louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00110968: Long-term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia
Official title: A Multicentre, Open-label Extension Phase to Study the Long-term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Abdominal Symptom relief
Fullness
Bloating
Indigestion
Functional dyspepsia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Detailed description: All patients having completed study ITOFD04-01 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months.

Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients must have completed the 8 week double-blind study ITOFD04-01
* Female patients must not be pregnant (must have a negative serum pregnancy test)

Exclusion Criteria:

* Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-01 study entry

Primary outcomes:
measure: Long-term safety
Secondary outcomes:
measure: Long-term relief of symptoms
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic, Rochester, Minn
name: Nicholas Talley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325168: The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)
Official title: The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
empathy
oxytocin
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.


Eligibility criteria: Inclusion Criteria:

* PTSD patients (DSM-IV criteria)
* Ability to provide written informed consent

Exclusion Criteria:

* Suicidality
* Psychosis
* Arrhythmia
* Cardiac disease (arrythmia, heart failure)
* Hyponatremia
* Severe renal insufficiency
* Liver cirrhosis
* Pregnancy

Primary outcomes:
measure: Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.
timeFrame: 1 hour after the inhalation the OT
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ehud Klein, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931268: Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Macrolane
Official title: Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy
Keywords: Lipoatrophy
Buttock treatment
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 10
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: The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.


Eligibility criteria: Inclusion Criteria:

* Have buttocks lipoatrophy and is unable to remain seated for more than 30 minutes due to pain.
* Have undergone HIV treatment for more than 2 years.
* Have RNA copies less than 50/ml.
* Have CD4 more than 200 cell/mm3.

Exclusion Criteria:

* Active infections.
* Active skin disease, inflammation or related conditions.
* Perineal pathology.
* Condition that may affect pain assessment.
* Skin with underlying fibrous tissue.
* BMI less than 19.
* Insufficient tissue cover in the area to be treated.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 14 days prior to treatment, or a history of bleeding disorders.
* Permanent implant placed in the treatment area.
* Other injectable implant, liposuction or other surgical therapy in the treatment area.
* Presence or history of connective tissue diseases.
* Tumors or pre-malign tissue disorder near or on the area to be treated.
* Contraindications for MRI
* Previous hypersensitivity to hyaluronic acid, or to the local anesthetic or antibiotic used in the study.

Primary outcomes:
measure: Change From 6 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
timeFrame: 6 months after treatment compared to baseline
Secondary outcomes:
measure: Change From up to 18 Months to Baseline in Visual Analogue Scale (VAS) Pain After 15 Minutes of Sitting
timeFrame: Baseline and up to 18 months after treatment
measure: Quality of Life Assessed by MOS-HIV (Medical Outcome Study-HIV) Questionnaire
timeFrame: Baseline and at 6 months after treatment
measure: Number of Participants With Global Esthetic Improvement
timeFrame: One month and up to 18 months after treatment
measure: Number of Participants With Gel Displacement Evaluated by Magnetic Resonance Imaging (MRI)
timeFrame: 12 months after treatment
measure: Adverse Event Recording
timeFrame: Up to 18 months after treatment
measure: Time Until it Became Impossible to Stay Sitting
timeFrame: Baseline and at 6 months after treatment
Other outcomes:
Locations:
city: Créteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Galderma R&D
name: Head of Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT00695968: Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI
Official title: A Prospective Study Evaluating Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography, and Magnetic Resonance Imaging in the Detection of Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 9
Sex: FEMALE
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 must have a suspicious breast lesion

Brief summary: To determine the sensitivity, specificity, and accuracy of preoperative ultrasound, elastography, mammography and breast MRI in women with dense breast tissue diagnosed with breast cancer; to test whether elastography or MRI can improve upon routine mammogram and conventional ultrasound in women with dense breast tissue.


Eligibility criteria: Inclusion Criteria:- Patients must have a suspicious breast lesion detected by a physical exam, mammography or U/S . that has not been surgically resected and is being considered to undergo biopsy if clinically indicated.

* Patients must be \>= 18 and \< 80 years of age, and female.
* Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria:- Patients who have already had primary surgical excision of the suspicious finding
* \<18 or \>80 years of age
* Pregnant or Lactating Women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Debra M Ikeda
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646568: Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve
Official title: hCG Stimulating Test of the Thecal Cells to Evaluate the Ovarian Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF
ovarian reserve
androgens
thecal cells
Fertility Agents, Female
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.

Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success

Detailed description: 20 women \>40 years old and 20 women \<35 years old, attended to our IVF unit were included in the study. Another 20 other young women (\<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results

Eligibility criteria: Inclusion Criteria:

* All women on IVF cycle

Exclusion Criteria:

* Any allergy to injection of human chorionic gonadotropin before

Primary outcomes:
measure: androgens levels after stimulation in relation to the ovarian reserve
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Assaf Ben-Meir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02417168: Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study
Official title: Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Bacteremia
Lead sponsor: CAMC Health System
Sponsor class: OTHER
Collaborators: name: CureSearch for Children's Cancer
First posted: 2015-04-15
Enrollment: 1
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between the ages of birth to seventeen years who have an existing oncologic diagnosis and who present with fever to Charleston Area Medical Center Women and Children's Hospital

Brief summary: Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result.

Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment.

In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.


Eligibility criteria: Inclusion Criteria:

* Children between the ages of birth to seventeen years.
* Present to Charleston Area Medical Center Women and Children's Hospital
* Existing pediatric oncology diagnosis.
* Temperature greater than 38.0 C or 100.5 Fahrenheit.
* Central venous access or functional port available.

Exclusion Criteria:

* Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient.
* The patient does not have central venous access or a port from which the blood can be drawn.

Primary outcomes:
measure: Change in procalcitonin levels
timeFrame: 24 hours
Secondary outcomes:
measure: The presence of bacteremia
timeFrame: 1 week
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC Health Systems
state: West Virginia
Study officials:
References:
Clinical trial NCT01412268: Does Bariatric Surgery Changes Eating Habits and Addiction in Morbid Obesity?
Official title: Study of Eating Habits and Addiction Changes in Short and Long Time Follow-up in Morbidly Obese Patients Who Undergo Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Behavioral changes
Eating habits
Eating addiction
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with BMI \> 40 kg/m2 Patients with BMI \> 35 kg7m2 \< 40 kg/m2 but with comorbidity Patients \> 18 years old Patients who sign the inform consent Patients who have no psychiatric disease Patients who have no endocrine disorders

Brief summary: 1. Obesity is a big health problem worldwide.
2. Mostly obese people have food addiction and bad eating habits.
3. Bariatric surgery is a good alternative for patients who failed to loose weight with other measures like behavioral changes, activities and sports, diet, etc..
4. The investigators know the changes occurred after surgery in eating habits due to restrictive and malabsorptive feature of the surgery performed.
5. There is no study in the literature to measure these changes.
6. The investigators will try to detect these kind of behavioral changes by a survey before and after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with BMI \> 40 kg/m2
* Patients with BMI \> 35 kg7m2 \< 40 kg/m2 but with comorbidity
* Patients \> 18 years old
* Patients who sign the inform consent
* Patients who have no psychiatric disease
* Patients who have no endocrine disorders

Exclusion Criteria:

* All obese patients who do not fulfill the criteria above mentioned

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sevincer GM, Konuk N, Bozkurt S, Coskun H. Food addiction and the outcome of bariatric surgery at 1-year: Prospective observational study. Psychiatry Res. 2016 Oct 30;244:159-64. doi: 10.1016/j.psychres.2016.07.022. Epub 2016 Jul 12.
Clinical trial NCT01150968: An Educational Intervention to Improve Resident Comfort With Communication at the End of Life
Official title: An Educational Intervention to Improve Resident Comfort With Communication at the End of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life Communication
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to investigate whether the addition of teaching on communication at the end of life to the pre-existing resident curriculum will positively impact residents' knowledge and attitudes regarding communication at the end of life.

Detailed description: Previous research has demonstrated a lack of resident training in communication at the end of life. This can lead to anxiety on the part of residents and poor experiences with these conversations. Residents at UCSF, and affiliated sites, participate in a daily formal teaching session from 12-1 pm and an informal case conference, known as Morning Report, from 7:30-8:30 am (8-9 am at VAMC). We propose to administer a pre-intervention survey to residents to assess knowledge and attitudes regarding communication at the end of life. Over two months, residents will receive one lecture during the noon session. Clinical cases will be presented for discussion during three sessions of morning report. All sessions are voluntary and take place at all three training sites, UCSF, SFGH, and the VAMC. As residents rotate every two months between the inpatient and outpatient settings, the intervention will be repeated once to ensure that the majority of residents have the opportunity to participate. A post-intervention survey, identical to the pre-intervention survey, will be administered to assess for impact of the educational intervention. This project only involves UCSF Internal Medicine residents. No patients will be involved in this study.

Eligibility criteria: Inclusion Criteria:

* UCSF internal medicine resident

Exclusion Criteria:

* Not UCSF internal medicine resident

Primary outcomes:
measure: Self-efficacy
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Program in Medical Ethics
state: California
Study officials:
References:
Clinical trial NCT00801268: Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease
Official title: Randomized Clinical Trial of Triptolide Woldifii for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Polycystic Kidney
Keywords: polycystic kidney disease
tripterygium wilfordii
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Triptolide has been approve effective in animal model.

Detailed description: Randomized

Eligibility criteria: Inclusion Criteria:

* Clinically established ADPKD
* eGFR\>30ml/min.
* Chinese nationality

Exclusion Criteria:

* Uncontrolled infections
* Non-ADPKD complications

Primary outcomes:
measure: MRI calculated kidney volume, eGFR
timeFrame: Every 3-6months
Secondary outcomes:
measure: End-stage kidney disease (ESRD)
timeFrame: every 2months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Liu ZH, Yao XD,Chen X,Hu YL
state: Jiangsu
city: Nanjing
country: China
facility: Yao Xiaodan
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital
name: Liu Zhihong, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01482468: Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting
Official title: Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 132
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease

Primary outcomes:
measure: incidence of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: severity of nausea
timeFrame: for 24 hours after sugery
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St Mary's hospital
Study officials:
References: