louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00621010: Safety Study of CTS21166 to Treat Alzheimer Disease
Official title: A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: CoMentis
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 56
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adult male \> age 21;
* non-smoker (minimum 6 months);

Exclusion Criteria:

* History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease
* History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
* Participation in another clinical trial within 30 days prior to dosing

Primary outcomes:
measure: To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
Secondary outcomes:
measure: To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
affiliation: CoMentis
name: Henry Hsu, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03419910: An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
Official title: An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index 18.0 to 32.0 kg/m2
* Weight ≥ 50 kg

Exclusion Criteria:

* Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
* History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
* Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* History of administration of live vaccines within 60 days before screening
* Any history or risk for tuberculosis (TB)

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 24 hours
measure: Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
timeFrame: 24 hours
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 20 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02633410: Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction
Official title: Prospective Randomized Clinical Study Comparing Anteromedial Portal Versus Transtibial Technique for Femoral Tunnel Positioning in Anterior Cruciate Ligament Reconstruction With Hamstring Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Panam Clinic
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2015-12-17
Enrollment: 96
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Detailed description: The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Eligibility criteria: Inclusion Criteria:

* sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention

Exclusion Criteria:

* concomitant collateral ligament tears
* significant chondromalacia (based on diagnostic imaging)
* previous lower limb surgery
* significant injury to either lower limb requiring surgery
* history of arthritis
* were unable to comply with rehabilitation protocols or study follow-ups
* were pregnant females or had other medical conditions which precluded participation.

Primary outcomes:
measure: Anterior cruciate ligament quality of life
timeFrame: 24-months postoperative
Secondary outcomes:
measure: KT-1000
timeFrame: 24-months post-operative
measure: Knee range of motion
timeFrame: 24-months post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Pan Am CLinic/University of Manitoba
name: Peter MacDonald, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04171310: Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
Official title: An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-11-20
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To determine the excretion balance and systemic exposure of radioactivity after oral administration of \[14C\]-SAR442168.

To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure of radioactivity.

To collect samples in order to determine the metabolic pathways of SAR442168 and identify the chemical structures and main excretion route of the main metabolites (samples will be analyzed according to metabolic analysis plan and results will be documented in a separate report).

Secondary Objective:

To assess the clinical and biological tolerability of an oral solution of SAR442168.

Detailed description: Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.

Eligibility criteria: Inclusion criteria :

Healthy male subjects 30 to 65 years of age. Body Mass Index 18 up to 32 kg/m2, inclusive. Signed informed consent. Subjects must agree to the use of an adequate method of contraception for up to 3 months after discharge from the clinical unit

Exclusion criteria:

Radiation exposure exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last five years (including diagnostic X-rays and other medical exposures).

Occupationally exposure to radiation (as defined in the Ionizing Radiations Regulations 2017).

Irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days) .

Social habits: smoking, alcohol abuse, drug abuse etc.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of radioactive dose excreted in urine and feces
timeFrame: Day 1 to Day 43
Secondary outcomes:
measure: Number of subjects with Adverse events
timeFrame: From Day -1 to 43
measure: Blood/plasma radioactivity ratio
timeFrame: Day 1 up to Day 43
measure: Blood/plasma radioactivity ratio
timeFrame: Day 1 up to Day 43
measure: Plasma SAR442168 /radioactivity ratio
timeFrame: Day 1 up to Day 43
measure: Plasma SAR442168 /radioactivity ratio
timeFrame: Day 1 up to Day 43
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Investigational Site Number 8260001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT04937010: Occipital Nerve Stimulation in Trigeminal Autonomic Cephalgias
Official title: Efficacy and Safety of Occipital Nerve Stimulation in Trigeminal Autonomic Cephalalgias: A Double-blind, Phase II, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Autonomic Cephalgia
Keywords: Occipital Nerve Stimulation
Lead sponsor: Alberta Health Services, Calgary
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the efficacy of occipital nerve stimulation (ONS) in the treatment of chronic trigeminal autonomic cephalalgias (TACs).

Detailed description: Several open studies and case series have shown improvement in pain scores using ONS specifically for cluster headache, which is the most common of the TACs. However, neuromodulation in the treatment of pain disorders is subject to strong placebo effect and bias, and the lack of controlled studies in this population makes its true efficacy unknown. Therefore, we plan to study ONS in a population of patients with chronic TACs using a double-blind, randomized, controlled, cross-over study. Using sub-threshold stimulation parameters, meaning patients will not know when therapeutic stimulation is active, subjects will rate their pain and quality of life during both therapeutic and sham stimulation periods. Following the cross-over period, all subjects will undergo therapeutic stimulation for 1-year in order to gauge long-term effects.

Eligibility criteria: Inclusion Criteria:

* Meets ICHD-3 diagnostic criteria for the chronic form of one of the trigeminal autonomic cephalgias (outlined below), as determined by the treating neurologist.
* Failed standard medical management, meaning at least 3 conventional preventative therapies.

Exclusion Criteria:

* Presence of uncontrolled or untreated psychiatric disease
* Presence of medical contraindications to surgery
* Patient does not consent to surgery
* Non-English speaking

Primary outcomes:
measure: Change in headache frequency
timeFrame: 6 months
Secondary outcomes:
measure: Safety of Occipital Nerve Stimulation
timeFrame: 6 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT03105310: Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
Official title: Pegylated Interferon Alone or in Combination With Ezetimibe for Patients With Chronic Hepatitis D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis D, Chronic
Keywords: Hepatitis D
Ezetimibe
Pegylated interferon
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 20
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: Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry, that include two hydrophobes and one hydrogen bond acceptor.

The aim of the study io evaluate the utility of Ezetimibe in combination with pegylated interferon in patients with chronic HDV infection.


Eligibility criteria: Inclusion Criteria:

* Presence of anti-HDV in serum
* Presence of quantifiable HDV RNA in serum
* Elevated ALT \> ULN

Exclusion Criteria:

* Decompensated liver disease
* Patients with ALT levels greater than 10 times ULN (400 U/L)
* Pregnancy or inability to practice adequate contraception.
* Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR \<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
* Systemic immunosuppressive therapy
* Evidence of another form of liver disease in addition to viral hepatitis
* Active substance abuse, such as alcohol or injection drugs
* Hepatocellular carcinoma
* Concurrent hepatitis C infection or HIV coinfection
* Diagnosis of malignancy in the five years
* Concurrent usage of statins
* Concurrent use of any other drug known to inhibit NTCP
* Inability to understand or sign informed consent

Primary outcomes:
measure: Change in HDV RNA quantitative measurements of >2 logs from baseline
timeFrame: 24 weeks of therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01287910: Transmyocardial Laser Revascularization and Cardiovascular Magnetic Resonance Imaging
Official title: Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Angina
Chest Pain
Keywords: Cardiac
Angina
Chest pain
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
First posted: 2011-02-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years of age or over
* Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
* Ejection fraction 25% or greater
* Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
* Ability and willingness to consent and Authorization for use of PHI

Exclusion Criteria:

* Patient cannot undergo a surgical procedure or general anesthesia
* Patient not eligible for CMR study
* Severe unstable angina
* Q-wave MI within 3 weeks prior to TMR
* NQWMI within 2 weeks prior to TMR
* Decompensated heart failure (class III/IV) at the time of procedure
* Known increased bleeding risk
* Implanted pacemaker or defibrillator
* Clinically unstable arrhythmia
* Not able or willing to adhere to the study tests and procedures
* Inability or unwillingness to consent and Authorization for use of PHI

Primary outcomes:
measure: Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
Study officials:
affiliation: Piedmont Heart Institute
name: Morris Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537210: Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
Official title: Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Aminosalicylic Acid
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth Hospital, Hong Kong
name: Alice Ho Miu Ling Nethersole Hospital
name: Tseung Kwan O Hospital, Hong Kong
First posted: 2015-09-01
Enrollment: 177
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 study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.

Detailed description: This is a randomized, double-blind, controlled trial in which patients with long-standing clinically inactive UC receiving ASA for maintenance of remission will be randomized to either continue 5-ASA or to receive an equivalent placebo for 12 months. The primary endpoint is clinical relapse at 12 months.

Eligibility criteria: Inclusion Criteria:

* have a confirmed diagnosis of UC according to established clinical, endoscopic and histologic criteria
* in long-standing clinical remission
* written informed consent

Exclusion Criteria:

* allergic to mesalazine
* prior bowel surgery except appendectomy
* hepatic or renal dysfunction
* malignant disease within 5 years
* pregnancy or breast feeding or women of child-bearing age without regular use of contraception
* on anti-tumor necrosis factor therapy
* terminal illness

Primary outcomes:
measure: The differences of relapse rates between the two arms
timeFrame: 12 months
Secondary outcomes:
measure: Patients' drug compliance
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Siew Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03535610: Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Official title: Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Leiomyoma
Keywords: Embolization
Uterine Leiomyoma
Embospheres
Microspheres
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-arm, open label study
Primary purpose: TREATMENT

Brief summary: To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).


Eligibility criteria: Inclusion Criteria:

* female patients from 18 to 50 years old;
* symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
* patient agrees with study procedures;
* patient signs the informed consent form.

Exclusion Criteria:

* asymptomatic women;
* isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
* leiomyoma diameter higher than 10 cm;
* leiomyoma above the umbilical scar;
* endometrial neoplasia or hyperplasia or presence of any malignancy
* pregnant or breast feeding women;
* active vasculitis;
* pelvic irradiation history;
* uncontrolled coagulopathies;
* renal insufficiency;
* contrast allergy;
* concomitant use of GnRH analogues.

Primary outcomes:
measure: Uterine Volume Reduction
timeFrame: 6 months
measure: Fibroid Reduction
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Improvement
timeFrame: 6 months
measure: Ovarian Function
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Certa Centro de Referência em Tratamentos Avançados
state: SP
Study officials:
References:
Clinical trial NCT02820610: Intraperitoneal Analgesia in Pediatric Laparoscopy
Official title: Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 97
Sex: MALE
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.

Detailed description: Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain.

additionally poor pain control could limit the activity of children following laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

1. age (1 to 6 years)
2. ASA physical status I or II.
3. scheduled for laparoscopic hernia repair under general anesthesia.

Exclusion Criteria:

1. Allergy to study drugs,
2. Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
3. sever hepatic or renal impairment,

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hr
Secondary outcomes:
measure: the functional recovery
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Faculty of Medicine Assuit University
state: Assuit
Study officials:
References: