louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05276076: A Prospective, Open Label, Dose-escalation, SAD/MAD, Multicenter, 24weeks, Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamics of Investigational Product (VM-001) in Patients With Graft-versus-host Disease(GvHD)
Official title: A Prospective, Open Label, Dose-escalation, SAD/MAD, Multicenter, 24weeks, Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamics of Investigational Product (VM-001) in Patients With Graft-versus-host Disease(GvHD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Graft Versus Host Disease
Lead sponsor: ViGenCell Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study is multi center, phase I/IIa clinical trial to evaluate the safety and pharmacodynamics of investigational Product (VM-001) in patients with graft-versus-host disease(GvHD). A total of 12 subjects (Part 1 SAD\[3 cohort(2 subjects/cohort)\], Part 2 MAD\[2 cohort(3subjects/cohort)\]) are recruited.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥19 years of age
* Acute GvHD or chronic GvHD after hematopoietic stem cell transplant
* Subjects who no longer have available standard treatment.
* ANC≥1,000cells./mm\^3
* AST, ALT, total bilirubin less than 3 times the upper limit of normal
* serum creatinine less than 1.5 times the upper limit of normal

Exclusion Criteria:

* Received an anti-thymocyte globulin(ATG) within 14 days before enrollment
* FCV or FEV less than 70%
* Any uncontrolled infection or active infection requiring ongoing systemic treatment
* Received an investigational agent within 6 months before enrollment.
* Evidence of bleeding diathesis or coagulopathy.
* Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
* Breastfeeding or pregnant.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of VM-001 [ Time Frame: 1 week ]
timeFrame: 7 day cycle
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea
name: Chang-Ki Min, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920776: Focused Ultrasound in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Keywords: critical ultrasound
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that lung ultrasound and echocardiography will benefit the septic shock patients by making the treatment more precisely and rapidly. Septic shock patients from multicenter will be enrolled in the study. They will be randomly divided into two groups. The routine treatment group will receive routine treatment according to the SSC guideline. The study group will receive additional ultrasound examination, which will decide the improvement of therapy. Therapy change based on ultrasound results and the prognosis will be recorded.


Eligibility criteria: Inclusion Criteria:

* age\>18yr
* survive more than 24hrs
* fulfilled septic shock

Exclusion Criteria:

* age \< 18yr
* pregnant
* DNR

Primary outcomes:
measure: mortality
timeFrame: 28day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital ICU
Study officials:
References:
citation: Du W, Wang XT, Long Y, Liu DW. Efficacy and Safety of Esmolol in Treatment of Patients with Septic Shock. Chin Med J (Engl). 2016 Jul 20;129(14):1658-65. doi: 10.4103/0366-6999.185856.
Clinical trial NCT03426176: The Interaction Between Oxytocin and Serotonin
Official title: The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: oxytocin
acute tryptophan depletion
emotion
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)

Detailed description: Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

Eligibility criteria: Inclusion Criteria:

* health subjects without past or current psychiatric or neurological disorders
* Right-handedness

Exclusion Criteria:

* History of head injury;
* Medical or psychiatric illness.
* High blood pressure, general cardio-vascular alterations
* History of drug or alcohol abuse or addiction.
* Allergy against medications or general strong allergies
* Sleep disorders.
* Visual or motor impairments

Primary outcomes:
measure: Neural processing during the emotion processing as assessed via fMRI
timeFrame: 6h after treatment
measure: Neural processing during the resting state as assessed via fMRI
timeFrame: 6h after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology
state: Sichuan
Study officials:
References:
Clinical trial NCT04737876: A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults
Official title: A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of Orally Administered BX002-A in Healthy Adult Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: BiomX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of study BMX-02-001 is to evaluate the safety, tolerability and feasibility of orally administered BX002-A to deliver viable bacteriophages to the gut.

Detailed description: Study BMX-02-001 is a randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and feasibility of orally administered BX002-A to deliver viable phages that can be measured in the stool.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults 18-65 years old
2. Able to understand study procedures and sign informed consent

Exclusion Criteria:

1. Evidence or history of clinically significant underlying conditions
2. Women who are pregnant or nursing, or plan to become pregnant during study, or women of childbearing potential not using adequate contraceptive measures
3. History of constipation, severe diarrhea and/or loose stools within 14 days
4. History of procedures aimed at modifying the gastrointestinal microbiota within past year (e.g., fecal microbiota transplantation)
5. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior or planned during study
6. Use of bowel cleansing or preparation in the 4 weeks prior or planned during study
7. Participation in another investigational trial within 30 days
8. Known allergy or hypersensitivity to an excipient in the study drug or placebo
9. Any other reason which according to investigator may impact proper study conduct
10. History of alcohol abuse; drug or medication abuse or tobacco use
11. Subject who cannot be contacted in case of emergency

Primary outcomes:
measure: Safety and Tolerability: adverse events
timeFrame: Through study completion Day 31 (+ 2 days)
Secondary outcomes:
Other outcomes:
measure: Plaque-Forming Unit analysis
timeFrame: Day -1 through Day 6
Locations:
city: Cincinnati
country: United States
facility: Medical Facility
state: Ohio
Study officials:
affiliation: BiomX, Inc.
name: Physician
role: STUDY_DIRECTOR
References:
Clinical trial NCT00313976: Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Official title: A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Early secondary progressive Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 0
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 the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS for no less than one year and no longer than ten years
* Disease in the secondary progressive (SP) phase
* At least one relapse the last 3 years
* Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months

Exclusion Criteria:

* Serious or acute heart disease
* Severe depression
* Serious or acute liver, kidney or bone marrow dysfunction
* Epilepsy not adequately treated
* Pregnancy or lactation
* Alcohol or drug abuse

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI): T2-lesions
timeFrame: At week 104
Secondary outcomes:
measure: Further Magnetic Resonance Imaging (MRI) parameters
timeFrame: At week 104
measure: Relapses
timeFrame: At week 104
measure: Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
timeFrame: At week 104
measure: Hospitalizations
timeFrame: At week 104
measure: Neutralizing antibodies
timeFrame: At week 104
measure: Adverse events
timeFrame: At week 104
Other outcomes:
Locations:
city: ask Contact
country: Denmark
city: Copenhagen
country: Denmark
city: Hillerød
country: Denmark
city: Holstebro
country: Denmark
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06274476: Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement
Official title: Short-Term Evaluation of Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement: Non-randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Maxillary Ridge and Mandibular Ridge
Keywords: implant
knife-edge ridge
ridge expansion
piezoelectric
implant-supported prosthesis
prosthetic complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: maxillary and mandibular atrophic ridge
Primary purpose: OTHER

Brief summary: evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.

Detailed description: twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique. The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders. Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla. Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading). Crestal bone levels were measured at different times: T0, TL, and T12 (12 months). Evaluation of prosthetic and surgical complications was carried out. Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.

Eligibility criteria: Inclusion Criteria:

* ridge of 2 to 4 mm of initial alveolar crest width
* bone height of at least 8 mm from vitastructures

good oral hygiene.

Exclusion Criteria:

patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.

Primary outcomes:
measure: implant success
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Mohamed yahia Sharaf
state: Sharkia
Study officials:
References:
Clinical trial NCT04059276: CNS Changes Following Stroke
Official title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke and healthy subjects.

Brief summary: The objective of this study is to better understand the structural and functional changes that the CNS undergoes following stroke and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in stroke patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms.

In terms of functional plasticity, we will combine fMRI with behavioural motor and sensory testing to understand i) the structural and functional interplay between spinal and supraspinal neural circuits after stroke possibly driven by beneficial plasticity/regeneration vs. maladaptive plasticity/degeneration and ii) which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.


Eligibility criteria: Inclusion Criteria - Patients:

* Age 18-80
* Stroke (\> 3months)
* Signed informed consent

Exclusion Criteria - Patients:

* Contraindications to magnetic resonance imaging
* Neurological impairment of body function impairments not induced by stroke
* BMI \> 40
* Pregnancy
* Claustrophobia

Inclusion Criteria - Healthy subjects:

* Age 18-80
* Signed informed consent

Exclusion Criteria - Healthy subjects:

* Contraindications to magnetic resonance imaging
* Pregnancy
* Neurological illness
* Impairment of body function induced by stroke
* Claustrophobia
* BMI \>40

Primary outcomes:
measure: Conventional magnetic resonance imaging (MRI) parameter
timeFrame: Up to 50 weeks]
Secondary outcomes:
measure: Magnetic resonance spectroscopy (MRS) parameter
timeFrame: Up to 50 weeks
measure: Functional MRI (fMRI) parameter
timeFrame: Up to 50 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03535376: Bariatric Surgery and Pharmacokinetics of Valsartan
Official title: Bariatric Surgery and Pharmacokinetics of Valsartan: BAR-MEDS Valsartan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Valsartan
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Valsartan concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082076: Prevention of Shivering Associated With Spinal Anesthesia
Official title: Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Shivering, Spinal Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy


Eligibility criteria: Inclusion Criteria:

- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

* Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.

Primary outcomes:
measure: Incidence of shivering
timeFrame: During operation time
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Essam Ez Abdelhakeem, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Seham Mo Moeen, Professor
role: STUDY_DIRECTOR
References: