louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03174561: Inuline Supplement in Patients With Irritable Bowel Syndrome
Official title: Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: SC Fiterman Pharma SRL
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.

Detailed description: In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.

The acquired data will be analyzed and published.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria

Exclusion Criteria:

* Patients with IBS with predominant diarrhea or mixt symptoms
* Patients with known hypersensitivity to any of the ingredients of the dietary supplement
* Patients who used prebiotic, probiotic or laxative products in the last 10 days
* Pregnancy and lactation

Primary outcomes:
measure: IBS symptoms severity score
timeFrame: the last 10 days
measure: number of bowel movements
timeFrame: the last 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"
Study officials:
affiliation: Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi
name: Vasile L Drug, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of public Health
name: Ioan Chirila, Consultant
role: STUDY_CHAIR
References:
Clinical trial NCT06507761: Thermotherapy in Acute Nonspecific Neck Pain
Official title: Comparison of the Short-term Effect of Superficial Thermotherapy Applications in Acute Nonspecific Neck Pain-Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Cold
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Medical and non-medical treatments such as physiotherapy are applied in its treatment. Patients with nonspecific neck pain (NBA) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. Although it is frequently used in clinical practice, there is no evidence that superficial thermotherapy (hot or cold) methods effectively relieve neck pain. Therefore, this study aims to compare the short-term effects of superficial hot or cold applications on pain, range of motion and functional status in patients with NBA.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with nonspecific neck pain by a doctor,
* To be between the ages of 18-65,
* Neck pain lasting for less than 1 month
* No previous neck or shoulder surgery,
* No shoulder pain due to any cause,
* A tumour or inflammatory disease underlying the neck pain not to be found,
* A clinically underlying stenosis or discogenic problem not to be present.
* Negative results from the following clinical examination tests;

Spurling test, Lhermitte test, Cervical distraction test, Adson test,

Exclusion Criteria:

* Not meeting the inclusion criteria,
* Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
* Systemic rheumatological or metabolic diseases or cancer
* Refusal to participate in the study,
* Failure to complete treatment,
* Having any neurological problem
* Severe psychological illnesses

Primary outcomes:
measure: The Numerical Rating Scale (NPRS-11)
timeFrame: Change from baseline pain score at 3th day
measure: Range of Motion
timeFrame: Change from baseline range of motion at 3th day
measure: Global Rating of Change scale (Patient Satisfaction)
timeFrame: Change from baseline Global Rating of Change scale at 3th day
Secondary outcomes:
measure: Neck disability index
timeFrame: Change from baseline disability scale at 3th day
measure: Pressure Pain Threshold
timeFrame: Change from baseline Pressure Pain Threshold at 3th day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nuray ALACA
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
References:
Clinical trial NCT01959061: Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
Official title: Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer Metastatic
Keywords: Advanced colorectal cancer of liver metastatic
Lead sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

Detailed description: evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma
2. Disease limited to the liver Unresectable disease by surgery or other local therapies
3. Age \>18 years
4. ECOG performance status 0-2,Child pugh A or B
5. Expected survival ≥ 3 months
6. Adequate hematological, hepatic, and renal function

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with severe organ dysfunction or failure
3. With severe cardiovascular disease, or mental
4. Extraliver metastases

Primary outcomes:
measure: Progression-free survivial
timeFrame: 8 months after last patient randomized
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianhua Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06561061: Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)
Official title: Zinc for Infection Prevention in Sickle Cell Anemia-2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Sickle Cell Disease
Keywords: Zinc
All-cause infections
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Global Health Uganda LTD
name: Makerere University
First posted: 2024-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized double-blinded placebo-controlled trial
Primary purpose: PREVENTION

Brief summary: A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA)

Detailed description: The study will be a randomized, placebo-controlled, double blind clinical trial in which 100 Ugandan children 1.00-4.99 years of age with SCA will receive zinc (20 mg oral dispersible tablet daily) or placebo (identical to zinc in appearance) for 6 months. The primary study outcome will be incidence of infection (all causes).

Eligibility criteria: Inclusion Criteria:

* Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
* Age range of 1.00-4.99 years, inclusive, at the time of enrollment
* Weight at least 5.0 kg at the time of enrollment
* Willingness to comply with all study-related treatments, evaluations, and follow-up
* Children whose parents or guardians give full written informed consent

Exclusion Criteria:

* Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
* Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \<-3, using WHO growth standards)
* Absolute neutropenia (absolute neutrophil count \<500)

Primary outcomes:
measure: Incidence of all-cause infections in the zinc vs. placebo groups
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of infections requiring hospitalization
timeFrame: 6 months
measure: Incidence of adverse events requiring discontinuation of study drug
timeFrame: 6 months
measure: Incidence of stroke or death
timeFrame: 6 months
Other outcomes:
measure: Change in Transcranial Doppler (TCD) velocity from enrollment to 6-month study endpoint
timeFrame: 6 months
Locations:
city: Jinja
country: Uganda
facility: Jinja Hospital
Study officials:
affiliation: Indiana University
name: Chandy C John, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390961: Comparison of Tolerability Between Two Allergy Drops
Official title: Comparison of Tolerability Between Two Allergy Drops
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: Hom, Milton M., OD, FAAO
Sponsor class: INDIV
Collaborators: name: Allergan
First posted: 2011-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comfort is compared between two allergy drops


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and over inclusive.
* Males or females
* Patient is in generally good \& stable overall health.
* Patient likely to comply with study guidelines \& study visits.
* Informed consent signed.
* History of allergic conjunctivitis
* Current symptoms of allergic conjunctivitis assessed by the investigator

Exclusion Criteria:

* Corneal refractive surgery or contact lens wear within 6 months of this study.
* Current use of Restasis
* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
* Pregnant or lactating women.
* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Primary outcomes:
measure: Tolerability
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Azusa
country: United States
facility: Milton M. Hom, OD, FAAO.
state: California
Study officials:
References:
Clinical trial NCT03923361: Neural and Antidepressant Effects of Propofol (Phase 2)
Official title: Neural and Antidepressant Effects of Propofol (Phase 2)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Treatment Resistant Depression
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.


Eligibility criteria: Inclusion Criteria:

* Age 18-55
* Diagnosis of major depressive disorder or bipolar disorder
* Current moderate-to-severe depressive episode
* Episode duration more than 2 months and less than 5 years
* Failure of at least 2 adequate antidepressant medication trials within the past 2 years
* Body mass index \< 40
* 16-item Quick Inventory of Depressive Symptomatology, self-rated \> 10

Exclusion Criteria:

* Contraindication to propofol or midazolam
* Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
* Symptomatic coronary artery disease or heart failure
* Poorly controlled hypertension or diabetes
* Abnormal kidney or liver function
* Pregnant or breast feeding
* Traumatic brain injury or significant neurologic signs (past year)
* Substance use disorder (past year)
* Obsessive compulsive disorder (current)
* Post-traumatic stress disorder (current)
* Schizophrenia-spectrum disorder (lifetime)
* Neurocognitive disorder (current)
* Personality disorder as a current focus of treatment
* ECT within the past 3 months
* Inappropriate for ECT, or poor response to ECT within the past 5 years
* Incompetent to provide consent

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 3 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Univeristy Neuropsychiatric Institute
state: Utah
Study officials:
References:
Clinical trial NCT05743361: Security Efficacy COVID-19 Vaccination
Official title: Studio Sierologico in Volontari Vaccinati Contro COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune State
SARS-CoV-2 Infection
Keywords: SARS-CoV-2
Vaccine
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare workers undergoing SARS-CoV-2 vaccination

Brief summary: Preliminary data support a possible molecular mimicry between SARS-CoV-2 and autologous components. This suggests the occurrence of autoimmunity during COVID-19. Consistently, autoimmunity may occur after SARS-CoV2 vaccination. The study aims to investigate the production of autoantibodies after vaccination in healtcare workers.

Detailed description: Healtcare workers undergoing SARS-CoV-2 vaccination (with RNA-vaccines) will be included on a voluntary basis. Blood samples will be collected before and after vaccination (1 -3 - 6 - 12 months). All the vaccination side effects will be registered.

Eligibility criteria: Inclusion Criteria:

* Healthcare workers undergoing SARS-CoV-2 vaccination

Exclusion Criteria:

* Pregnancy
* Full blown autoimmune diseases
* Active vaccinations within 3 months before enrolment (excluding the influenza vaccine)
* Previous vaccination severe side effects

Primary outcomes:
measure: Change in Autoantibody Levels
timeFrame: Before vaccination and 1, 6 and 12 months after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
affiliation: Istituto Auxologico Italiano IRCCS
name: Pierluigi Meroni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06116461: Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
Official title: Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Melanoma
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 34
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: Patients with advanced melanoma are, amongst others, currently treated with nivolumab monotherapy or with nivolumab and ipilimumab followed by nivolumab. Even though registration studies administered nivolumab in a 3 mg/kg 2 weekly scheme, currently, nivolumab monotherapy is either administered in a 240 mg 2-weekly scheme or in a 6 mg/kg or 480 mg 4-weekly scheme. With the current dosing regimen, steady-state is achieved after approximately 5 to 6 months, whereas a tumour response is usually observed earlier in patients with metastatic melanoma. Moreover, PD-1 receptor occupancy is almost saturated above doses of 0.3 mg/kg, or at nivolumab serum levels of 10 mg/L, which is a concentration that is achieved after one treatment cycle. In melanoma patients, the additional probability on response in patients treated with 3 mg/kg compared to 1 mg/kg seems limited. PFS and OS for 3 mg/kg were not superior to 1 mg/kg. Therefore, in this study, our aim is to investigate nivolumab trough levels and pharmacokinetic parameters after 3 reduced nivolumab doses.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Advanced or metastatic melanoma
* Current treatment with nivolumab for advanced or metastatic melanoma, in a 6 mg/kg or 480 mg, 4 weekly scheme
* Documented confirmed and ongoing CR, PR or SD according to RECIST v1.1
* On treatment for at least 6 months

Exclusion Criteria:

* Unable to draw blood for study purposes
* Patients willing to participate or already included in the SAFE-STOP trial

Primary outcomes:
measure: Difference between the nivolumab mean trough level after 3 reduced doses (240 mg every 4 weeks) and after the first dose of 6 mg/kg or 480 mg.
timeFrame: Through study completion, an average of four months
Secondary outcomes:
measure: - PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses
timeFrame: Through study completion, an average of four months
measure: Grade ≥3 adverse events (CTCAE) during reduced doses
timeFrame: Through study completion, an average of four months
measure: Number of patients with new PD during 3 reduced doses
timeFrame: Through study completion, an average of four months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Pending
Study officials:
References:
Clinical trial NCT02573961: Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females
Official title: Laser Acupuncture Versus High Protein/Low Carbohydrate Diet on Endothelial Markers in Obese Females. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of laser acupuncture and high protein low carbohydrate diet on the treatment of obesity and lowering of endothelial markers.

Detailed description: Sixty females above 20 years of age with a body mass index (BMI) of over 30 kg/m2 will be divided into three groups (20 in each): two experimental groups (laser; high protein low carbohydrate diet) and control. Each subject will receive the treatment relevant to their group, in addition to obtaining 3 days dietary recalls and measurements including BMI, serum insulin and endothelial markers. Laser and control group will receive 24 activated or sham laser acupuncture treatments. High protein low carbohydrate group will be instructed to take a tailored high protein/low carbohydrate diet.

Eligibility criteria: Inclusion Criteria:

* obese females of BMI more than 30 kg/m2, and
* of age range from 20 to 50 years.

Exclusion Criteria:

* medical history of chronic diseases,
* pregnancy,
* photosensitivity reactions to laser treatment,
* a pacemaker,
* medications known to affect one's weight up to 1 month in advance, or
* are unwilling to comply with the study protocol.

Primary outcomes:
measure: weight loss
timeFrame: 8 weeks
Secondary outcomes:
measure: decrease cardiovascular risks
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: Giza
Study officials:
affiliation: National Research Centre, Egypt
name: Neveen H Abou El-Soud, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziccardi P, Nappo F, Giugliano G, Esposito K, Marfella R, Cioffi M, D'Andrea F, Molinari AM, Giugliano D. Reduction of inflammatory cytokine concentrations and improvement of endothelial functions in obese women after weight loss over one year. Circulation. 2002 Feb 19;105(7):804-9. doi: 10.1161/hc0702.104279.
citation: Soenen S, Bonomi AG, Lemmens SG, Scholte J, Thijssen MA, van Berkum F, Westerterp-Plantenga MS. Relatively high-protein or 'low-carb' energy-restricted diets for body weight loss and body weight maintenance? Physiol Behav. 2012 Oct 10;107(3):374-80. doi: 10.1016/j.physbeh.2012.08.004. Epub 2012 Aug 19.