louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02627664: Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
Official title: Prospective Study of Dysarthria, Swallowing Disorders and Respiratory in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Idiopathic early
Parkinson's Disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: France Parkinson Association
First posted: 2015-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )

Brief summary: The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

Detailed description: Patients were evaluated at baseline and after 2 years in off drug condition. Clinical, psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing video fluoroscopy, dysarthria, gait and axial disorders.

Eligibility criteria: Inclusion Criteria:

* idiopathic parkinson's disease

Exclusion Criteria:

* dementia
* severe axial gait disorders
* respiratory or ENT pathology
* Pregnancy

Primary outcomes:
measure: dysarthria severity assessed by the BECD scale
timeFrame: 2 years
Secondary outcomes:
measure: respiratory insufficiency detection
timeFrame: 2 years
measure: swallowing function
timeFrame: 2 years
measure: gait axial function (freezing)
timeFrame: 2 years
measure: Mattis scale
timeFrame: 2 years
measure: LARS scale
timeFrame: 2 years
measure: MADRS scale
timeFrame: 2 years
measure: PAS scale
timeFrame: 2 years
measure: MoCA
timeFrame: 2 years
measure: Genetic Polymorphisme
timeFrame: 2 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Francine Niset
Study officials:
affiliation: CHRU LILLE FRANCE
name: luc defebvre, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00092664: An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia (0653A-038)(COMPLETED)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Primary hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).


Eligibility criteria: Inclusion Criteria:

* High cholesterol

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Primary outcomes:
measure: Plasma LDL-C.
Secondary outcomes:
measure: Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bays HE, Ose L, Fraser N, Tribble DL, Quinto K, Reyes R, Johnson-Levonas AO, Sapre A, Donahue SR; Ezetimibe Study Group. A multicenter, randomized, double-blind, placebo-controlled, factorial design study to evaluate the lipid-altering efficacy and safety profile of the ezetimibe/simvastatin tablet compared with ezetimibe and simvastatin monotherapy in patients with primary hypercholesterolemia. Clin Ther. 2004 Nov;26(11):1758-73. doi: 10.1016/j.clinthera.2004.11.016.
citation: Feldman T, Ose L, Shah A, Zakson M, Meehan A, Johnson-Levonas AO, Maccubbin D, Tribble DL, Veltri E, Mitchel Y. Efficacy and safety of ezetimibe/simvastatin versus simvastatin monotherapy in hypercholesterolemic patients with metabolic syndrome. Metab Syndr Relat Disord. 2007 Spring;5(1):13-21. doi: 10.1089/met.2006.0033.
citation: Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.
citation: Ose L, Reyes R, Johnson-Levonas AO, Sapre A, Tribble DL, Musliner T. Effects of ezetimibe/simvastatin on lipoprotein subfractions in patients with primary hypercholesterolemia: an exploratory analysis of archived samples using two commercially available techniques. Clin Ther. 2007 Nov;29(11):2419-32. doi: 10.1016/j.clinthera.2007.10.004.
Clinical trial NCT04004364: Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes
Official title: Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: First Episode Psychosis
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-02
Enrollment: 700
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 to 40 year olds with first episode psychosis enrolled in network CSC program

Brief summary: The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

Detailed description: The RAISE ETP study, designed and conducted by our group, signaled that a Coordinated Specialty Care (CSC) model could be feasibly delivered in community mental health clinics in multiple states and was effective. Since then, with the support of SAMSHA block grants to states, there are CSC programs across the nation.

The goal of this project is to develop a learning health system with sites providing CSC treatment of first-episode psychosis (FEP). Sites are drawn from five states: Connecticut, Florida, Michigan, Oklahoma and South Carolina. They vary in populations served, levels of funding available and research experience. All are committed to advancing the development of CSC using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Eligibility criteria: Inclusion Criteria:

* Enrolled in CSC program

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of Enrolled participants
timeFrame: 5 years of the project
Secondary outcomes:
Other outcomes:
Locations:
city: Lauderdale Lakes
country: United States
facility: Henderson Behavioral Health
state: Florida
Study officials:
References:
Clinical trial NCT06588764: Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy
Official title: Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graves Ophthalmopathy
Surgery
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
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: To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.

Detailed description: The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.

Eligibility criteria: Inclusion Criteria:

1. EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
2. CAS≤3 score;
3. stable thyroid function for at least 6 months;
4. able and willing to participate in clinical trials and ensure regular follow-up;

Exclusion Criteria:

1. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
2. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
3. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
4. those who were considered by the researchers to be excluded

Primary outcomes:
measure: best corrected visual acuity (BCVA)
timeFrame: within 24 weeks of surgery
Secondary outcomes:
measure: value of Hertel
timeFrame: within 24 weeks of surgery
measure: the mean deviation value of visual field (VF)
timeFrame: 24 weeks after surgery
measure: pattern standard deviation value of visual field
timeFrame: within 24 weeks of surgery
measure: the P100 latency of pattern visual evoked potential (PVEP)
timeFrame: within 24 weeks of surgery
measure: N75-p100 amplitude of PVEP
timeFrame: within 24 weeks of surgery
measure: clinical activity score (CAS)
timeFrame: within 24 weeks of surgery
measure: volume of adipose tissue
timeFrame: during the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03884764: Ganglion Impar Denervation and Radiofrequency on Sacral Root 3 for Chronic Prostatic Pain
Official title: for Patients With Chronic Pelvic Pain Due to Chronic Prostatitis, do Combined Ganglion Impar Denervation and Pulsed Radiofrequency on Sacral Root 3 Acheive Better Analgesia Than Ganglion Impar Alone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 60
Sex: MALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the authors will evaluate the added analgesic benefit of pulsed radiofrequency on sacral root 3 with ganglion impar denervation on chronic pelvic pain due to chronic prostatitis


Eligibility criteria: Inclusion Criteria:

* patients with chronic pelvic pain due to chronic prostatitis for at least 3 months
* VAS pain score more than 5
* failed analgesic drug treatment

Exclusion Criteria:

* coagulopathy
* neurogenic bladder
* infection at site of procedure

Primary outcomes:
measure: the percentage of patients that achieve more than 50% change of their initial pain on VAS pain score
timeFrame: patients will be evaluated at 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
state: Assuit
Study officials:
References:
Clinical trial NCT06297564: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments
Official title: Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Women Undergoing Assisted Reproductive Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progesterone Primed Endometrial Protocol
Gonadotropin Releasing Hormone Antagonist Protocol
Assisted Reproductive Treatments
Lead sponsor: New Valley University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.

Detailed description: Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.

The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.

The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.

Eligibility criteria: Inclusion Criteria:

* Age 21 to 40 years.
* A basal antral follicle count (AFC) \<6.
* All patients had to have a body mass index between 18.5 to 29.9 kg/m2.
* Undergoing IVF/ICSI cycles.
* With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).

Exclusion Criteria:

* Cycles with fresh embryo transfer.
* Transfers of cleavage embryos (d2/d3).
* Embryos from cycles with preimplantation genetic screening.
* Cryopreservation of oocytes.
* Oocyte donation cycles.
* Cycles that produced embryos but without et at the time of the analysis.

Primary outcomes:
measure: The number of retrieved oocytes
timeFrame: 34 to 36 hours post HCG administration
Secondary outcomes:
measure: Pregnancy rate
timeFrame: Fourteen days following the transfer
Other outcomes:
Locations:
city: New Valley
country: Egypt
facility: New Valley University
Study officials:
References:
Clinical trial NCT03329664: Autologous Killer Cell Therapy in Colon Cancer Patients
Official title: Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colon Cancer Stage IV
Lead sponsor: Sabz Biomedicals
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Health and Medical Education
name: Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
First posted: 2017-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed colorectal cancer at stage IV
* ECOG performance status 0-2
* Adequate cardiac/renal/hepatic function
* Adequate bone marrow function (blood cell count)

Exclusion Criteria:

* Patients that have received prior chemotherapy or immune cell therapy
* Patients that have previously participated in another clinical trial
* History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
* Presence of Active infections
* Patients with immunodeficiencies, autoimmunities, or severe allergies
* Receiving immunosuppressive regimens

Primary outcomes:
measure: Safety of administering CIK cells plus chemotherapy
timeFrame: one month post infusion
measure: Progression-free Survival (PFS)
timeFrame: 2 years
measure: Time to progression (TTP)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: Patient quality of life
timeFrame: each 3 months for 2 years
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences
Study officials:
affiliation: Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
name: Naser Ahmadbeigi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04976764: The Correlation Between Cirrhotic Cardiomyopathy and Perioperative Cardiovascular Events in Liver Transplantation
Official title: Affiliated Hospital of Qingdao University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis, Liver
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study, the patients with decompensated liver cirrhosis who received liver transplantation from January 1, 2012 to June 1, 2021 in the Affiliated Hospital of Qingdao University were reviewed through the Yidu cloud platform. According to the 2019 cirrhosis cardiomyopathy (CCM) diagnostic criteria, they were divided into two groups according to the presence or absence of cardiomyopathy.The incidence of CCM , the predictive factors of perioperative and postoperative cardiovascular complications were followed up. At the same time,we analysed the influence of CCM on the survival rate.

Brief summary: Liver transplantation is an effective treatment for end-stage liver disease. Cardiovascular complications are the common causes of death in liver transplant recipients. The presence of cirrhosis cardiomyopathy has a potential impact on the prognosis of liver transplant recipients. Therefore, it is important to identify the high risk factors with cirrhotic cardiomyopathy before transplantation, so as to intervene earlier and improve the prognosis of patients.


Eligibility criteria: Inclusion Criteria:

1. Diagnostic criteria for decompensated liver cirrhosis: according to the guidelines for diagnosis and treatment of liver cirrhosis in 2019;
2. Diagnostic criteria for cirrhotic cardiomyopathy: in accordance with the revised criteria of CCM of international multidisciplinary Alliance for cirrhotic cardiomyopathy in 2019, the preoperative echocardiographic images of all patients were reviewed, and the systolic and diastolic dysfunction of all patients were evaluated.

Exclusion Criteria:

1. the compensatory liver cirrhosis, primary liver cancer without liver cirrhosis
2. Multiple organ transplantation or multiple organ transplantation
3. The preoperative echocardiographic data were not fully recorded, so that the exact diagnosis could not be made
4. There was no follow-up data or baseline data

Primary outcomes:
measure: perioperative cardiovascular events
timeFrame: 2012.1.1-2022.8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06190964: Integrative Medicine for Hospital Workers Exposed to War
Official title: Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Hospital Workers Exposed Directly or Indirectly to Terror, Trauma or War
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Acute Stress Disorder
Anxiety
Integrative medicine
Hospital workers
War
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: During the "Iron Swords" war in Israel in 2023, the residents of the Gaza Strip and the surrounding area, along with the soldiers of the security service, were exposed to a very high intensity of trauma. Added to this is an extensive cycle of trauma for those who were directly and indirectly exposed to loss and terror throughout the country. Medical teams in the hospitals and in the community were exposed with the highest intensity to these traumatic aspects which were amplified by the collapse of many of the resilience and mental health centers in the south.

An integrative medicine treatment clinic was established at the Bnai Zion Medical Center for the purpose of providing a response to all hospital employees who are exposed and will be exposed (directly or indirectly) to the wounded and patients expressing trauma, including symptoms of acute stress disorder, as a result of war and terrorism. Hospital employees are invited to register for complementary medicine treatments on the hospital's website according to indications that include anxiety, emotional distress and/or typical Acute Stress Disorder (ASD) symptoms, including physical distress (such as pain, breathing disorder, digestive system symptoms, exhaustion, etc.). The employees are treated by a team from the system for integrative medicine, including practitioners of acupuncture; touch/movement techniques (for example, qigong, reflexology, shiatsu) or mind-body medicine (for example, relaxation and breathing exercises) and may include one or more of the above 3 treatment areas.

In the proposed study, the investigators plan to examine the effect of these treatments on various symptoms experienced by hospital employees during this period.


Eligibility criteria: Inclusion Criteria:

* Hospital employees
* Anxiety, emotional distress and/or typical ASD symptoms directly or indirectly related to exposure to the trauma of terrorism or war

Exclusion Criteria:

* None

Primary outcomes:
measure: Symptom relief
timeFrame: Before intervention; 24 hours after intervention
Secondary outcomes:
measure: Stress and anxiety
timeFrame: Before intervention; 4 to 8 weeks after intervention
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Complementary Medicine Service
name: Samuel Attias, PhD
role: PRINCIPAL_INVESTIGATOR
References: