louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00311935: Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia
Official title: Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Hernia
Inguinal
Groin
Laparoscopic
Open
Abdominal wall
Lead sponsor: Waitemata District Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Tyco Healthcare Group
First posted: 2006-04-06
Enrollment: 350
Sex: MALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.

Detailed description: Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.

Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.

Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.

Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.

Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.

Cost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.

Interim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.

Eligibility criteria: Inclusion Criteria:

* Male \<60yrs with primary inguinal hernia

Exclusion Criteria:

* Recurrent hernia
* Bilateral hernia
* Non-reducible/obstructed hernia
* Previous lower abdominal surgery/radiotherapy

Primary outcomes:
measure: Hernia recurrence rates at 2 years post surgery.
Secondary outcomes:
measure: Complication rates.
measure: Duration of procedure.
measure: Cost of equipment use.
measure: Rate of conversion to open procedure
measure: Length of hospital stay.
measure: Time to return to work and usual activities.
measure: Pain scores and analgesic use.
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Waitemata District Health Board
Study officials:
affiliation: Waitemata District Health Board
name: Michael Rodgers, MBCHB,FRACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02009735: Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Official title: Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enterovirus 71 and Influenza Virus
Keywords: Enterovirus 71 and Influenza Virus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza Virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators evaluate the performance of virosensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and case-fatality rate.

Detailed description: 1. Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have influenza-like illness or enterovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Virosensor - based real-time diagnosis.
2. Virosensor diagnosis： Virosensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-Enterovirus 71-virus) and its influenza virus antigen (or Enterovirus 71 antigen) present in patients'and normal samples.
3. Gold standard： viral isolation and RT-PCR

Eligibility criteria: Inclusion Criteria:

* The patients with confirmed or suspected infection.
* The healthy person without disease.

Exclusion Criteria:

* None

Primary outcomes:
measure: Influenza virus or Enterovirus 71 detection
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01580735: ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Official title: A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small-cell Lung Cancer
Keywords: NSCLC
c-MET
EGFR mutation-positive
gefitinib
erlotinib
EGFR-TKI resistance
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.


Eligibility criteria: Key Inclusion Criteria:

* Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
* Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Key Exclusion Criteria:

* Prior therapy with a c-Met inhibitor.
* Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
* Major surgical procedure within 4 weeks prior to randomization
* Known symptomatic brain metastases.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: To examine the progression free survival
timeFrame: 30 months
measure: To examine the overall survival
timeFrame: 30 months
measure: To examine the disease control rate
timeFrame: 30 months
measure: To estimate the safety profile
timeFrame: 30 months
Other outcomes:
Locations:
city: Arakawa-ku
country: Japan
state: Tokyo
Study officials:
References:
citation: Azuma K, Hirashima T, Yamamoto N, Okamoto I, Takahashi T, Nishio M, Hirata T, Kubota K, Kasahara K, Hida T, Yoshioka H, Nakanishi K, Akinaga S, Nishio K, Mitsudomi T, Nakagawa K. Phase II study of erlotinib plus tivantinib (ARQ 197) in patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer just after progression on EGFR-TKI, gefitinib or erlotinib. ESMO Open. 2016 Jul 21;1(4):e000063. doi: 10.1136/esmoopen-2016-000063. eCollection 2016.
Clinical trial NCT03857035: COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
Official title: A PROSPECTIVE SPLIT MOUTH CLINICAL STUDY: OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impacted Third Molar Tooth
Keywords: Trismus
piezosurgery
pain
swelling
Lead sponsor: Konya Necmettin Erbakan Üniversitesi
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.

Detailed description: The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients' comfort.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.

Exclusion Criteria:

* Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.

Primary outcomes:
measure: All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling.
timeFrame: Up to 1 week
Secondary outcomes:
measure: Pain will be assessed using a visual analogue scale.
timeFrame: Up to 1 week
measure: Trismus will be evaluated using a caliper at maximum mouth opening.
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University, Faculty of Dentistry
state: Karatay
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Karatay
Study officials:
affiliation: Necmettin Erbakan University
name: Dilek Menziletoglu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01036035: Effects of Novel Combinations of Tolterodine/Pilocarpine on Pharmacokinetics (PK) and Pharmacodynamics (PD) of Tolterodine in Healthy Subjects
Official title: Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Incontinence
Keywords: Tolterodine
Over active Bladder (OAB)
Incontinence
Lead sponsor: TheraVida, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).

Detailed description: Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy males, 18 - 45 years of age.
* BMI 20-30 m2.

Exclusion Criteria:

* Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
* Clinically significant ECG, vital signs and clinical laboratory indices.

Primary outcomes:
measure: Reductions in stimulated salivary flow (SSF)
timeFrame: From Baseline
Secondary outcomes:
measure: Determine the pharmacokinetics of tolterodine and the agonist.
timeFrame: From Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Queensland Institute for Medical Research
name: Joanne Marjason
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04932135: Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Official title: Resting Heart Rate Monitoring for Optimized Treatment and Surveillance of Hyperthyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperthyroidism
Graves Disease
Keywords: Heart rate; Pulse rate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Graves' disease at the beginning and after cessation of anti-thyroid drug treatment

Brief summary: The investigators want to investigate if a continuous heart rate monitoring with a wrist worn fitnesstracker can be useful in the treatment and surveillance of patients suffering from Graves' disease.The aim of our research project is two-fold: First, to evaluate the use of continuous heart rate monitoring as a potential substitute for hormone measurements during treatment of hyperthyroidism. Second, to use continuous heart rate monitoring as a tool for early detection of relapse after discontinuation of antithyroid drugs.


Eligibility criteria: Inclusion Criteria:

All participants:

* BMI 17 to 35 kg/m2
* Diagnosis of Graves' disease (matching one of the following criteria: elevated TRAb and/or ultrasonography and functional imaging consistent with Graves' disease)
* In possession of a smart phone
* Able to use a wearable device and willing to regularly upload their biometric data
* Informed consent as documented by signature (Appendix Informed Consent Form)

Group "treatment":

* TSH \< 0.2 mIU/l and
* fT4 \> 25 pM or fT3 \> 8 pM
* ATD planned, additional treatment with propranolol allowed

Group "surveillance":

* TSH within the reference range between 0.3 and 4.5 mlU/l
* Cessation of ATD is planned within the next 2-4 weeks

Exclusion Criteria:

* Chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol)
* Treatment with amiodarone
* Pacemaker with continuous stimulation.
* Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
* Abuse of alcohol or illicit drugs
* Allergic to nickel or silicone
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Primary outcomes:
measure: resting heart rate
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References:
Clinical trial NCT00426335: Evaluation of Group CBT Programme With Breast Cancer Patients
Official title: An Evaluation of a Group CBT Programme for Women With Primary Breast Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast
cancer
cognitive behaviour therapy
psychological
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 78 participants in total including 39 female RMH patients with primary breast cancer and are post adjuvant treatment.

Brief summary: The purpose of this study is to examine whether a group CBT intervention is effective in reducing psychological distress in women with primary breast cancer.

Detailed description: The diagnosis and treatment of cancer is associated with high levels of psychological distress, which can be long-term in duration. The end of adjuvant therapy can be a time which patients find anxiety provoking; as concerns of recurrence and how to return to life after treatment often arise at this juncture.

Cognitive behaviour therapy has demonstrated efficacy in reducing anxiety and depression in people with cancer on a 1:1 basis. The CBT model has been shown to be significantly more beneficial than supportive counselling. Therapy delivered in groups is considered desirable because of its cost effectiveness, and its potential to confer additional benefits in terms of peer support, reduced isolation and modelling of adaptive strategies by other group members.

No studies have looked at the changes in participants health beliefs and beliefs about their ability to copy (self-efficacy) with stress and tolerance of uncertainty following group CBT and the relationship with psychological distress.

The aim of this study is to evaluate a GCBT programme intervention against a waiting list control and to examine its effects on health beliefs, self-efficacy, coping, tolerance of uncertainty and psychological distress in women with early diagnosed breast cancer.

Eligibility criteria: Inclusion Criteria:

* Female
* Primary breast cancer
* post adjuvant treatment

Exclusion Criteria:

* Women with metastatic disease
* Severe cognitive impairment (will not be able to obtain consent or participant in group intervention)
* Inability to complete a questionnaire

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Maggie Watson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04127435: High Dose Rate Interstitial Brachytherapy With Three Dimensional Printing Template for Recurrent Gynecologic Tumors
Official title: Clinical Study on Pelvic Recurrence of Gynecologic Tumors After External Irradiation by Three Dimensional Printing Personalized Template Assisted With 192Ir High Dose Rate Interstitial Brachytherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed pelvic recurrence of cervical cancer.

Brief summary: This is a single-center study.Eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .

Detailed description: The results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192Ir high dose rate interorganizational braided therapy were statistically analyzed .

Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed pelvic recurrence of cervical cancer.
* Age ≥ 18 years and ≤ 75 years.
* Previous accept pelvic radiotherapy;
* Karnofsky ≥60；
* Patients reject or cannot tolerate surgery;
* Received 192Ir high dose rate intertissue salvage therapy;
* Ultrasound guidance or computed tomography guidance;
* Regular review and follow-up.

Exclusion Criteria:

* Patients participated in clinical trials of other drugs within four weeks;
* The patient had a previous history of bleeding, and any bleeding event with severity rating of CTCAE5.0 or above occurred within 4 weeks prior to screening;
* There are any puncture taboos.
* Patients with severe cardiovascular and cerebrovascular diseases.
* Unable to treat as planned.
* Patients lack major indicators and cannot participate in post-treatment review and follow-up.

Primary outcomes:
measure: Local Progression Free Survival
timeFrame: 2 years
measure: Tumor Response Rate
timeFrame: three months
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Safety and Tolerability
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Study Principal Investigator
name: Ping Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706635: Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis
Official title: Impact of Enhanced Information Provision by Using a Mobile App on Subjective Information Level As the Basis for Shared-decision Making and Patient-reported Outcome Measures (PROMs) in Patients with Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis Disease
Keywords: aortic stenosis
mobile app
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 250
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 aim of this trial is to evaluate if an enhanced information by using a mobile App can increase subjective information level in patients with severe aortic stenosis and may therefore improve patient-reported outcomes.


Eligibility criteria: Inclusion Criteria:

* severe aortic valve stenosis
* planned aortic valve replacement (TAVI)
* Patient is willing and able to complete the surveys in German language
* Written informed consent by the trial subject

Exclusion Criteria:

- Language barrier

Primary outcomes:
measure: Subjective information level (EORTC QOL-INFO 25 questionnaire)
timeFrame: From enrollment to the end of FU at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
Study officials:
References: