louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00756743: Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers
Official title: A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-04802540 multiple dose safety study
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Detailed description: Evaluation of safety and pharmacokinetics

Eligibility criteria: Inclusion Criteria:

* Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
* Body mass index in the range of 18 to 30 kg/m2 and body weight\>45 kg.
* Healthy as determined by the investigator on the basis of screening evaluation.

Exclusion Criteria:

* Use of prescription or nonprescription drugs
* Any condition possibly affecting drug absorption

Primary outcomes:
measure: Adverse events
timeFrame: 12 days
measure: Safety assessments: vital signs, ECG, physical examination, laboratory tests
timeFrame: 12 days
measure: Pharmacokinetics
timeFrame: 12 days
Secondary outcomes:
measure: No secondary outcomes measures.
timeFrame: Timeframe N/A
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01365143: Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Prostatic Neoplasms
Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Deemed a surgical candidate for a bilateral nerve bundle preservation
* Potent
* Continent of urine
* Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
* Age \>18

Exclusion Criteria:

* Previous treatment of prostate cancer (radiation, hormones, etc.)

Primary outcomes:
measure: Trifecta
timeFrame: at 2 years
Secondary outcomes:
measure: Continence
timeFrame: at 3, 12, and 24 months
measure: Potency
timeFrame: at 3, 12, and 24 months
measure: Free from biochemical recurrence
timeFrame: at 3, 12, and 24 months
measure: Acute complications
timeFrame: Within 30 days of surgery
measure: Long-term complication
timeFrame: >30 days
measure: Estimated blood loss
timeFrame: Participants will be followed for the duration of the operation, an expected average of 3 hours
measure: Operative time
timeFrame: Participants will be followed for the duration of the operation, an expected average of 3 hours
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT04992143: TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC
Official title: The Efficacy and Safety of TACE Combined With Tilelizumab and Sorafenib in Treating BCLC Stage C HCC Patients: a Single-center, Single-arm, Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: BCLC Stage C Hepatocellular Carcinoma
Keywords: BCLC Stage C
Hepatocellular Carcinoma
Transarterial Chemoembolization
Sorafenib
Tilelizumab
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2021-08-05
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: According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Child-Pugh score≤ 7
* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2019
* the primary HCC being in BCLC C stage according to NCCN guideline
* No previous systemic therapy for HCC

Exclusion Criteria:

* Diffuse HCC
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy

Primary outcomes:
measure: 1-year survival rate
timeFrame: at 1 year after enrolled
Secondary outcomes:
measure: Time to progression
timeFrame: at 12 weeks and up to 2 years after enrolled
measure: Progression free survival
timeFrame: at 12 weeks and up to 2 years after enrolled
measure: Objective response rate
timeFrame: at 12 weeks and up to 2 years after enrolled
measure: Disease control rate
timeFrame: at 12 weeks and up to 2 years after enrolled
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Jun-hui Sun, MD,PH.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01141790: Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Official title: Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consciousness Disorders
Communication
Intensive Care
Keywords: Glasgow Coma Scale
Glasgow Outcome Scale
Ethics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: (1) To check music or voice message influence on vital signs, facial expressions or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To evaluate the relation between the response and the score of Glasgow Outcome Scale.


Eligibility criteria: Inclusion Criteria:

* To be in disorder of consciousness;
* To be evaluated according to one of the Scales and to have a score in the study range: in physiological comas, score between 3 to 8 Glasgow Coma Scale (GCS); in induced coma, one of the last two scores of Ramsay Sedation Scale (RSS), R5 or R6;
* To have hearing function preserved according to family;
* To have written consent from the family or responsible party for the patient's participation

Exclusion Criteria:

* Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HCFMUSP - Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References:
Clinical trial NCT02454790: Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer
Official title: Standard Follow-up Program (SFP) for Esophageal Cancer Patients Treated With Radiotherapy or Chemoradiation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Keywords: Acute toxicity
Late toxicity
Prediction models
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 10000
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: Patients with esophageal cancer receiving a radiotherapy dose \> 40 Gy

Brief summary: Motive:

In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients.

Goal:

To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life.

A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with esophageal cancer
* Patients receiving a radiotherapy dose \> 40 Gy

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria

Primary outcomes:
measure: Acute toxicity
timeFrame: Highest during and within 2 weeks after last day of radiation therapy
measure: Late toxicity
timeFrame: Highest within one year after last day of radiation therapy
Secondary outcomes:
measure: Overall survival
timeFrame: At 1,2,3,4 and 5 years after first day of radiation therapy
measure: Loco-regional tumor control
timeFrame: At 1,2,3,4 and 5 years after first day of radiation therapy
Other outcomes:
measure: Patient-rated symptoms and Quality-of-Life
timeFrame: Before first day of radiation therapy and at 3,6,12,24,36,48,60 months after first day of radiation therapy
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT02524990: Simplified Medical Abortion Follow-Up
Official title: Simplified Medical Abortion Follow-Up Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abortion
Pregnancy Tests
Keywords: Medical abortion
pregnancy tests
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 53
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.


Eligibility criteria: Inclusion Criteria:

* She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
* She is willing to use the semiquantitative pregnancy test at home;
* She is wiling and able to comply with the study procedures;
* She speaks and reads English;
* She has signed the study informed consent form.

Primary outcomes:
measure: Patients' compliance in performing the semiquantitative pregnancy test and reporting results
timeFrame: Within 2 weeks after medical abortion
Secondary outcomes:
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: Carafem Health Center
state: Maryland
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD,MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03375190: A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
Official title: A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers.

Detailed description: This study will involve the placement of subcutaneous peripheral nerve catheters in healthy volunteers utilizing 6 different securement techniques. The primary outcome is the force required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the catheter dressing.

Eligibility criteria: Inclusion Criteria:

* Age 18-85 years
* American Society of Anesthesiologists Physical Status I-II
* BMI 18-30 kg/m2

Exclusion Criteria:

* Inability to cooperate with or understand protocol
* Inability to understand or speak English
* Allergy to adhesive or tape
* Local infection in lower extremities
* Neurologic deficit or disorder
* Anticoagulation

Primary outcomes:
measure: Force required to dislodge catheter by 1 centimeter
timeFrame: 1 study day
Secondary outcomes:
measure: Force required to disrupt catheter dressing
timeFrame: 1 study day
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Michael Shaughnessy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar AH, MacLeod DB, Kumar KR, Ray N, Gadsden J. Comparison of perineural catheter fixation methods: a volunteer study. Anaesthesia. 2021 May;76(5):714-716. doi: 10.1111/anae.15372. Epub 2021 Jan 6. No abstract available.
Clinical trial NCT05104190: Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets
Official title: Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Orthodontic Appliance Complication
Keywords: Orthodontic pain
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 148
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of this study was to evaluate different methods of controlling pain during debonding

Detailed description: Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were divided into two groups, 55 patients in each group, based on method of controlling pain during debonding. To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.

Eligibility criteria: Inclusion Criteria:

Patients between 13-21 years of age who can understand, assess, and answer the questionnaires. 2) No missing teeth except extracted premolars 3) Undergoing upper and lower fixed orthodontic treatment with Roth prescription 0.022-inch metal brackets . 4) Finishing arch wires present for at least two months

Exclusion Criteria:

1. The subjects with a previous history of facial or mandibular surgery or syndromes affecting the jaw or face .
2. Patient with history of jaw sugeries.
3. Patients with history of taking medicine periodically or in the last 24 hours (eg, painkillers, corticosteroids, and antiflu drugs),
4. Patient with history of debonded brackets and replacement.
5. Patient with history of tooth transplantation or microscrews placement.

Primary outcomes:
measure: Measurement of pain
timeFrame: Immediatey after debonding
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Kashif Iqbal
state: Sindh
Study officials:
affiliation: AFID
name: Zahra Khalid, BDS, FCPSII
role: STUDY_CHAIR
References:
Clinical trial NCT02878590: Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Official title: Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: InnoMed Healthscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: RVW Clinical Consulting
First posted: 2016-08-25
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, non-randomized, open label study

Detailed description: This study is a prospective, non-randomized, open label, single-center clinical study for the BONGO NASAL device for the treatment of obstructive sleep apnea. The study consists of two in laboratory polysomnographic studies and a one two week in home period.

Eligibility criteria: Inclusion Criteria:

* • Capacity and willingness to sign informed consent

  * ≥ 21 years of age
  * Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI ≤ 30) within 12 months of the screening visit with the 3% hypopnea criteria
  * Able to tolerate using the device during a day time trial/acclimation
  * Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

Exclusion Criteria:

* • Nasal deformities

  * Severe nasal allergies
  * Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
  * Co-morbid sleep disorders
  * Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
  * Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
  * Full Face Mask user
  * Mouth breather
  * Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)

Primary outcomes:
measure: Change in Apnea-Hypopnea Index (AHI)
timeFrame: At Diagnostic Baseline PSG and at Final Treatment PSG with the device
Secondary outcomes:
Other outcomes:
Locations:
city: Alameda
country: United States
facility: California Center for Sleep Disorders
state: California
Study officials:
affiliation: California Center for Sleep Disorders
name: jerrold kram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02508090: Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin
Official title: Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Santaris Pharma A/S
First posted: 2015-07-24
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll null responders with CHC genotype 1 virus infection who have participated in Study SPC3649-207.

Brief summary: Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.


Eligibility criteria: Inclusion Criteria:

* Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection

Exclusion Criteria:

* Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 36 months
measure: Incidence of sustained virologic response (SVR)
timeFrame: 48 weeks after end of treatment (EOT)
measure: Change from Baseline in HCV ribonucleic acid (RNA) level
timeFrame: Up to 36 months
measure: Incidence of HCV resistance
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: