louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06073899: Biopsychosocial Factors in Resistance Exercise in Individuals with Knee Pain
Official title: Biopsychosocial Factors in Resistance Exercise in Individuals with Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to examine changes in pain sensitivity during high fatigue exercise, low fatigue exercise, and no treatment in individuals who are currently experiencing knee pain. Dosing dynamic resistance exercise intensity based on fatigue level is a novel, clinically feasible method. Dynamic resistance exercise at a high intensity (75% 1 repetition maximum (RM)) produces significant hypoalgesia at local sites compared to no treatment; however, dosing intensity based on 1RM can be challenging to implement in the clinical setting. Fatiguing endurance tasks produce local and systemic reductions in pressure pain threshold with low intensity isometric exercise completed until failure resulting in the largest exercise induced hypoalgesia effects. Fatigue may be an important mediator in pain response to exercise.


Eligibility criteria: Inclusion Criteria:

* Experiencing knee pain symptom intensity rated as 3/10 or higher in the past 24 hours

Exclusion Criteria:

* non-English speaking
* history of knee surgery or fracture within the past 6 months
* history of quadriceps tendon rupture
* history of a chronic pain condition, such as fibromyalgia
* systemic medical conditions that affect sensation, such as uncontrolled diabetes or neurological conditions
* blood clotting disorder, such as hemophilia
* known presence of cardiovascular, pulmonary, or metabolic disease
* current use of tobacco products
* contraindication to the application of ice, including blood pressure over 140/90 mmHg, -conditions that cause hives or blood in urine when exposed to cold, and any reductions in blood flow to arms or legs.
* not physically ready to exercise without a medical exam as indicated by the Physical Activity Readiness Questionnaire + (PAR-Q+)
* pain during active knee range of motion 0-90 degrees (examined during screening)
* Pregnant
* unable to attend 4 sessions

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: This procedure will be completed two times before and after each set of exercise with the average analyzed. Outcomes are examined during each intervention visit from enrollment to study completion, about 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Abigail Wilson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02415699: DC-CIK Immunotherapy Plus Chemotherapy vs Chemotherapy Alone in the Adjuvant Treatment of Stage III Colorectal Cancer
Official title: Randomized Controlled Trial Comparing DC-CIK Immunotherapy Combined With Adjuvant Chemotherapy and Adjuvant Chemotherapy Alone in Stage III Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stage III colorectal cancer constitutes more than half of the colorectal patients, and the prognosis does not improve much recently although varies of adjuvant drugs have been tried. DC-CIK immunotherapy has been proved to improve survival in cancer patients, but its role in stage III colorectal cancer patients stains unclear. The investigators study will focus on the efficacy and safety of DC-CIK immunotherapy plus chemotherapy in the adjuvant treatment of stage III colorectal cancer, compared with chemotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Stage III colon cancer
* Undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* ECOG performancer status 0-2
* Adequate hematologic, hepatic and renal functions

Exclusion Criteria:

* HIV positive or other Immunodeficiency disease
* Uncontrolled hypertension
* History of recent cancers in the past 5 years
* Patients with previous or concurrent malignancy or any anti-cancer therapy
* Patients who were allergic to platinum drugs or fluorouracil
* Pregnant patients

Primary outcomes:
measure: Disease free survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Side Effect
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00282399: A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome
Official title: Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome
MGI Pharma
Decitabine
Dacogen
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Detailed description: Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS

Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.

Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy

Eligibility criteria: Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

1. Prior therapy with decitabine or azacytidine (Vidaza).
2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
3. Clinically significant anemia.
4. Prior history of malignancy other than MDS.
5. Any active infection.
6. Radiotherapy within 14 days prior to study enrollment.

Primary outcomes:
measure: Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.
timeFrame: Up to 8 cycles (224 days)
measure: Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.
timeFrame: Up to 12 cycles (336 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
References:
Clinical trial NCT04204499: Analysis of Screen-detected Lung Cancers' Genomic Traits
Official title: Analysis of Screen-detected Lung Cancers' Genomic Traits
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Genomic signatures
Screen-detected cancer
Non-invasive biological and radiological parameters
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 526
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Screen detected lung cancer patients.

Brief summary: Prospective, observational cohort study of patients undergoing surgical resection for low dose CT (LDCT) screen-detected lung cancer (detected through the SUMMIT study- ClinicalTrials.gov Identifier: NCT03934866/ lung screening programmes), in which translational research is a fundamental aspect.

Detailed description: The ASCENT study seeks to examine the genomic signatures of screen-detected cancers, in order to categorise the biological behaviour of such lesions and correlate this against non-invasive biological and radiological parameters. From these data, the plan is to explore strategies to characterise LDCT-detected cancers through non-invasive means, which the researchers believe may prove key in mitigating potential screening-associated harms.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with confirmed lung cancer or probable lung cancer via LDCT screening.
2. Planned for, or completed primary surgical resection either for histologically confirmed lung cancer, or strongly suspected lung cancer.
3. Able to provide written informed consent (or verbal informed consent for participants consenting to retrospective diagnostic samples and data collection only).

Exclusion Criteria:

1. Treatment with neoadjuvant therapy for current lung malignancy as per local MDT treatment decision.
2. Known Active Human Immunodeficiency Virus (HIV), Hepatitis B virus, Hepatitis C Virus or Syphilis.

Primary outcomes:
measure: Genomic exploratory research
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bart's Hospital
city: London
country: United Kingdom
facility: UCLH
Study officials:
affiliation: UCL
name: Sam Janes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645499: An Open-Label Study to Assess Safety
Official title: An Open-Label Study to Assess the Efficacy and Potential for Adrenal Suppression Following Maximal Use Treatment With TA-102 Topical Formulations in Subjects With Plaque Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open-Label study to assess safety

Detailed description: An Open-Label study to assess the efficacy and potential for adrenal suppression following maximal use treatment with TA-102 topical formulations in subjects with Plaque Psoriasis.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of plaque psoriasis.
2. Definite clinical diagnosis of stable plaque psoriasis for at least 6 months.
3. Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of plaque psoriasis.

Exclusion Criteria:

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. History of allergy or sensitivity to retinoid, corticosteroids and/or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the Subject or the results of the study.

Primary outcomes:
measure: number of participants with adrenal suppression
timeFrame: 84 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Taro Pharmaceuticals Inc
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT03580499: Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
Official title: A Pilot Study of the Effects of Vitamin B6 on Hot Flash Symptoms in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Prostate Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 43
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot phase II trial studies how well vitamin B6 works in reducing hot flashes in participants with prostate cancer undergoing antiandrogen therapy. A nutritional supplement such as vitamin B6 may help improve hot flashes caused by antiandrogen therapy in participants with prostate cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the effect of Vitamin B6 in improves the frequency or severity of hot flashes in prostate cancer patients receiving antiandrogen therapy (androgen deprivation therapy \[ADT\]).

OUTLINE:

Participants receive vitamin B6 orally (PO) daily for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Subjects are currently receiving ADT for prostate cancer and will continue on ADT for at least 13 weeks after enrollment. Patient may have been started on ADT at any past time point because patients experience hot flashes throughout ADT treatment
* Subjects are experiencing bothersome hot flashes per the study questionnaires
* Subjects are capable of giving informed consent.
* Willing to comply with all study procedures and be available for the duration of the study
* Able to obtain and take an acceptable form of vitamin B6

Exclusion Criteria:

* Subjects without a diagnosis of prostate cancer
* Subjects already receiving other treatment for hot flashes
* Subjects taking selective serotonin reuptake inhibitors (SSRIs)
* Subjects are currently taking vitamin supplementation which includes vitamin B6 at doses \> 10 mg

Primary outcomes:
measure: Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Median change in response to 10-point hot flash scale (1 = hot flash is not bothersome, 10 = hot flash is Most Severe)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Costas Lallas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01253499: Multiple Dose Study of TRx0037
Official title: A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: TauRx Therapeutics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2010-12-03
Enrollment: 31
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.


Eligibility criteria: Inclusion Criteria:

* Male and female 55 and over
* No clinically important abnormal physical finding
* No clinically significant lab results
* Normal ECG
* Normal BP and HR
* BMI between 19 and 32
* Weight 50 to 100 kg
* Able to communicate
* Provide written informed consent
* Non smokers
* Males to use contraception
* Females to be surgically sterile or post menopausal

Exclusion Criteria:

* Administration of any IMP other than study drug within 12 weeks before entry
* Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
* Surgical or medical condition that might interfere with IMP
* History of drug or alcohol abuse
* Clinically significant allergy requiring treatment
* Loss of greater than 400ml of blood within 12 weeks.
* Serious adverse reaction or hypersensitivity to any drug
* Presence of Hep B, Hep c or HIV-1 or HIV-2 at screening
* Presence of G6PD at screening
* History of methaemoglobinaemia
* Partner who is pregnant of lactating
* Positive Pregnancy test

Primary outcomes:
measure: Bioavailability
timeFrame: 19 Days (7-10 day follow up)
measure: Pharmacokinetics
timeFrame: 19 Days (7-10 day follow up)
measure: Safety and tolerability
timeFrame: 19 Days (7-10 day follow up)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Quotient Clinical
name: Stuart Dr Mair, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06478199: PLR and NLR as Predictor Factors for Semen Abnormality
Official title: PLR and NLR as Predictor Factors for Semen Abnormality
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fertility Issues
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient correlat to inclusion criteria

Brief summary: The aim of this study was to evaluate the relationship of seminal parameters with the neutrophil-to-lymphocyte ratio (NLR) and the platelet-to-lymphocyte ratio (PLR), which are inflammatory markers, in men with an abnormal semen analysis and men with normozoospermia.


Eligibility criteria: Inclusion Criteria:

* adult above 18 years primary not do varicocelectomy

Exclusion Criteria:

* young secondry infertility recurrent varicocele

Primary outcomes:
measure: Laboratory result
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University hospital
Study officials:
References:
Clinical trial NCT01438099: Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients
Official title: Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: epidural analgesia
ultrasound
labor analgesia
labor
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all women after thirty weeks of pregnancy, experiencing spontaneous or induced labor

Brief summary: This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

Detailed description: This study has four specific aims:

1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
2. to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
3. to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
4. to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.

Eligibility criteria: Inclusion Criteria:

* all women who request epidural analgesia for labor

Exclusion Criteria:

* all women who present contraindication for epidural analgesia

Primary outcomes:
measure: The congruity between palpatory technique and ultrasound lumbar evaluation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Longitudinal and transverse ultrasound epidural space depth in obese and normal parturients
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda ospedaliera ospedale Circolo e Fondazione Macchi
Study officials:
affiliation: Universita' degli Studi dell'Insubria, Varese, Italy
name: Paolo Severgnini, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02108899: Retrieval Practice and Schizophrenia
Official title: Retrieval Practice in Patients With Schizophrenia : an Exploratory Study Using Descriptive Stories
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Schizophrenia
Episodic Memory Deficits
Keywords: Schizophrenia
Episodic memory deficits
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When people are tested on a previously learned material, they will later remember it better even when compared to a condition where they can re-study it. This phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. This paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties.

The objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia.

If effective, this method could be used in cognitive remediation programs.

Since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia.


Eligibility criteria: Inclusion Criteria:

* French is the native language, or acquired before 5 years old
* People must be able to understand and follow the trial instructions

Specific inclusion criteria (for patients) :

* Diagnostic of schizophrenia, according to the DSM -5, clinically stable
* The treatment must remain unchanged during the trial

Exclusion Criteria:

* Severe or acute cerebral disease
* Other actual psychiatric disorder
* Use of drugs with high anticholinergic effect
* Irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent)
* Inappropriate use of drugs

Specific exclusion criteria (for healthy subjects) :

- Diagnostic of schizophrenia of a relative up to the third degree

Primary outcomes:
measure: Number of items properly recalled
timeFrame: Final test : 2 days after the first experimental session
Secondary outcomes:
measure: Difference between final performance recall and memory span score
timeFrame: Final test : 2 days after the first experimental session
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie - Hôpital Civil - CHRU Strasbourg
Study officials:
References: