louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00160511: A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel-group, 16 Week, Multicenter Trial Evaluating the Efficacy and Safety of Levetiracetam 500 mg Tablets in Bid Administration (Daily Dose Ranging From 1000 mg to 3000 mg), in Adults (≥ 18 Years of Age) Suffering From Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Keywords: Postherpetic Neuralgia (PHN)
Levetiracetam
Keppra
Nerve Pain
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.


Eligibility criteria: Inclusion Criteria:

* male or female outpatient greater than or equal to 18 years of age.
* suffering presently from neuralgia, which has been present for at least 3 months since healing of acute herpes zoster skin rash.
* PHN pain at entry into the study must meet the following criteria: a VAS of at least 40 mm at visit 2 (to assess pain intensity during the past week) and with an average daily score of at least 4 on the PIS during the baseline period as evaluated on a minimum of 4 days.
* an estimated creatinine clearance of at least 50 ml/min.

Exclusion Criteria:

* receiving professional psychological support (such as cognitive behavioral therapy) currently or within 2 weeks prior to visit 1 specifically for coping with PHN.
* previous neurolytic or neurosurgical therapy for PHN, at any time in the subject's history or treatment with TENS (transelectroneuro stimulation) currently or within the past 2 weeks.
* known co-existent source of pain or painful peripheral neuropathy.
* known significant neurological disorder other than the study disease or a condition which can mimic stroke with distal neurological deficit (amyotrophy, radiculopathy, history of TIAs, multiple sclerosis, or any amputations).
* conditions known to be associated with immunosuppressive states.
* clinically significant major depression defined as a Beck Depression Inventory Score \> 21 at selection including those with a history of Bipolar Disorder.

Primary outcomes:
measure: Assess efficacy of levetiracetam in the treatment of Post Herpetic Neuralgia by measuring the absolute change in the average weekly Pain Intensity Scale (PIS).
Secondary outcomes:
measure: Assess the efficacy, safety and tolerability of levetiracetam in the treatment of Post Herpetic Neuralgia; Reduction in the mean PIS over the last week of the evaluation period compared to the baseline period.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04269811: Flu-Bu-Mel Conditioning Regimen for Myeloid Disease
Official title: Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapse Rate After Allo-HSCT
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 49
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

Detailed description: For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

Eligibility criteria: Inclusion Criteria:

* acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome
* patients with HLA matched sibling, unrelated or Haplo-identical donor

Exclusion Criteria:

* patients with active infection
* patients with abnormal liver function damage: ALT/AST above 2X normal range
* patients with abnormal renal function damage Scr\>160µmol/L;
* patients with insufficient pulmonary function (FEV1，FVC，DLCO\<50%）and heart failure or with EF \<50%)
* patients with mental instability or unwilling to give inform consent

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: 1 year after transplantation
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 1 year after transplantation
measure: Relapse rate
timeFrame: 1 year after transplantation
measure: non-relapse mortality (NRM)
timeFrame: 1 year after transplantation
measure: acute graft versus host disease (aGVHD)
timeFrame: day 180 after transplantation
measure: chronic graft versus host disease (cGVHD)
timeFrame: 1 year after transplantation
measure: relapse free survival (GRFS)
timeFrame: 1 year after transplantation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
city: Shanghai
country: China
facility: Shanghai No6 Hospital
Study officials:
affiliation: Head BMT program, Rui Jin Hospital
name: Jion HU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05963711: The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation
Official title: The Penile Microbiome in Partners of Women with Recurrent BV and Its Response to Decolonization Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Microbial Colonization
Keywords: Penile microbiome
Vaginal microbiome transplant
Male partners
Bacterial vaginosis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In those with BV-associated penile microbiome, a decolonization attempt will be conducted, (daily wash for 5 days with chlorhexidine gluconate 4%). if decolonization fails, an antibiotic cream will be used to eradicate BV associated bacteria.
Primary purpose: DIAGNOSTIC

Brief summary: There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.

Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.

This study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.


Eligibility criteria: Inclusion Criteria:

* The subject has s female partner who participates in VMT study ( NCT04517487).
* The subject is defined by the woman as her male regular partner.
* Willing to use a condom as instructed by the protocol.
* Willing to comply with decolonization protocol.

Exclusion Criteria:

* A known skin disease involving the penile skin.
* A known sensitivity to chlorhexidine gluconate
* Any of the partners (female/male) has more than one sexual partner.

Primary outcomes:
measure: Penile microbiome composition
timeFrame: 1 year
measure: Penile microbiome composition after disinfection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT01010711: Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Official title: Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine
Keywords: migraine
children
dietary supplement
q10
prevention
Lead sponsor: Complen Health GmbH
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 76
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).

Detailed description: Children or adolescents with migraine and both parents are informed in detail about the study.Probands are advised to fill in a special childrens´ diary for migraine daily. After a 4 week-run-in period they start to take the dietary supplement (powder to be dissolved in water)plus a capsule with omega-3-fatty acids from fish oil for 12 weeks daily. Afterwards there is a follow-up without supplement treatment for another 12 weeks.76 participants will be included in the trial for statistical evaluation.

Eligibility criteria: Inclusion Criteria:

* at least 3 days of migraine per month

Exclusion Criteria:

* not able to communicate in german or english language
* any disease that forbids the participation in the trial according to the investigators assessment
* pregnancy
* no willingness to participate in the trial
* known allergy to fish or soya

Primary outcomes:
measure: number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement
timeFrame: headaches before and after 12 weeks of treatment
Secondary outcomes:
measure: frequency, duration and intensity of the migraine
timeFrame: before and after 12 weeks of treatment
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26,
state: Nordrhein-Westfalen
city: Königstein Im Taunus
country: Germany
facility: Migräne und Kopfschmerzklinik Königstein
Study officials:
affiliation: Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, D-45147 Essen
name: Charly Gaul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618111: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
Official title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Prevention of nausea and vomiting associated with radiation or chemotherapy
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess bioequivalence of a potential generic 1 mg granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet, Kytril, following a single 1 mg dose, under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to granisetron or any other comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, 4-period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services
state: Nebraska
Study officials:
affiliation: MDS Pharma Services
name: James Kissling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560611: A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery
Official title: The Somatic-to-cerebral Oxygen Saturation Gradient as a Non-invasive Index of Anaerobic Threshold in High-risk Cardiac Surgical Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgical Procedures
High-risk Surgical Patient
Anaerobic Threshold
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgical procedures under cardiopulmonary bypass in Strasbourg University Hospital

Brief summary: In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yo
* Cardiac surgical procedure under cardiopulmonary bypass
* High-risk surgical patient fulfilling one of the following items:

  * Euroscore \>= 6
  * Ejection fraction \< 40%
  * Creatinine clearance \< 40mL/min
  * Pulmonary arterial pressure \> 45mmHg
* Signed informed consent
* Social security affiliation

Exclusion Criteria:

* Emergency situation
* Patient on ECMO
* Pregnancy or lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Pôle d'anesthésie réanimation - Nouvel Hôpital Civil
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Julien POTTECHER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02564211: Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)
Official title: A Phase III, Multicenter, Open-label Long-term Treatment Trial to Assess the Safety and Efficacy of Addition of Ipragliflozin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Sitagliptin Monotherapy in Addition to Diet and Exercise Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-09-30
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.


Eligibility criteria: Inclusion Criteria:

* Has Type 2 diabetes mellitus
* Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
* Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
* Currently has a urinary tract infection or genital infection with subjective symptom

Primary outcomes:
measure: Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
timeFrame: Up to 54 weeks
measure: Percentage of Participants Who Had Study Drug Discontinued Due to an AE
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS, Kaufman KD. Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on sitagliptin. Diabetes Obes Metab. 2021 Sep;23(9):2099-2108. doi: 10.1111/dom.14448. Epub 2021 Jun 15.
Clinical trial NCT05833711: Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (IIM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dermatomyositis
Polymyositis
Idiopathic Inflammatory Myopathies
Lead sponsor: Immunoforge Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-27
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Froniglutide in Patients With Idiopathic Inflammatory Myopathy ("FROniGlutide Study")


Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of IIM (DM or polymyositis \[PM\]) as per Bohan and Peter classification criteria
* MMT-8 ≤125 units and two out of the following CSM items, or MMT-8 \>125 units and three out of the following CSM items, together with verifiable muscular weakness A. PGA VAS ≥2 cm B. SGA VAS ≥2 cm C. HAQ-DI ≥0.25 D. Extramuscular activity (MDAAT) ≥2 cm E. Increase in one or more muscle enzyme (CK, LDH, AST, ALT, aldolase) values (must be ≥1.3 × ULN)
* On treatment with standard of care (immunosuppressants and/or corticosteroids) for \>12 weeks and on stable therapy for at least 4 weeks

Key Exclusion Criteria:

* Inclusion body myositis (IBM) or amyopathic DM
* Severe muscle damage (myositis damage index \[MDI\] \>7/10 cm). Permanent deterioration caused by reasons other than PM/DM, or myositis with cardiac involvement
* Clinically significant renal/hepatic impairment
* Severe interstitial lung disease requiring supportive oxygen therapy

Primary outcomes:
measure: IMACS-TIS Moderate Improvement at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: IMACS-TIS Minimal Improvement at Week 4, 8, 12, 16, 24
timeFrame: Week 4, 8, 12, 16, 24
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References:
Clinical trial NCT03220711: Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
Official title: Study of Performance of Confocal Endomicroscope With Fluorescein Imaging Agent in the Colon
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colonic Dysplasia
Adenomatous Polyps
Irritable Bowel Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The overall aim of this research project is to evaluate the imaging performance of a confocal endomicroscope. Fluorescein, an FDA-approved topical fluorescent dye, will be used to provide topical mucosal contrast. The purpose of this instrument is to provide real-time endoscopic "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group. This endomicroscope probe will be used during colonoscopies in subjects with colonic dysplasia, known colonic adenomatous polyps scheduled for endoscopic resection, or suspected dysplasia in subjects with Inflammatory Bowel Disease (IBD).

Detailed description: The device is being tested in small groups of individuals: generally less than 10 for each of a variety of histologically different colonic lesions or diseases (eg. IBD, adenomas, sessile seriated adenomas (SSAs), hyperplastic polyps, normal tissue).

Eligibility criteria: Inclusion Criteria:

Subject meets at least one of the following criteria:

* At increased risk for colorectal cancer and colonic polyps
* Known colonic adenomas scheduled for colonic polyp resection
* Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia.

Exclusion Criteria:

Subject meets all of the following criteria:

* Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at University of Michigan Health System.
* Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study.
* Age 18 to 100 years
* Willing and able to sign informed consent

Primary outcomes:
measure: Depth-imaging capability of the confocal endomicroscope using an imaging contrast agent, fluorescein
timeFrame: five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Danielle Kim Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: