louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02216656: Phase 2 Study of KHK7580
Official title: A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Subjects who have voluntarily consented to participate in this study
* Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
* Subjects with an intact Parathyroid hormone of \>= 240 pg/mL at screening

Exclusion Criteria:

* Subjects with primary hyperparathyroidism
* Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
* Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
* Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
* Subjects with uncontrolled hypertension and/or diabetes
* Subjects with severe heart disease.
* Subjects with severe hepatic dysfunction.
* Subjects who have received any other investigational drug within 12 weeks before screening
* Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.

Primary outcomes:
measure: The percent changes in intact Parathyroid hormone levels from baseline
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus.
timeFrame: Up to 3 weeks
measure: Safety
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Study officials:
References:
Clinical trial NCT01799356: Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pelvic Inflammatory Disease
Keywords: Treatment, moksifloksasin
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2013-02-26
Enrollment: 1303
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days


Eligibility criteria: Inclusion Criteria:

1. Women diagnosed uncomplicated PID
2. Patients age are between 14 with 45
3. Pelvic tenderness and vaginal discharge

Exclusion Criteria:

1. Urinary Tract Enfections
2. Tubo-ovarian abscess and complicated PID
3. Hıstory of antibiotics treatment
4. Other pelvic pain causes
5. Endometriosis
6. Delivery,abortion and surgery within last months

Primary outcomes:
measure: Clinically cure
timeFrame: 21 Days
Secondary outcomes:
measure: Microbiological cure
timeFrame: 21 Days
Other outcomes:
Locations:
city: Samatya
country: Turkey
facility: T.C.S.B. İstanbul Training Research Hospital
state: Fatih
city: İstanbul
country: Turkey
facility: T.C.S.B. Kanuni Sultan Suleyman Training Hospital
state: Kucukcekmece
city: Mardin
country: Turkey
facility: T.C.S.B Mardin Women and Children Hospital
city: Şişli
country: Turkey
facility: T.C.S.B. Şişli Etfal Training Research Hospital
Study officials:
affiliation: T.C.S.B. Kanıni Sultan Suleyman Training Hospital
name: Kemal Gungorduk, md
role: STUDY_CHAIR
References:
citation: Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.
citation: Boothby M, Page J, Pryor R, Ross JD. A comparison of treatment outcomes for moxifloxacin versus ofloxacin/metronidazole for first-line treatment of uncomplicated non-gonococcal pelvic inflammatory disease. Int J STD AIDS. 2010 Mar;21(3):195-7. doi: 10.1258/ijsa.2009.009374.
citation: Savaris RF, Fuhrich DG, Maissiat J, Duarte RV, Ross J. Antibiotic therapy for pelvic inflammatory disease. Cochrane Database Syst Rev. 2020 Aug 20;8(8):CD010285. doi: 10.1002/14651858.CD010285.pub3.
Clinical trial NCT06674356: The Effects of Chin Tuck Against Resistance Exercise on Acute Stroke Patients With Dysphagia
Official title: The Effects of Chin Tuck Against Resistance Exercise on Swallowing Function, Depression, and Quality of Life in Acute Stroke Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Stroke
Dysphagia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.

Detailed description: The study is an experimental research design, with participants randomly assigned to either the experimental group or the control group. The experimental group will undergo chin tuck against resistance exercises, while the control group will receive traditional swallowing rehabilitation training. The subjects of this study are patients from the neurology and rehabilitation wards of a medical center in northern Taiwan. The research tools include a personal basic information questionnaire, the standardized swallowing assessment, the Functional Oral Intake Scale, the Patient Health Questionnaire-9, and the Taiwan version of the Swallowing Quality of Life Questionnaire. Data collection for both groups will be conducted using a pre-test and post-test method.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with hemorrhagic or ischemic stroke, including those with initial diagnoses or recurrent strokes.
2. Patients who did not pass the swallowing screening based on the standard swallowing scale.
3. Adults aged 18 years and older.
4. Vital signs are stable: systolic blood pressure (hemorrhagic \< 160 mmHg, ischemic \< 220 mmHg), heart rate 40-130 beats per minute, and oxygen saturation \> 92%.
5. The patient's consciousness is clear, able to express themselves, can communicate in Mandarin or Taiwanese, and can follow commands to perform actions.
6. The patient can be in a seated position.

Exclusion Criteria:

1. Patients who have had a stroke for more than one month (inclusive).
2. Patients with a history of depression or related mental health disorders.
3. Patients with a history of neck pain, injury, or disease.
4. Patients who have previously undergone tracheostomy or have a tracheostomy tube in place.

Primary outcomes:
measure: swallowing function
timeFrame: before intervention and up to 6 weeks
Secondary outcomes:
measure: Depression
timeFrame: before intervention and up to 6 and 10 weeks
measure: Swallowing-Related Quality of Life
timeFrame: before intervention and up to 6 and 10 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Nursing, National Taiwan University
Study officials:
References:
Clinical trial NCT03283956: Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan
Official title: Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan (SERENADE-T)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Non-resectable
Chemoembolization, Therapeutic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Cheng-Kung University Hospital
name: Taichung Veterans General Hospital
First posted: 2017-09-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical records of all patients who underwent DC bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7

Brief summary: To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular carcinoma in Taiwan.

Detailed description: To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular carcinoma in Taiwan.

This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC bead TACE in hepatocellular carcinoma (HCC) in Taiwan

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7.

All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY, USA). Demographic and baseline lab data are presented by using descriptive statistics Student's t-test. Survival analysis will includes all patients.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.
* Patient received DC bead TACE.

Exclusion Criteria:

* Patients with current any other cancer except non-melanomatous skin cancer.
* Infiltrative HCC
* Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no matter it is cTACE or DC bead TACE)
* Patients received DC bead TACE and simultaneously received other therapy, such as radiotherapy, sorafenib etc.
* Presence of collateral vessel pathways potentially endangering normal territories during embolization.
* Presence of arteries supplying the lesion not large enough to accept DC Bead® microspheres.

Primary outcomes:
measure: Safety of the DC bead TACE
timeFrame: One year.
Secondary outcomes:
measure: Tumor response
timeFrame: One year.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Hung Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03875456: Needle Aspiration for Large Cephalohematoma
Official title: Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cephalohematoma
Keywords: Cephalohematoma
Infant, Newborn
Perinatal Care
Plagiocephaly
Nonsynostotic
Skull/pathology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-03-14
Enrollment: 67
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting cephalohematoma

Brief summary: The cephalohematoma is a common pathology of newborns. Observation is the primary treatment for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. The objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.

Detailed description: This is a retrospective study of 67 newborns followed at the University Hospital of Montpellier between 2010 and 2017. Treatment was puncture under local anesthesia between 2 and 4 weeks of life.

Any potential complication events were searched retrospectively during the month after the puncture. Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure

Eligibility criteria: Inclusion criteria:

* diagnosis of cephalohematoma was performed by the two senior plastic pediatric surgeon of the study
* the diagnosis was confirmed by ultrasound examination

Exclusion criteria:

* Skull fracture (seen by ultrasound examination)
* Intra-cranial complication (ultrasound examination)

Primary outcomes:
measure: Complication events during the month after the puncture.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Guillaume CAPTIER, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04286256: Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
Official title: Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Caries
Keywords: Early Childhood Caries
Motivational Interviewing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's aim was to investigate if a motivational interviewing intervention (MI) improved oral self-care behaviors of AIAN caregivers of infants and determine if the MI intervention promoted positive changes in caregivers' ECC risk-related behaviors.


Eligibility criteria: Inclusion Criteria:

- healthy mothers/caregivers of infants

Exclusion Criteria:

* Subjects with recent antibiotic use (within 3 months)
* Subjects on any medication that is immunosuppressive
* Subjects who self-report they have xerostomia due to medication use

Primary outcomes:
measure: Change in Concentration of Lactobacilli
timeFrame: Baseline, 8 months
measure: Change in Concentration of Mutans Streptococcus
timeFrame: Baseline, 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Christine Blue, BSDH, MS, DHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blue CM, Arnett MC, Ephrem H, Lunos S, Ruoqiong C, Jones R. Using motivational interviewing to reduce parental risk related behaviors for early childhood caries: a pilot study. BMC Oral Health. 2020 Mar 29;20(1):90. doi: 10.1186/s12903-020-1052-6.
Clinical trial NCT04174456: Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy
Official title: Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dilated Cardiomyopathy
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study proceeds with prospective, randomized, open and controlled clinical trials. The subject of the investigator's study was the first patient diagnosed with dilated cardiomyopathy. Subjects who agreed to participate in the study and were determined to meet the selection / exclusion criteria were randomly assigned to each group, and the experimental group was treated with 20 mg of olmesartan and 5 mg of rosuvastatin for 6 months, and the control group is treated with 40 mg of valsartan and 5 mg of rosuvastatin.

Detailed description: Myocardial viability plays an important role in improving the function of the heart. To date, the most reproducible and objective method has been established as a method or tool for assessing myocardial viability.

Olmesartan is known to have the strongest inhibitory ability of angiotensin receptors compared with other angiotensin receptor binding inhibitors. Research has been reported that statin drugs may help improve vascular endothelial function, and several researchers have suggested that these mechanisms may affect the improvement of myocardial survival. In addition, studies have shown that angiotensin receptor binding inhibitors and statins may improve left ventricular function in patients with left ventricular function. However, since the studies did not assess myocardial survival, the mechanisms could not be clearly identified.

The purpose of this study is to investigate the effect of olmesartan on myocardial survival in patients with dilated cardiomyopathy who have left ventricular dysfunction.

Eligibility criteria: Inclusion Criteria:

* dilated cardiomyopathy

Exclusion Criteria:

* contraindication to angiotensin receptor blocker
* cardiogenic shock
* sensitive to rosuvastatin
* liver cirrhosis more than Child class B

Primary outcomes:
measure: Rate of glucose metabolism
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Department of Internal Medicine,Dong-A University College of Medicine
Study officials:
affiliation: Dong-A University Hospital
name: Kyungil PARK
role: STUDY_DIRECTOR
References:
citation: Jo S, Moon H, Park K, Sohn CB, Kim J, Kwon YS, Kim SH. Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial. Trials. 2022 Jan 15;23(1):36. doi: 10.1186/s13063-021-05970-7.
Clinical trial NCT00221585: The National Danish Schizophrenia Project
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) 'Supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'Integrated, assertive, psychosocial and educational treatment programme', and 3) 'Treatment as usual'.

Detailed description: The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed:

Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere

Eligibility criteria: Inclusion Criteria:

consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29).

-

Exclusion Criteria:

* patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Risskov
country: Denmark
facility: Psychiatric Hospitäl in Aarhus
state: Aarhus
Study officials:
affiliation: Psychiatric Center Glostrup, Dernmark
name: Bent Rosenbaum, DMSci
role: STUDY_DIRECTOR
References:
citation: Rosenbaum B, Valbak K, Harder S, Knudsen P, Koster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jorgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode psychosis. Br J Psychiatry. 2005 May;186:394-9. doi: 10.1192/bjp.186.5.394.