louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317213: Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
Official title: Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: Smoking
Nicotine
Withdrawal
Phospholipids
Cell membrane fluidity
Smoking cessation
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
Collaborators: name: Modus Biological Membranes, Ltd.
First posted: 2006-04-24
Enrollment: 500
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: It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery. The company has focused on nicotine withdrawal in smoking cessation,as primary target.

Detailed description: A randomized,double-blind, dose-finding,phase IIB study with Libertal has been performed in 493 volunteer smokers, wishing to quit. They were divided into 5 arms: 4 treatment groups of 0.5, 1.0, 2.0 and 4.0g/day respectively, and one placebo, divided BID. Treatment was administered during one week prior to smoking cessation, then continued during 8 weeks (56 days), followed by another 4 weeks without treatment (up to day 84). The primary endpoint was complete smoking cessation during at least 28 consecutive days. There were 6 on-site visits and 4 telephone interviews.

Eligibility criteria: Inclusion Criteria:

* Smokers of at least 1 year duration
* Smoking at least 10 cigarettes/day
* Having failed at least one previous smoking cessation effort.
* Without a major cardio-vascular or metabolic disease or condition.

Exclusion Criteria:

* An uncontrolled major cardiovascular, metabolic, or other condition condition.
* Need for surgery during the period of participation in the trial.
* Any treatment for smoking cessation during the 2 months preceding enrollment in the present trial.

Primary outcomes:
measure: Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
measure: Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
Secondary outcomes:
measure: Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
Other outcomes:
Locations:
city: Tel-Aviv and Rehovot
country: Israel
facility: Arazi Clinic and Modus Clinic
Study officials:
affiliation: Kaplan Medical Center
name: Zeev T. Handzel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Modus Biological Membranes
name: Avner Shenfeld, Ph.D,
role: STUDY_DIRECTOR
References:
Clinical trial NCT02481713: Improving Adherence to Cognitive Rehabilitation
Official title: Enhancing Adherence to Cognitive Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: psychosis
adherence
motivation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-25
Enrollment: 114
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: Purpose of study is to evaluate impact of brief motivational interviewing vs. feedback on learning styles in improving attendance to cognitive training

Detailed description: This study is evaluating whether motivational enhancement can improve outcomes of cognitive rehabilitation in Veterans with schizophrenia spectrum disorders. Approximately 120 individuals will be randomized to either a 2-session motivational interview (MI, experimental condition) or a 2-session assessment and feedback on learning styles (CI, active control), and will then be asked to participate in 4 months of cognitive rehabilitation. Booster MI or CI sessions will be administered monthly over the course of the cognitive rehabilitation. Primary outcome is number of cognitive rehabilitation sessions attended.

Eligibility criteria: Inclusion Criteria:

* diagnosis of psychotic disorder
* 18 years old or older

Exclusion Criteria:

* meeting criteria for substance abuse/dependence in past 30 days
* psychiatric hospitalization in past 30 days
* change in psychiatric medications in past 30 days
* severe auditory/visual impairment
* evidence of developmental disability

Primary outcomes:
measure: Number of Sessions Attended
timeFrame: end of four month training period
measure: Number of Sessions Attended
timeFrame: end of 4 month training period
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Joanna M. Fiszdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02449213: A Biobehavioral Model of Diabetes Risk in Chinese Immigrants
Official title: A Biobehavioral Model of Diabetes Risk in Chinese Immigrants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 650
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 foreign-born Chinese Americans

Brief summary: This prospective, longitudinal study of Chinese American immigrants will examine whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time, and whether such associations are mediated by inflammatory pathways.

Detailed description: It is now well-documented that immigration to the US leads to increased risk for various chronic diseases, including type 2 diabetes. The increased diabetes risk observed among Chinese immigrants has been primarily attributed to changes in diet and weight gain following immigration, but these changes can only partially explain disparities in disease risk. Models of immigrant health suggest that the stress of adapting to life in a new country has a considerable impact on physical health. However, few studies have considered the psychosocial impact of immigration upon biomarkers of health and disease risk. Therefore, this longitudinal study of US Chinese immigrant men and women will examine: (1) whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time; and (2) whether the association between psychosocial factors and diabetes risk markers is mediated by inflammatory pathways.

Eligibility criteria: Inclusion Criteria:

* Chinese heritage;
* migration from Asia in adulthood (aged 18 years or older); and
* age 35-65 years

Exclusion Criteria:

* Current or prior history of diabetes
* Self-reported conditions of cancer, auto-immune disorders, HIV, or psychiatric illness
* Use of medications that may impact study outcomes (e.g., steroidal or non-steroidal anti-inflammatory medications)
* Inability to provide informed consent.

Primary outcomes:
measure: Insulin resistance
timeFrame: 24 months post-baseline
Secondary outcomes:
measure: glycated hemoglobin (HbA1c)
timeFrame: 24-months post-baseline
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Y. Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06436313: DBS Virtual Learning Experience
Official title: The Value of Virtual Education on Deep Brain Stimulation for Surgical Candidates
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The success of Deep Brain Stimulation (DBS) is more correlated to fulfillment of patients' expectations, than merely improvement of motor status1. Therefore, it is of utmost importance to inform the DBS candidates as good as possible to set realistic expectations. Currently, the patient - most of the time accompanied by a family member - is informed about the surgery and its benefits and risks during the outpatient consultation of the neurologist, and later on during the consultation of the neurosurgeon. Written information is provided in the form of a booklet that the patients take home.

Due to the large amount of information, not all of it can be captured by the patient. Therefore, we would like to investigate whether an additional online immersive educational session on DBS would better educate the patient. The online session is a 1-hour video call with a small group of DBS candidates and their caregivers, lead by DBS experts, where testimonials of other patients are shown, together with multiple infographics. Two weeks later their will be a second online session summarizing the information and providing the opportunity for Q\&A.


Eligibility criteria: Inclusion Criteria:

1. Patients of any age over 18 who are capable of understanding and granting informed consent.
2. Consecutive enrollment of Parkinson's disease patients, eligible for DBS surgery who will be operated in Toronto Western Hospital.
3. Targets of surgery (STN or GPi) equally in each study arm.
4. Patients must be able to follow the assessment procedure.

Exclusion Criteria:

1. people with limited digital skills (to the discretion of the PI).

Primary outcomes:
measure: The Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline, 3 months post op
measure: MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale)
timeFrame: Baseline, 3 months post op
measure: Parkinson Anxiety Scale (PAS)
timeFrame: Baseline, 3 months post op
measure: The Beck Depression Inventory (BDI)
timeFrame: Baseline, 3 months post op
measure: Structured survey
timeFrame: Baseline, one day before surgery, 3 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Movement Disorders Centre - Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT03515213: Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Fenofibrate as a Treatment for Huntington's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington Disease
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 10
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 purpose of this research study is to study the safety and efficacy of fenofibrate, an FDA-approved drug for high cholesterol and/or elevated triglycerides (fats), as a treatment for Huntington's disease (HD). Subjects who meet the entry criteria will be randomized (3:1) to either 145mg of fenofibrate or placebo.


Eligibility criteria: Inclusion Criteria:

* An adult of either sex, ages 25-85 inclusive,
* Have proficiency with written and spoken English and corrected vision or hearing to complete the cognitive testing,
* Are able to give informed consent,
* Have good overall health status with no known problems anticipated over the course of the trial,
* Have a diagnosis of HD supported by positive gene test within the past 6 months.

Exclusion Criteria:

* Other major neurological disease \[e.g., multiple sclerosis, parkinson's disease, cortical stroke, etc\]
* Clinically significant hepatic or renal disease,
* Current or recent (\< 1 month) use of dopamine blocking agents such as tetrabenazine, anticonvulsants, neuroleptics, HAART, antiemetics, and antipsychotics for any reason,
* Current use of Warfarin (Coumadin). Enrollment in another investigational drug study within the prior three months.

Primary outcomes:
measure: Change in PGC-1alpha RNA Expression
timeFrame: Baseline compared to 3 and 6 months.
measure: Change in PGC-1alpha Protein Abundance.
timeFrame: Baseline compared to 3 and 6 months.
Secondary outcomes:
measure: Change in Fenofibric Acid Level.
timeFrame: Baseline to 3 and 6 months.
measure: Change in Unified Huntington Disease Rating Scale Motor Score.
timeFrame: Baseline and 6 months
measure: Change in Montreal Cognitive Assesment Score.
timeFrame: Baseline compared to 3 and 6 months.
measure: Changes in Unified Huntington Disease Rating Scale - Behavioral
timeFrame: Baseline, Month 3 and 6 months
measure: Change in Functional Assessment Scores
timeFrame: Baseline compared to 3 and 6 months.
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Neal Hermanowicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Leslie Thompson, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02597413: Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study
Official title: Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Women
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all paturient women admitted to delivery rooms.

Brief summary: The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.

Detailed description: Secondarily, we will evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of acute urine retention (first voiding volume \> 500cc) and on post-partum bacteriuria rates.

Eligibility criteria: Inclusion Criteria:

* Paturient women admitted to the delivery room

Exclusion Criteria:

* Patients who have been catheterized during the third trimester of the current pregnancy
* History of surgery on the urinary tract

Primary outcomes:
measure: Presence/absence of a post-voiding residue
timeFrame: Day 0 to Day 2 (just after first voiding)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Mathias Neron
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916213: The Valve of Hyaluronic Binding Selection (PICSI) in Improving IVF Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators would like to assess whether selecting mature sperm using PICSI (selecting for sperm that bind hyaluronan) can optimize the IVF outcome of ICSI .

Aim

1. Primary outcome: To compare routine sperm selection using ICSI with sperm selection using PICSI plates in terms of implantation and fertilization rates for couples with male factor fertility
2. Secondary outcome : To compare live birth rates ,ongoing pregnancies and miscarriage rates for couples with male factor infertility using routine sperm selection with ICSI compared to using PICSI plates for sperm selection

Hypothesis:

Sperm selected for ICSI using (PICSI) will reveal increased implantation rates in comparison to sperm selected for conventional ICSI


Eligibility criteria: Inclusion Criteria:

* In order to participate in the study women must be 42 years old or younger and suffer from male factor infertility however they may have other causes for their infertility
* male factor infertility as defined by one or more of the following sperm parameters: \<20 Million /ml sperm concentration \< 30% normal morphology \< 3% Kruger morphology \< 50% motility sion Criteria:

Primary outcomes:
measure: implantation rate
timeFrame: 12 months
Secondary outcomes:
measure: fertilization rate
timeFrame: 12 months
Other outcomes:
Locations:
city: New york
country: United States
facility: Continuum Reproductive Center
state: New York
Study officials:
References:
Clinical trial NCT06931613: Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
Official title: Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment With or Without Bendamustine
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Relapsed or Refractory Hodgkin Lymphoma
Children
Nivolumab
Autologous Haemopoietic Stem Cell Transplant
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
* Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
* Number of previous lines of therapy \>2
* Karnofsky index ≥60%
* availability of signed informed consent -

Exclusion Criteria:

* Number of previous lines of therapy ≤ 2
* Karnofsky index \< 60
* Intolerance to drugs used in the study
* Presence of a second tumor
* Pregnancy or lactation
* Participation in another study within six months
* Presence of concomitant severe disease
* Presence of HIV and/or viral hepatitis (B or C)

Primary outcomes:
measure: Event free survival
timeFrame: 5-year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N. N. Blokhin Russian Cancer Research Center, Moscow, Russia
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov University, RM Gorbacheva Research Institute
Study officials:
References:
Clinical trial NCT06947213: Orthorexia Nervosa in Postmenopausal Osteoporosis
Official title: Fragile Bones, Strong Obsessions: A Controlled Study on Orthorexia Nervosa, Body Image and Mood in Postmenopausal Women With Osteoporosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 128
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of postmenopausal women with osteoporosis and age-matched healthy controls

Brief summary: A total of 64 female patients diagnosed with osteoporosis based on dual-energy X-ray absorptiometry (DXA) measurements performed within the last six months, and 64 age-matched healthy controls without osteoporosis, will be included in our study. Sociodemographic data such as age, sex, height, weight, and BMI will be recorded. Additionally, information regarding the duration of osteoporosis diagnosis, current treatments, history of fractures, history of falls, comorbidities, and smoking status will be collected. Femoral neck and L1-L4 T-scores and bone mineral density values obtained from existing DXA scans will be documented. Orthorexia nervosa-related symptoms will be assessed using the ORTO-11 scale, mood will be evaluated using the Hospital Anxiety and Depression Scale (HADS), and body image will be assessed using the Body Appreciation Scale-2.


Eligibility criteria: Inclusion Criteria:

* Women between 55-75 years
* Women diagnosed with osteoporosis based on DXA measurements performed within the past six months.
* Women aged similarly to the osteoporosis group without a diagnosis of osteoporosis (healthy controls).
* Willingness to participate and provision of written informed consent.

Exclusion Criteria:

* Refusal to participate in the study.
* Diagnosed psychiatric disorders.
* Cognitive impairment.
* Presence of malignancy.
* Presence of endocrine disorders (e.g., hyperthyroidism, Cushing's syndrome).
* Use of glucocorticoids.
* Use of medications affecting mood.

Primary outcomes:
measure: ORTO-11 Scale
timeFrame: Baseline
Secondary outcomes:
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: Baseline
Other outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)- Anxiety Score
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)- Depression Score
timeFrame: Baseline
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References: