louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00269763: Clinical Use and Safety of the Fentanyl Transdermal Therapeutic System (TTS) in the Management of Pain in Patients With Cancer
Official title: The Clinical Use and Safety of TTS (Fentanyl) in the Management of Pain in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: patch
pain
fentanyl
narcotic
Cancer
Lead sponsor: Alza Corporation, DE, USA
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.

Detailed description: This is a single-arm, non-randomized, open-label, multi-center trial to assess the safety and clinical utility of the fentanyl Transdermal Therapeutic System (TTS) for the treatment of pain in patients with cancer. Patients requiring narcotics for pain management are converted from conventional analgesics to oral morphine, and titrated to a stable dose prior to the initiation of fentanyl TTS. The stabilized morphine dose provides the basis for the calculation of the equi-analgesic dose of fentanyl TTS based on established analgesic potency ratios. Patients replace the fentanyl TTS patch every 3 days. Immediate-release morphine is available as rescue medication for breakthrough pain. The adequacy of analgesia, use of morphine rescue medication, and routine safety evaluations are obtained at scheduled intervals throughout the trial.

fentanyl patch

Eligibility criteria: Inclusion Criteria:

* Patients currently taking narcotic analgesics for relief of cancer pain
* Able to communicate effectively
* Living with a constant caretaker
* Who have achieved a stabilized morphine dose that provides adequate pain control

Exclusion Criteria:

* Patients with a life expectancy of less than 30 days
* Having history of carbon dioxide (CO2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression)
* Has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain
* Has a mental or psychiatric disease
* If female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception

Primary outcomes:
measure: Assessment of pain relief; Rescue medication usage
Secondary outcomes:
measure: Incidence and severity of adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Alza Corporation, DE, USA
name: Alza Corporation Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06628063: Examination of Pregnant Women in Third Trimester by Ultrasound to Detect Any Congenital Anomalies
Official title: Second and Third Trimestric Scan Versus Second Trimestric Scan Alone in Detection of Congenital Fetal Anomalies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Anomaly
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: normal pregnancies attending outpatient clinic in Sohag university Hospital

Brief summary: this study aims to help the physicians to evaluate the practice of routine Third trimestric fetal scan whether it should be routinely performed to all cases including those with low risk singleton pregnancies.

Detailed description: The third-trimester ultrasound scan ,traditionally performed at 32-34weeks, can assess fetal viability , presentation, anatomy , growth, amniotic fluid volume, placental location and fetoplacental Doppler.

There are multiple other indications that can trigger a third-trimester scan, including antepartum bleeding , reduced fetal movements, preterm rupture of the membranes and suspected abnormalities of fetal growth based on physical examination. In addition, ultrasound may be used to guide other procedures in the third trimester, such as external cephalic version. However, as yet, there is no convincing evidence that routine universal third-trimester ultrasound examination in a low-risk population improves either perinatal or maternal outcome especially in low socioeconomic countries with limited resources

Eligibility criteria: Inclusion Criteria:

* Singleton healthy pregnancy at second and third trimesters of pregnancy.
* Fetuses were considered normal based on second trimestric fetal scan in our feto-maternal unit

Exclusion Criteria:

* Exclusion criteria were patients with multiple gestations, maternal medical complications as Preeclampsia, DM ,Cardiac or renal diseases , or fetal abnormalities

Primary outcomes:
measure: newly discovered congenital anomaly at third trimester of pregnancy
timeFrame: from October 2024 to April 2025
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: sohag university , Department of obstetric and gynecology
name: Mahmoud desoky Desoky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06696963: Impact of TTC Following Neoadjuvant Chemotherapy on the Prognosis of LAGC
Official title: Impact of Time to Initiation of Postoperative Adjuvant Chemotherapy Following Neoadjuvant Chemotherapy on the Prognosis of Locally Advanced Gastric Cancer: a Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Gastric cancer
Neoadjuvant chemotherapy
Adjuvant chemotherapy
Time to chemotherapy
survival
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally Advnced Gastric Cancer who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021

Brief summary: he present study retrospectively analyzed the clinicopathological data of 524 patients diagnosed with LAGC who underwent D2 radical gastrectomy after NACT between January 2010 and December 2021 at 2 centers. This study was conducted in accordance with the ethical principles outlined in the World Medical Association's Declaration of Helsinki. Informed consent was obtained from all patients and their legal guardians. All procedures were approved by the institutional review board.

Detailed description: This is a retrospective, multicenter study.

Eligibility criteria: Inclusion Criteria:

* (1) Locally advanced gastric cancer with preoperative clinical staging of cT2-4NxM0 before neoadjuvant chemotherapy. (2) No history of other malignant tumors. (3) No evidence of distant metastasis or invasion of adjacent organs. (4) Underwent gastrectomy after receiving neoadjuvant chemotherapy.

Exclusion Criteria:

* (1) History of prior gastrectomy. (2) History of acute cardiovascular diseases (such as cerebral or coronary artery injuries) within the past three months. (3) Emergency surgery. (4) Did not undergo postoperative adjuvant chemotherapy. (5) Lack of specific information regarding chemotherapy regimens. (6) Loss to follow-up.

Primary outcomes:
measure: 3-year all-caused mortality, 3-year Gastric-Cancer Specific Motality
timeFrame: 3 years or 36 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT01299363: Dilators for Dyspareunia Prevention
Official title: Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Dyspareunia
Keywords: Prolapse
Pain with intercourse
Dyspareunia
Post operative pain
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: American College of Obstetricians and Gynecologists
First posted: 2011-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.


Eligibility criteria: Inclusion Criteria:

* Women who undergo pelvic organ prolapse surgery with a posterior repair
* Age ≥18 years
* Sexually active with heterosexual vaginal intercourse
* English speaking
* Available for 6 month follow up
* Able to complete study questionnaires
* Able to use dilators

Exclusion Criteria:

* Significant baseline dyspareunia
* Pregnancy by self-report or positive pregnancy test
* Prior pelvic radiation therapy
* Active pelvic infection, herpes, candidiasis

Primary outcomes:
measure: To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy).
timeFrame: 6 months
Secondary outcomes:
measure: Sexual function
timeFrame: 6 month
measure: Physical exam
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
References:
citation: Antosh DD, Gutman RE, Park AJ, Sokol AI, Peterson JL, Kingsberg SA, Iglesia CB. Vaginal dilators for prevention of dyspareunia after prolapse surgery: a randomized controlled trial. Obstet Gynecol. 2013 Jun;121(6):1273-1280. doi: 10.1097/AOG.0b013e3182932ce2.
Clinical trial NCT00002363: The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Official title: Study of the Safety and Effects of Two Doses of SPC3, Administered Daily Intravenously in HIV-1 Seropositive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.

Detailed description: The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening.

Patients must have:

* HIV seropositivity for at least 6 months.
* CD4 \>= 100 cells/mm3.
* HIV RNA PCR (Amplicor) \> 10,000 copies/ml.
* No significant active opportunistic infection or tumor at study entry.

FDA DISCLAIMER:

* The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person.

Prior Medication:

Allowed:

* Prior antiretrovirals.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

Inability to communicate with investigator or deemed likely to be noncompliant on study.

Concurrent Medication:

Excluded:

* Any drug that may interact with SPC3 (e.g., suramin).

Patients with the following prior condition are excluded:

History of relevant drug hypersensitivity.

Prior Medication:

Excluded:

* Investigational drug within the past 4 weeks.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown Univ School of Medicine
state: Rhode Island
Study officials:
References:
Clinical trial NCT03635463: Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency
Official title: Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Class II Division 1 Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Detailed description: in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Eligibility criteria: Inclusion Criteria:

1. Skeletal Class II relationship (ANB \> 4°).
2. Mandibular retrognathy (SNB \< 78°).
3. Overjet ≥ 5 mm.
4. Minimal crowding in dental arches (≤4 mm).
5. Class II molar relation.
6. Growing female patients.
7. Patients with CMV3 maturation stage of the cervical verbrae.

Exclusion Criteria:

1. No history of orthodontic treatment either prior to or during functional Appliance therapy.
2. Posterior cross bites or severe maxillary transverse deficiency.
3. Severe facial asymmetry determined by clinical or radiographical examination.
4. Poor oral hygiene.
5. Systemic diseases that may affect the orthodontic treatment results.
6. Patients past their peak growth spurt.

Primary outcomes:
measure: enhancing mandibular skeletal growth
timeFrame: 9 months
Secondary outcomes:
measure: dentoalveolar changes
timeFrame: 9 months
measure: Improvement of soft tissue profile
timeFrame: 9 months
measure: Patient's compliance
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00000363: Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Keywords: Antibiotics
Adrenal Cortex Hormones
Histamine H1 Antagonists
Infant
Otitis Media
Lead sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sponsor class: NIH
First posted: 1999-11-03
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.


Eligibility criteria: Inclusion Criteria:

* Have had two documented prior episodes of acute otitis media.
* Have no current middle ear effusion (fluid).

Exclusion Criteria:

* Have chronic otitis media.
* Have acute otitis media in addition to chronic otitis media.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Univ of Texas Med Branch Children's Hosp
state: Texas
Study officials:
name: Dr. Tasnee Chonmaitree
role: STUDY_CHAIR
References:
citation: Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. doi: 10.1067/S0022-3476(03)00293-2.
citation: McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30. doi: 10.1016/s0165-5876(02)00372-5.
Clinical trial NCT06442163: Average Volume-assured Pressure Support as Rescue Therapy in Obesity Hypoventilation Syndrome
Official title: Outcome Measures of Auto-titrating Average Volume-assured Pressure Support (AVAPS) as Rescue Therapy After CPAP Titration Failure in Patients With Obesity Hypoventilation Syndrome: Adherence and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Hypoventilation Syndrome (OHS)
Keywords: ventilation, Obesity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-04
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: SUPPORTIVE_CARE

Brief summary: It remains unclear whether CPAP therapy should be prescribed if significant hypoxemia persists during CPAP titration, despite optimization of upper airway obstructive events, if maximum CPAP pressure is reached.

The goal was to examine the effects of 6 months of home AVAPS therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed CPAP titration due to persistent hypoxemia.

Detailed description: Obesity hypoventilation syndrome (OHS) is one of the leading indications of home non-invasive ventilation (NIV) initiation. In patients with OHS, NIV improves daytime vigilance, decreases PaCO2, improves sleep quality, and improves physical activity.

Thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (AVAPS-AE) ventilation on objective sleep quality and adherence to therapy in stable patients with OHS who failed CPAP titration.

Eligibility criteria: Inclusion Criteria:

* All Clinically stable OHS patients with

  * Body mass index of 30 kg/m2 ,
  * Daytime hypercapnia (PaCO2 \&gt;45 mm Hg) who had failed to respond to CPAP therapy
  * had no other cause for their chronic respiratory failure and were naive to any PAP therapy.

Exclusion Criteria:

* Patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections)
* Patients who had been intubated during the last 3 months
* Patients who had received any other form of ventilatory support before hospital admission were also excluded from the study

Primary outcomes:
measure: To compare the initial diagnostic, and therapeutic sleep study parameters using either CPAP and (AVAPS-AE) titration study in patients with OHS.
timeFrame: 1 week
Secondary outcomes:
measure: The effects of 6 month of home AVAPS- AE therapy on patient adherence and sleep quality in OHS patients who failed CPAP titration due to persistent hypoxemia.
timeFrame: at 1 ,3,6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University Hospital
state: Assuit
Study officials:
affiliation: Assiut University
name: Doaa Magdy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927263: A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
Official title: A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis -A Double-blind, Active Drug-controlled Study and Long-term Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Nichi-Iko Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-22
Enrollment: 242
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate similarity between NI-071 and infliximab(the comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately responding to Methotrexate.


Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of RA as defined by the American College Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria (ACR/EULAR 2010)
2. Patients who received MTX treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit

Exclusion Criteria:

1. Patients with a following past History or concomitant diseases

   * Other Connective tissue disorders which may interfere the efficacy assessment
   * Chronic or recurrent infectious disease
   * Demyelinating disease
   * Congestive heart failure
   * lymphoproliferative disorder or myelodysplastic syndrome
   * Malignancy
   * Interstitial lung disease
2. Patients with active or latent tuberculosis or history of tuberculosis

Primary outcomes:
measure: Efficacy : Changes in DAS28-ESR
timeFrame: week 0 to week 14
Secondary outcomes:
measure: Efficacy : Changes in DAS28
timeFrame: week 0 to week 54
measure: Efficacy : Changes in ACR20, 50, 70
timeFrame: week 0 to week 54
measure: Efficacy : Changes in ACR core-set
timeFrame: week 0 to week 54
measure: Safety : Long term safety (Adverse Events, Immunogenicity, etc.)
timeFrame: to 54 weeks
Other outcomes:
Locations:
city: Sendai-Shi
country: Japan
facility: NichiIko Investigational Site
Study officials:
References: