louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384279: The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
Official title: The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: metformin
topiramate
obesity
metabolic syndrome
Lead sponsor: Beitou Armed Forces Hospital, Taipei, Taiwan
Sponsor class: OTHER_GOV
First posted: 2011-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to investigate the efficacy of metformin and topiramate on second-generation antipsychotic-induced obesity. The secondary domain we look at is the adverse effects of both drugs. The investigators hypothesize that metformin and topiramate are effective in treating obesity induced by second-generation antipsychotics.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis: schizophrenia or schizoaffective disorder
2. Age: 20 to 65
3. BMI\>27
4. Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)

Exclusion Criteria:

1. Allergy to metformin or topiramate
2. Currently taking metformin or topiramate
3. Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan.
4. Being pregnant or planning to become pregnant during the study period,
5. History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders
6. History of hypoglycemia
7. History of suicidal attempt
8. Current scale of Hamilton Depression Rating Scale\>8

Primary outcomes:
measure: The changes in metabolic panel as the primary outcome
timeFrame: up to six months
Secondary outcomes:
measure: Number of Participants with Adverse Events (including psychiatric adverse events) as a Measure of Safety and Tolerability
timeFrame: up to six months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Beitou Armed Forces Hospital
Study officials:
affiliation: Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
name: Chiang Kuo-Tung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693679: Telbivudine Renoprotective Effect in Patients With HBV-related Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HBV-related Liver Cirrhosis
Keywords: Tebivudine eGFR non-Tebivudine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: • To estimate renoprotective efficacy of Telbivudine treated patients with HBV-related liver cirrhosis.


Eligibility criteria: Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

* Aged between 18-75 years (inclusive).
* Male or female.
* Subjects with positive HBsAg for more than 6 months and anti-HBs negative regardless of HBeAg status , HBV DNA ≥2×103 IU/ml
* Subjects with HBV-related liver cirrhosis, including compensated cirrhosis and decompensated, but only Child-Pugh A or B.
* The ablility to understand and sign a written informed consent prior to any study related procedure and comply with the requirements of the study.

Exclusion Criteria:

* Subjects meeting any of the following criteria must not be enrolled in the study

  * Subjects with non-HBV cirrhosis
  * Co-infection with HAV/HCV/HDV/ HIV
  * Subjects who take nucleosides within 6 months
  * Kidney injury due to non-HBV factors
  * Inability to comply with study requirements as determined by the study investigator
  * Patients with very low GFR, who may need dialysis or renal transplantation

Primary outcomes:
measure: Change from Baseline in glomerular filtration rate and Serum creatinine at 96 weeks
timeFrame: May 2014
Secondary outcomes:
measure: Change from Baseline in ALT normalization rate,• The rate of complications,• Percentage of participants with HBeAg loss & HBeAg seroconversion and Percentage of subjects achieving HBV DNA<300copies/mL at96 weeks
timeFrame: May 2014
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03984279: Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures
Official title: Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Interventional procédures With CT
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Brief summary: The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.


Eligibility criteria: Inclusion Criteria:

* adult patients (\> 18 years),
* indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Exclusion Criteria:

* MRI contra indication
* persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code

Primary outcomes:
measure: number of major complications
timeFrame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
measure: number of targets reached
timeFrame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
measure: Dose Length Product (DLP)
timeFrame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Secondary outcomes:
measure: number of controls required to place the needle
timeFrame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT03234179: A Prognosis and Predicting Genetic Study of Lung Cancer
Official title: A Prognosis and Predicting Genetic Study of Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Genetic Predisposition to Disease
Keywords: Non small cell lung cancer
Genetic study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diagnosis of primary non small cell lung cancer

Brief summary: Lung cancer is a leading cause of cancer mortality among adults worldwide. The incidence rates of lung cancer among never smoking females in some parts of East Asia are among the highest in the world. The adenocarcinoma of lung being the most frequently identified histological type is more weakly associated with smoking, and often occurs in females and never-smokers. Although family history of lung cancer has been associated with histological subtypes, the inherited susceptibility factors that affect specific histology are unknown.

Genetic factors that determine individual predisposition to lung cancer have been identified via genome-wide association studies. These known common loci, however, explain only a small fraction of the familial risk of lung cancer. The hypothesis of this study is that there are genetic factors that confer inherited susceptibility among patients with primary non-small-cell lung cancer (NSCLC).

Detailed description: To delineate the genetic etiology underlying NSCLC, this study proposes to employ a family-based linkage analysis, together with rich data generated from NGS, to search for disease susceptibility locus for the patients with strong family history of primary NSCLC. By using family pedigrees, linkage analysis will be able to find co-segregation of alleles through multiple generations at a genetic susceptibility locus and a known genetic marker, and then the highly penetrate gene loci may be detected by our study. These gene loci will be a good genetic predictor of NSCLC which should be a great advantage in treatment, prevention and screening of NSCLC in the future.

Eligibility criteria: Inclusion Criteria:

1. The patient's family (within third-degree relatives) has at least one diagnosed of primary non-small cell lung cancer.
2. The patient was diagnosed of primary non-small cell lung cancer at the age \< 45 years old.

Exclusion Criteria:

1. Patients without the diagnosis of primary non-small cell lung cancer.
2. Patients who are combined with other malignancy and ongoing chemotherapy / radiation therapy.
3. Patients combined with coagulopathy.

Primary outcomes:
measure: Genetic information of lung cancer patients
timeFrame: One week after the study subjects sign the permit of informed consents
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Shing Chen, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02784379: Electromyography of the Pectoral Muscle in Mastalgia Patients
Official title: The Comparison Both of the Electromyography Results of the Pectoral Muscle in Unilateral Mastalgia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastalgia
Keywords: Mastalgia
electromyography
Pectoral
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 31 patients who has unilateral mastalgia

Brief summary: Mastalgia is a common problem for women. The aim of this study is to investigate the role of neuromuscular pathologies of the thorax wall at mastalgia ethiopathogenesis.

Detailed description: Mastalgia is a common health problem for women especially these days. Studies demonstrated that 48% of the women with mastalgia have serious difficulties in their sexual life, 36% have physical activity difficulties, 13% have social activity difficulties and 6% have work or school activity difficulties. The etiology of the mastalgia is not clear. Because of the women with mastalgia tested out lots of examinations for the etiology. Also this problem has financial load because of the unknown etiology.

Eligibility criteria: Inclusion Criteria:

* Subject has unilateral mastalgia

Exclusion Criteria:

* Subject has pregnancy
* Subject has breast cancer
* Subject has a history of breast operation
* Subject has diabetes mellitus
* Subject has 1 cm or above cystic or solid lesions in the breasts.

Primary outcomes:
measure: Electromyography results of the pectoral muscle.
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Etfal Training and Research Hospital
name: Cemal Kaya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kernerman E, Park E. Severe Breast Pain Resolved with Pectoral Muscle Massage. J Hum Lact. 2014 Aug;30(3):287-291. doi: 10.1177/0890334414535842. Epub 2014 May 29.
citation: Joyce DP, Alamiri J, Lowery AJ, Downey E, Ahmed A, McLaughlin R, Hill AD. Breast clinic referrals: can mastalgia be managed in primary care? Ir J Med Sci. 2014 Dec;183(4):639-42. doi: 10.1007/s11845-013-1066-z. Epub 2014 Jan 9.
citation: Salzman B, Fleegle S, Tully AS. Common breast problems. Am Fam Physician. 2012 Aug 15;86(4):343-9.
Clinical trial NCT03907579: Screen to Save: A Colorectal Cancer Educational Intervention
Official title: Screen to Save: A Colorectal Cancer Educational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Knowledge
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age: 50-74 years old
* Attendee at event where educational module is offered

Primary outcomes:
measure: Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening
timeFrame: Baseline and immediately following intervention
measure: Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention
timeFrame: Immediately following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Tracy Onega, PhD, MA, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02849379: Combination of Cryosurgey and NK Immunotherapy for Recurrent Tongue Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Tongue Cancer
Keywords: tongue cancer
cryosurgery
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent tongue cancer.

Detailed description: By enrolling patients with recurrent tongue cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507179: Retention of Complete Denture Using Rapid Prototyping
Official title: Retention of Complete Denture Using Rapid Prototyping Versus a Conventional Complete Denture: Cross Over Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retention of 3D Printed Dentures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.

For both groups, a preliminary impression will be made \& after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper \& lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.

For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.

But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.

For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.

Detailed description: Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.

Eligibility criteria: Inclusion Criteria:

1. Age ranging from 40-70 years.
2. Cooperative patients.
3. male or female patients

Exclusion Criteria:

1. Pathological changes of residual ridges.
2. Patients with any systemic diseases.
3. Patients with xerostomia.
4. Patients with flabby and flat ridges.
5. Patients with allergy to resins.
6. Patient with sever undercuts, or irregular bony exostosis. -

Primary outcomes:
measure: retention
timeFrame: immediately after denture construction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00938379: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR
Official title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Malaria
Dengue
Japanese Encephalitis
Keywords: mosquito
repellent
vector control
malaria
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Population Services International
First posted: 2009-07-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).


Eligibility criteria: Inclusion Criteria:

* working in agriculture
* available for monthly follow-up

Exclusion Criteria:

* allergy to repellent
* pregnant / breastfeeding

Primary outcomes:
measure: reduction in malaria incidence
timeFrame: monthly over 7 months
Secondary outcomes:
measure: Reduction in Japanese Encephalitis and / or Dengue infections
timeFrame: After 7 months intervention
Other outcomes:
Locations:
city: Pakse
country: Lao People's Democratic Republic
facility: Rural villages in Attepu and Sekong Provinces, Laos PDR
state: Attepu
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Nigel Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen-Hussey V, Carneiro I, Keomanila H, Gray R, Bannavong S, Phanalasy S, Lindsay SW. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET) in Lao PDR. PLoS One. 2013 Aug 14;8(8):e70664. doi: 10.1371/journal.pone.0070664. eCollection 2013.