louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02976116: A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
Official title: Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC
Keywords: Fruquintinib
NSCLC
1st line
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 50
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: Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study

Detailed description: This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form.
* Age between 18 to 75 years old.
* Histologically or cytological documented stage IIIB/IV non-squamous non-small cell lung cancer patients who have never received systematic treatment for the late-stage disease.
* ECOG 0-1
* Patients must have measurable lesions

Exclusion Criteria:

* Prior systematic treatment for the advanced NSCLC
* Absolute neutrophil count (ANC) \< 1.5×10\^9 /L, or platelet count \< 100 ×10\^9/L, or hemoglobin \< 9 g/dL
* Total bilirubin \> 1 ULN; SGOT (AST), SGPT (ALT), \> 1.5 ULN; for patient with liver metastasis，AST or ALT \> 3 ULN
* Known HIV positive
* Hypersensitivity to either of the investigation drugs

Primary outcomes:
measure: tumor objective response rate
timeFrame: Patients will be followed until study completion, an average of 1 year
measure: Safety and tolerability
timeFrame: Each patient will be followed for 30 days after the last dose
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Patients will be followed until study completion, an average of 1 year
measure: Duration control rate (DCR)
timeFrame: Patients will be followed until study completion, an average of 1 year
measure: Time to response (TTR)
timeFrame: Patients will be followed until study completion, an average of 1 year
measure: Duration of response （DoR）
timeFrame: Patients will be followed until study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang University
Study officials:
affiliation: Hutchison MediPharma Ltd
name: Hongyan Yin
role: STUDY_DIRECTOR
References:
Clinical trial NCT00253916: Exercise in Men Receiving Radiation Therapy for Prostate Cancer.
Official title: Exercise in Men Receiving Radiation Therapy for Prostate Cancer: Effects on Fatigue, Toxicity, Body Composition, Muscular Fitness, Cardiorespiratory Fitness and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Trials Group
First posted: 2005-11-15
Enrollment: 121
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Androgen Deprivation Therapy is a commonly used treatment for men with Prostate Cancer. Unfortunately this can lead to functional decline, fatigue, increased body fatness, loss of lean body tissue and impaired QOL. Previous research has demonstrated the exercise can may reduce fatigue and improve QOL in men on ADT. This study will evaluate whether aerobic versus resistance exercise over a 24 week period of training will reduce morbidity and improve QOL in men receiving radiation plus or minus ADT with curative intent

Detailed description: A total of 220 men with a diagnosis of prostate cancer, scheduled to receive radiation will be recruited. The study is a parallel 3-group design with groups stratified for intended duration of ADT ( greater or less than 12 weeks) and random assignment to aerobic, resistance or Wait List control groups. The dependent variable of interest will fatigue measured at 24 weeks by the 13 item FACT-Fatigue. Dependent variables of secondary interest will be toxicity of radiation, body composition, muscular fitness, cardio-respiratory fitness, metabolic fitness, and prostate specific QOL. All exercise sessions will be performed 3 times per week at the Ottawa Hospital regional Cancer Center

Eligibility criteria: Inclusion Criteria:

* Prostate Cancer
* Radiation Therapy with curative Intent
* ADT

Exclusion Criteria:

* Contraindication to exercise
* Uncontrolled hypertension
* Uncontrolled Cardiac Disease
* Uncontrolled psychotic condition
* Unable to obtain informed consent

Primary outcomes:
measure: Fatigue- FACT F
timeFrame: 24 weeks
Secondary outcomes:
measure: Toxicity of Radiotherapy Body Composition Muscular Fitness Cardiorespiratory Fitness Metabolic Fitness Prostate Specific QOL
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital-Integrated Cancer Program
state: Ontario
Study officials:
affiliation: OHRI
name: Roanne Segal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Segal RJ, Reid RD, Courneya KS, Malone SC, Parliament MB, Scott CG, Venner PM, Quinney HA, Jones LW, D'Angelo ME, Wells GA. Resistance exercise in men receiving androgen deprivation therapy for prostate cancer. J Clin Oncol. 2003 May 1;21(9):1653-9. doi: 10.1200/JCO.2003.09.534.
Clinical trial NCT04931316: Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty
Official title: Incidence and Management of Ocular Hypertension Following Deep Anterior Lamellar Keratoplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unrecognized Condition
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with DALK

Brief summary: This is a retrospective case series study that included patients who performed deep anterior lamellar keratoplasty and presented with elevated intraocular pressure during follow up.

Detailed description: This is a retrospective case series study that included patients who performed deep anterior lamellar keratoplasty and presented with elevated intraocular pressure during follow up. Patients' demographic characteristics, medical, and ocular history will be recorded.

Inclusion criteria will include patients who were diagnosed with elevated intraocular pressure (IOP) after DALK surgery performed from 2018 to 2020 with follow up duration more than 6 months. Patients with less than 6 months of follow-up will be excluded from the study.

Patients' demographic characteristics, medical and ocular history will be recorded. Baseline complete ophthalmic examination was performed. It included best corrected visual acuity (BCVA) using Landolt C chart that was converted to log minimum angle of resolution (log MAR) for statistical analysis, slit lamp anterior segment examination (with attention to cornea, bulbar conjunctiva and AC), intraocular pressure measurement using rebound system (I care tonometer, Topcon, Canada), angle assessment and fundus examination using Goldman 3 mirror contact lens.

High IOP was defined as intraocular pressure more than 25 mmHg. Data will be collected with attention to appropriate management done either medical treatment or surgical intervention.

Eligibility criteria: Inclusion Criteria:

* patients who were diagnosed with elevated IOP after DALK surgery performed from 2018 to 2020

Exclusion Criteria:

* Patients with penetrating keratoplasty

Primary outcomes:
measure: Intraocular pressure values
timeFrame: this is a retrospective study . collection of data from patients records over 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlyia
Study officials:
affiliation: Mansoura University
name: AHMED El WEHEDY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Hatem El Awady, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: AYA HASHISH, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: AMGAD EL NOKRASHY, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01778816: Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Ruptures
Keywords: Achilles tendon, muscle volume, Achilles tendon length, force, ATRS, Hannover, AOFAS
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Hospital Fribourg, Switzerland
name: Hospital Liestal, Switzerland
First posted: 2013-01-29
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Age 20-65 years
* BMI \< 40
* no injury to leg
* no injury on contralateral leg

Brief summary: Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments.

Comparing force torque measurements, muscle volume and clinical scores.


Eligibility criteria: Inclusion Criteria:

* 20-65 years of age,
* a healthy, contralateral leg
* physiological, clinically determined alignment of the knee, foot and ankle
* no trauma to the healthy leg
* no neuromuscular impairments including muscle dystrophies
* no other posttraumatic injuries or osteoarthritis of the knee, foot or ankle of the affected leg.

Exclusion Criteria:

* re-rupture or reoperation of the Achilles tendon
* surgical site infection
* neuromuscular diseases including muscle dystrophies
* ankle valgus of more than 15° or ankle varus of more than 5°
* other known pathologies of the non-affected leg
* general MRI exclusion criteria (e.g. pacemaker, other metal not qualifying for an MRI, tattoos and claustrophobia)
* body mass index (BMI) of \> 40 kg/m2

Primary outcomes:
measure: Muscle Volume
timeFrame: at least 3 years after injury
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00667316: The Influence of Different Factors on Workers' Disability Due to Low Back Pain
Official title: Study to Identify the Influence of Different Factors on Workers' Disability Due to Low Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Keywords: low back pain
workers
disability
sick leave
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2008-04-28
Enrollment: 7300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers from companies and workers' health care organizations who are currently active.

Brief summary: The purpose of this study is to determine, in Spanish workers, the influence of different factors (personal, psychological, work related and clinical) on the risk of being on sick leave during the 18 months after baseline assessment, and on the duration of that sick leave.


Eligibility criteria: Inclusion Criteria:

* Subjects who get their checkups at participating health services
* With a labor contract that won't make it likely that they stop work before the next 18 months, for causes other than their health
* Who sign the informed consent form

Exclusion Criteria:

* Don't sign the informed consent form
* Inability to fill our the questionnaires
* Bedridden
* Rheumatologic inflammatory disease, cancer or fibromyalgia
* Suspicion of fibromyalgia
* Red flags for systemic disease
* Criteria for surgery
* Criteria for urgent referral to surgery

Primary outcomes:
measure: The influence of different factors on risk of sick leave for low back pain
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation,Palma de Mallorca, Spain
name: Mario Gestoso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo HR, Tanaka S, Cameron LL, Seligman PJ, Behrens VJ, Ger J, Wild DK, Putz-Anderson V. Back pain among workers in the United States: national estimates and workers at high risk. Am J Ind Med. 1995 Nov;28(5):591-602. doi: 10.1002/ajim.4700280504.
citation: Turner JA, Franklin G, Fulton-Kehoe D, Sheppard L, Wickizer TM, Wu R, Gluck JV, Egan K. Worker recovery expectations and fear-avoidance predict work disability in a population-based workers' compensation back pain sample. Spine (Phila Pa 1976). 2006 Mar 15;31(6):682-9. doi: 10.1097/01.brs.0000202762.88787.af.
citation: Kovacs FM, Muriel A, Castillo Sanchez MD, Medina JM, Royuela A; Spanish Back Pain Research Network. Fear avoidance beliefs influence duration of sick leave in Spanish low back pain patients. Spine (Phila Pa 1976). 2007 Jul 15;32(16):1761-6. doi: 10.1097/BRS.0b013e3180b9f5f7.
Clinical trial NCT02673216: Infection and Adverse Pregnancy Outcome
Official title: Infection and Adverse Pregnancy Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Birth
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
First posted: 2016-02-03
Enrollment: 2200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending for antenatal care or with spontaneous miscarriage

Brief summary: Miscarriage (spontaneous abortion, stillbirth, and preterm birth) is the most common adverse out-come of pregnancy and a significant proportion is caused by infection. The investigators aim to study vaginal specimens from 1200 pregnant women recruited before 14 weeks of gestation with follow-up at mid-term (week 19) as well as 300 women aborting spontaneously. Adverse pregnancy outcome will be correlated to the presence of bacterial vaginosis (BV) subclasses, to vaginal fluid inflammation markers, and to the presence of novel Chlamydia-like bacteria, in particular Waddlia chondrophila. Species specific quantitative PCR assays for BV-related bacteria as well as next-generation-sequencing will be applied on selected specimens with the aim to identify markers allowing for a personalised treatment approach.


Eligibility criteria: Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* None

Primary outcomes:
measure: Preterm birth <37 weeks of gestation
timeFrame: 37 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby University Hospital
Study officials:
affiliation: Statens Serum Institut
name: Jorgen S Jensen, DMedSci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03326024: The Ovarian Reserve and Laparoscopic Ovarian Drilling
Official title: Long Term Assessment of Ovarian Reserve After More Than Two Years of Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: OUPATIENT CLINICS OF women health hospital - Assiut university

Brief summary: Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome

Detailed description: Inclusion criteria:

Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared

Eligibility criteria: Inclusion Criteria:

* Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.

Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling

Exclusion Criteria:

1. Age \<19 or \> 35 years.
2. BMI \<19 or \> 35
3. patients refusing to participate in the study.
4. previous ovarian cystectomy.

Primary outcomes:
measure: Level of anti-mullerian hormone after laparoscopic ovarian drilling
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02405624: CPAP for Infantile Pompe Disease
Official title: Efficacy of Continuous Positive Airway Pressure of Treatment of Hypernasality of Children With Infantile Pompe Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pompe Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 3
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with infantile onset Pompe disease will be trained with continuous positive airway pressure to see if hypernasality can be improved.


Eligibility criteria: Inclusion Criteria:

1. confirm as Pompe disease
2. Age 4 and can speak 2-words sentence by order
3. mild to severe hypernasality
4. have regular speech therapy for 8 weeks or longer

Exclusion Criteria:

(1）hearing loss （2）congenital pharyngeal or laryngeal structure anomalies including cleft palate （3）cerebral palsy （4）recent otitis media effusion （5）very severe hypernasality （6）use non-invasive ventilator

Primary outcomes:
measure: decrease in hypernasality
timeFrame: 6 months
Secondary outcomes:
measure: increase in speech intelligibility
timeFrame: 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580524: Phasix Mesh Use in Complex Open Ventral Hernias Study
Official title: Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria:

* Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
* Unlikely to follow-up (live out of state, unable to be reached by phone or email)
* Non-English and non-Spanish speakers
* Pregnant or breast-feeding patients
* Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate

Primary outcomes:
measure: Major complication free
timeFrame: 2 years post-operative
Secondary outcomes:
measure: Surgical site occurrences
timeFrame: 90 days post-operative
measure: Clavien-Dindo complication grade
timeFrame: 90 days post-operative
measure: Hospital duration
timeFrame: 90 days post-operative
measure: Emergency room visits
timeFrame: 90 days post-operative
measure: Cost Analysis
timeFrame: 2 years
measure: Post-operative abdominal pain
timeFrame: Day of consent and post-operatively at 1 month, 1 year and 2 years
measure: Patient centered outcomes
timeFrame: Day of consent and post-operatively at 1 month, 1 year and 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital-Texas Medical Center
state: Texas
Study officials:
affiliation: UTHealth
name: Julie Holihan, MD
role: PRINCIPAL_INVESTIGATOR
References: