louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05314556: Group Psychotherapy in Narcolepsy Type 1
Official title: Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Narcolepsy Type 1
Keywords: Narcolepsy Type 1
Narcolepsy
Narcolepsy with cataplexy
Group psychotherapy
Group therapy
Psychotherapy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 10
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 aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance.


Eligibility criteria: Inclusion Criteria:

* Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 \* 062 and orexin A / hypocretin 1
* Age between 18 and 65 years
* Signed informed consent
* Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI\>10/h)

Exclusion Criteria:

* Presence of severe psychiatric comorbidity
* Other psychotherapy during the study period
* Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis.

Primary outcomes:
measure: Fatigue (Severity)
timeFrame: Week 0-24
measure: Daytime sleepiness
timeFrame: Week 0, Week 6, Week 12, Week 24
measure: Sleep quality
timeFrame: Week 0-24
measure: Emotion regulation
timeFrame: Week 0-24
Secondary outcomes:
measure: Disease processing, acceptance & coping
timeFrame: Week 0, Week 6, Week 12, Week 24
measure: Anxiety & depression
timeFrame: Week 0, Week 6, Week 12, Week 24
measure: Health-related quality of life (HRQOL)
timeFrame: Week 0-24
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Clinic for Psychosomatic Medicine, Cantonal Hospital St.Gallen
Study officials:
affiliation: Klinik für Psychosomatik und Konsiliarpsychiatrie, Kantonsspital St.Gallen
name: Dagmar A Schmid, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05846256: Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
Official title: Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Male
Keywords: Sperm DNA Fragmentation
Lifestyle
Doublestrand DNA Fragmentatio
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: ExamenLab Ltd
First posted: 2023-05-06
Enrollment: 125
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with unexplanied infertility undergoing fertility treatment

Brief summary: The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.


Eligibility criteria: Inclusion Criteria:

* Unexplained infertile men who will undergo 1st or 2nd IVF treatment
* Age over 18 years
* Normal sperm parameters according to WHO criteria
* IVF treatment

Exclusion Criteria:

- ICSI

Primary outcomes:
measure: The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.
timeFrame: 30-60 minutes
Secondary outcomes:
measure: The proportion of single-stranded DNA damage in sperm of men with unexplained infertility
timeFrame: 30-60 minutes
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Regional Hospital Skive
Study officials:
References:
Clinical trial NCT01093456: Diurnal Variation of Uremic Solutes in Peritoneal Dialysis
Official title: Diurnal Variation of Mineral Metabolism and Protein Fermentation Metabolites in Peritoneal Dialysis Patients and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: diurnal variation
peritoneal dialysis
uremic retention solutes
phosphorous
indoxyl sulfate
p-cresol sulfate
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peritoneal dialysis patients Healthy volunteers

Brief summary: Study on the daytime variation of uremic retention solutes and markers of bone-mineral metabolism in patients with end-stage kidney disease treated with peritoneal dialysis

Detailed description: Many epidemiological studies have pointed to the association between serum parameters of phosphate metabolism (phosphate, FGF23) and microbiotic protein fermentation (p-cresyl sulphate \[PCS\], indoxyl sulphate \[IS\]) on the one hand and increased risk of all-cause and cardiovascular death on the other hand.

Hypothesis: Due to failing feed-back mechanisms, diurnal variation of serum concentrations of serum phosphate and fermentation metabolites will be more pronounced in dialysis patients, especially in those with negligible residual kidney function.

Clinical studies assessing this issue are scarce to non-existing.

Eligibility criteria: Inclusion Criteria:

* Age 18-55
* Normal dietary habits

Exclusion Criteria:

* Treatment with systemic antibiotics within one month Major abdominal surgery Drugs known to affect gastrointestinal physiology (acid secretion inhibitors, prokinetics, laxatives, probiotics, prebiotics,..)

Primary outcomes:
measure: To evaluate the diurnal variation of serum concentrations of phosphate and protein fermentation metabolites in healthy volunteers as compared to dialysis patients.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Pieter Evenepoel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676856: Hematopoietic Stem Cell Microtransplantation for in AML
Official title: Hematopoietic Stem Cell Microtransplantation for Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
hematopoietic stem cell microtransplantation
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Peking University People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Zhujiang Hospital
First posted: 2016-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of hematopoietic stem cell microtransplantation for in acute myeloid leukemia (AML)patients who can not receive hematopoietic stem cell transplantation (HSCT).

Detailed description: Despite allogeneic HSCT is the only curative therapy for AML, some patients can not receive transplantation due to intolerance of transplant-related toxicity or unwillingness of HSCT. For these patients, microtransplantation seems an optional therapy. However, the efficacy still remain unclear.

Eligibility criteria: Inclusion Criteria:

* AML patients who have received induction chemotherapy with moderate-high dose Ara-C and 3 courses consolidate chemotherapy
* Intolerance or unwillingness of allogeneic HSCT
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: CR rate
timeFrame: 2 years
measure: relapse rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Disease-free Survival
timeFrame: 2 years
measure: Incidence of chimerism
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kong X, Chen Y, Wang LI, Zhou Y, He Y, Nie W, Zhang X, Yin X. Effect of the microtransplantation of allogeneic hematopoietic stem cells as maintenance therapy for elderly patients with acute leukemia. Oncol Lett. 2015 May;9(5):2331-2334. doi: 10.3892/ol.2015.2995. Epub 2015 Feb 27.
Clinical trial NCT05361356: Spectral CT Clinical Trial
Official title: Spectral CT Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adult ALL
Keywords: CT scanning, image assessment
Lead sponsor: Philips (China) Investment CO., LTD
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.

Detailed description: Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.

Eligibility criteria: Inclusion Criteria:

* Volunteers (ages 18 to 75);
* Negative pregnancy tests for women of childbearing age;
* Agree to participate in the clinical trial and sign the subject informed consent form;
* Enhanced scan requires laboratory evidence of normal renal function.

Exclusion Criteria:

* The body cannot comply with CT examination;
* Pregnant and lactating women;
* Claustrophobia;
* People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);
* Patients deemed unsuitable for participation in this clinical trial by the investigator.

Primary outcomes:
measure: Excellent and good rate of clinical imaging (score≥3）
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Common functions assessment
timeFrame: through study completion, an average of 1 year
measure: Convenience evaluation assessment
timeFrame: through study completion, an average of 1 year
measure: Machine function and stability assessment
timeFrame: through study completion, an average of 1 year
measure: Adverse events and serious adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Xi'an
country: China
facility: The First Hospital of Xian Jiaotong University
Study officials:
affiliation: Peking Union Medical College Hospital
name: Daming Zhang
role: STUDY_DIRECTOR
affiliation: Nanfang Hospital, Southern Medical University
name: Yikai Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ting Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT00967356: AZD5985 Single Ascending Dose Study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD5985 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aims of this study are to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD5985 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Healthy male subjects aged 18 to 45 years (inclusive)
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a methodological study (no drug) 1 month prior to Visit 2

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Frequent sampling occasions during study days
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Marianne Hartford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580056: Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs
Official title: Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hysteroscopy, Oocyte Recipients
Keywords: Hysteroscopy
Fundus Endometrial Incision
Oocyte acceptors
pregnancy outcome
uterine scratching
Lead sponsor: Assisting Nature
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2020-10-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women 30-50 years old with infertility undergoing IVF treatment with donor oocytes. 1-2 blastocysts are transferred per cycle with endometrium preparation with Hormone Replacement Therapy.The study population has underwent hysteroscopy with fundus endometrial incision before the embryo transfer.

Brief summary: A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

Detailed description: A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.

Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury

Eligibility criteria: Inclusion Criteria:

* oocyte acceptors
* age 30-50
* embryo transfer with Hormone Replacement Therapy
* embryo transfer within 6 months of hysteroscopy

Exclusion Criteria:

* previous uterine pathology
* sperm sample \<1mil/ml
* leiomyoma
* septate uterus

Primary outcomes:
measure: Implantation Rate
timeFrame: 6 weeks to 42 weeks after embryo transfer]
measure: Delivery Rate
timeFrame: 6 weeks to 42 weeks after embryo transfer]
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Assisting Nature
Study officials:
affiliation: Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
name: Evangelos Papanikolaou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111356: Determine Functions of Pinhole Glasses on the Eyes
Official title: Quantative Analysis of Functional Changes by the Pinhole Glasses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vision, Ocular
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pinhole glasses which is using pinhole effect may induce a functional change on the eyes, including Distance and near visual acuity(DVA, NVA), Pupil size, DOF, Accomodative amplitude, CS, Visual field(VF), Stereopsis.


Eligibility criteria: Inclusion Criteria:

* Age : between 20 and 50 years old
* Visual acuity : correctable distant and near visual acuity by glasses up to 20/20
* Others : Normal intraocular pressure, optic discs with a healthy appearance, and normal ocular alignment.

Exclusion Criteria:

* History of systemic or topical medication that might affect accommodation
* Others : Corneal pathologic features, previous ocular surgery, glaucomatous optic discs, glaucoma, cataracts of grade II or greater, vitreous opacity, or retinal abnormalities that might limit the accuracy of test.

Primary outcomes:
measure: Distance and near visual acuity(DVA, NVA)
timeFrame: Change from baseline at 1 week
Secondary outcomes:
measure: Pupil size
timeFrame: Change from baseline at 1 week
measure: Depth of focus
timeFrame: Change from baseline at 1 week
measure: Accomodation
timeFrame: Change from baseline at 1 week
measure: Visual field
timeFrame: Change from baseline at 1 week
measure: Contrast sensitivity
timeFrame: Change from baseline at 1 week
measure: Stereopsis
timeFrame: Change from baseline at 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Chung-Ang University School of Medicine, Chung-Ang University Hospital
Study officials:
affiliation: Ophthalmology, Chung Ang University Hospital
name: WonSoo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim WS, Park IK, Chun YS. Quantitative analysis of functional changes caused by pinhole glasses. Invest Ophthalmol Vis Sci. 2014 Aug 12;55(10):6679-85. doi: 10.1167/iovs.14-14801.
Clinical trial NCT04491656: Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT
Official title: Evaluating Clinical Outcomes for Determining the Optimal Delay to Skin Incision Under WALANT: a Prospective Series of 34 Patients From a Low Resource Tertiary Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Surgery
Orthopedic Surgery
Lead sponsor: East Avenue Medical Center, Philippines
Sponsor class: OTHER_GOV
First posted: 2020-07-29
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Further studies are needed to establish the effects of WALANT in performing most common hand surgeries, in relation to its clinical outcomes and intraoperative blood loss. Therefore, this study aims to identify the best interval time to perform elective hand surgeries using WALANT technique, document clinical outcomes and identify potential complications

Detailed description: To propose the optimal time delay from the injection to skin incision for most WALANT surgeries of the hand or wrist by analyzing not only intraoperative blood loss, but also postoperative pain scores and complication rates

To determine if there is a difference between performing the WALANT technique with a waiting interval of 7 minutes as compared to 30 minutes prior to incision in relation to blood loss, pain scores, and complications.

Initiate the use of WALANT technique and its application in practice of Orthopaedic Residents in East Avenue Medical Center

Eligibility criteria: Inclusion Criteria:

1. . Signed Consent Form
2. Elective Hand Surgeries
3. Minor Hand Surgeries
4. Adult Male/Female ages 18 and above
5. Multiply injured

Exclusion Criteria:

1. No Consent
2. Multiply injured patient
3. Traumatic Hand Injuries
4. Known allergic reaction to either Epinephrine or Lidocaine.
5. Known heart condition
6. Patients on anticoagulants
7. Patients diagnosed with bleeding disorders

Primary outcomes:
measure: VRS Score
timeFrame: 24 weeks
Secondary outcomes:
measure: Blood Loss
timeFrame: 24 weeks
Other outcomes:
measure: Complications
timeFrame: 24 weeks
Locations:
city: Quezon City
country: Philippines
facility: East Avenue Medical Center; Department of Orthopedics
Study officials:
affiliation: East Avenue Medical Center, Department of Orthopedics
name: Mamer S. Rosario, MD
role: STUDY_CHAIR
References: