louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03514017: Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Official title: Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: Lymphocytic
Leukemia
CLL
Blood disease
White blood cells
Bone marrow disease
Immunotherapy
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Janssen Scientific Affairs, LLC
First posted: 2018-05-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of sequential overlapping treatment with PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous immune function in previously untreated, high-risk CLL patients. Immune function will be evaluated through various laboratory correlative tests.


Eligibility criteria: Inclusion Criteria:

* Have high risk CLL
* Have documented previously untreated CLL according to IWCLL criteria
* Willing and able to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Demonstrate adequate organ function
* Able to take oral medication and willing to adhere to the medication regimen

Exclusion Criteria:

* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment
* Meets IWCLL criteria to start therapy
* Has had any treatment for CLL including any investigational agent, chemotherapy, mAb, anti-PD-1, anti-PDL-1, or anti-CTLA-4
* Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia)
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment
* Major surgery or a wound that has not fully healed within 4 weeks of first dose
* Additional criteria may apply

Primary outcomes:
measure: Overall Response Rate (ORR) to the Therapeutic Intervention
timeFrame: Up to 2 years
measure: Time to Best Response
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Julio Chavez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807817: Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
Official title: Synergistic Effects of Anxiety and Alcohol Use Among Latinos and Its Sociocultural Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Racism
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-01-17
Enrollment: 99
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the pharmacological effects of alcohol on acute anxiety levels in a sample of Latino drinkers, and cultural experiences influencing these relationships.


Eligibility criteria: Inclusion Criteria:

1. 21-65 years of age
2. moderate or heavy drinker based on a past-month AUDIT score \>= 8.

Exclusion Criteria:

1. Possibility of being pregnant (verified by urine sample);
2. Self-reported history of or treatment for alcohol/other drug problems (as required by the IRB in past human alcohol administration research);
3. Moderate risk for drug problems as indicated by SMAST scores ≥ 5 or ASSIST scores of ≥ 4 (see Measures);
4. Medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease);
5. Current use of psychiatric meds or any meds with alcohol contraindication (e.g., antibiotics);
6. Current non-alcohol substance use disorder;
7. Active suicidality (i.e., suicidal ideation, intent, and/or plan) or current psychosis.

Primary outcomes:
measure: State-Trait Anxiety Inventory, State Version (STAI-S)
timeFrame: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.
measure: Alcohol Urge Questionnaire (AUQ)
timeFrame: 5 minutes before alcohol administration, and 5 minutes after alcohol administration.
measure: Amount of alcohol consumed in "standard drinks" (0.6 oz. ethanol equivalents, 12 oz. U.S. domestic beer, 5 oz. 12% alcohol table wine, 1.5 oz. 80-proof hard liquor)
timeFrame: 5 minutes after participating in the stressor task.
Secondary outcomes:
measure: Kulis, Marsiglia & Nieri's (2009) Substance Use Attitudes/Expectancies Scale
timeFrame: 5 minutes before alcohol administration.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Andres G Viana, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851317: The Relationship Between Patients' Head Position and ETT Intracuff Pressure
Official title: The Relationship Between Patients' Position and Endotracheal Tube Intracuff Pressure in Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing ENT Surgery With Cuffed ETT
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 200
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing otolaryngological surgery with cuffed endotracheal tube

Brief summary: This study is designed to investigate the relationship between patients' position and endotracheal tube intracuff pressure in the pediatric population.

Detailed description: There are currently no data in the literature as to the effect of changes in head position on CP. As the cuff is located in the patients' trachea, the shape of the patents' trachea may be change depending on the position of the patient's head and therefore, the CP may also change. If the intracuff pressure will increase as the patient's head is moved into a flexed or extended position, these patients may be at risk for tracheal damage. The investigators will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery.

Eligibility criteria: Inclusion Criteria:

* Age less than 18 years
* Undergoing otolaryngological surgery with endotracheal intubation

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine

Primary outcomes:
measure: Endotracheal tube intracuff pressure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Hiromi Kako, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04313517: Yoga@Work Intervention to Reduce Work-related Stress Among Information Technology Workers
Official title: Yoga@Work Intervention to Reduce Work Related Stress Among Information Technology Workers: Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Stress
Psychological Stress
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Brunel University
name: NMP Medical Research Institute
name: Ananda Yoga (Hong Kong)
name: Vrije Universiteit Brussel
First posted: 2020-03-18
Enrollment: 140
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: Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Workplace wellness programs has been very feasible access to employees at their own convenience and need. Yoga@Work Program was developed to suit the need for information technology workers.


Eligibility criteria: Inclusion Criteria:

* Information Technology employee, or trainee willing and able to participate in a 6-week self-care program during the work day.
* Willing to give informed consent

Exclusion Criteria:

* medical or psychiatric conditions limiting practice of yoga in general
* Cognitive impairment

Primary outcomes:
measure: Reductions in occupational stress
timeFrame: From baseline to 6-week post intervention
Secondary outcomes:
measure: Mental health problems
timeFrame: From baseline to 6-week post intervention
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UNRI
city: Hong Kong
country: Hong Kong
facility: Ananda Yoga
city: Jaipur
country: India
facility: NMP Medical Research Institute
state: Rajasthan
city: London
country: United Kingdom
facility: Yog-Kulam
Study officials:
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Jaydeep Joshi, BAMS
role: STUDY_DIRECTOR
affiliation: Brunel University
name: Monomita Nandy
role: STUDY_CHAIR
References:
Clinical trial NCT01437917: NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.
Official title: NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: glycemic index
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2011-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.


Eligibility criteria: Inclusion Criteria:

* Healthy individual,
* Age between 19-65 years
* With normal food habits with at least 2 main meals per day
* Non smoking
* Having filled the consent form

Exclusion Criteria:

* BMI \> 25 kg/m2,
* Diabetes or any illness susceptible to alter
* Coeliac disease
* Past history of intestinal diseases.
* Treatment susceptible of modifying glycemia.
* Allergy

Primary outcomes:
measure: Glycemic index for each bread
timeFrame: 2 hours
Secondary outcomes:
measure: AUC for insulinemia for the 2 hours following the ingestion of each bread.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
Study officials:
affiliation: Rennes University Hospital
name: Fabrice BONNET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04505917: Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women
Official title: Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Overweight and Obese Women :a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled trial
Primary purpose: PREVENTION

Brief summary: To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese women

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* multi parous women requesting copper IUD insertion
* body mass index more than 25

Exclusion Criteria:

* pregnancy,
* null parous women,
* contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
* untreated active cervicitis or vaginitis,
* undiagnosed abnormal uterine bleeding

Primary outcomes:
measure: The difference in visual analog scale pain scores during intrauterine device insertion
timeFrame: 10 minuts
Secondary outcomes:
measure: Intensity of pain: visual analogue scale
timeFrame: 30 minutes after the procedure
measure: the difference in visual analog scale pain scores during tenaculum application
timeFrame: 10 minutes
measure: the ease of IUD insertion
timeFrame: 10 minutes
measure: women's satisfaction level: score
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT03226717: Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy
Official title: Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatitis C virus

Brief summary: The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger different immune-mediated extrahepatic disorders. A variable combination of HCV with other unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients with mild arthritis, conservative manegement using analgesics with anti- inflammatory activity is recommended. In patients who have contraindications to their use, short term low dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity of liver disease using the child- pugh- turcotte classification. For patients with severe cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a combination of immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon improves the musculoskeletal manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir, velpatasvir, ombitasvir and simeprevir.


Eligibility criteria: Inclusion Criteria:

* Antiviral patients with arthropathy concomitant HCV (proved by PCR testing).

Exclusion Criteria:

* patients with child-pugh B and child-pugh C decompensated cirrhosis.
* patients more that 60 years.
* patients with chronic infection e.g.(pulmonary T.B).
* patients with organ failure e.g.( heart failure, respiratory failure).
* patients with CKD with GFR lead that 60 ml/ ministry/1.73m2.
* patients on immunosuppressive agents.
* patients with HBV- coinfection.

Primary outcomes:
measure: rate of Improvement of manifestations of arthropathy
timeFrame: 3_6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: yasmin AbdElazim Mohamed Turkey
Study officials:
References:
Clinical trial NCT06260917: The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS
Official title: The Effect of Urinating Through The Zipper or By Pulling Down The Trousers on Uroflowmetry Parameters in Patients With LUTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Micturition Disorder
Urinary Obstruction
Urinary Tract Disease
Urologic Diseases
Keywords: benign prostatic obstruction
uroflowmetry
urodynamics
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 80
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on alpha blocker therapy with LUTS due to BPO

Brief summary: There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined.


Eligibility criteria: Inclusion Criteria:

* Having lower urinary tract symptoms due to BPO

Exclusion Criteria:

* Having a neurogenic bladder
* Previous prostate surgery
* Having urethral stricture
* Bladder neck stenosis
* Having a bladder stone or tumor
* Having a urinary system infection
* Finding a suspicious nodule in digital rectal examination

Primary outcomes:
measure: Qmax
timeFrame: During the procedure
measure: PVR
timeFrame: Immediately after procedure
measure: Qave
timeFrame: During the procedure
measure: Duration of voiding
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
Clinical trial NCT00309517: Randomized Study on Neoadjuvant Radio-Chemotherapy in Rectal Carcinoma Dukes B and C
Official title: A Prospectively Randomized Study on Neoadjuvant Radio-Chemotherapy in Patients With Operated Rectal Carcinoma Dukes B and C (pT2, pN1-3; pT3-4, pN0-3; M0.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rectal Cancer Dukes B, Dukes C
Keywords: Fluorouracil
Leucovorin
MAb 17-1A
Rectal cancer
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
First posted: 2006-04-03
Enrollment: 700
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 clinical investigation examined the influence of preoperative radiotherapy in combination with postoperative 5-fluorouracil + leucovorin chemotherapy vs. 5-fluorouracil + leucovorin + MAb 17-1A chemo-immunotherapy on patients' local recurrence rate and overall survival time following surgery for rectal carcinoma Dukes B or C (T2-4, N0-3, M0).


Eligibility criteria: Inclusion Criteria:

* Patients with histologically verified operable rectal cancer Dukes B and C (Stage II, T2-4, N0-3, M0), R0
* Age: 18-80 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve (leukocytes \> 4,000, thrombocytes \> 105/mm3, Hb \> 10g %), renal and hepatic functions (total bilirubin and creatinine \< 1.25 x ULN)

Exclusion Criteria:

* Colon cancer
* R1, R2; carcinosis peritonei
* Start of treatment \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy
* Previous application of a murine or chimeric monoclonal antibody or antibody fragment
* Medical therapy with steroids, cyclosporin or antithymocyte globulin within 3 months pre-study
* Known hypersensitivity to animal protein
* Serious concomitant disease: HIV, chronically inflammatory intestine, diabetes mell. gravis, cerebral seizure disorder, et al.
* Pregnancy or lactation

Primary outcomes:
measure: Local recurrence-free survival
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Oberpullendorf
country: Austria
facility: Hospital Oberpullendorf
state: Burgenland
city: Baden bei Wien
country: Austria
facility: Hospital Baden
state: Lower Austria
city: Hainburg
country: Austria
facility: Hospital Hainburg
state: Lower Austria
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt, Surgery
state: Lower Austria
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Linz
country: Austria
facility: General Hospital Linz
state: Upper Austria
city: Linz
country: Austria
facility: Hospital BHB Linz
state: Upper Austria
city: Vienna
country: Austria
facility: Medical University of Vienna, General Hospital
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Raimund Jakesz, MD
role: PRINCIPAL_INVESTIGATOR
References: