louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006513: Assessing the Occupation Burden in COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-11-21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To assess the population burden of occupational exposures in the prevalence and progression of chronic obstructive pulmonary disease (COPD).

Detailed description: BACKGROUND:

Chronic obstructive pulmonary disease is the only one of the top four or five leading causes of death in the U.S. with worsening epidemiological trends. Cigarette smoking accounts for approximately 85 percent-90 percent of cases, but the other 10 percent-15 percent of the attributable risk still represents a substantial fraction of this disease that remains unexplained. Recently, several studies, in various countries, have addressed whether certain occupational exposures (primarily those relating to dusts, vapors, gases, and/or fumes) are potential risk factors for COPD. Most of these studies have shown elevated odds ratios or relative risks, although not always to a statistically significant level.

DESIGN NARRATIVE:

A population sample of the continental United States of those aged 55-75, supplemented by an enriched sample in geographic "hot spots" identified by the National Institute for Occupational Safety and Health (NIOSH) through respiratory diseases mapping. Structured telephone interviews assessed demographics, health status, smoking exposures, and occupational histories. High risk jobs were coded using a job matrix system independent of subject report of specific exposures. Two hundred thirty-four of those with COPD, with over-sampling of those with greater severity, were followed at 12-14 months to assess health status and health services utilization, as well as decrements in quality of life.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Paul Blanc
References:
citation: Trupin L, Earnest G, San Pedro M, Balmes JR, Eisner MD, Yelin E, Katz PP, Blanc PD. The occupational burden of chronic obstructive pulmonary disease. Eur Respir J. 2003 Sep;22(3):462-9. doi: 10.1183/09031936.03.00094203.
citation: Blanc PD, Eisner MD, Trupin L, Yelin EH, Katz PP, Balmes JR. The association between occupational factors and adverse health outcomes in chronic obstructive pulmonary disease. Occup Environ Med. 2004 Aug;61(8):661-7. doi: 10.1136/oem.2003.010058.
Clinical trial NCT03286413: Comparison of Microwave Ablation With Cryoablation for Breast Tumor
Official title: Comparison of Ultrasound Guided Percutaneous Microwave Ablation With Cryoablation for Breast Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Tumor
Microwave Ablation
Cryoablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(MWA) and cryoablation of benign and malignant breast lesion under ultrasound (US) guidance.

Detailed description: A total of more than 200 patients diagnosed with benign breast lesions and 50 patients with malignant breast lesions in two centers of China will be recruited in this study and underwent US-guided percutaneous MWA and cryoablation treatment. Information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. Ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Eligibility criteria: Inclusion Criteria:

* (a) the breast tumor obtained the pathological diagnosis by using core-needle biopsy; (b) for the benign lesion, continually increasing during a half year followup,with the symptoms of local pain, discomfortable or compression considered probably relating to the mass of breast; the patient with evidently psychological pressure due to the occurrence of the BBL despite clearly benignancy on imaging; (c) for the malignant lesion, with the tumor size smaller than 2cm and without other metastasis.

Exclusion Criteria:

* (a) the patients who were pregnant or breast-feeding; (b) the patients with evidence of coagulopathy or acute or severe pulmonary insufficiency or heart dysfunction; (c) the patients during menstrual period; (d) the patients referring to other therapies including surgical excision and vacuum-assisted biopsy.

Primary outcomes:
measure: volume reduce rate
timeFrame: 3 year
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
measure: local tumor progress
timeFrame: 5 year
measure: metastasis
timeFrame: 5 year
measure: complication
timeFrame: 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05427513: Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss in Bone Sarcoma Patient
Official title: Efficacy of Tranexamic Acid in Preventing Post Operative Blood Loss and Associated Complications in Bone Sarcoma Patients Treated With Limb Salvage Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Blood Loss, Surgical
Lead sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: investigator will see the efficacy of tranexamic acid in limb salvage surgery patients which will prevent blood loss and help in conservation of blood products.


Eligibility criteria: Inclusion Criteria:

* Limb sarcoma of upper and lower limb
* Limb salvage

Exclusion Criteria:

* liver insufficiency
* renal insufficiency
* allergic to drug
* history of thromboembolic condition
* pregnancy
* metastatic disease

Primary outcomes:
measure: blood loss
timeFrame: 72 hour post operatively
measure: no of blood transfused
timeFrame: 72 hour
Secondary outcomes:
measure: duration of hospital stay
timeFrame: total hospital stay post operatively for 02 month
measure: volume of drain out put
timeFrame: measure till drain out in 72 hour
measure: thromboembolic events
timeFrame: observed for 6 week determine on out patient visits
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaukat Khanum Memorial Cancer Hospital & Research Center
state: Punjab
Study officials:
References:
Clinical trial NCT01970813: Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
Official title: Efficacy of Acupuncture and Bee Venom Acupuncture on Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease
Idiopathic Parkinson's disease
acupuncture
bee venom acupuncture
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of acupuncture and bee venom acupuncture (BVA) for idiopathic Parkinson's disease (IPD) through a sham-controlled trial and investigate whether there is sustainability of treatments effects by follow-up assessments after the end of the treatment.

Detailed description: A total of 90 patients with idiopathic Parkinson's disease (IPD) who have been on a stable dose of anti-parkinsonian medication for at least one month with two or more symptoms among tremor, rigidity, postural instability, and bradykinesia will be included in this study. Participants will be randomly assigned to the study, the control, or the waiting group (2:2:1).

Initial assessment will be performed with the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III, the Parkinson's Disease Quality of Life Questionnaire (PDQL), the Beck Depression Inventory (BDI), and evaluation of the 20-m walking time and the steps to walk 20-m, as well as postural instability.

Acupuncture and BVA treatments will then be performed on the study group, and sham acupuncture and normal saline injections will be performed on the control group twice a week for 12 weeks. The waiting group does not receive any added treatment during the 12 weeks.

The initial assessment will be repeated after 12 weeks in all groups. In the study and the control groups, an additional assessment will be repeated after 16 and 20 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with IPD who have been on a stable dose of anti-parkinsonian medication for at least one month.
* Hoehn \& Yahr scale I-IV
* More than one point in two or more items (tremor, rigidity, postural instability, and bradykinesia) in the UPDRS Part III, etc.

Exclusion Criteria:

* Severe psychiatric or organic brain disorders other than PD, previous or current
* Secondary Parkinsonism due to cerebrovascular disease, tumor, infection, etc.
* Atypical Parkinsonian or Parkinson plus syndrome

Primary outcomes:
measure: Change of the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III
timeFrame: baseline, up to 12 weeks, 16 weeks, and 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyunghee University
name: Seong-Uk Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05179213: Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma
Official title: Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Angioimmunoblastic T-cell Lymphoma
Keywords: Angioimmunoblastic T-cell Lymphoma
Azacytidine
Chidamide
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Longfu Hospital
First posted: 2022-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.

Detailed description: Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
* Age≥18years;
* ECOG≤2;
* Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment;
* Adequate bone marrow hematopoietic function: ANC\>1.5 × 109/L，HGB\>90g/L，PLT\>80 × 109/L;
* Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
* Pregnant or lactating women;

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1year
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 1 year
measure: Duration of response (DOR)
timeFrame: through study completion, an average of 1 year
measure: overall survival (OS)
timeFrame: through study completion, an average of 2 year
measure: Adverse Events
timeFrame: During the whole treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Wei Zhang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01639313: Comparison of Nexfin Pulse Contour Analysis and Cardiac Magnetic Resonance Imaging for the Measurement of Cardiac Output
Official title: Is Arterial Pulse Contour Analysis Using Nexfin a New Option in the Non-invasive Measurement of Cardiac Output? - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Diseases
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hemodynamically stable patients undergoing CMR

Brief summary: A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR).


Eligibility criteria: Inclusion Criteria:

* indication for CMR

Exclusion Criteria:

* contraindication for CMR
* claustrophobia
* no consent obtained

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
Study officials:
References:
Clinical trial NCT05146713: Effect of Propolis Nanoparticles on Postoperative Pain and Bacterial Reduction in Mandibular Premolars
Official title: Effect Of Propolis Nanoparticles Versus Sodium Hypochlorite As Root Canal Irrigant On Postoperative Pain And Bacterial Reduction In Mandibular Premolars With Necrotic Pulps (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Necrotic Pulp
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.


Eligibility criteria: Inclusion Criteria:

1. Systematically healthy patient (ASA I,II).
2. Age between 20 and 55 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Teeth with:

   * Immature roots
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.

Primary outcomes:
measure: Postoperative pain
timeFrame: up to 48 hours postoperatively
Secondary outcomes:
measure: Intracanal bacterial load change
timeFrame: Throughout the chemo-mechanical preparation of the canal.
measure: Number of analgesic tablets taken by the patient after endodontic treatment
timeFrame: Up to 48 hours postoperative.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03066713: Post-prandial Glucose Response From Phytochemical Rich Potato Products
Official title: Post-prandial Glucose Response From Phytochemical Rich Potato Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2017-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the impact of high antioxidant potato products on postprandial glycemic response and subsequent appetite and food intake.

Detailed description: Preliminary results from anthocyanin rich potato products suggest that a reduced postprandial glycemic response might be expected from certain types of potato products and that phenolic antioxidants may play a critical role in predicting the physiological response from potato products. Further, if consumed early in the day, such as at breakfast, a reduced glycemic response may serve to mitigate appetite and food consumption later in the day. Investigators aim to better understand how characteristics of commercial potato products (i.e. frozen potato products) with different phenolic profiles and content, may alter postprandial glycemic response and subsequent appetitive behavior. Specifically, investigators will assess the glycemic response from a serving of potato products in the morning using continuous glucose monitoring. Further, appetite and subsequent food consumption later in the day will be assessed through appetite logs and continuous glucose monitoring.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-25, male or female

Exclusion Criteria:

* BMI outside 18.5-25

Primary outcomes:
measure: Change in Blood Glucose over 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Appetite
timeFrame: Every hour for 24 hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05674513: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Official title: Disparities in Emergency Contraceptive Metabolism Dictate Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Contraceptive Usage
Keywords: Ulipristal acetate
Emergency contraception
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-01-06
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.

Detailed description: Each of us can respond differently to a drug or medication based on our genetics. An emergency contraceptive, ulipristal acetate or UPA, normally works by stopping or delaying the ovary from releasing an egg (ovulation). Our bodies break down UPA in order to use it through a system call the cytochrome P450 pathway but this pathway can be faster or slower depending on our genetics. The investigators want to learn more about how our individual genetic differences in this pathway change how the ovary responds to UPA. The overall goal of this research is to improve the effectiveness of emergency contraception for all people.

Eligibility criteria: Inclusion Criteria:

* Generally healthy women
* Aged 18-40
* regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng/mL or greater during the luteal phase of the screening cycle.

Exclusion Criteria:

* Pregnant, seeking pregnancy, or breastfeeding
* Known allergy to study medication
* Recent use of hormonal contraception
* Irregular periods (\<21 days or \>35 day cycles)
* Routine use of nonsteroidal anti-inflammatory drugs
* Metabolic disorders
* Smoking
* Any condition that would preclude the provision of informed consent
* Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates

Primary outcomes:
measure: Delay in follicular rupture
timeFrame: over 1 menstrual cycle (assessed up to approximately 30 days)
measure: Concentration of UPA
timeFrame: 5 days after taking study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: ALISON EDELMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315313: The Link Between the Clinical Resting Heart Rate and Sympathetic Overactivation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiovascular disease patient

Brief summary: It is a retrospective study with no products limitation to investigate the link between clinical resting HR and SOA. Use HR≤60bpm as control group, compare other three groups with the control group and find out the correlation between HR and SOA indexes.


Eligibility criteria: Inclusion Criteria:

1. Provision of subject informed written or oral consent
2. Female and male aged≥ 20 to ≤ 80 years;
3. Records on mean clinical heart rate and SOA indexes were available.

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 6 months;
2. Drug intervention on heart rate 1 month prior to the inclusion;
3. Patients with missing data in the database from the Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai.

Primary outcomes:
measure: The difference of HRV, BPV, LF/HF between each groups
timeFrame: 1min HR measure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: