louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04924777: Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus
Official title: Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.

Detailed description: To the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in Pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.

Eligibility criteria: Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Male/female
* Diabetic type 2 patients
* Age: 30-70 years
* BMI \>25
* Overweight
* Fat % in male\> 25
* Fat % in female \>35
* HbA1c level more than 48mmol/mol or \>6.5%
* Fasting Plasma Glucose level \>126 mg/dl (7.0 mmol/l)
* Random Plasma glucose level \>200 mg/dl (11.1 mmol/l)
* Physically active ( have no mobility problems)

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.
* Type 1 diabetes
* Insulin dependant type 2 diabetes
* Gestational Diabetes
* Hypertension
* Cigarette smoking
* Cardiovascular Disease
* Cerebrovascular disease
* Cardiopulmonary Disorders
* Cognition Problems
* Peripheral Artery Disease
* Dyslipidemia
* Proliferative or preproliferative retinopathy
* Nephropathy
* Neuropathy

Primary outcomes:
measure: HbA1c Levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah Rehabilitation Center
Study officials:
affiliation: Riphah International University
name: Waqar Ahmad Awan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355377: Hepatic Artery From Origin to Segmental Branching: a 500 Case CT Study
Official title: Hepatic Artery From Origin to Segmental Branching: a 500 Case CT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Artery
Keywords: Hepatic Artery
Anatomy
MDCT
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Systematic inclusion of patients undergoing CT imaging with arterial abdominal contrast between November 2019 and April 2020

Brief summary: The origin of the hepatic artery is known to be highly variable, as reported by Michels in 1966 and other authors. This variability has an indisputable impact regarding hepatic, pancreatic and upper gastro-intestinal surgery.

As the investigators go deeper into the liver's parenchyma, full-liver and segment IV studies have also found high levels of variability. Only few cadaveric studies have analyzed the entire liver and with limited sample size.

The current CT technology allows for an accurate analysis of the arterial branching thanks to the 0.625mm voxel.

The aim of this CT study is to describe the anatomy of hepatic arterial segmental branching from the origin of the hepatic artery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing CT with arterial abdominal imaging

Exclusion Criteria:

* imaging with radiological artefact (movement, biliary prothesis,..)
* hepatic resection (except small non anatomic resections)

Primary outcomes:
measure: Anatomic description of the hepatic artery
timeFrame: November 1rst 2019 to May, 30 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT05921877: AMH and Functional Hypothalamic Amenorrhea
Official title: AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amenorrhea Secondary
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 34
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with functional hypotalamic amenorrhea (FHA) will be recruited from the DH of Dysfunctional Gynecology (UOSD Diagnostic and Medical Therapy of Menstrual Dysfunction and Marital Infertility) Department of Women's, Children's and Public Health Sciences of the A. Gemelli IRCCS University Polyclinic Foundation. Possible enrollment in the study protocol will not affect or alter in any way the patient's clinical course or adherence to good clinical practice guidelines. A group of healthy controls will also be enrolled, respecting the same exclusion criteria, from among the patients afferent to the Day Hospital of Dysfunctional Gynecology (healthy control is defined as: patient not suffering from functional hypothalamic amenorrhea, not from polycystic ovary syndrome and with 10-12 menstrual cycles per year).

Brief summary: The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.


Eligibility criteria: Inclusion Criteria:

* Women aged 15-34 years.
* Diagnosis of functional hypothalamic amenorrhea (for at least 2 years).
* Signature of informed consent.

Exclusion Criteria:

* Polycystic ovary syndrome
* Taking oral contraceptives in the previous three months
* Other clinically relevant endocrinopathies
* positive MAP-test (Medroxyprogesterone acetate test)
* Estroprogestin replacement therapy
* Autoimmune disorders
* Failure to sign informed consent

Primary outcomes:
measure: AMH assay
timeFrame: 12 months
Secondary outcomes:
measure: To correlate AMH levels with other parameters
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Rosanna Apa
Study officials:
References:
Clinical trial NCT06265077: Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients
Official title: Efficacy and Safety of Loratadine and Famotidine Combination on Preventing Filgrastim-Induced Bone Pain in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Filgrastim Adverse Reaction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain.


Eligibility criteria: Inclusion Criteria:

1. Eligible patients were 18 years or older.
2. Confirmed diagnosis of breast cancer.
3. Patients completed adriamycin and cyclophosphamide (AC) regimen and are planned to receive four cycles or more of paclitaxel chemotherapy with G-CSF support starting in cycle 1 and continuing throughout each of the four paclitaxel cycles.
4. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.

Exclusion Criteria:

1. Patients with signs and symptoms of grade 2 or 3 bone pain at baseline.
2. Patients receiving famotidine in the previous 72 hours.
3. Patient receiving any antihistaminic in the previous 72 hours.
4. Hypersensitivity to famotidine or loratadine.
5. Patient receiving opioid or adjuvant analgesic.

Primary outcomes:
measure: The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Province
Study officials:
References:
Clinical trial NCT03093077: Kinematics After Total Knee Arthroplasty
Official title: Kinematics Following Total Knee Arthroplasty Performed With Different Surgical Alignment Techniques
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate and compare implant kinematics of conventional mechanically aligned and anatomically aligned total knee arthroplasties (TKA) at 1 year post-operatively.

Detailed description: Participants will be randomized to receive a primary TKA using either an anatomic alignment or a conventional mechanical alignment technique.

Participants will undergo a kinematic analysis of a deep knee bend using single-plane fluoroscopy at 1 year post-operatively. The primary outcome will be based on the 6 degree of freedom kinematics and associated joint component proximity during the knee bend task. Secondary outcomes include the Knee Society Score, the Knee Injury and Osteoarthritis Outcome Score, and the Forgotten Knee Score.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Primary arthroplasty for treatment of osteoarthritis
* Age between 40 and 80 years old
* Willingness to provide written consent for study participation

Exclusion Criteria:

* Revision arthroplasty
* Pre-operative knee flexion lower than 90 degrees
* Varus knee deformity greater than 15 degrees
* Pre-operative valgus knee deformity
* Presence of infections, highly communicable diseases or metastatic disease
* Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing
* Congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with total knee prosthesis survival or success
* Presence of previous prosthetic knee or hip replacement device
* BMI \> 40
* Pregnant women

Primary outcomes:
measure: Knee motion, as determined by 6 degree freedom of movement kinematics and associated joint proximity during the knee bend task.
timeFrame: 1 year post surgery
Secondary outcomes:
measure: Participants perception of knee function, as determined by the Knee injury Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year post surgery
measure: Participant's awareness of the joint implant, as determined by the Forgotten Joint Score (FJS-12)
timeFrame: 1 year post surgery
measure: Knee joint and ambulatory function based on physical exam, as determined by the Knee Society Score (KSS)
timeFrame: 1 year post surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kristin D. Zhao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293277: Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sedation
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male 18 - 40 years of age
* Body weight \>/= 50 kg (male) or \>/= 45 kg (female), with BMI between 19.0 and 26.0 kg/m2, inclusive
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
* Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; positive drug or alcohol test
* Major surgery within 4 weeks of screening

Primary outcomes:
measure: Adverse Events
timeFrame: Baseline to 7 days after dose administration
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT04802577: Fatigue in Primary Sjögren's Syndrome
Official title: The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjogren's Syndrome
Fatigue
Pain Syndrome
Depression
Anxiety
Fibromyalgia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.

Brief summary: Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Detailed description: While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
* Healthy hospital staff

Exclusion Criteria:

* Pregnant women
* Cancer patients
* Those with other connective tissue diseases other than PSS
* Multiple sclerosis patients
* Chronic obstructive pulmonary disease
* Those with heart failure and adrenal insufficiency
* Those with renal failure: GFR \<60 ml/min
* Anemia: Hemoglobin \<11 g / dl in women, hemoglobin \<12 g / dl in men
* Hypothyroidism: TSH \>5 mu / L
* Those with electrolyte disturbance

Primary outcomes:
measure: FACIT-F
timeFrame: day 1
Secondary outcomes:
measure: BDI
timeFrame: day 1
measure: BAI
timeFrame: day 1
measure: ISS
timeFrame: day 1
measure: PDQ
timeFrame: day 1
Other outcomes:
Locations:
city: Yıldırım
country: Turkey
facility: Koray Ayar
state: Bursa
Study officials:
affiliation: Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
name: Koray Ayar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540877: A Human Experimental Model for Neuropathic Pain Using Combined Application of Capsaicin and Local Anesthetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ipsi- and Contralateral Hypoesthesia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Main of the present study was to develop a model of concomitant C-fibre block and sensitization eliciting spontaneous pain as well applying topical capsaicin and local anesthetics (LA) to examine the sensory alterations after combined C-fiber block and sensitization in both different application orders (sensitization of blocked C-fibers and block of sensitized C-fibers), compared to each of both mechanisms alone. Thereby, we expect stronger sensory changes during the combined substance application than during the monoapplication. We expect also contralateral sensory alterations mirroring the changes on the intervention site after the combined capsaicin and LA application, being stronger than after sensitization alone absent after C-fiber block alone.


Eligibility criteria: Inclusion Criteria:

* healthy subject, older than 18 years, provided written informed consent

Exclusion Criteria:

* insufficient comprehension of the German language, history of severe internal, neurological or dermatological diseases, substance abuse, manifest psychiatric diseases, chronic and acute pain, any medication intake (except contraceptives in females) regularly or on demand during the last 14 days before study inclusion and during the study period, hypersensitivity to lidocaine or other amide-type anesthetics, hereditary or acquired methemoglobinemia, pregnancy, nursing, abnormal sensory profile in the quantitative sensory testing (QST) with side-to-side differences beyond the normal range at baseline and participation in clinical trials during the last month.

Primary outcomes:
measure: grade of the ipsi- and contralateral hypoesthesia
timeFrame: 6 months
Secondary outcomes:
measure: area of the ipsi- and contralateral hypoesthesia
timeFrame: 6 months
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Pain Medicine
Study officials:
References:
citation: Enax-Krumova EK, Pohl S, Westermann A, Maier C. Ipsilateral and contralateral sensory changes in healthy subjects after experimentally induced concomitant sensitization and hypoesthesia. BMC Neurol. 2017 Mar 23;17(1):60. doi: 10.1186/s12883-017-0839-9.
Clinical trial NCT01889277: Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy


Eligibility criteria: Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* Subject with albuminuria

Exclusion Criteria:

* History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
* Serum potassium level \<3.5 or \>5.0 mmol/L
* Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
* Subjects with clinically significant hypotension

Primary outcomes:
measure: Frequency and nature of treatment-emergent adverse events and serious adverse events.
timeFrame: 20 weeks
measure: Plasma concentrations of MT-3995 and its major metabolite
timeFrame: 20 weeks
Secondary outcomes:
measure: Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Kawasaki
country: Japan
facility: Koukan Hospital
state: Kanagawa Pref.
Study officials:
affiliation: Division of Nephrology and Endocrinology University of Tokyo School of medicine
name: Masaomi Nangaku, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondou, Adviser
role: STUDY_DIRECTOR
References: