louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04550299: ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Official title: Results of the Anterior Cruciate Ligament Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Injuries
ACL Tear
ACL Injury
Sports Injury
Lead sponsor: Vita Care
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2020-09-16
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

Detailed description: In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.

Primary outcome is graft ligamentization assessed in MRI images at 4-6 months

Eligibility criteria: Inclusion Criteria:

isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)

Exclusion Criteria:

intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form

Primary outcomes:
measure: Bone-graft integration
timeFrame: 4-6 months
Secondary outcomes:
measure: Clinical scores
timeFrame: 4-12 months
measure: Retear
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Vita
state: SP
Study officials:
affiliation: Instituto Vita
name: Wagner Castropil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073799: Storage Symptom After Laser Prostatectomy
Official title: Change in Storage Symptoms Following Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 486
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate and in whom 12-months follow-up data were available

Brief summary: Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of prostatic hyperplasia
* underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
* 12-months follow-up data were available

Exclusion Criteria:

* previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease

Primary outcomes:
measure: the subtotal storage symptom score of the International Prostate Symptom Score (IPSS)
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02792842: Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer
Official title: Phase 2 Clinical Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer: a Multicenter Randomized Placebo-controlled Double-blind Study to Investigate the Efficacy and Safety of ART-123
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Stage II/III Colon Cancer
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-06-08
Enrollment: 79
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.


Eligibility criteria: Main Inclusion Criteria:

* Diagnosed with stage II / III colon cancer
* Deemed to have undergone curative A (Cur A) surgery
* Planning to undergo postoperative adjuvant chemotherapy

Main Exclusion Criteria:

* Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant)
* Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
* With active double cancer

Primary outcomes:
measure: The Cumulative Rates of Participants With NCI-CTCAE Grade 2 or Higher Peripheral Sensory Neuropathy: Up to End of Study Treatment
timeFrame: 42 days after the start of cycle 12 (each cycle is 2 weeks).
measure: Least-squares (LS) Means of Functional Assessment of Cancer Therapy/Gynecological Oncology Group-Neurotoxicity-12 (FACT/GOG-Ntx-12) Version 4.0 Score at Cycle 12
timeFrame: At baseline, at each cycle (up to cycle 12 with each cycle of 2 weeks), and follow-up assessment.
measure: The Discontinuation Rate of Oxaliplatin Due to Oxaliplatin-Induced Peripheral Neuropathy (OIPN)
timeFrame: Cycle 12（each cycle is 2 weeks）
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
state: Hyogo
city: Nerima
country: Japan
state: Tokyo
Study officials:
affiliation: Asahi Kasei Pharma Corporation
name: Asahi Kasei Pharma Corporation
role: STUDY_CHAIR
References:
citation: Kotaka M, Saito Y, Kato T, Satake H, Makiyama A, Tsuji Y, Shinozaki K, Fujiwara T, Mizushima T, Harihara Y, Nagata N, Kurihara N, Ando M, Kusakawa G, Sakai T, Uchida Y, Takamoto M, Kimoto S, Hyodo I. A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2020 Nov;86(5):607-618. doi: 10.1007/s00280-020-04135-8. Epub 2020 Sep 23.
Clinical trial NCT00357942: Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy
Official title: Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Mucositis
Keywords: Morphine
Mouthwash
Mucositis
Pain
Cancer
Child
Adolescent
Lead sponsor: Danish University of Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2006-07-28
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect.

The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
* Receiving chemotherapy in relation to a cancer disease
* Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
* Negative pregnancy test, when relevant (judged by physician)
* Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
* Signed informed consent

Exclusion Criteria:

* Allergic to the investigational medical product
* Alcohol or drug abuse

Primary outcomes:
measure: Use of supplemental analgesics
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score at rest
timeFrame: 24 hours
measure: Pain score at activity (performance of oral hygiene)
timeFrame: 24 hours
measure: Time to first dose of supplemental analgesics
timeFrame: 24 hours
measure: Frequency and severity of side effects
timeFrame: 24 hours
measure: Oral intake of food
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Study officials:
affiliation: Faculty of Pharmaceutical Sciences, University of Copenhagen
name: Bettina N Nielsen, PhD student M.Sc.Pharm
role: STUDY_CHAIR
References:
Clinical trial NCT06027242: Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
Official title: Oral Supplementation of Glutamine on Gastric Cancer Patients After Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Immunonutrition
Gastrostomy
Keywords: Gastric cancer
Gastrectomy
sarcopenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glutamine has the potentials of immunomodulation and adjustment of protein metabolism. The primary objective of this study is to evaluate the efficacy of glutamine on sarcopenia in gastric adenocarcinoma patients undergoing gastrectomy. The secondary endpoints, including the physical activity, weight loss, and nutritional profiles, will be evaluated among these patients.

Detailed description: This will be a double-blind, randomized, and placebo-controlled study. At least 80 evaluable patients who are scheduled for gastrectomy for gastric adenocarcinoma cancer will be randomly assigned to the control or treatment group. Each group will have at least 40 patients. The CT scan will be evaluated before surgery and on postoperative day (POD) 90. Moreover, the patient will wear the smart watch to record daily walking steps. Laboratory data will be check before gastrectomy and on POD 90.

Eligibility criteria: Inclusion Criteria:

* adult gastric cancer receiving gastrectomy

Exclusion Criteria:

* Hepatic insufficiency
* Renal insufficiency
* can not tolerate oral or enteral feeding 7 days after gastrectomy
* can not receive computed tomograph
* can not waer the wearable devices

Primary outcomes:
measure: Change of area of psoas muscle
timeFrame: 84 days after gastrectomy
Secondary outcomes:
measure: Walking steps
timeFrame: 28,56, and 84 days after gastrectomy
measure: body weight
timeFrame: 84 days after gastrectomy
measure: Change of serum albumin value
timeFrame: 84 days after gastrectomy
measure: Change in white blood cells counts
timeFrame: 84 days after gastrectomy
measure: Change in lymphocyte cells counts
timeFrame: 84 days after gastrectomy
measure: Change of serum pre-albumin value
timeFrame: 84 days after gastrectomy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Ming Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610542: School-based Interventions for Test Anxiety in Adolescents
Official title: Reducing Clinical Anxiety in Adolescents Through Selective Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Test Anxiety
Wellbeing
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: Manchester University
name: Leeds University
First posted: 2018-08-01
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of three conditions: Cognitive behavioural therapy with no booster sessions, Cognitive behavioural therapy with 2 booster sessions or a no intervention control arm.
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical and cost effectiveness of test anxiety as a form of selective prevention for clinical anxiety. Participants will be randomly allocated to cognitive behavioural therapy without booster sessions, cognitive behavioural therapy with two booster sessions, or a no intervention control.

Detailed description: Test anxiety affects a substantial proportion of adolescents, who show an increased risk of suicide, and of developing clinical anxiety and poor mental health. Externally resourced school-based cognitive behavioural therapy (CBT) interventions have been shown to be effective in treating test anxiety. Intervening in test anxiety, a sub-clinical anxiety, may prevent anxieties from developing into a clinical disorder. The primary outcomes are test anxiety, clinical anxiety, and wellbeing, measured at baseline, post-intervention, and 6 and 12-month follow-up. In addition, to identify treatment mechanisms additional measures are taken of uncertain control, metacognition, and emotional regulation.

Eligibility criteria: Inclusion Criteria:

* Participants are aged 14-16 years of age
* In the upper 66th percentile of test anxiety scores

Exclusion Criteria:

* Participants are receiving other treatment for anxiety
* Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder

Primary outcomes:
measure: Test Anxiety Inventory
timeFrame: Change assessed over a 12 month period
Secondary outcomes:
measure: The Metacognition Questionnaire
timeFrame: Change assessed over a 12 month period
measure: Cognitive Emotion Regulation Questionnaire (short version)
timeFrame: Change assessed over a 12 month period
measure: Motivation and Engagement Scale (uncertain control subscale)
timeFrame: Change assessed over a 12 month period
measure: Revised Children's Anxiety and Depression Scale (panic, generalized anxiety, and social anxiety subscales)
timeFrame: Change assessed over a 12 month period
measure: School-related Wellbeing Scale
timeFrame: Change assessed over a 12 month period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06029842: The Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients in a Primary Medical Center in Jordan
Official title: A Randomized Controlled Trial to Assess the Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients for Optimum Treatment Outcomes in a Primary Medical Center in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacist-Patient Relations
Keywords: clinical pharmacist
medical center
Ministry of Health
Collaborative approach
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic patients outcomes in a primary health care center.

Detailed description: About 103 patients with type 2 diabetes were randomized to control or intervention group, the control group received a standard care, while the intervention group received the collaborative care between the clinical pharmacist and physicians. Fasting blood glucose, HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three months of follow-up. Treatment related problems (TRPs), quality of life, adherence, and patients knowledge about their medications were assessed. Cost avoidance and clinical significance of implemented clinical pharmacist interventions were assessed too.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more at the time of diagnosis

Exclusion Criteria:

* pregnant patients
* breastfeeding patients
* patients with urgent or emergent cases
* patients with cognitive impairment
* if the patient is unable to provide informed written consent

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: Lipid profile
timeFrame: 3 months
measure: Fasting blood glucose
timeFrame: each month for 3 months
measure: Patients knowledge about their medications
timeFrame: 3 months
measure: Cost avoidance of implemented clinical pharmacist interventions
timeFrame: 3 months
measure: Patients adherence to medications
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Abu-Nsair medical center
Study officials:
References:
Clinical trial NCT06045442: Dialysis Exercise With a Bed Compatible Leg TRAiningstool
Official title: Exercise During Hemodialysis With a Bed Compatible Trainingstool: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Hemodialysis
Keywords: Dialysis
Intradialytic exercise
Hemodialysis training
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment in 1:1 ratio to either the intervention group (intradialytic exercise; twice a week for 30 min per dialysis session) or control group (Usual care)
Primary purpose: TREATMENT

Brief summary: This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.

Detailed description: Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Patients who started dialysis more than 3 months ago
* Patients must be mentally and physically able to participate in exercise

Exclusion Criteria:

* Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.

Primary outcomes:
measure: Sit-to-stand test (STS60)
timeFrame: 3 month
measure: Timed-up-and-go test (TUG)
timeFrame: 3 month
Secondary outcomes:
measure: muscle mass
timeFrame: 3 month
measure: body fat mass
timeFrame: 3 month
measure: Quality of life by Kidney Disease Quality of Life Instrument (KDQOL)
timeFrame: 3 month
measure: Fatigue by Fatigue Assessment Scale (FAS)
timeFrame: 3 month
measure: activity by Freiburg Questionnaire of physical activity
timeFrame: 3 month
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bavaria
Study officials:
affiliation: Universitätsklinikum Erlangen
name: Mario Schiffer, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05759442: Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
Official title: Clinical Efficacy and Safety of Metformin Versus Apple Cider Vinegar (ACV) in Prediabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetes
Metformin HCl
Apple cider vinegar
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 46
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open label, prospective, clinical trial
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare efficacy and safety of metformin versus apple cider vinegar in prediabetics . The main question\[s\] it aims to answer are:

* Efficacy of metformin versus apple cider vinegar in prediabetics
* Safety of metformin versus apple cider vinegar in prediabetics

Researchers will compare group of prediabetics taking metformin with group of prediabetics taking apple cider vinegar to see if there is difference in safety and efficacy..


Eligibility criteria: Inclusion Criteria:

* Males and Female
* 17-40 years age
* Body Mass index (BMI) overweight and obese
* FBS (100-125 mg/dl)
* HBA1c 5.7% to 6.4%

Exclusion Criteria:

* Concomitant medical problems as established diabetes, hepatic or renal insufficiencies etc.
* Known allergy or intolerance to metformin or apple cider vinegar

Primary outcomes:
measure: Glycated Hemoglobin
timeFrame: 12 weeks
measure: Fasting Blood Sugar
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Diabetologist Clinics (02)
Study officials:
affiliation: Bahria University Health Sciences Campus
name: Dr.Shizma Junejo, MBBS,MSc
role: PRINCIPAL_INVESTIGATOR
References: