louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00037362: Measuring Sensitivity to Nonignorability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2002-05-17
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop a new statistical index that measures sensitivity to non-ignorability (index of sensitivity to nonignorability, or ISNI) for model-based inferences.

Detailed description: BACKGROUND:

Despite a considerable number of recent developments, missing data and associated methodology continues to be an important topic of research in biostatistics, medicine and public health. As investigators begin to understand the limitations of model-based inferences under the assumption of non-ignorable missingness, recent attention has turned to the formulation and implementation of sensitivity analyses. Having a general-purpose index to assess sensitivity to departures from ignorability would be extremely useful to researchers in a variety of fields in the health sciences. This is especially true if the index is relatively easy to compute and interpret.

DESIGN NARRATIVE:

It would be useful to have a general, easily computed diagnostic that characterizes data sets with respect to their potential for sensitivity to nonignorability. The investigators have developed a diagnostic that measures the effect of small perturbations from ignorability on coefficient estimates in the univariate linear model with missing observations.They will extend their analysis in a number of directions: i) They will develop a general class of diagnostics for Bayes and direct- likelihood inferences, and demonstrate its application to a number of important special cases. ii) They will develop an analogous theory for sensitivity to nonignorability in frequentist estimation and testing. iii) They will develop a general form of the diagnostic for the coarse-date model, a generalization of missing data that includes censoring and rounding as special cases. iv) They will analyze a number of real- world data sets that represent important cases where nonignorability is of interest, including dropout in longitudinal data, censored survival data, and cross-over in clinical trials.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University Health Sciences
name: Daniel Heitjan
References:
citation: Ma G, Troxel AB, Heitjan DF. An index of local sensitivity to nonignorable drop-out in longitudinal modelling. Stat Med. 2005 Jul 30;24(14):2129-50. doi: 10.1002/sim.2107.
Clinical trial NCT03291262: Survival Outcomes of Ovarian Malignancies in Chinese Population
Official title: Survival Outcomes of Ovarian Malignancies in Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Neoplasms
Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 5000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with definite diagnosis of primary ovarian malignancies confirmed by pathologic examinations.

Brief summary: This study aims to determine survival outcomes (overall survival and progression-free survival) of primary ovarian malignancies in China and relevant risk factors in a prospective cohort study.


Eligibility criteria: Inclusion Criteria:

* Primary ovarian malignancies.

Exclusion Criteria:

* Metastatic malignancies to ovaries.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: China/Beiing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun T, Li L. A cohort study of hypersensitivity reaction in patients with epithelial ovarian cancer treated with carboplatin. Int J Gynecol Cancer. 2019 Mar;29(3):566-571. doi: 10.1136/ijgc-2018-000072. Epub 2018 Dec 22.
Clinical trial NCT00782262: Weight Loss Effects on Heart and Blood Vessel Function in Obesity
Official title: Effects of Obesity and Diet Induced Weight Loss on Cardiovascular Risk Factors, Vascular and Ventricular Structure and Function in Obese Men
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Royal Adelaide Hospital
First posted: 2008-10-31
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a growing epidemic and is associated with an increased risk of heart attack and stroke. The investigators know that obesity leads to abnormalities in how the blood vessels and the heart function and that these abnormalities are an important cause of this increased risk in obese individuals. While improvements in these abnormalities have been reported with marked weight reduction (eg surgery) and lifestyle changes including exercise training, it is not clear that these abnormalities can be substantially reversed with standard dietary interventions. Additional information is needed regarding the degree of weight loss required, the time course of these improvements, nor the mechanisms. All of these have major implications for the potential role of weight loss in the management of these patients.

The investigators will assess the effects of dietary induced weight loss in both the short and long term on the function of blood vessels and the heart, and the relationship of any changes with markers of inflammation that are present in obesity.

By understanding the factors that are important in reversing these abnormalities in obesity the investigators will be better to identify and reduce heart attack and stroke in obese individuals in the future.


Eligibility criteria: Inclusion Criteria:

* Obese Caucasian men age 18-65 years, who are non smokers, and consuming 2 or fewer standard alcoholic drinks per day (on average over the past 5 years) will be recruited.
* Obesity, for the purposes of this study, is defined by a BMI \> 30 and a waist circumference \> 102 cm.
* Caucasian men only are enrolled because the cut-off points for the definition of obesity vary significantly by race.

Exclusion Criteria:

* Men are excluded if they have any previously diagnoses or symptomatic atherosclerotic disease, or are taking any cardiovascular medication.
* Men with known gallstones, history of gout, or any contraindication to MRI are also excluded.

Primary outcomes:
measure: This will be the first analysis of the impact of rapid aggressive weight loss in obese individuals on both short and long-term cardiovascular indices.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide, Royal Adelaide Hospital
state: South Australia
Study officials:
References:
Clinical trial NCT02489162: The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients
Official title: The Role of MyotonPro in Assessing the Biomechanical Properties of Facial Muscles in Facial Paralysis Patients and Its Role in Monitoring Recovery Following Facial Reanimation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Nerve Palsy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the research is to determine whether the MyotonPRO has a valid and reliable application in facial, head and neck surgery. In addition, the study aims to compare this new technology with current electromyography.

Detailed description: Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3 including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial reanimation surgery

Eligibility criteria: Inclusion Criteria:

1. unilateral peripheral facial nerve palsy
2. Mental capacity to give consent
3. The patient is able to sit independently

Exclusion Criteria:

1. Adults who have undertaken strenuous exercise within the last twenty-four hours
2. Adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum A toxin)
3. Adults with poor mobility (unable to lie prone).
4. Adults with a body mass index (BMI) \>30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Primary outcomes:
measure: Muscle tone (Hz)
timeFrame: 12 months
Secondary outcomes:
measure: stiffness (N/m)
timeFrame: 12 months
Other outcomes:
measure: elasticity (Logarithmic decrement)
timeFrame: 12 months
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton
name: John Blythe, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: European Face Centre, Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof.Dr.Mult
role: STUDY_CHAIR
affiliation: Saint Martin Private Hospital Caen
name: Daniel Labbé, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04913662: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Official title: Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stomach Neoplasm
Peritoneal Metastases
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Hospicare Co., Ltd.
First posted: 2021-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.


Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as gastric adenocarcinoma
* Imaging scans or diagnostic laparoscopic findings suggestive of peritoneal metastasis
* HER-2 negative tumor
* Laboratory tests adequate for chemotherapy (within 2 weeks of enrollment)
* Absolute Neutrophil Count: ≧ 1,500/mm³
* Hemoglobin level: ≧ 8.0g/dL
* Platelet Count: ≧ 10×104/mm³
* AST (GOT), ALT (GPT): ≦ 100U/L
* Total Bilirubin: ≦ 2.0mg/dL
* Creatinine Clearance (CCl): ≧ 50mL/min
* ECOG 0 - 2

Exclusion Criteria:

* Patients with other major medical disease or malignant tumors other than gastric cancer
* Contraindication to 5-FU, Oxaliplatin, Leukovorin or Paclitaxel
* Pregnant, breast-feeding women or with birth plan
* History of gastrointestinal surgery
* Patients refusing treatment

Primary outcomes:
measure: Recommended dose
timeFrame: Dose-limiting toxicity within 2 weeks after 1st intraoperative PIPAC (each cycle is 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06324162: Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?
Official title: Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket? A Comparative Study of Two Bracket Systems and Two Debonding Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Debonding
Orthodontic Brackets
Keywords: orthodontic brackets
pain measurement
dental debonding
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.

Detailed description: 100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. Prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. Subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.

Eligibility criteria: Inclusion Criteria:

* fixed appliance in both dental arches
* brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions

Exclusion Criteria:

* periodontal disease
* restorations or caries on buccal surfaces of the teeth,
* consumption of analgesics within eight hours preceding the debonding appointment

Primary outcomes:
measure: Pain during active treatment
timeFrame: On the day of debondig (at the end of active treatment).
measure: Pain during brackets removal
timeFrame: On the day of debondig (after debonding of each single bracket).
measure: Pain on adhesive removal
timeFrame: On the day of debondig (after adhesive removal in each quadrant).
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Collegium Medicum
Study officials:
affiliation: Department of Orthodontics, Jagiellonian University Medical College
name: Piotr Fudalej, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05676762: Contraceptive Counselling: Impact on Awareness of the Risk of Unwanted Pregnancy and on the Appeal of Contraception
Official title: Le Conseil Minimal Autour de la Contraception : Quel Impact Sur la Prise de Conscience du Risque de Grossesse Non désirée et Sur l'Attrait à la Contraception
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contraception
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On the basis of 30 participating GPs, the estimation of the number of inclusions is 400 women, which seems sufficient for this study.

The desired number of inclusions is 45 women/month (400 women over 9 months).

Brief summary: The hypothesis of this study is that the generalisation of minimal contraceptive advice in general medical consultations among women of childbearing age in Reunion Island who do not use contraception but who have sexual relations and do not wish to become pregnant within the year could induce an awareness of the risk of unwanted pregnancy and lead to a change in behaviour with regard to contraceptive methods.


Eligibility criteria: Inclusion Criteria:

* Women from 18 to 50 years old
* Consulting in a general practice in Reunion Island
* French or Creole speaking
* Not having any contraceptive means
* Having sexual intercourse
* Not having any desire to become pregnant within the year
* Collection of non-opposition

Exclusion Criteria:

* Consultation for a desire or follow-up of a pregnancy
* Consultation for an abortion
* Consultation for a contraceptive method
* Known infertility
* Inability to answer the telephone (hearing impaired, mute)
* Severe cognitive disorder (mental retardation, dementia, active psychosis)
* Women under guardianship or curatorship

Primary outcomes:
measure: Impact of a minimal councelling regarding the contraception awareness of risk of unwanted pregnancy
timeFrame: between Day 1 and Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Philippe
country: Réunion
facility: Cabinet de médecine générale
Study officials:
affiliation: Universite de La Reunion
name: Sébastien LERUSTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317862: A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Induction of Labor
Keywords: labor induction, transcervical foley catheter, prostaglandin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to prostaglandins for preinduction cervical ripening and labor induction in term nulliparous women with unfavorable cervix.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* nulliparous women
* gestational age \>= 37.0 weeks
* Bishop score \<= 5
* intact amniotic membrane
* abscence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* major congenital anomaly

Primary outcomes:
measure: Successful labor induction
timeFrame: Twelve hours of initiating oxytocin on the fist day of induction
Secondary outcomes:
measure: Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins
timeFrame: When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyo Hoon Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00215462: Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Official title: A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Stomach Cancer
Keywords: gastric adenocarcinoma
esophageal adenocarcinoma
vinorelbine
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2005-09-22
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 collect anti-tumor activity of vinorelbine when given to patients with esophageal or gastric tumors. We will also collect information on the toxicities of vinorelbine in these patients.

Detailed description: * Patients will receive vinorelbine intravenously once per week for eight weeks. These treatments will be repeated after the initial eight weeks as long as the patient continues to receive benefit from the treatment. If the patient experiences significant toxicities, the dose may be reduced or the chemotherapy may be discontinued.
* Before beginning treatment and during therapy, routine laboratory tests, scans and x-rays will be done to check the body's response to treatment. A physical exam will be done at the start of the study and before each course of treatment. Scans will be done after eight weeks of therapy.
* Patients will remain on this study as long as their disease does not become worse or they do not experience severe side effects.

Eligibility criteria: Inclusion Criteria:

* Locally unresectable or metastatic esophageal adenocarcinoma. Locally unresectable or metastatic gastric adenocarcinoma. Only patients with measurable tumors are eligible.
* No more than one prior chemotherapy regimen
* ECOG performance status of 0-1
* Life expectancy of \> 12 weeks
* Greater than or equal to 1,200 calorie/day intake
* ANC \> 1,500/mm3
* AST \< 3 x ULN
* Total bilirubin \< 2.0 ng/dl
* Platelets \> 100,000/mm3
* Serum creatinine \< 2.0 mg/dl

Exclusion Criteria:

* Prior therapy with vinca alkaloids
* Chemotherapy within the past three weeks
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Peripheral neuropathy \> 1

Primary outcomes:
measure: To assess the anti-tumor activity of vinorelbine when administered to patients with locally advanced or metastatic esophageal or gastric adenocarcinoma.
Secondary outcomes:
measure: To evaluate the toxicities of vinorelbine in this patient population.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew Kulke, MD
role: PRINCIPAL_INVESTIGATOR
References: