louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01269593: PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Official title: PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Non-Hodgkin's Lymphoma
Myeloma
Active Solid Malignancy
Keywords: PET Scan
124I-PUH71
10-139
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Samus Therapeutics
First posted: 2011-01-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.


Eligibility criteria: Inclusion Criteria:

* Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
* Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
* This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
* Age between 18-90
* Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
* No breast-feeding

Exclusion Criteria:

* Previous allergic reaction to contrast medium.
* Hypersensitivity to iodide products.
* Known hyperthyroidism

Hepatic:

* Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
* AST/ALT \>2.5 x ULN
* Albumin \< 2 g/dl
* GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN. Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min.
* Positive serum pregnancy test for females
* Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)

Primary outcomes:
measure: To study the pharmacokinetics
timeFrame: 2 years
Secondary outcomes:
measure: To study the metabolism
timeFrame: 2 years
measure: To study the biodistribution
timeFrame: 2 years
measure: To study the radiation dosimetry
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Mark Dunphy, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357693: Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
Official title: Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: nausea, postoperative
postoperative nausea
postoperative vomiting
vomiting, postoperative
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

Detailed description: High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Eligibility criteria: Inclusion Criteria:

* high risk patients for nausea and vomiting

Exclusion Criteria:

* cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Primary outcomes:
measure: Incidence of nausea and vomiting in postoperative period
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Angela Maria Sousa
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Hazem a Ashmawi, phD
role: STUDY_DIRECTOR
References:
citation: Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.
Clinical trial NCT00006193: Effectiveness of Atkins Diet for Weight Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-08
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Dr. Atkins' New Diet Revolution has sold over 10 million copies and has been on the New York Times best seller list for 158 weeks. This and other low-carbohydrate diets, such as the ZONE, Sugar Busters, and the Carbohydrate Addicts Diet, have attracted much popular attention but little scientific evaluation. Given the widespread use of these diets, it seems prudent to evaluate them both for safety and efficacy. Therefore, the purpose of the study is to compare the effectiveness of two different weight control programs over the course of 52 weeks. These two programs are 1) the Atkins' New Diet Revolution, a low-carbohydrate, high-protein diet, and 2) Brownell's LEARN Program, a high carbohydrate, low fat diet based on behavior modification. Specifically, this study will compare short-term changes in weight, food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are randomized to either the Atkins' Diet or the LEARN Program for a period of one year. During this year, they will be under medical supervision. We will examine the effect of the two weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and eating behavior. This is a feasibility study and thus the data will ultimately be used to design a large randomized trial with adequate statistical power.


Eligibility criteria: - BMI 25-40 kg/m2 inclusive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT04474093: Monolithic CAD/CAM Single Tooth Ceramic Crowns
Official title: Monolithic CAD/CAM Single Tooth Crowns Made From Different Ceramics: One Year Preliminary Results of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowns (MeSH Unique ID: D003442), Single Tooth
Dental Porcelain (MeSH Unique ID: D003776)
Keywords: Zirconium-reinforced glass ceramics(ZRGC)
Lithium disilicate glass ceramics(LGC)
Resin infiltrated glass ceramics(RIGC)
Monolithic single tooth restoration
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the development of Computer Aided Design and Computer Aided manufacturing (CAD / CAM) systems, all ceramic restorations have been used with high success rates during the past 30 years in order to eliminate the disadvantages of metal ceramic restorations. Based on these developments, in every passing days new ceramic materials has been added to dental market. The aim of the present study was evaluating clinical results of single-tooth ceramic crowns in the posterior region produced from three different monolithic ceramic materials.


Eligibility criteria: Inclusion Criteria:

* 18 years old
* Individuals who have signed the informed consent form
* Periodontally stable patients
* Having devital teeth need to be restored in the posterior region
* Having natural dentition or minimally invasive restoration against the restored tooth.

Exclusion Criteria:

* Diagnosed patients with temporomandibular joint problems
* Insufficient supportive tooth tissue for restoration

Primary outcomes:
measure: Survival rate and success (changes over time)
timeFrame: 1 year (Baseline to 12 months)
measure: Prosthetic evaluation changes
timeFrame: 1 year (Baseline to 12 months)
measure: Periodontal evaluation changes
timeFrame: 1 year (Baseline to 12 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Instructor
name: Diler DENİZ, DDS, MSD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Güliz AKTAŞ, DDS,PhD
role: STUDY_DIRECTOR
affiliation: Associate Professor
name: M.Barış GÜNCÜ, DDS,PhD
role: STUDY_CHAIR
affiliation: Professor
name: Güliz N. GÜNCÜ, DDS,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00792493: Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741
Official title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 51
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examinations
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-90 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
* Susceptibility to severe allergic reactions
* Regular consumption of more than 14 units of alcohol per week
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination
* Participation in a drug study within 3 months prior to the start of this study

Primary outcomes:
measure: Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
timeFrame: about a month
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 12 days per period
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Forenap Pharma
Study officials:
affiliation: Forenap Pharma
name: Déborah Metzger, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03089593: Thermogenic Effect of Ginger
Official title: Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Thermic Effect of Food
Energy Expenditure
Ginger
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The main objective of the study is to evaluate the thermogenic effect of ginger.

Detailed description: Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven days washout period.

Eligibility criteria: Inclusion Criteria:

* Females;
* Aged between 18 and 60 years old;
* Body mass index between 18.5 and 24.9 kg/m²;
* Agree to sign the informed consent.

Exclusion Criteria:

* Any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease);
* Previous operation for weight loss;
* Medications known to affect total energy expenditure;
* Pregnancy and breast-feeding;
* Smoking;
* Alcohol use (\>2 doses/day).

Primary outcomes:
measure: Change in postprandial energy expenditure
timeFrame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Secondary outcomes:
measure: Change in oxygen consumption
timeFrame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
measure: Change in blood pressure
timeFrame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
measure: Change in axillary temperature
timeFrame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
measure: Change in metabolic profile
timeFrame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
measure: Change in heart rate
timeFrame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
measure: Change in metabolic profile
timeFrame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
measure: Change in metabolic profile
timeFrame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Gabriela BP Fagundes
role: STUDY_CHAIR
References:
citation: Fagundes GBP, Rodrigues AMDS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:168-174. doi: 10.1016/j.clnesp.2020.10.001. Epub 2020 Nov 9.
Clinical trial NCT04025593: Biomarker Guided Treatment in DLBCL
Official title: A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
* ECOG 0,1,2
* Life expectancy\>6 months
* Informed consented
* IPI\>1

Exclusion Criteria:

* Chemotherapy before
* Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* LVEF≤50%
* Lab at enrollment (Unless caused by lymphoma) Neutrophile\<1.5\*10\^9/L Platelet\<75\*10\^9/L ALT or AST \>2\*ULN,AKP or bilirubin \>1.5\*ULN Creatinine\>1.5\*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Primary outcomes:
measure: complete response rate
timeFrame: 21 days after 6 cycles of treatment (each cycle is 21 days)
Secondary outcomes:
measure: progression free survival
timeFrame: 2 year
measure: overall survival
timeFrame: 2 year
measure: overall response rate
timeFrame: 21 days after 6 cycles of treatment (each cycle is 21 days)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Up to 30 days after completion of study treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05211193: Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Official title: Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder (OAB)
Failed Any OAB Pharmacotherapy
Lead sponsor: Stimvia s.r.o.
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.

Brief summary: Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.

Detailed description: Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).

Eligibility criteria: Inclusion Criteria:

* Women 18 years or older, inclusive
* Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
* Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
* Treatment Satisfaction VAS \<50
* Ability to understand and sign ICF
* Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
* Subject agreed not to participate in another research study from the time of screening until the final study visit
* Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit

Exclusion Criteria:

* Prior treatment with botulotoxin for OAB
* Previous pharmacotherapy for OAB if \>12 months ago
* Urinary retention with post void residual \> 150ml
* Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
* History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant

Primary outcomes:
measure: Change of severe urgency episodes
timeFrame: baseline and end of study (6weeks treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Příbram
country: Czechia
facility: MUDr. Michal Rejchrt
state: Czech
Study officials:
References:
Clinical trial NCT06362993: Breast Cancer Screening in Ghana
Official title: Testing Approaches to Promote Breast Cancer Screening in Rural Ghana
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: University of Ghana
First posted: 2024-04-12
Enrollment: 118
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim.


Eligibility criteria: Inclusion Criteria:

* ≥20 years. The age cutoff reflects early onset of BC in Ghana and the government's guidelines on screening.

Exclusion Criteria:

* ever clinically diagnosed with a case of breast cancer, as the study's aim is to reach women who would normally not visit or have experience with the health system with regard to breast cancer.

NOTE: For men in the MEGH arm, Inclusion and Exclusion Criteria are:

Inclusion Criteria: aged ≥20 years who are identified as male partners or relatives by the women enrolled in the MEGH group.

Exclusion Criteria: none.

Primary outcomes:
measure: Clinical breast exam (CBE) utilization at the local clinic
timeFrame: 6 months. Outcome is measured at endline survey at the end of the 6-month period.
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
affiliation: The Pennsylvania State University
name: Nancy Luke, Ph.D.
role: STUDY_CHAIR
affiliation: University of Ghana, Regional Institute for Population Studies
name: Adriana Biney, Ph.D.
role: STUDY_CHAIR
References: