louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02002351: Prospective Study on Rehabilitation Patients With Pulmonary Hypertension and Other Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Diseases
Rehabilitation
Lead sponsor: Paracelsus Harz Clinic Bad Suderode.
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2013-12-05
Enrollment: 450
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: All rehabilitation patients with pulmonary diseases in the Paracelsus-Harz-Clinic Bad Suderode will be included, starting December 2013,ending Novermber 2014.

Brief summary: This monocentric registry should provide information on the extent how patients with pulmonary diseases such as pulmonary hypertension will benefit from rehabilitation treatment. The data may provide a basis for further prospective studies showing the treatment of patients with pulmonary diseases especially by physical activation.


Eligibility criteria: Inclusion Criteria:

* Pulmonary Disease

Exclusion Criteria:

* Inability or refusal to give written informed consent

Primary outcomes:
measure: Data collection
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Quedlinburg
country: Germany
facility: Paracelsus Harz Clinic Bad Suderode
state: Saxony-Anhalt
Study officials:
References:
Clinical trial NCT07021651: COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA
Official title: A Two-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Paravertebral Block
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Secondary aims were to compare these groups in terms of Riker Agitation-Sedation Scale (RASS) scores, postoperative complications, postoperative opioid consumption, and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients who will undergo thoracotomy and are between the ages of 18-65
* have American Society of Anesthesiologists (ASA) risk classification I-II will be included in the study.

Exclusion Criteria:

* Patients who did not agree to participate in the study,
* had an infection in the application area,
* had coagulopathy,
* were morbidly obese (Body mass index (BMI)\>35),
* had drug allergy,
* had chronic pain, long-term opioid use, psychiatric illness history, and required emergency surgery were excluded from the study.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes:
measure: Riker Agitation and Sedation Scale
timeFrame: Immediately after extubation
measure: Patient satisfaction score:
timeFrame: Post-operative 30 minutes
measure: 24-hour Tramadol usage:
timeFrame: posoperative 24 hours
Other outcomes:
Locations:
city: Kayapinar
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Di̇yarbakir
Study officials:
References:
Clinical trial NCT01712451: Dose-ranging Study
Official title: Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Contour Defects
Keywords: adiposity
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dose ranging study


Eligibility criteria: Inclusion Criteria:

* 18 - 45 years of age inclusive
* abdominal contour defect
* BMI \<25 kg/msq
* Stable diet and exercise and body weight

Exclusion Criteria:

* Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
* Known hypersensitivity to study drugs

Primary outcomes:
measure: Safety
timeFrame: 8 weeks treatment
measure: Change in abdominal circumference
timeFrame: Baseline to 9 weeks
Secondary outcomes:
measure: Change in global clinician scale score
timeFrame: Baseline to 9 weeks
measure: Change in global patient scale score
timeFrame: Baseline to 9 weeks
measure: Change in Photonumeric scale score
timeFrame: Baseline to 9 weeks
measure: Change in Patient Reported Outcome Score
timeFrame: Baseline to 9 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Nashville
country: United States
state: Tennessee
city: Plano
country: United States
state: Texas
Study officials:
affiliation: Neothetics, Inc
name: Murray Maytom
role: STUDY_DIRECTOR
References:
Clinical trial NCT01015651: Assessment of the Nociception During Lumbar Surgery
Official title: Assessment of the Nociception During Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Surgery
Keywords: nociception, intraoperative, baroreflex
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2009-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
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 aim of the study is to assess the accuracy of a new paradigm in measuring the level of nociception during lumbar surgery. The paradigm is based the measurement of the baroreflex in response to noxious stimuli in anesthetized patients.

Detailed description: The study aims at exploring the changes in the baroreflex induced by 3 noxious stimulation in anesthetized patients: tracheal intubation, tetanic stimulus, and surgical incision. Patients are randomly assigned to one of 2 groups: remifentanil-2 or remifentanil-4, corresponding to the target effect site concentration of this drug delivered through a TCI system. Other drugs included propofol and cisatracurium.

The paradigm exploring the baroreflex collects information continuously recorded of the RR intervals and the changes in systolic arterial pressure, before and during noxious stimuli. The hypothesis is that this paradigm explores nociception as the group with smaller doses in remifentanil will have more cardiovascular reactions in response to noxious stimuli.

Eligibility criteria: Inclusion Criteria:

* ASA classification I-II
* undergoing lumbar surgery for discal hernia
* body mass index \<30 kg/m2

Exclusion Criteria:

* ASA classification III-IV
* cardiac history that precludes RR recording : atrial fibrillation, arterial hypertension, active cardiac pacing, chronic treatment with beta-blockers, alpha-blockers, calcium-blockers and angiotensin receptors inhibitors
* diabetes
* regular intake of cocaine, alcohol
* pregnancy

Primary outcomes:
measure: changes in the baroreflex in response to noxious stimuli
timeFrame: intraoperative
Secondary outcomes:
measure: perioperative requirements in anesthetic agents.
timeFrame: intraoperative
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Francois PAYEN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00079651: Montessori-Based Activities for Elderly Persons With Dementia
Official title: Programming for Dementia: Maximizing Abilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dementia
Keywords: Aged
Nursing Homes
Assisted Living Facilities
Lead sponsor: Menorah Park
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.

Detailed description: Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines.

This study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of dementia
* Living in or attending programs at participating sites

Exclusion Criteria:

* Medical conditions that would interfere with study participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: Mandel Adult Day Program
state: Ohio
city: Beachwood
country: United States
facility: Stone Gardens
state: Ohio
city: Cleveland
country: United States
facility: Eliza Bryant Village
state: Ohio
city: Cleveland
country: United States
facility: Jennings Center for Older Adults
state: Ohio
city: Lyndhurst
country: United States
facility: The Greens Adult Living Communities
state: Ohio
Study officials:
affiliation: Myers Research Institute
name: Cameron J. Camp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901251: Reproducibility Study of Over Active Bladder Symptom Score [OABSS]
Official title: Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: OABSS
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma China, Inc.
First posted: 2009-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic OAB patients having urgency episodes

Brief summary: The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.


Eligibility criteria: Inclusion Criteria:

* Symptoms OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * Number of micturition ≥8 times/day
  * Number of urgency episode in 3 days ≥1

Exclusion Criteria:

* Indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy

Primary outcomes:
measure: OABSS
timeFrame: Weeks of 0 and 2
Secondary outcomes:
measure: 3-day micturition diary
timeFrame: 2 times in 2-week interval
Other outcomes:
Locations:
city: Beijing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Wuhan
country: China
Study officials:
affiliation: Astellas Pharma China, Inc.
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02616354: Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
Official title: Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis
Keywords: Pharmacokinetics; pharmacodynamic; imipenem; sepsis
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2015-11-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.

Detailed description: Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.

Eligibility criteria: Inclusion Criteria:

* sepsis or severe sepsis or severe infections in the previous 48 hours
* treatment with imipenem/cilastatin (recommended by hospital microbiologists)
* expected duration of hospital stays in the ICU ≥ 72 h from recruitment
* recruited patients agreed to participate in this trial, and had set up a signed informed consent

Exclusion Criteria:

* with an allergy to carbapenems or with an adverse drug reaction to imipenem
* acute or chronic renal failure assessed by serum creatinine concentrations \> 280 μmol/L (or creatinine clearance \<20mL/min) or those requiring continuous renal replacement therapy
* drug or alcohol abuse
* Pregnant and lactant women
* patients near to death

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 9 months
Secondary outcomes:
measure: Plasma Concentration
timeFrame: up to 9 months
Other outcomes:
measure: PK/PD indices
timeFrame: up to 9 moths
Locations:
city: Nanjing
country: China
facility: Kang Xu
state: Jiangsu
Study officials:
References:
citation: Huang Y, Xu K, Zhan Y, Zha X, Liu S, Xie J, Liu L, Li Q, Shao H, Yang Y. Comparable Effect of Two-Step Versus Extended Infusions on the Pharmacokinetics of Imipenem in Patients with Sepsis and Septic Shock. Adv Ther. 2020 May;37(5):2246-2255. doi: 10.1007/s12325-020-01339-5. Epub 2020 Apr 10.
Clinical trial NCT03557554: Investigating the Preventative Ability of Massage Therapy on Paclitaxel Induced Peripheral Neuropathy
Official title: A Prospective Feasibility Study Investigating Primary Preventive Ability of Massage Therapy of Paclitaxel-Induced Peripheral Neuropathy in Patients With Newly Diagnosed Breast Cancer Scheduled to Undergo a Paclitaxel Based Regimen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Neuropathy
Neuropathy;Peripheral
Keywords: Massage
Breast Cancer
Neuropathy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Massage Therapy Foundation
First posted: 2018-06-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feasibility study to examine the preventative ability of massage therapy on paclitaxel induced peripheral neuropathy in breast cancer


Eligibility criteria: Inclusion Criteria:

1) Breast cancer diagnosis 2) Planning to receive chemotherapy treatment with paclitaxel in the curative setting (adjuvant or neoadjuvant) on a weekly or bi-weekly schedule

Exclusion Criteria:

1)Diabetes or other neurological disorder 2) Current or previous peripheral neuropathy 3)Previous treatment with paclitaxel 4)Active deep vein thrombosis (DVT) within last 12 months or history of untreated lower extremity DVT

Primary outcomes:
measure: Feasibility of Recruitment
timeFrame: 1 year
measure: Feasibility of Retention
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of paclitaxel induced peripheral neuropathy
timeFrame: 10 months
measure: Severity of paclitaxel induced peripheral neuropathy
timeFrame: 10 months
measure: Rate of pharmacological interventions
timeFrame: 10 months
measure: Paclitaxel dose modification
timeFrame: 4 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Bryan Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05741554: Low Grade Serous Ovarian Carcinoma and Uterine Involvement : Should Hysterectomy be the Rule
Official title: LOw Grade Serous Ovarian Carcinoma and Uterine Involvement : Should hYSTerectomy be the Rule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serous Ovarian Carcinoma
Low Grade Serous Ovarian Carcinoma
Keywords: Serous ovarian carcinoma
Low grade serous ovarian carcinoma
Fertility sparring surgery
Hysterectomy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated in hospices Civils de Lyon for a Low grade serous ovarian cancer between January 2000 and May 2022

Brief summary: Investigators studied a population of 28 low grade serous ovarian carcinoma treated in Hospices civils de Lyon between 2000 and 2022. The primary objective is to determinate the rate of myometrial involvement by the cancer at pathology examination. Then, investigators compared patients with or without myometrial involvement : survival parameters, predictive factors of myometrial involvement (age, CA 125 level, surgery characteristics, pathology characteristics).


Eligibility criteria: * Inclusion Criteria :

  * 18 years old or more
  * low grade serous ovarian cancer (MDACC classification)
  * Grade 1 serous ovarian carcinoma (Silverberg classification)
* Exclusion Criteria :

  * no sufficient data available
  * grade 2 and 3 serous ovarian carcinoma

Primary outcomes:
measure: Percentage of myometrial involvement
timeFrame: After pathology examination, average 2 to 3 weeks after cytoreductive surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices civils de Lyon
Study officials:
References:
Clinical trial NCT00944554: Relapse Prevention With Varenicline
Official title: Relapse Prevention With Varenicline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrence
Smoking Cessation
Substance-Related Disorders
Keywords: Relapse
Smoking Cessation
Substance Abuse
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-07-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking and will delay or prevent relapse compared to placebo.

Detailed description: In this study, the investigators plan to use an experimental model of a lapse, in which volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this study are to assess the impact of varenicline on the subjective and reinforcing effects of cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.

Eligibility criteria: Inclusion Criteria:

* Age 18-75 years old
* Reports smoking at least 10 cigarettes per day AND provides a urine sample that tests positive for nicotine metabolites at intake
* Contemplating a smoking cessation attempt in the near future
* Willing to engage in a practice quit attempt during which they will be asked to smoke on one occasion
* Able to give informed consent

Exclusion Criteria:

* Currently meets Diagnostic and Statistical Manual (DSM-IV) criteria for depression, bi-polar disorder, or schizophrenia
* History of attempted suicide or expresses any current suicidal ideation
* Pregnant, breast feeding, or planning to become pregnant within the next 3 months
* Reports desire for immediate treatment of tobacco/nicotine dependence
* Severe impairment of renal function indicated by Glomerular Filtration Rate (GFR) less than 30 ml/min calculated using the Cockcroft and Gault prediction method (plasma creatinine adjusted by weight, gender, and age)

Primary outcomes:
measure: Days to Relapse
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Behavioral Pharmacology Research Unit
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Maxine L Stitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000254: Isoflurane at Subanesthetic Concentrations - 6
Official title: Isoflurane at Subanesthetic Concentrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: isoflurane
general anesthetic
inhalant
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 10
Sex: MALE
Minimum age (years): 21
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pain response
timeFrame: Post inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anesthesiology, 1995, 83: A287