louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02759042: An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study
Official title: An Expanded Compassionate Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PRO140_CD02 Study
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HIV
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Amarex Clinical Research
First posted: 2016-05-03
Sex: MALE
Minimum age (years): 55
Maximum age (years): 56
Standard ages: ADULT

Brief summary: The primary objective is to provide continued access to PRO 140 to a subject who has completed participation in PRO140_CD02.

Detailed description: This is an open label, single center study designed to provide continued access to PRO 140 to a subject who have completed participation in PRO140_CD02 and continue to receive clinical benefit.

The subject will receive weekly PRO 140 SC injection along with oral ART regimen during the Treatment Phase. The study treatment (PRO 140 SC injections) will be administered by a qualified medical professional or self-administered by the subject.

Eligibility criteria: This study will recruit one treatment-experienced, HIV-1 infected patient with CCR5-tropic virus, who has participated in PRO 140_CD02 clinical trial and is continuing to derive clinical benefit from PRO 140 treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: CD02 EA Investigational site
state: Florida
Study officials:
affiliation: Orlando Immunology Center
name: Edwin DeJesus, MD, FIDSA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382442: A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
Official title: A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
Collaborators: name: Summit Therapeutics
First posted: 2022-05-19
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of colorectal adenocarcinoma
* Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
* Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and organ function

Exclusion Criteria:

* Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
* Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C
* Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
* Pregnancy or lactation
* Dysphagia

Primary outcomes:
measure: Objective response rates (ORR)
timeFrame: Up to approximately 2 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Progression-free survival 2 (PFS2)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Summit Therapeutics Research Site
state: California
city: Guanzhou
country: China
facility: The Sixth Hospital,Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04807842: Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Official title: A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginoses
Lead sponsor: Karo Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2021-03-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded, randomized placebo controlled.
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.

Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%))
* Women of childbearing potential
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
* Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel criteria (clue cells detection)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Use of antibiotics for any reason in the last 14 days
* Use of intravaginal devices during the investigation or in the last 14 days
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Primary outcomes:
measure: Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
timeFrame: 3 weeks
Secondary outcomes:
measure: Microbiological cure rate (based on Nugent score <4) at Visit 2
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Praxis Dr. Peters
Study officials:
References:
Clinical trial NCT03225742: The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery
Official title: The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Voiding Dysfunction, Urinary Retention and Success of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Surgery
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the women who have stress incontinence at physical examination and urodynamics tests

Brief summary: After incontinence surgery, the patients randomly will be divided two groups. In group A postoperative urinary catheterization time will be applied one day, In group B catheterization will be applied two days. After removal of urinary catheter, residual volume will be measured and voiding function will be controlled. In postoperative period; third, sixth month and one year after surgery stress test will be applied to control success of surgery


Eligibility criteria: Inclusion Criteria:

* stress incontinence
* resistant to medical treatment

Exclusion Criteria:

* had no surgery before
* has no accompanying uterine descensus
* has no neurogenic disorder

Primary outcomes:
measure: early postoperative voiding dysfunction and urinary retention
timeFrame: two days
Secondary outcomes:
measure: The success of stress urinary incontinence surgery
timeFrame: third month, sixth month and one year
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kerem Doga Seckin
Study officials:
References:
Clinical trial NCT00032942: Lofexidine for Opiate Withdrawal - 1
Official title: A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Britannia Pharmaceuticals Ltd.
First posted: 2002-04-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 evaluate lofexidine for opiate withdrawal.

Detailed description: An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

Eligibility criteria: Inclusion Criteria:

Male or female as least 18 yrs of age \& above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

Exclusion Criteria:

Additional criteria available during screening at the site

Primary outcomes:
measure: Opiate withdrawal symptoms
measure: Potential Abuse Liability
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Philadelphia Veterans Medical Center
state: Pennsylvania
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Ann Montgomery, R.N.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04395742: 1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
Official title: 1,3,7-Trimethylxanthine as a Treatment of COVID-19: Results of a Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease 2019
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting the eligibility criteria and wishing to participate in the study

Brief summary: This is observational study to assess the prognosis of patients hospitalized with COVID-19 confirmed by RT-PCR and exposed to trimethylxanthine (TMX).

Trimethylxanthine is the active molecule present in coffee. Due to the lack of etiologic treatments and considering interest about old treatments as an avenue for research, we conducted a comparative study aiming to evaluate the effect of 1,3,7-trimethylxanthine on COVID-19 infected patients. This is actually a study about methodology.

The objective of this study is therefore not to demonstrate the effect of the substance on the disease but the importance of a rigorous methodology in scientific research. This project is called "Method and Teaching of Scientific Studies".


Eligibility criteria: Inclusion Criteria:

* Age \> 18,
* No Trimethylxanthine contraindications (defined as allergy, previous reported secondary effects),
* Infectious Disease Unit admission.

Exclusion Criteria:

* Secondary effects about Trimethylxanthine,
* Refuse to participate

Primary outcomes:
measure: Comparison of vital status
timeFrame: 6 days
Secondary outcomes:
measure: Comparaison of duration of hospital stay
timeFrame: 6 days
measure: Comparaison of severity
timeFrame: 6 days
measure: Comparaison of secondary effects (adverse events that needed disruption of treatment (anemia, tachycardia, osteoporosis) : secondary effects of coffee).
timeFrame: 6 days
measure: Comparaison of use of antibiotics
timeFrame: 14 days after hospital admission.
Other outcomes:
Locations:
Study officials:
References:
citation: Belaroussi Y, Roblot P, Peiffer-Smadja N, Delaye T, Mathoulin-Pelissier S, Lemeux J, Le Moal G, Caumes E, Roblot F, Bleibtreu A. Why Methodology Is Important: Coffee as a Candidate Treatment for COVID-19? J Clin Med. 2020 Nov 17;9(11):3691. doi: 10.3390/jcm9113691.
Clinical trial NCT05283642: D-chiro-inositol and Endometrial Thickness
Official title: The Effects of D-chiro-inositol in Endometrial Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Diseases
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.


Eligibility criteria: Inclusion Criteria:

- altered endometrial thickness

Exclusion Criteria:

* patients with cancer
* patients under hormonal treatments (progestogens and/or estrogens)
* patients supplemented with inositols

Primary outcomes:
measure: Change in endometrial thickness
timeFrame: Two time points: baseline and after three months
Secondary outcomes:
Other outcomes:
Locations:
city: Terni
country: Italy
facility: ASL Umbria 2
state: Umbria
Study officials:
References:
Clinical trial NCT03594942: Diagnostic Outcomes of Patients Presenting With Per Rectal Bleed in Surgical Departments of Services Hospital Lahore
Official title: Diagnostic Outcomes of Patients Presenting With Per Rectal Bleed in Surgical Departments of Services Hospital Lahore
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Bleeding
Lead sponsor: Services Hospital, Lahore
Sponsor class: OTHER_GOV
First posted: 2018-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patintes will be from lahore city and adjacent areas

Brief summary: It is a cross sectional study in which investigators will be recruiting patients of any sex above 12 years of age who will present to surgical outdoor with per rectal bleed. Investigators will then follow them through investigations to reach a certain diagnosis. Then investigators will be able to compile the data of diseases and their frequency, which are presenting with rectal bleed in their setup.


Eligibility criteria: Inclusion Criteria:

* Patient of any sex above 12 years old
* patients with rectal bleed in OPD

Exclusion Criteria:

* Patient with acute rectal bleeding due to infection like dysentry
* Acute proctitis
* Acute colitis

Primary outcomes:
measure: Frequency of diseases in patients with rectal bleed
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services hospital
state: Punjab
Study officials:
affiliation: Services Hospital, Lahore
name: Mahmmood Ayyaz, mbbs, fcps
role: STUDY_DIRECTOR
References:
Clinical trial NCT01232842: Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia
Official title: Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-02
Enrollment: 20
Sex: FEMALE
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with acute myeloid leukemia.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.

OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosed with acute myeloid leukemia
* Known CD34+ progenitor cells
* Available freshly isolated, uncultured cell samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors
measure: Extent of clonal hematopoiesis in small numbers of AML cells
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Roland Walter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05675670: Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism
Official title: Artificial Intelligence-enable Electrocardiogram for Diagnosis and Outcome in Hyperthyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperthyroidism
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 35000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: hyperthyroidism


Eligibility criteria: Inclusion Criteria:

* Patients in outpatient department.
* Patients recieved at least 1 ECG examination.
* Patients without TSH test before ECG examination or patients with subclinical hyperthyroidism without anti-thyroid drug usage.

Exclusion Criteria:

* The patients recieved ECG at the period of inactive AI-ECG system.

Primary outcomes:
measure: New-onset hyperthyroidism
timeFrame: Within 30 days
measure: New-onset anti-throid drug treatment
timeFrame: Within 60 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: Within 1 year.
measure: Cardiac event
timeFrame: Within 1 year.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
Clinical trial NCT02965170: Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in MS
Official title: Validation of a Laboratory Test Measuring Natalizumab (Tysabri®) Serum Levels in a Multiple Sclerosis Patient Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Rocky Mountain MS Research Group, LLC
Sponsor class: OTHER
Collaborators: name: Abreos Biosciences
First posted: 2016-11-16
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients with multiple sclerosis who have had one or more doses of Tysabri® (natalizumab) and are currently being treated with Tysabri® will be included in this study.

Brief summary: Validating a peptide-based laboratory test enabling the measurement of Tysabri® serum levels (pharmacokinetics, PK) in multiple sclerosis patients undergoing therapy. The results of this newly developed test will be compared to Tysabri® serum levels measured in parallel using an independent test. We will also simultaneously measure a pharmacodynamic marker of Tysabri®, receptor saturation levels on blood immune cells, which is thought to correlate with Tysabri® serum levels.

Detailed description: From a single site, consenting patients with relapsing forms of multiple sclerosis who are currently begin treated with Tysabri® (natalizumab) and meeting the eligibility criteria will be asked to provide blood samples on the same day, and prior to, a scheduled infusion of Tysabri® 300 mg IV. Up to 500 patients will be enrolled in this study. Each patient may be asked to donate blood up to 2 times (one blood draw per cycle) to obtain longitudinal data points. Each patient will also be asked to fill out a wellness patient reported outcome (PRO) questionnaire along with the blood draws

Eligibility criteria: Inclusion Criteria:

* Infusing with Tysabri at a single site, Rocky Mountain MS Clinic

Exclusion Criteria:

* If subject donated or received blood, plasma, or any other blood products between the last Tysabri® infusion and the time of sample collection.

Primary outcomes:
measure: Natalizumab Concentrations in Serum
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Rocky Mountain MS Clinic
state: Utah
Study officials:
affiliation: Rocky Mountain MS Research Group
name: John F Foley, MD
role: PRINCIPAL_INVESTIGATOR
References: