louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02083614: The Effect of Clamping the Indwelling Urethral Catheter Before Removal From Patients After Type III Radical Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The effect of clamping the indwelling urethral catheter before removal is an unsettled issue in clinical practice. No studies have done before in the patients with gynecologic cancers who received radical hysterectomy. We hypothesized that clamping the catheter would decrease the rate of recatheterization. In addition, the feeling of urination during clamping is correlated with lower rate of recatheterization after removal.


Eligibility criteria: Inclusion Criteria:

* patients receiving Piver III radical hysterectomy
* catheterization over 7 days

Exclusion Criteria:

* catheterization shorter than 7 days

Primary outcomes:
measure: rate of recatheterization
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Fulan Wang
Study officials:
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Clinical trial NCT03607214: Longterm Effects of Expectations on Mood
Official title: Longterm Effects of Expectations on Mood: An Experimental Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 90
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: BASIC_SCIENCE

Brief summary: The study tries to identify whether positive expectations, induced with a placebo nasal-spray, have short- and longterm effects on participant's mood.

Detailed description: Healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. They will randomly be assigned to the experimental group (taking the antidepressant which is in fact an active placebo) or the control group (not taking a placebo). Then participants watch a well established film sequence to induce sadness. Sadness is assessed before and after receiving the nasal spray and watching the film sequence. In the seven consecutive days the participant's mood is assessed each day, only the experimental group is taking the placebo each day. Afterwards participants will watch another sad film sequence and sadness will be assessed before and afterwards.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* fluent in German language

Exclusion Criteria:

* mental disorders
* allergic to capsaicin
* allergic to sesame oil
* intake of psychopharmacological drugs
* intake of illegal drugs in the last two weeks
* consumption of alcohol in the last twelve hours
* students in medicine, pharmacy, or psychology
* completed studies in medicine, pharmacy or psychology

Primary outcomes:
measure: Change in Positive and Negative Affect Schedule (PANAS-X)
timeFrame: Directly before and after watching the film sequence and on the following seven days, each assessment is taking four minutes, in total 36 minutes.
Secondary outcomes:
measure: Coping with stress and daily hassles, general mood and concentration.
timeFrame: On seven consecutive days, each assesment is taking 3-5 minutes, in total 21 to 35 minutes
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
state: Deutschland
Study officials:
affiliation: Philipps-Univeristy of Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02399514: Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema
Official title: Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Emphysema
Keywords: Sleep
emphysema
coils
lung volume reduction
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2015-03-26
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: BASIC_SCIENCE

Brief summary: Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema.

Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.

Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.

Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).


Eligibility criteria: Inclusion Criteria:

* Written consent
* RePneu Coil treatment according to clinical criteria

Exclusion Criteria:

* Pregnancy or nursing period
* Participation in another clinical trial within the last 4 weeks
* Incapable of giving consent
* Known OSA (AHI\>10)

Primary outcomes:
measure: Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
timeFrame: 3 times in one year
Secondary outcomes:
measure: Quality of life Questionnaire
timeFrame: 3 times in one year
Other outcomes:
measure: Activity: Physical activity measured by an actimeter over 7 days, before and 6 month after the coil treatment. The device is able to capture activity levels, sleep and wake times .
timeFrame: 1 week in baseline and 6 month after coil treatment
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Ambrock
state: NRW
Study officials:
affiliation: Helios Klinik Ambrock
name: Karl-Josef Franke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franke KJ, Domanski U, Schroder M, Nilius G. Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema. Sleep Breath. 2021 Jun;25(2):727-735. doi: 10.1007/s11325-020-02176-0. Epub 2020 Aug 26.
Clinical trial NCT02489214: Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
Official title: A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Keywords: donafenib
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2015-07-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

Detailed description: This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.

Eligibility criteria: Inclusion Criteria:

* All patients provided written, informed consent.
* Have histological or cytological documentation of gastric adenocarcinoma;
* Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
* Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of at least 3 months;
* Have adequate bone-marrow, liver, and renal function at the start of the trial.
* Prothrombin time international normalized ratio≤1.5；

Exclusion Criteria:

* Patients with brain metastases.
* Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
* Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease).

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 54 weeks
Secondary outcomes:
measure: Tumor response
timeFrame: 54 weeks
measure: Progression-free survival time
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Beijing
country: China
facility: Affiliated Cancer Center of Academy of Military Medical Sciences
Study officials:
affiliation: The affiliated hospital of Nanjing University Medical School
name: Bao Rui, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04967014: Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-Dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics After Oral Administration of HIP2101 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteer
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers

Detailed description: A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg to 90.0kg.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

* Gastrointestinal disorders (Crohn's disease or Acute/chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs.
* Aspartate aminotransferase and alanine aminotransferase exceed 2 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within 6 months before the first administration or who cannot abstain from consent to post-study visit.
* Heavy smoker (\>10 cigarettes/day).

Primary outcomes:
measure: Duration time with integrated gastric pH>4 / 24hr
timeFrame: 0-24hours
Secondary outcomes:
measure: Median 24 hr gastric pH
timeFrame: 0-24hours
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose
timeFrame: 0-24hours
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk University Hospital
Study officials:
References:
Clinical trial NCT05678114: Inositol Treatment in Different Type of PCOS Phenotype
Official title: The Effect of Inositol Treatment in Women With PCOS of Different Phenotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)


Eligibility criteria: Inclusion Criteria:

* women with PCOS of any phenotype

Exclusion Criteria:

* hormonal treatment (such as contraceptive pill)
* use of supplements containing myo-inositol
* severe co-morbidities

Primary outcomes:
measure: Regularization of the menstrual cycle
timeFrame: Change from baseline number of women with irregular menstrual cycle at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Alma Res
Study officials:
References:
Clinical trial NCT02386514: Emergency Department, Rapid Assessment for Sexually Transmitted Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: sexually transmitted infection
gonorrhea
chlamydia
presumptive therapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Cepheid
First posted: 2015-03-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients greater than 18 years of age presenting with a complaint that triggers the providing clinician to obtain a gonorrhea and chlamydia test by the traditional format.

Brief summary: To evaluate if a rapid urine Nucleic Acid Amplification Testing (NAAT) is non-inferior to the traditional swab NAAT for gonorrhea and chlamydia when performed in the Emergency Department.

Detailed description: All patients presenting to the Emergency Department during the study period who are tested for gonorrhea and chlamydia by the traditional swab NAAT will concurrently have their urine tested for gonorrhea and chlamydia using the Cepheid GeneXpert rapid NAAT. The result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional NAAT. Both the traditional and Cepheid GeneXpert rapid NAAT are FDA and CDC approved for evaluation of gonorrhea and chlamydia. However, the Cepheid GeneXpert rapid NAAT has not been prospectively validated in the Emergency Department setting. We intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional NAAT. The Cepheid GeneXpert rapid NAAT will not be used in patient care decisions.

Eligibility criteria: Inclusion Criteria:

* Clinical concern for gonorrhea and/or chlamydia infection
* Concurrent testing for gonorrhea and chlamydia using traditional NAAT assay

Exclusion Criteria:

* age \<18 years

Primary outcomes:
measure: Diagnosis of a chlamydia trachomatis or neisseria gonorrhoeae
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References:
citation: Wilson SP, Vohra T, Goldberg J, Price C, Calo S, Mahan M, Miller J. Reliable Rapid Assay for Gonorrhea and Chlamydia in the Emergency Department. J Emerg Med. 2017 Dec;53(6):890-895. doi: 10.1016/j.jemermed.2017.08.094. Epub 2017 Oct 23.
Clinical trial NCT02042014: Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan
Official title: An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension, QTI571, open label study
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment
Primary purpose: TREATMENT

Brief summary: To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Detailed description: This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Eligibility criteria: Inclusion Criteria:

* patient is receiving QTI571 for the treatment of Pulmonary Arterial Hypertension (PAH) and is currectly enrolled in a long-term extension study (CQTI571A2301E1) in Japan.
* Patient is currently benifitting form the treatment with QTI571 in the opinion of the investigator.

Exclusion Criteria:

* Patient has been permanently discontinued from QTI571 study treatment in the parent study.
* Concomitant use of oral vitamin K antagonist medication.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: Approximately 2.9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sendai-city
country: Japan
facility: Novartis Investigative Site
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Mitaka-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
References:
Clinical trial NCT05058014: Skeletal Metastasis Registry
Official title: The International Skeletal Metastasis Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Bone Tumor
Keywords: Biopsy-proven or clinically-obvious metastatic bone disease
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Murtha Cancer Center
name: Defense Health Programs with the U.S. Army Medical Research and Materiel Command
First posted: 2021-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic bone disease

Brief summary: This is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at Sibley Memorial Hospital and Johns Hopkins Medicine to an international registry hosted by the Swedish Regional Cancer Centrum in Stockholm, Sweden. This protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the International Skeletal Metastasis Registry (ISMR)

Detailed description: The registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. The models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Eligibility criteria: Inclusion Criteria:

* Adult patients, age 22 or older
* Biopsy-proven or clinically-obvious metastatic bone disease
* Symptomatic bone lesion requiring intervention o Including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 24 Months post surgery
Secondary outcomes:
measure: Reoperation or retreatment for any reason
timeFrame: Up to 24 24 months post surgery
measure: Time to reoperation or retreatment for any reason
timeFrame: Up to 24 months post surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Adam Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537614: Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2M UI colimycin either as an aerosol or after IV injection, the administration being separated by 5 to 10 days intervals


Eligibility criteria: Inclusion Criteria:

* Males and females, adults.
* Suffering from stable cystic fibrosis
* Colonized by P. aeruginosa
* Having given informed consent.
* Able to follow the protocol
* Having a social insurance

Exclusion Criteria:

* Renal insufficiency
* Allergy to colistin or polymixins
* Myasthenia
* Recent severe hemoptysis
* Liver cirrhosis and hepatic insufficiency
* Hypoalbuminemia
* Colonization by Burkholderia cepaea or Stenotrophomonas maltophilin
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
References: