louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04447937: Immunodeficiency in MS
Official title: Analysis of Medical Therapy and History as Risks of Immunodeficiency in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Hypogammaglobulinemia
Immunodeficiency
Infection, Bacterial
Lead sponsor: Advanced Neurosciences Institute
Sponsor class: OTHER
Collaborators: name: Novel Pharmaceutics Institute
First posted: 2020-06-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective data from 1500 patients with immune-mediated CNS disease is expected to be used from the electronic medical record eClinicalWorks and other electronic and paper archives of Advanced Neurosciences Institute.

Brief summary: The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS.

Detailed description: The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS. By understanding this relationship future studies can be designed to create a model of immunosenescence in multiple sclerosis, which could help healthcare providers to predict and assess health risks. Preventative strategies can then be tested to look for ways to prevent these immune-related risks.

Eligibility criteria: Inclusion Criteria

* One or more immunoglobulin level results and medical history available
* 18 years of age or older at the time of data collection
* Patients with first symptom MS or other isolated demyelinating syndromes, neuromyelitis optica, or rheumatic-associated CNS inflammation

Exclusion Criteria:

* No evidence of CNS autoimmune disease
* Less than 18 years of age at the time of data abstraction
* Undergoing plasma exchange at the time of any lab tests drawn

Primary outcomes:
measure: Immunoglobulin Levels
timeFrame: 1 year
Secondary outcomes:
measure: Infections
timeFrame: 1 year
measure: Immune-mediated conditions
timeFrame: 1 year
measure: Malignant and pre-malignant conditions
timeFrame: 1 year
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Advanced Neurosciences Institute
state: Tennessee
Study officials:
affiliation: Advanced Neurosciences Institute
name: Samuel F Hunter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05342337: Exercise Therapy With Telerehabilitation in Patients Living With HIV
Official title: Investigation of the Effectiveness of Biopsychosocial Exercise Therapy Approach With Telerehabilitation in Patients Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Telerehabilitation
Biopsychosocial Approach
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effectiveness of the Biopsychosocial Exercise Therapy Approach (BETY) approach with the Telerehabilitation in patients living with HIV (PLWH).

Detailed description: 55 individuals living with HIV (PLWH) were included in the study. Among those individuals, 25 individuals who volunteer to exercise with telerehabilitation will be grouped in the telerehabilitation group. The rest of the individuals who do not participate in the exercise group will be in the control group.

Group 1: Telerehabilitation group: Individuals in the telerehabilitation group attend sessions that last for one and a half hours, 3 days a week for 12 weeks, in the company of an investigator over the videoconference through zoom. The investigator, who provides supervision during the sessions, also participates in the exercises simultaneously.

Group 2: Control group: Individuals in the control group continue their routine drugs.

Both the telerehabilitation exercise group and the control group continue their drug treatments during the 12 weeks of the period.

Eligibility criteria: Inclusion Criteria:

* Patients living with HIV (PLWH),
* Ages between 18 and 65 years old,
* Participants attend and follow instructions through telerehabilitation.

Exclusion Criteria:

* Participants who use recreational drugs
* Participants who do not adapt to the exercises through telerehabilitation,
* Participants who did not agree to be volunteers are not included in our study.

Primary outcomes:
measure: Change from Baseline in Biopsychosocial Exercise Therapy Questionnaire (BETY-BQ) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in Short Form-36 (SF-36) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in FRAIL scale at 12 weeks
timeFrame: Baseline, 12 weeks
measure: Change from Baseline in Clinical Frailty Scale (CFS) scale at 12 weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Aysenur Tuncer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01162837: Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne
Official title: An Evaluation of the Safety and Effectiveness of the BEAM Device in the Treatment of Mild-to-moderate Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Keywords: Acne
Lead sponsor: Oregon Aesthetic Technologies
Sponsor class: INDUSTRY
First posted: 2010-07-15
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.


Eligibility criteria: Inclusion Criteria:

1. Age 15 years or older of either gender and of any racial/ethnic group.
2. At least 8 acne inflammatory lesions (see section 9) in the treatment and control areas.
3. Presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the Global Acne Severity Scale, see below)
4. Subjects must be in generally good health.
5. Subjects must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

1. Oral retinoid use within six months of entry into the study.
2. Systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study.
3. Topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study.
4. Microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study.
5. Subjects with a history of dermabrasion or laser resurfacing at the site to be treated.
6. Use of topical lipid absorbing substances (Clinac AC) within 1 week of entry into the study.
7. Non-compliant subjects.
8. Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
9. Subjects using alcohol-based topical solutions or "exfoliating" agents within 1 week of entry into the study.
10. Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
11. Pregnant or nursing females.
12. Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
13. Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.

Primary outcomes:
measure: Reduction in inflammatory lesion count
timeFrame: 8 weeks
Secondary outcomes:
measure: Global Acne Severity Score
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Baumann Cosmetic & Research Institute
state: Florida
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Portland
country: United States
facility: Oregon Dermatology & Research Institute
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Ben Ehst, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924437: Evaluation of the Uterine Cavity After Operative Hysteroscopy
Official title: Evaluation of the Uterine Cavity After Operative Hysteroscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Uterine Abnominalies
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It will be held in the department of Obstetrics and Gynecology during the period from February 2025 to February 2026. The study will include all recruited patients who will be selected for operative hysteroscopy during that period.

Brief summary: This study will focus on evaluation of the uterine cavity after operative hysteroscopy using three-dimentional tranvaginal ultrasonography and office hysteroscopy to detect and residual or recurrent abnormalities or intrauterine adhesions to optimize the results of operatve hysteroscopy in different uterine pathologies such as uterine polyps, fibroids, adhesions in addition to mullerian anomalies especially septate uteri.


Eligibility criteria: Inclusion Criteria:

1. Patients in reproductive age group
2. Patients already selected for operative hysteroscopy
3. Patients accepted to share in the study
4. Patients accepted to come for follow up ( within 3 months after the initial operative procedure, at least after 4 weeks

Exclusion Criteria:

1. Patients outside the age of reproduction
2. Patients with negative findings at operative hysteroscopy
3. Patients refused to share in the study
4. Patients not available for follow up
5. Infection
6. pregnancy or design of pregnancy

Primary outcomes:
measure: 1- accuracy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00619437: Genetics of Schizophrenia
Official title: Genetics of Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: schizophrenia
genetics
family
multiplex
haplotypes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: schizophrenia

Brief summary: Genetic etiology in schizophrenia is widely accepted. However, many chromosomal sites were shown to characterize the families of patients with schizophrenia. This is probably due to the high genetic heterogenity of this illness. Thus, it is important to investigate the genetic factor in relatively genetically homogenous populations. Many studies have indicate that Ashkenazy Jews show relative gentic homogenity. Indeed, the genes responsible for most Mendelian disorders of Jewish peoples have been identified. The study will apply genome-wide mutation screening methods to identify candidate allells in subjects of Ashkenazi Jewish ancestry with multiplex schizophrenia.


Eligibility criteria: Inclusion Criteria:

1. Age 18+;
2. Meet DSM-IV criteria for Schizophrenia;
3. At least one first-degree relative who Meet DSM-IV criteria for Schizophrenia;
4. Can sign the informed consent form.

Exclusion Criteria:

1. Patients suffering from terminal or incurabale disease;
2. Minors, incompetents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Psychiatric ward, Sheba Medical Center
name: Michael Bunzel, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00900237: Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Official title: A Phase I, Single Centre, Open, Randomised, Parallel Study to Evaluate the Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine in Healthy Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Partial Epilepsy
Keywords: Partial
Epilepsy
Eslicarbazepine acetate
Pharmacokinetics
Tolerability
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to measure the concentrations of two anti-epileptic drugs (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid and blood plasma of healthy subjects and also to assess how these drugs are tolerated.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Aged 18-55 years
* Body mass index (18.5-29 kg/m3)

Primary outcomes:
measure: Cmax - Maximum Plasma Concentration in Plasma and Cerebral Spinal Fluid
timeFrame: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
measure: AUC0-t AUC From Time Zero to the Last Sampling Time
timeFrame: Day 9 - Pre-dose; 0.5h; 1h; 1.5h; 2h; 3h; 4h; 6h; 8h; 12h; 16h; 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit Antwerpen
Study officials:
affiliation: SGS LSS Clinical Pharmacology Unit Antwerpen
name: Luc Cavens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03301337: Amino-acid Uptake After Meat Protein Intake
Official title: Amino-acid Uptake After Hydrolyzed Meat Protein Intake in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amino Acid Metabolism
Keywords: Amino acid uptake
Aging
Meat protein
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: DC Ingredients
First posted: 2017-10-04
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-blindet randomized cross-over study
Primary purpose: OTHER

Brief summary: The purpose of the project is to provide evidence for the use of hydrolysed meat protein (HMP) as a protein supplement for elderly who has difficulty meeting the recommended daily protein intake.

The study will investigate how the meat protein derived amino acids (from either HMP, steak or minced meat) are absorbed and released into the blood circulation of elderly persons. Hereby, the study will explore the the anabolic potential of HMP compared with common meat products.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Untrained

Exclusion Criteria:

* below 65 years of age
* BMI above 30
* Smokers
* Vegetarians
* Subjects with diabetes or other metabolic diseases
* Medical treatment affecting protein synthesis
* Gastro-intestinal problems, reduced liver or kidney function, elevated blood pressure, atherosclerosis
* More than 5 ours regular physical activity per week (except physical activity related to commuting)

Primary outcomes:
measure: D5-phenylalanine appearance
timeFrame: 5 hours
Secondary outcomes:
measure: Insulin concentration
timeFrame: 5 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Jakob Agergaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00605137: Safety of Insulin Detemir in Children With Type 1 Diabetes
Official title: Safety of Insulin Detemir and Insulin NPH in Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of trial is to investigate the safety of insulin detemir and insulin NPH in children with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least one year
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
* HbA1C below 11.0%
* Willing to comply with Investigator's instructions
* Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total daily insulin dose of more than 2.00 IU/kg
* Current treatment or expected at the screening to start treatment with systemic corticosteroids

Primary outcomes:
measure: Incidence of hypoglycaemic episodes
timeFrame: during treatment
Secondary outcomes:
measure: Adverse events
measure: Laboratory assessments and other safety endpoints
measure: HbA1C, self monitored blood glucose and within-subject variability of glucose
measure: Height
measure: Insulin doses
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01135537: Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Official title: Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Malignancy
Metabolic Disease
Genetic Disorder
Keywords: allogeneic hematopoietic stem cell transplantation
pharmacokinetics
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 30
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).

Detailed description: Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD). Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and serum levels will be collected, as per schedule, with the last sample taken +100 days post-HSCT.

Eligibility criteria: Inclusion Criteria:

* All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician.
* Written, informed consent

Exclusion Criteria:

* Hypersensitivity to rabbit proteins or to any product excipients
* Active acute or chronic infections, which would contraindicate any additional immunosuppression
* Known pregnancy or breastfeeding

Primary outcomes:
measure: Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course
timeFrame: 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital For Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Tal Schechter-Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02674737: Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: A Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Sedation,Gastrectomy, Enhanced Recovery After Surgery
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2016-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and follow up for 3 days.


Eligibility criteria: Inclusion Criteria:

* 18-85 years old
* underwent gastrectomy in the hospital and operation duration lasted at least 2 hours

Exclusion Criteria:

* take part in other clinical trials
* quinolone antibiotics intake 4 weeks prior to or within the study
* NSAIDS intake within one month
* history of peptic ulcer
* respiratory insufficiency
* renal insufficiency
* acute hepatitis or severe liver disease (Child-Pugh class C)
* pregnancy or lactation
* abnormal ECG with clinical significance
* uncontrolled hypotension
* bleeding tendency or hematological diseases
* untreated mechanical intestinal obstruction
* unable to express or any kind of mental disease.

Primary outcomes:
measure: postoperative pain assessed by Prince Henry Pain Scale
timeFrame: 1-3d after gastrectomy
measure: recovery of gastrointestinal function assessed by time to first defecation after surgery
timeFrame: 30 days after gastrectomy
measure: white blood cell count (10^9/L)
timeFrame: 1-3d after gastrectomy
measure: C-reactive protein (mg/L)
timeFrame: 1-3d after gastrectomy
Secondary outcomes:
measure: percentage of time within target sedation range
timeFrame: 1-3d after gastrectomy
measure: risk of bradycardia requiring interventions
timeFrame: 1-3d after gastrectomy
measure: risk of hypotension requiring interventions
timeFrame: 1-3d after gastrectomy
measure: use of opioids and use of benzodiazepins
timeFrame: 1-3d after gastrectomy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Institute of General Surgery of Jinling Hospital
state: Jiangsu
Study officials:
References: