louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02608554: Taichi for Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
Official title: Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary sybdrome
Taichi
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined.


Eligibility criteria: Inclusion Criteria:

* Women aged between 19 and 35 years;
* Diagnosis of PCOS according to the modified Rotterdam criteria;
* 2 years after menarche;
* Body mass index (BMI) equal to or greater than 23 kg/m\*m.

Exclusion Criteria:

* Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
* Patients with other endocrine disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
* Patients with known severe organ dysfunction or mental illness.

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: 3 months
Secondary outcomes:
measure: Fasting plasma glucose (Glu)
timeFrame: 3 months
measure: Fasting insulin (Ins)
timeFrame: 3 months
measure: HOMA-IR
timeFrame: 3 months
measure: Testosterone (T)
timeFrame: 3 months
measure: Luteinizing hormone (LH)
timeFrame: 3 months
measure: Follicle stimulating hormone (FSH)
timeFrame: 3 months
measure: Waist/hip ratio
timeFrame: 3 months
measure: Ferriman-Gallwey score
timeFrame: 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Heilongjiang University Of Chinese
name: Lihui Hou, Bachelor
role: STUDY_CHAIR
References:
citation: Li Y, Peng C, Zhang M, Xie L, Gao J, Wang Y, Gao Y, Hou L. Tai Chi for Overweight/Obese Adolescents and Young Women with Polycystic Ovary Syndrome: A Randomized Controlled Pilot Trial. Evid Based Complement Alternat Med. 2022 Jun 17;2022:4291477. doi: 10.1155/2022/4291477. eCollection 2022.
citation: Li Y, Peng C, Cao G, Li W, Hou L. Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials. 2018 Sep 20;19(1):512. doi: 10.1186/s13063-018-2893-z.
Clinical trial NCT03567954: The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients
Official title: The Diagnostic Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Patients Who Sustained a Proximal Humerus Fracture
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rotator Cuff Tear
Proximal Humeral Fracture
Keywords: Diagnostic ultrasound
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Viborg, Skive
name: Tampere University Hospital
First posted: 2018-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of adults referred to Viborg Regional Hospital and Tampere University Hospital, Finland, under suspicion of a proximal humerus fracture.

Brief summary: The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.

Detailed description: Although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. Ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. It is a user-dependent modality and health professionals must possess the competence and training before using it. To the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.

Eligibility criteria: Inclusion Criteria:

* Displaced proximal humeral fracture
* Referred to operative treatment

Exclusion Criteria:

* Younger than 18 years old
* Non-independent
* Does no understand written and spoken guidance in local language, Danish, Swedish or Finnish
* Open fracture
* Isolated tuberculum fracture

Primary outcomes:
measure: Full-thickness rotator cuff tear in the shoulder
timeFrame: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Secondary outcomes:
measure: Partial-thickness rotator cuff tear in the shoulder
timeFrame: Ultrasound scan is performed once; Baseline (prior to operation which is the golden standard)
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Viborg Regional Hospital
name: Helle Østergaard, MSc., PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01595854: Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Official title: Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor (Part 1 and 2, Open, Non-randomised, 2 Parallel Groups) and Assessment of Ticagrelor Interaction Potential With Dabigatran (Part 3, Open, Randomised, Two-period Cross-over) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new pharmacodynamic methods


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects

   Exclusion criteria:
2. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
measure: Total Dabigatran: Maximum Measured Concentration (Cmax)
timeFrame: -1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours
Secondary outcomes:
measure: Number of Participants With Drug Related Adverse Events
timeFrame: From screening until the end-of-study examination
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1160.141.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT04193254: LPP , MP and DP:Relation With Mortality and SOFA in Mechanically Ventilated Patients in ER, Ward and ICU
Official title: Relation of Pulmonary Protective Ventilation, Mechanical Power and Driving Pressure With Mortality and SOFA of Mechanically Ventilated Patients in ER, Ward and ICU at General Hospital 11 IMSS Piedras Negras, Coahuila
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Mechanical Power
Driving Pressure
Lung Protective Ventilation
Keywords: lung protective ventilation
mechanical power
driving pressure
SOFA
Lead sponsor: IMSS Hospital General de Zona 11, Piedras Negras
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients that required invasive mechanical ventilation.

Brief summary: Prospective, observational, longitudinal study, September 2019 to March 2020 of all adult patients who required invasive mechanical ventilation treated at General Hospital of Zone 11 IMSS in Piedras Negras, Coahuila. The investigators aim to assess the relation of lung protective ventilation, mechanical power and driving pressure in mortality and SOFA of mechanically ventilated patients inside and outside ICU at the General Hospital of Zona 11 Piedras Negras, IMSS

Detailed description: Prospective, observational, longitudinal study from Sept 2019 to Feb 2020 of all adult patients who required invasive mechanical ventilation treated at General Hospital of Zone 11 IMSS in Piedras Negras Coahuila.

Independent variable: Lung protective ventilation, Mechanical power, Driving pressure Dependent variable: Hospital Mortality, Sequential Organic Failure Assessment (SOFA)

Also will be registered:

1. Primary diagnosis
2. Compliance with lung protective ventilation
3. Complications associated to mechanical ventilation
4. Quality of attention indicators for MV patients as defined by Semicyuc.
5. Real mortality vs Expected mortality analysis

Eligibility criteria: Inclusion Criteria:

* Patients with 18 years or older, with invasive mechanical ventilation

Exclusion Criteria:

* Patients with 17 years or younger

Primary outcomes:
measure: Correlation of Lung protective ventilation with mortality and SOFA (Sequential Organic Failure Assessment)
timeFrame: Sept 19-Feb 20
measure: Correlation of mechanical power with mortality and SOFA
timeFrame: Sept 19-Feb 20
measure: Correlation of driving pressure with mortality and SOFA
timeFrame: Sept 19-Feb 20
Secondary outcomes:
Other outcomes:
Locations:
city: Piedras Negras
country: Mexico
facility: Hospital General Zona 11 Imss Piedras Negras Coahuila
state: Coahuila
Study officials:
affiliation: HGZ 11 IMSS PIEDRAS NEGRAS COAHUILA
name: JOSE IVAN RODRIGUEZ DE MOLINA SERRANO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917254: Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
Official title: Phase II/III Study of YM150 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients Undergoing Elective Total Knee Replacement Surgery -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Thromboembolism
Keywords: YM150
Thrombosis
VTE
Knee Replacement
Anticoagulant
FXa inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 369
Sex: ALL
Minimum age (years): 20
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 examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects is scheduled for elective primary total knee replacement surgery
* Written informed consent obtained before screening

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to the screening visit
* Subject has an acute bacterial endocarditis, retinopathy, hypertension, or thrombocytopenia
* Subject is receiving anticoagulants/antiplatelets

Primary outcomes:
measure: Overall incidence of venous thromboembolism
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of individual venous thromboembolism
timeFrame: 2 weeks
measure: Incidence of bleeding events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
city: Touhoku
country: Japan
city: Changhua
country: Taiwan
city: Chia-Yi
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05775354: Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
Official title: Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Artery Disease
Atrial Fibrillation
Heart Failure
Valvular Heart Disease
Keywords: early diagnosis
cardiovascular diseases
cohort study
primary health care
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 1476
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project.

The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.


Eligibility criteria: Inclusion Criteria:

* Aged 50-80 years
* Being a participant of LRGP
* Having indicated in the LRGP informed consent to be interested in participating in further research.

Exclusion Criteria:

* Diagnosed with coronary artery disease and atrial fibrillation and heart failure.
* Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment.
* Not willing to give written informed consent for RED-LRGP.
* Not allowing incidental findings to be reported to him/herself or their own GP.

Primary outcomes:
measure: Coronary artery disease
timeFrame: 1 year
measure: Atrial fibrillation
timeFrame: 1 year
measure: Heart failure
timeFrame: 1 year
measure: Valvular heart disease
timeFrame: 1 year
Secondary outcomes:
measure: Echocardiographic abnormalities
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 1 year
measure: CVD family history and women's reproductive history
timeFrame: 1 year
measure: Cardiovascular risk profile
timeFrame: 1 year
measure: Costs
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: Monika Hollander, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385354: Main Pancreatic Duct Diameter
Official title: Normal Values of Main Pancreatic Duct Diameter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Duct Dilatation
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract

Brief summary: The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:

* Pancreatic head
* Pancreatic neck
* Pancreatic body
* Pancreatic tail

Detailed description: All patients without pancreatic or biliary disorders undergoing upper-GI endoscopic ultrasound (EUS) are eligible for the study.

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts:

* Pancreatic head
* Pancreatic neck
* Pancreatic body
* Pancreatic tail

Eligibility criteria: Inclusion criteria:

* Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
* Indication for EUS is undependent from the study
* Written informed consent
* Age ≥18 years

Exclusion Criteria:

* Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
* Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
* Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
* Elevated Bilirubin and/or Lipase

Primary outcomes:
measure: Maximal diameter of main pancreatic duct in millimeters
timeFrame: The measurement is performed once during endosonography.
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Clinic and Policlinik of Internal Medicine II
state: Bavaria
Study officials:
References:
Clinical trial NCT00004654: Phase III Randomized, Placebo-Controlled, Crossover Study of Soy Protein Isolate for Hereditary Hemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hereditary Hemorrhagic Telangiectasia
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 2000-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate migraine prophylaxis with soy protein isolate in patients with hereditary hemorrhagic telangiectasia.

II. Assess whether soy protein isolate reduces the frequency and severity of epistaxis and gastrointestinal bleeding in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. One group of patients is treated with soy protein isolate for 12 weeks. The control group receives a placebo for 12 weeks.

Patients cross to the alternate group following a 4-week washout.

Eligibility criteria: * Hereditary hemorrhagic telangiectasia (HHT) with 2 of the following:
* First-degree relative with HHT
* History of recurrent epistaxis or gastrointestinal bleeding
* Three or more skin telangiectasia
* Migraine headache meeting International Headache Society criteria 3 or more times a month for more than 1 year
* No pattern of daily headaches
* No severe head trauma
* No onset of headaches after 50 years of age
* At least 1 month since migraine prophylaxis
* At least 1 month since any of the following medications: Beta blockers; Calcium channel blockers; Divalproex sodium; Tricyclic antidepressants; Selective serotonin re-uptake inhibitors
* Concurrent regular treatment for migraine and gastrointestinal hemorrhage allowed
* Creatinine no greater than 2.5 g/dL
* No allergy to soy
* No pregnant women
* No women with intent to become pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Joshua R. Korzenik
role: STUDY_CHAIR
References:
Clinical trial NCT05982054: Bone Marrow Cells With Core Decompression for AVN Treatment
Official title: Percutaneous Autologous Bone Marrow Cells With Core Decompression for Treating Avascular Hip Necrosis Under Local Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Avascular Necrosis of the Femoral Head
Keywords: avascular necrosis of the femoral head
core decompression
bone marrow cells
local anesthesia
Lead sponsor: Global Stem Cell Center, Baghdad
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. this is a single armed study to be done from July 2023 till January 2024, the total number of patients anticipated is 10, total joints treated around 20, The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Detailed description: Avascular necrosis of the femoral head (AVN) is a progressive pathological process resulting from disruption of blood supply to the femoral head and elevation of intraosseous pressure. Early stage AVN can be managed by various techniques, the results have been disappointing, total hip arthroplasty is frequently the only durable option for pain relief and restoration of function. This procedure is usually a high risk procedure under general anesthesia ,with The newer treatment modalities include using high stem cell concentration in the vicinity of the necrosed tissue with core decompression to prevent disease progression. this study is a single armed study to be done from July 2023 to January 2024, the total number of patients is 10, Etiology include corticosteroids use, systemic lupus erythematosus mostly related to steroid use in covid 19 epidemic,. The age of the patients range from 25-55 years. The procedure includes core decompression with autologous bone marrow derived mononuclear cell injection inside the femoral head using local anesthesia ultrasound and fluoroscopy guided without drilling.

Eligibility criteria: Inclusion Criteria:

1. Avascular hip necrosis irrespective Of stage.
2. age from 25-55 years. -

Exclusion Criteria:

1. history of bleeding tendency.
2. history of malignant disease.
3. critically ill patient. -

Primary outcomes:
measure: clinical improvement
timeFrame: 6 months
Secondary outcomes:
measure: disease progression
timeFrame: around 6 months from starting recruitment
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ministry of Health
Study officials:
affiliation: clinical stem cell studies
name: abdulmajeed a hammadi, MD
role: PRINCIPAL_INVESTIGATOR
References: