louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06359730: Incidence and Risk Factors of Low Anterior Resection Syndrome
Official title: Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: rectal cancer
anterior resection
LARS
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who had anterior resection surgery for rectal carcinoma

Brief summary: Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.

With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.


Eligibility criteria: Inclusion Criteria:

* Age more than 18

  * Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
  * Tumors of the rectum (2-15 cm) from anal verge

Exclusion Criteria:

* • cognitive dysfunction

  * Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
  * Age less than 18
  * Metastatic cancer or tumor recurrence
  * Rectal tumors within 2 cm from anal verge( abdominoperineal)

Primary outcomes:
measure: age
timeFrame: from 2017 to 2022
measure: sex
timeFrame: from 2017 to 2022
measure: medical disease
timeFrame: from 2017 to 2022
measure: site of tumor
timeFrame: from 2017 to 2022
measure: neoadjuvant therapy
timeFrame: from 2017 to 2022
measure: site of anastmosis
timeFrame: from 2017 to 2022
measure: type of meso-rectal excision
timeFrame: from 2017 to 2022
measure: adjuvant therapy
timeFrame: from 2017 to 2022
measure: type of surgery
timeFrame: from 2017 to 2022
measure: type of anastmosis
timeFrame: from 2017 to 2022
measure: LARS score
timeFrame: from 2017 to 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
Study officials:
affiliation: faculty of medicine Zagazig University
name: Reham Zakaria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00678730: Pharmacogenetics of Cannabinoid Response
Official title: Pharmacogenetics of Cannabinoid Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: COMT Gene Polymorphism
Keywords: THC
COMT gene polymorphism
schizophrenia
cannabis use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study attempts to examine genetic influences on the effects of tetrahydrocannabinol (Δ9-THC), the active ingredient of marijuana, cannabis, "ganja", or "pot".


Eligibility criteria: Inclusion Criteria:

* 18 and 55 years (extremes included) on the day of the first dosing.

Exclusion Criteria:

* Cannabis naïve individuals.

Primary outcomes:
measure: Behavioral Measures
timeFrame: Baseline, +15, +25, +60, +300
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranganathan M, De Aquino JP, Cortes-Briones JA, Radhakrishnan R, Pittman B, Bhakta S, D'Souza DC. Highs and lows of cannabinoid-dopamine interactions: effects of genetic variability and pharmacological modulation of catechol-O-methyl transferase on the acute response to delta-9-tetrahydrocannabinol in humans. Psychopharmacology (Berl). 2019 Nov;236(11):3209-3219. doi: 10.1007/s00213-019-05273-5. Epub 2019 Jun 11.
citation: Ranganathan M, Radhakrishnan R, Addy PH, Schnakenberg-Martin AM, Williams AH, Carbuto M, Elander J, Pittman B, Andrew Sewell R, Skosnik PD, D'Souza DC. Tetrahydrocannabinol (THC) impairs encoding but not retrieval of verbal information. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):176-183. doi: 10.1016/j.pnpbp.2017.06.019. Epub 2017 Jun 20.
Clinical trial NCT05457530: Doravirine and Weight Gain in Antiretroviral Naive
Official title: Effect of Modified, Rapid-start, DOR/3TC/TDF or DOR + FTC/TAF or BIC/FTC/TAF on Body Weight and Composition, Metabolic Risk Parameters, and Measures of Bone Strength in Treatment-Naïve Black and Hispanic Women With HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Body Weight Changes
Human Immunodeficiency Virus
ART
Obesity
Minority Health
BMD
Metabolic Syndrome
Fasting
Keywords: Treatment Naive
African American Women
Hispanic Women
Fasting Glucose
Fasting Insuline
Negative pregnancy test
18 years or older
Lead sponsor: Prism Health North Texas
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-07-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

Detailed description: Study is three-arm, open-label, randomized, interventional trial, in which all patients who are successfully enrolled will be randomized 1:1:1 to initiate ART therapy with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs. Doravirine + Emtricitabine/Tenofovir Alefenamide, Bictegravir/Emtricitabine/Tenofovir Alafenamide. All patients will be followed or a total o 48 weeks.

.

Eligibility criteria: Inclusion Criteria:

* 18 years or older;
* No prior exposure to antiretroviral therapy for \>7 days prior to study entry;
* Plasma HIV1 RNA concentration \>/=5000 copies/mL;
* CD4 T cell count \>/=200 cells/µL.
* For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry
* Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

* Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.
* Creatinine clearance \<60 mL/min
* Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)
* Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation

Primary outcomes:
measure: Change from Baseline of BMI after Initiation of ART Therapy at Week 48
timeFrame: Week 48
measure: Change of BMI Category after Initiation of ART Therapy at Week 48
timeFrame: Week 48
measure: Change in Regional Lean and Body Mass
timeFrame: Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Prism Health North Texas
state: Texas
Study officials:
affiliation: Prism Health North Texas
name: Roger Bedimo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00071630: Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders
Official title: Process as a Predictor of Outcomes in CBT for Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anxiety Disorders
Keywords: Adolescent
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 130
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome.

Detailed description: Anxiety disorders are common among children; if untreated, they can negatively affect children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but the causal mechanisms between therapy and beneficial outcomes have not been thoroughly investigated.

Audio and videotaped sessions of children currently receiving CBT and those who received CBT in previous trials will be examined. Various rating scales will be used to rate therapeutic alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate potential process variables that contribute to participant drop-out, this study will compare the early process variables for children who complete treatment and for those who discontinue treatment.

Eligibility criteria: Inclusion criteria:

* Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia
* At least one English-speaking parent

Exclusion criteria:

* IQ \< 80
* Psychotic symptoms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
Study officials:
References:
Clinical trial NCT02180230: Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
Official title: Immediate Function of NobelSpeedy Shorty and Brånemark System® Mk III Shorty Implants in Daily Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Complete Edentulism
Keywords: Short implants
prospective multicenter study
maxilla & mandible
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the 7 mm long implants NobelSpeedy Shorty and Brånemark System Mk III Shorty: by determining the marginal bone remodeling, implant survival rate, soft tissue health and maintenance.

Detailed description: The primary endpoint was the change in marginal bone levels (in mm) from the time of implant insertion to follow-up visits (3, 6, 12, 36 and 60 months).

Further endpoints were:

* cumulative survival rates of the implants
* soft tissue parameters (papilla index, bleeding on probing)
* plaque formation

Eligibility criteria: Inclusion Criteria:

* The subjects should have an osseous architecture enough to receive an implant with a diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length of 7 mm.
* The final tightening torque at installation should be 35-45 Ncm without further rotation and should not exceed 45 Ncm.
* The subject as well as the implant site(s) should fulfill criteria for immediate provizionalization.
* Immediate insertion (e.g. placement of the implant immediately after extraction) will not constitute an exclusion criterion.
* The implants site(s) should be free from extraction remnants.
* The subject should be healthy and compliant with good oral hygiene.
* The subject should be available for the 5-year term of the investigation.
* Favorable and stable occlusal relationship

Exclusion Criteria:

* Alcohol or drug abuse as noted in patient records or in patient history.
* Health conditions, which do not permit the surgical procedure.
* Reason to believe that the treatment might have a negative effect on the subject's total situation (psychiatric problems), as noted in patient records or in patient history.
* The subject is not able to give her/his informed consent to participate.
* Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
* Severe bruxism or other destructive habits.

Primary outcomes:
measure: Marginal Bone Remodeling
timeFrame: from implant insertion to 6, 12, 36 and 60 months
Secondary outcomes:
measure: Cumulative Survival Rates of the Implants
timeFrame: implant insertion to follow-up visits (6, 12, 36 and 60 months)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06588530: PFAS Exposure and Immune Response to Vaccination in Adults
Official title: Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Innate Inflammatory Response
Vaccination
Diphtheria
Tetanus
Environmental Exposure
Vaccine
Antibodies
Adult
Immunity
Pollution; Exposure
Keywords: PFAS
Perfluoroalkyl substances
Polyfluoroalkyl substances
Vaccine
fluorocarbons
tetanus-diphtheria vaccine
prospective study
Adaptive immunity
innate immunity
PFNA, Perfluorononanoic Acid
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine. The study focuses on participants from a community with known prior PFNA exposure through contaminated drinking water. The main question it aims to answer is:

* Does exposure to PFNA weaken the body's initial immune response, leading to lower levels of protective antibodies after vaccination?

Participants will:

* Receive Tetanus and Diphtheria (Td) booster vaccination
* Visit the study office 7 times over a 30-day period
* Have blood and saliva collected at each study visit


Eligibility criteria: Inclusion Criteria:

* Participated in the Paulsboro PFAS Health Study
* Provided a blood sample for the Paulsboro PFAS Health Study
* Weigh at least 110 pounds

Exclusion Criteria:

* Currently Pregnant
* History of difficult blood draws
* History of adverse reaction to prior vaccinations
* Currently taking immune suppressants
* Recent dental surgery or dental procedure within 4 weeks of starting study
* Had a Td booster in the past 10 years

Primary outcomes:
measure: Change in Tetanus-diptheria specific IgG
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paulsboro
country: United States
facility: EOHSI Paulsboro Office
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Robert Laumbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03142230: Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
Official title: Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Score
Keywords: feeding tube
gastric
newborn infant
nursing
pain
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
Collaborators: name: Centre National de Ressources de lutte contre la Douleur
First posted: 2017-05-05
Enrollment: 71
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, randomized, multicentric, open-label, randomized study
Primary purpose: OTHER

Brief summary: Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn

Detailed description: After inclusion, the nurse performs randomization by opening the envelope. The newborn then receives the care with the introduction of the gastric tube after randomization (experimental arm with holed baby bottle nipple and control arm: with pacifier). The treatment is filmed and recorded by a previously installed camera. The films are viewed by two independent experts from the pain of the study, to assess pain by scale score (DAN acute pain of the newborn

Eligibility criteria: Inclusion Criteria:

* Newborn term, or premature (from 32 weeks) from 48 hours to 14 days of life.
* Presence of sucking reflex
* Patient whose authors of parental authority have given their written consent for their participation
* Patient affiliated to or benefiting from a social security scheme

Exclusion Criteria:

* Newborn intubated or NIV and / or sedated
* Newborn with malformation (especially cleft palate)
* Contra-indication to sugar administration
* Newborn previously included in the study
* Administration of analgesics in the previous 8 hours
* Atresia of the unoperated esophagus
* Non-operated oeso-tracheal fistula
* Major swallowing disorders
* Necrotizing ulcerative colitis

Primary outcomes:
measure: pain evaluation
timeFrame: Time of nurse care - thirty minutes maximum
Secondary outcomes:
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Michele Granier, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02259530: Case Series for Traumatized Refugees With Khat Dependence
Official title: Sustainable and Adapted Treatment Strategies to Restore Psychological Functioning and Mental Health Among Displaced Somalis: Preparation of a Multicenter Treatment Study (P114/02/2014): Pilot Study 3.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Khat Use Disorder
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Africa Mental Health Foundation
First posted: 2014-10-08
Enrollment: 20
Sex: MALE
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 research project will offer psychotherapeutic treatment to Somali refugees with PTSD and comorbid khat dependence. In this case series, evidence-based techniques will be applied and adapted to the cultural background of Somali refugees in Kenya.

Detailed description: More than 500.000 Somali refugees live in Kenya. This group is especially burdened by high rates of exposure to traumatic events, high prevalence of PTSD and a high comorbidity with substance use disorders, mainly related to khat (catha edulis). There's a shortage of literature on psychotherapeutic methods that are applicable in this group. The aim of this case series is to develop modifications of standard therapeutic techniques to the Somali culture and to the needs of this group. Twenty successive cases will be recruited from a community clinic where refugees often seek for treatment because of psychiatric problems. Senior level psychotherapists will apply and adapt techniques and approaches like Community Reinforcement Approach (CRA), Relapse Prevention (RP), and Narrative Exposure Therapy (NET); all sessions will be video recorded. Regular supervision with external experts and group discussions will be held to evaluate and adapt the single procedures and techniques. The aim of this study is the development of a standardized approach that can be used in a Randomized Controlled Trial which will be conduced in the future.

Eligibility criteria: Inclusion Criteria:

PTSD (DSM-IV) Khat Dependence (DSM-IV)

Exclusion Criteria:

Severe Psychotic Disorder Suicidality Mental Disability

Primary outcomes:
measure: Posttraumatic Stress Diagnostic Scale (PDS)
timeFrame: 3 months
measure: Time-Line Follow Back(TLFB)
timeFrame: 3 months
Secondary outcomes:
measure: Hopkins Symptom Checklist (HSCL)
timeFrame: 3 months
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Africa Mental Health Foundation
Study officials:
References:
Clinical trial NCT04206930: Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
Official title: Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alexithymia
Alcohol Use Disorder
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-12-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Art therapy support combined with standard care for people with an alcohol use disorder coming to a day hospital for withdrawal could be beneficial compared to standard care alone because it would improve the alexithymia of these patients, helping them to better identify their feelings and / or emotions, and improve their self-confidence, their self-esteem self and their oral communication.

Detailed description: Alexithymia is an inability to identify and describe one's emotions associated with outward thinking. Frequently found in people with an alcohol use disorder, a true mental handicap, alexithymia has been clearly identified as a relapse factor in addictive problems related to alcohol. The ALEXART study intends to study the evolution of alexithymia in people with an alcohol use disorder hosted in an Addictology Day Hospital unit through the use of an approach non-drug that is art therapy. Our hypothesis is that art therapy can help patients with alcohol use disorders to develop a better understanding of their own behaviors, to name their emotions and feelings, and to improve their communication with others and thereby be able to choose to change their behavior.

Eligibility criteria: Inclusion Criteria:

* Adult 18 or over
* Patient with an alcohol use disorder starting day hospital care in the psychiatry and addiction department of the Angers University Hospital
* Subjects who gave and signed informed consent to participate in the study with alexithymia (Toronto Test greater than or equal to 56)

Exclusion Criteria:

* Non-understanding of the French language
* Non-affiliation to a social security scheme
* Major cognitive impairment
* Motor problems preventing walking
* Protective patients
* Pregnant or lactating women
* Patients under protection of justice or deprived of liberty
* Patients under protective supervision or guardianship

Primary outcomes:
measure: Echelle de Toronto (TAS)
timeFrame: 3 month after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU ANGERS SERVICE DE PSYCHIATRIE ADDICTOLOGIE
name: BENEDICTE GOHIER
role: STUDY_DIRECTOR
References: