video chat-capable device and reliable Wi-Fi network

Exclusion Criteria:

* Diagnosis of, or high suspicion for, sleep disorders other than insomnia
* Meet probable DSM-5 criteria for bipolar disorder, psychotic disorder, or post-traumatic stress disorder (PTSD)
* Terminal or progressive physical illness (e.g., cancer), neurological degenerative disease (e.g., dementia), or presence of an unstable medical condition that is the specific cause of insomnia
* Self-reported pregnancy or intention to become pregnant during the study

Primary outcomes:
measure: Score from the insomnia severity index (ISI)
timeFrame: Immediately post treatment
measure: Percent days abstinent from alcohol as documented in the timeline follow-back (TLFB)
timeFrame: Immediately post treatment
Secondary outcomes:
measure: Score from Multidimensional Fatigue Inventory (MFI), General Fatigue sub-scale
timeFrame: Immediately post treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: J Todd Arnedt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279874: Qualitative Interview Study Regarding Dentists' Repair Behaviour
Official title: Qualitative Interview Study Regarding Dentists' Repair Behaviour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behavior
Keywords: decision-making
repair behavior
interviews
Lead sponsor: University of Göttingen
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2017-09-12
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dentists who are working in dental offices in Germany

Brief summary: The aim of the present study is to determine dentists' barriers and facilitators for performing repairs on partially defective dental restorations.

Detailed description: Potential barriers and facilitators for treating partially defective dental restorations by repair instead of complete replacement are going to be assessed by interviewing German dentists.

Eligibility criteria: Inclusion Criteria:

* Dentists who are working in dental offices in Germany and who are able to give written consent

Exclusion Criteria:

* Non-fulfillment of the inclusion criteria
* Lack of capacity to consent
* No German language skills in written and spoken language

Primary outcomes:
measure: Completion of a questionnaire
timeFrame: 5 minutes
measure: Interview
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology
state: Lower Saxony
Study officials:
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
name: Philipp Kanzow, PD Dr. Dr. med. dent., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanzow P, Hoffmann R, Tschammler C, Kruppa J, Rodig T, Wiegand A. Attitudes, practice, and experience of German dentists regarding repair restorations. Clin Oral Investig. 2017 May;21(4):1087-1093. doi: 10.1007/s00784-016-1859-3. Epub 2016 Jun 2.
citation: Kanzow P, Dieckmann P, Hausdorfer T, Attin T, Wiegand A, Wegehaupt FJ. Repair restorations: Questionnaire survey among dentists in the Canton of Zurich, Switzerland. Swiss Dent J. 2017 Apr 10;127(4):300-311. doi: 10.61872/sdj-2017-04-267. English, German.
citation: Kanzow P, Wiegand A, Schwendicke F. Cost-effectiveness of repairing versus replacing composite or amalgam restorations. J Dent. 2016 Nov;54:41-47. doi: 10.1016/j.jdent.2016.08.008. Epub 2016 Aug 26.
citation: Kanzow P, Kanzow AF, Wiegand A, Schwendicke F. Implementation of repairs in dental practice: Randomized behavior simulation trial. J Am Dent Assoc. 2023 Jul;154(7):610-619.e11. doi: 10.1016/j.adaj.2023.04.007. Epub 2023 May 22.
Clinical trial NCT01216774: The Role of Mechanical Stress and Muscle Fatigue in Strength Gains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strength Training
Muscle Strength, Muscle Mass, Inflammatory Processes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the impact of different levels of mechanical stress and muscle fatigue in strength training conditions on muscle strength, muscle mass and inflammatory processes.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Knee pathology
* Systematic training

Primary outcomes:
measure: Force-velocity characteristics of knee extensors with biodex dynamometer
timeFrame: Pre and post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of Kinesiology and Rehabilitation Sciences
Study officials:
References:
Clinical trial NCT00269074: Effect of IDEA-070 on Pain and Inflammation Induced by PDT
Official title: Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced by PDT. The primary objective is to detect a statistically significant difference of pain and inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated areas.


Eligibility criteria: Inclusion Criteria:

Diagnosis ot actinic keratosis to be treated with PDT affecting equal sized areas of both sides of the head affecting at least 10% of the area of photoexposure

Exclusion Criteria:

Morpheaform basal cell carcinoma, Major hypertrophy of lesions, Porphyria, Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 month prior to screening, Concomitant use of other analgesics including topical NSAIDs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Dermatological department of university hospital
state: Nordrhein-Westfalen
Study officials:
affiliation: Dermatological department of university Duesseldorf
name: Julia Reifenberger, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262074: Effect of Structured Training Program in Diabetic Patients
Official title: Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.

Detailed description: The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:

What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?

Group 1:

Patients in group 1 will receive a structured exercise program.

Group 2:

Patients in group 2 will receive a non-structured exercise program. This group will allow us to compare the effects of a structured and a non-structured exercise program.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus with moderate to severe DPN
* Subjects of both gender
* Age from 40 to 70 years
* Independent walking
* MNSI score more than 2 out of 13

Exclusion Criteria:

* Presence of an active planter ulcer
* History of surgery during intervention period
* Neurological diseases other than DPN

Primary outcomes:
measure: Michigan neuropathy screening instrument (MNSI)
timeFrame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
measure: Biothesiometer
timeFrame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
measure: NeuroQoL
timeFrame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Secondary outcomes:
measure: NPRS
timeFrame: The measurement will be taken during the baseline assessment and again after the completion of treatment.
Other outcomes:
Locations:
city: Ambala
country: India
facility: MMIPR
state: Haryana
Study officials:
affiliation: Maharishi Markandeshwar Instirtute of Physiotherapy and Rehabilitation, Ambala, Haryana, 133207
name: Khushboo Kumari, BPT, (MPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230074: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Official title: A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis; ALS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-30
Enrollment: 350
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Detailed description: This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.

Eligibility criteria: Inclusion Criteria:

* Completed original protocol, Study No. CTCH346A2211
* Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained

Exclusion Criteria:

* Exclusion criteria as described in the original protocol will remain applicable into the extension protocol

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
Secondary outcomes:
measure: Survival time
measure: Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
References:
Clinical trial NCT05457374: A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Official title: A Clinical Study of Portal Vein Embolization and Liver Venous Deprivation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Venous Deprivation
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Partial hepatectomy+PVE Partial hepatectomy+LVD
Primary purpose: TREATMENT

Brief summary: The main obstacle to achieving R0 resection in future liver remnant（FLR） deficient liver cancer is the inability to retain sufficient FLR to avoid postoperative liver failure. From the initial portal vein embolization(PVE), to the later ALPPS, this problem has been solved to some extent. However, both have their own shortcomings. The effect of liver hyperplasia after PVE is poor and the waiting time is long. The incidence of complication and mortality after ALPPS is always the focus of controversy. In recent years, LVD has emerged, combining PVE and HVE in the one operation. This topic will conduct a clinical controlled study of PVE and LVD.


Eligibility criteria: Inclusion Criteria:

* ① Age 18 to 75 years old, male or female.

  * hepatocellular liver cancer diagnosed by pathological histology, immunohistochemistry or imaging examination, with large tumor size that cannot be removed in one stage surgery

    * No distant metastasis of the lesion.

      * FLR\<20% in patients with normal liver function; FLR\<30% in patients with combined fatty liver and receiving chemotherapy; FLR\<40% in compensated cirrhosis ⑤ Normal function of major organs other than liver-related functions. ⑥ Subjects voluntarily enrolled in this study, signed informed consent, good compliance, and cooperated with follow-up.

        * Patients who the investigator believes can benefit.

Exclusion Criteria:

* Withdrawal of consent by the subject.

  * Having adverse reactions. ③ Failure to receive treatment due to progression.

    * Death of the patient.

      * Loss to follow-up. ⑥ Others.

Primary outcomes:
measure: FLR growth rate
timeFrame: 15days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui province hospital
state: Anhui
Study officials:
References: