louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05338944: DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity
Official title: Dialectal Behavioural Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prevention
Type2Diabetes
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Diabetes Canada
name: Children's Hospital Research Institute of Manitoba (CHRIM)
First posted: 2022-04-21
Enrollment: 6
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 90 youth will be randomized (2:2:1) into one of the three arms of the trial; DBT + lifestyle, lifestyle alone, control
Primary purpose: PREVENTION

Brief summary: This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.


Eligibility criteria: Inclusion Criteria:

* 14-17 years old
* BMI z-score \>1.6
* signs of mild-moderate depression (PHQ-9 score 5-19)
* willing and able to comply with study procedures

Exclusion Criteria:

* more than one health co-morbidity
* being treated with medication for obesity
* taking steroids
* currently being treated for atypical antipsychotics
* have an orthopedic injury or chronic illness that would prevent them from performing the intervention
* experienced weight loss or enrolled in weight loss program in the six months prior to the study
* self reported history of alcoholism or drug abuse
* history of self-harm or suicide attempts in the past 12 months
* currently enrolled in psychotherapy or DBT
* parents do not approve of you participating
* unable/unwilling to give assent/consent

Primary outcomes:
measure: Enrollment rates
timeFrame: 6 weeks
measure: Adherence to the intervention
timeFrame: 16 weeks
measure: Retention for follow up measurements
timeFrame: one week at week 16 and week 32
Secondary outcomes:
measure: Barriers for lifestyle change
timeFrame: 2 weeks at 16 weeks
measure: Delivery of behavioral intervention
timeFrame: 2 weeks at 16 weeks
measure: DBT skills training
timeFrame: 2 weeks at 16 weeks
measure: DBT benefits and challenges
timeFrame: 2 weeks at 16 weeks
measure: Patient centered
timeFrame: 2 weeks at 16 weeks
measure: Feedback
timeFrame: 2 weeks at 16 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT04898244: Obstetricians' Views on the Reasons for Egypt's High Caesarean Section Rates
Official title: Causes of High Caesarean Section Rates in Egypt: Perception of Obstetricians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section Rate
Egypt
Keywords: Caesarean Section
high CS rates
Egypt
Minia university
Obstetricians
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 201
Sex: ALL
Minimum age (years): 28
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obstetricians from different hospitals and areas

Brief summary: Handling of questionnaires to a number of obstetricians from different hospitals to show their perceptions about causes of high cs rate in Egypt

Detailed description: An open-ended self-administered questionnaire Handled to a number of obstetricians from different hospitals to show their perceptions about causes of the high cs rate in Egypt.

Eligibility criteria: Inclusion Criteria:

Obstetricians from different hospitals. -

Exclusion Criteria:

Refusal to participate

-

Primary outcomes:
measure: Reasons of the High Caesarean Section Rates in Egypt.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
References:
Clinical trial NCT05567744: Registry for CADASIL
Official title: Research Registry for Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy
Keywords: CADASIL
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study team will inform the lay community and professional society's memberships of the registry to assist with referrals for enrollment. Participants who are being contacted for other CADASIL research projects will be asked whether they would also like to enroll in the registry. Clinicians or other members of a patient's care team may also recruit participants out of their clinics.

Brief summary: This study is being done in order to create a registry (list) of people interested in Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) research. It may be that you have a family member or other loved one with CADASIL, or that you may have CADASIL or are at risk. Participation means that your name will be added to a list of people who will be invited to participate in future research studies on CADASIL. Participants must be 18 years or older, and will remain on the registry until they request to be removed.

Detailed description: The purpose of this registry is to allow Dr. Jane Paulsen and her CADASIL research teams to contact individuals on the list who may fit a study's eligibility requirements. All individuals interested in CADASIL research who either have a family member or loved one, or are at risk themselves, are eligible to participate in this registry. Information collected as part of the registry will be used solely to determine potential participant's eligibility to participate research.

A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* have a loved one or a family member with CADASIL, or are at-risk for CADASIL themselves

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: A Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) Registry
timeFrame: Up to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jane Paulsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02356744: Maternal and Neonatal Outcome in Pregnant Women Before and After 1 Year Since Bariatric Operation
Official title: Comparison of Maternal and Neonatal Outcome Before and After 1 Year of Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Complications
Keywords: Maternal outcome
Fetal outcome
bariatric surgery
Third Trimester
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in third trimester after laparoscopic adjustable gastric banding done within last 1 year or earlier

Brief summary: Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.

Detailed description: Ultrasound follow up for 9 months pregnancy in women who had laparoscopic adjustable gastric banding done within last 1 year or earlier.

Eligibility criteria: Inclusion Criteria:

* 1.Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier

Exclusion Criteria:

* medical disorders affecting pregnancy as diabetes, hypertension, SLE

Primary outcomes:
measure: maternal outcome
timeFrame: though 9 months of pregnancy and 6 weeks postpartum
Secondary outcomes:
measure: Neonatal outcome
timeFrame: 2 weeks after birth
measure: Route of delivery
timeFrame: time of delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed M Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645744: Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
Official title: A Long-term Follow-up Study in Patients Previously Treated With Mustang Bio, Inc. CAR-T Cell Investigational Products
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Chronic Lymphocytic Leukemia in Relapse
Small Lymphocytic Lymphoma, Relapsed
Waldenstrom's Macroglobulinemia Recurrent
Follicular B-cell Non-Hodgkin's Lymphoma
B-cell Lymphoma Refractory
Mantle Cell Lymphoma Recurrent
Hairy Cell Leukemia
Diffuse Large B Cell Lymphoma
Waldenstrom's Macroglobulinemia Refractory
Mantle Cell Lymphoma Refractory
Keywords: Long-term follow-up
CAR-T cell therapy
MB-102
MB-106
Lead sponsor: Mustang Bio
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study.

Brief summary: A long-term follow-up study to assess safety and efficacy in patients previously treated with Mustang Bio chimeric antigen receptor (CAR)-T cell investigational products.

Detailed description: Non-interventional, multi-center, long-term follow-up study of subjects previously treated with a Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study. Subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.

Eligibility criteria: Inclusion Criteria:

* Patients previously treated with a Mustang Bio CAR-T cell investigational product in a prior Mustang Bio sponsored clinical study.
* Patient has provided signed and dated informed consent.

Exclusion Criteria:

* None. All patients who have received prior treatment with Mustang Bio CAR-T cell investigational product in a Mustang Bio sponsored clinical study are eligible for this long-term follow up (LTFU) study.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to a total of 15 years
measure: Replication competent lentivirus (RCL)
timeFrame: Up to a total of 15 years
Secondary outcomes:
measure: Survival
timeFrame: Up to a total of 15 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: UC Irvine Health - Chao Family Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Mustang Bio
name: Bruce Dezube, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03435744: Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.
Official title: A Multicentre 12-week Randomised, Double Blind, Placebo Controlled Trial of Simvastatin as Augmentation Treatment for Treatment-resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment Resistant Depression
Major Depressive Disorder
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2018-02-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1-Simvastatin plus TAU, 2- Placebo plus TAU
Primary purpose: TREATMENT

Brief summary: In this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. We will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (TAU) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to TAU.


Eligibility criteria: Inclusion Criteria:

* DSM-5 current major depressive episode
* Must currently be on an antidepressant and must have had a non-response to \>2 oral antidepressant treatments in the current episode (including the one they are currently taking).
* Capacity to give informed consent
* Willing to use adequate contraception
* Give written informed consent

Exclusion Criteria:

* Primary psychotic or bipolar disorder
* History of intolerance to statins or presence of any contraindication to statins
* Presence of any serious medical condition or neurological problem
* Presence of autoimmune or inflammatory disorder
* Alcohol or drug dependence
* Active suicidal ideation
* Pregnant or breast-feeding.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS; Montgomery Asberg, 1979)
timeFrame: Week-2, Week-4, Week-8 and Week-12
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Civil Hospital
city: Karachi
country: Pakistan
facility: Civil Hospital
city: Karachi
country: Pakistan
facility: Abbasi Shaheed Hospital
city: Rawalpindi
country: Pakistan
facility: Institute of Professional Psychology
Study officials:
References:
citation: Husain MI, Chaudhry IB, Khoso AB, Husain MO, Rahman RR, Hamirani MM, Hodsoll J, Carvalho AF, Husain N, Young AH. Adjunctive simvastatin for treatment-resistant depression: study protocol of a 12-week randomised controlled trial. BJPsych Open. 2019 Jan;5(1):e13. doi: 10.1192/bjo.2018.84.
Clinical trial NCT02476344: Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects
Official title: Classification and Characterization of Physical Strains During Sorting Series: Physiological Aspects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Activity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-06-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 2 young candidates have tragically died during army pre-recruitment sorting series in 2006. As part of the classification and characterization of the physical aspects of the training, this experiment was requested.

We aim at determining the characteristics of physical strains in sorting series, by objective and subjective parameters and evaluating the difficulty levels and intensity of those strains.

Detailed description: each subject will perform the following 3 days experiment protocol, consisting of army training exercises:

1. sack carrying exercise; the subjects will go up and down through a steep slope with sand sack on their back (path length is 200 meters,10 repetitions).

   the first day will also include recruitment and medical examination, in addition to the exercise.
2. crawling exercise; the subjects will crawl with knee's protectors back and forth (path length is 20 meters,15 repetitions).
3. combined exercise: sprints session (path length 600 meter, 3 repetitions),15 min break, sack carrying session (same protocol as first day), 45 min break and crawling session (same protocol as the second day).

during all exercises heart rate, core temperature, lactic acid and CPK levels will be monitored continuously.

Eligibility criteria: Inclusion Criteria:

* Aged 18-22 years.
* Healthy civilian volunteers.
* without skeleton-muscle illnesses.
* without Infectious disease 2 weeks prior to the experiment.

Exclusion Criteria:

* any physical condition.
* physician decition.

Primary outcomes:
measure: heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch)
timeFrame: 3 experiment days
Secondary outcomes:
measure: CPK measured from blood sample (3ml) in the lab
timeFrame: 3 experiment days
measure: lactic acid measured using lactat-meter (Lactate pro LT-1710)
timeFrame: 3 experiment days
measure: body core temperature monitored using telemetry pill
timeFrame: 3 experiment days
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806792: Post-menopausal Women Osteoporosis(Phase III)
Official title: For 4 Months, the Multi Center, Double Blinded, Randomized, Active Controlled, Comparative Clinical Study to Assess the Efficacy and the Safety to Improvement Effect of Vit.D of Risenex Plus M Tablet in Patients With In Post-menopausal Women Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women Osteoporosis
Keywords: Osteoporosis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

Detailed description: The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Eligibility criteria: Inclusion Criteria:

1. women osteoporosis
2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of \< -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of \< -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level \> 40 IU/L, with a reported hysterectomy
3. low levels of 25(OH)D \> 9 ng/mL
4. patients who give written consent of agreement to voluntarily participate in the clinical study
5. patients who can read and understand written instructions

Exclusion Criteria:

1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures
2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
3. low levels of 25(OH)D (less than 9 ng/mL).
4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of \> 200 IU.
5. drug administration after diagnosing as alcoholic or psychical disease
6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation

Primary outcomes:
measure: proportion of patients with 25(OH)D level < 20 ng/mL at 16 weeks.
timeFrame: 16 weeks form first drug adminstration.
Secondary outcomes:
measure: proportion of patients with 25(OH)D level < 9 ng/mL at 16 weeks, change of 25(OH)D level and Bone Markers.
timeFrame: 16 weeks form first drug administration.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang university hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Hyoung-Moo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03192592: Safety and Effectiveness Evaluation of the Apotech® Diabetic Body Moisturizer
Official title: Safety and Effectiveness Evaluation of a New Moisturizer Formulation With Antioxidant, Anti-inflammatory and Anti-microbial Effects in the Prevention of a Diabetic Skin Dryness and Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Diseases, Metabolic
Skin Care
Lead sponsor: ANS Pharma
Sponsor class: INDUSTRY
Collaborators: name: Allergisa Pesquisa Dermato-Cosmetica LTDA
First posted: 2017-06-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study aim to verify the improvement of texture, elasticity and general appearance of the skin through the application of the cosmetic product Apotech®.
Primary purpose: PREVENTION

Brief summary: Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications.

Detailed description: Safety and effectiveness evaluation of a new moisturizer formulation with antioxidant, anti-inflammatory and anti-microbial effects in the prevention of diabetics dry skin and complications. This study aim to address the target population, subjects with controlled diabetes, to verify the improvement of texture, elasticity, and general appearance of the skin through the application of the cosmetic product Apotech®.

Eligibility criteria: Inclusion Criteria:

* Subjects with controlled diabetes
* Any phototype and all skin types

Exclusion Criteria:

* Pregnant women
* Subjects that not match the inclusion criteria

Primary outcomes:
measure: Skin general appearance
timeFrame: 28 days
measure: Skin texture
timeFrame: 28 days
measure: Skin hydration
timeFrame: 28 days
measure: Skin elasticity and visible cracking
timeFrame: 28 days
Secondary outcomes:
measure: Sensory evaluation of the product
timeFrame: 28 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmetica
state: São Paulo - Brazil
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: Lucas O. Guerra, MSc
role: PRINCIPAL_INVESTIGATOR
References: