louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02685644: Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels
Official title: Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Ovarian Reserve
Keywords: endometrioma
laparoscopy
anti-mullerian hormone
ovarian reserve
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit healthy women besides having endometrioma cysts who will undergo laparoscopic removal of such lesions.

Brief summary: Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.


Eligibility criteria: Inclusion Criteria:

* Women with endometrioma cyst(s)
* Women of age under 35 years old
* Women without any previous ovarian surgery

Exclusion Criteria:

* Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment
* Having another cystic lesion besides endometrioma
* Need for extensive bipolar coagulation during surgery
* Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound
* Postoperative pathology excluding endometrioma

Primary outcomes:
measure: Anti-Mullerian hormone levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Erkan Kalafat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725044: Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.
Official title: Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Inha University Hospital
First posted: 2023-02-13
Enrollment: 88
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.

Detailed description: Previous studies have indicated that ginseng root may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine FSS(fatigue severity scale), CIS, lactate, Ammonia, Exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.

Eligibility criteria: Inclusion Criteria:

- CIS \> 76 points

Exclusion Criteria:

* A person who feels tired due to surgical operation within 6 months.
* drug/alcoholic hepatitis, cirrhosis, and fatty liver
* anorexia or bulimia
* a person on night duty, shift work, or heavy redundancy
* A person who is unable to perform an exercise load test
* A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
* A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
* A person who continues to exercise regularly within three months of visiting
* Immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines

Primary outcomes:
measure: CIS
timeFrame: 8 weeks
measure: FSS
timeFrame: 8 weeks
measure: NRS
timeFrame: 8 weeks
measure: Blood Indicators Related to Physical Fatigue
timeFrame: 8 weeks
measure: Blood Indicators Related to Mental Fatigue
timeFrame: 8 weeks
measure: exercise test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
affiliation: Inha University Hospital
name: Kyung Lim Joa, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04380844: Effects of an Activity Control System in Patients With Diabetes: a Randomized Controlled Trial
Official title: Effects of an Activity Control System in Patients With Diabetes: a Randomized
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: artificial intelligence
diabetes mellitus
self-care
telemedicine
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2020-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Using a smart device (Beprevent) to monitor activities of daily living improves the lifestyle of patients with DM2

Detailed description: A 6-month randomized clinical trial to evaluate a home activity control system (Beprevent) in the management of the patient with DM2, through the individualized labeling of objects related to them. The study will include 20 patients with DM2 (10 in the intervention group and 10 in the control group) who live alone or with people who can´t move on their own. Data will be recorded to measure the degree of satisfaction of professionals and participants in the study, and clinical and epidemiological data at the start of the study (in its baseline situation) and at the end of the study (at 6 months), to assess the changes produced and Compare them between both study groups.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years, with the ability to give informed consent
* Patient who has autonomy to carry out activities of daily living (Barthel = 100)
* patient diagnosed with Diabetes Mellitus
* patient in pharmacological treatment
* To live alone or with a person who cannot move on their own
* they do not plan to change their address in the 6 months after inclusion in the study

Exclusion Criteria:

• DM2 patients whose most recent HbA1c value is ≤7%

Primary outcomes:
measure: Diabetes Knowledge Questionnaire
timeFrame: 15 minuts
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: Jesús Gómez Lama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio de Murcia
name: David Pérez Cruzado
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06498544: HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase
Official title: HighCycle Study: Effect of High Altitude on Sleep Disordered Breathing in Women Related to Their Menstrual Cycle Phase. A Prospective Cohort Study at 3600 m.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep-Disordered Breathing
Keywords: Periodic breathing
Hypoxia
Prevention
Acetazolamide
Women
Altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
name: University Hospital Heidelberg
name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2024-07-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, non-smoking, premenopausal women, age 18-44 years, without any disease and need of regular medication (including oral contraceptives).

Brief summary: Prospective cohort study investigating the menstrual cycle phase (MCP) dependent sleep disordered breathing (SDB) in women travelling to 3600 m.


Eligibility criteria: Criteria: Inclusion Criteria:

* Healthy, non-smoking women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal, eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptives (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides

Primary outcomes:
measure: Nocturnal oxygen saturation (SpO2)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
Secondary outcomes:
measure: Nocturnal oxygen desaturation index (ODI)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Nocturnal oxygen desaturation index (ODI)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Apnea/hypopnea index (AHI)
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Apnea/hypopnea index (AHI)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Subjective sleep quality
timeFrame: Night 1 at 760 m and Night 1 at 3600 m
measure: Subjective sleep quality
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
measure: Nocturnal oxygen saturation (SpO2)
timeFrame: Night 1 at 760 m and Night 2 at 3600 m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Michael Furian, Prof. Dr.
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant Sooronbaev, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01667744: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Official title: Citalopram for Sx/Util in Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Angina
Acute Coronary Syndrome
Emotional Distress
Citalopram
Health Care Utilization
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.

This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.

Detailed description: Not applicable. Study not funded.

Eligibility criteria: Inclusion Criteria:

* Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins

Exclusion Criteria:

* age less than 18
* cognitive impairment (per MMSE)
* geographic unavailability for followup
* unwillingness to participate
* illiteracy
* Hx cardiac transplant
* untreated hypothyroidism
* hepatic dysfunction
* prior adverse reaction to citalopram
* history of Bipolar Disorder
* untreated Sleep Apnea
* chronic steroid therapy
* active substance abuse (e.g., within past year)
* near term mortal illness
* current mental health treatment
* signitificant suicide risk

Primary outcomes:
measure: Frequency of ACS Symptoms
timeFrame: 6 months
measure: Treatment usage
timeFrame: 6 months
Secondary outcomes:
measure: Emotional Distress
timeFrame: 6 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Mark W Ketterer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749644: Switching From Tobramycin Inhalation Treatment to Tobramycin Inhaler Treatment: The Effect on CF Patients' Adherence and Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alteration in Quality of Life of CF Patients, Following Change of Treatment From Antibiotic Inhalation to Antibiotic Inhaler
Keywords: Cystic Fibrosis, Chronic Pseudomonas Infection, Inhaled Tobramycin
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF patients with chronic pseudomonas infection

Brief summary: Pseudomonas is a common and virulent respiratory bacteria in patients with Cystic Fibrosis (CF). With time, the infection with Pseudomonas becomes chronic and very difficult to eradicate. The standard treatment of chronic Pseudomonas infection is inhaled Tobramycin which is given every other month.. Inhalation of Tobramycin was proven as an effective treatment that improves the respiratory function and reduces the concentration of bacteria in the sputum. However, inhaled treatment lasts between 15 to 30 minutes twice a day and therefore adherence is a major problem. The effect of switching from inhalation treatment to inhaler treatment on patient's adherence and quality of life has not been studied.


Eligibility criteria: Inclusion Criteria:

* Age 6 years and above, Chronic Pseudomonas infection

Exclusion Criteria:

* Younger than 6 years; No chronic PSeudomonas infection

Primary outcomes:
measure: Improvement in quality of life
timeFrame: 1 year
Secondary outcomes:
measure: Difference in exacerbation events
timeFrame: 1 year
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Safra Children's Hospital, Sheba Medical Center
Study officials:
affiliation: Safra Children's hospital, National CF Center
name: Ori Efrati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Safra Children's Hospital, National CF center
name: Ifat Sarouk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04961892: Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI
Official title: Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Ankle Instability
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.

Brief summary: The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.

Detailed description: The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CAI
* The contralateral ankle joint is healthy

Exclusion Criteria:

* Accompanied by other musculoskeletal injuries

Primary outcomes:
measure: FAAM
timeFrame: pre-surgery, one year after sugery
Secondary outcomes:
measure: IDFAI
timeFrame: pre-surgery, one year after sugery
measure: Ligament injury by MRI
timeFrame: pre-surgery, one year after sugery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Yuelin Hu, bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT06135792: The Effect of Arginine on Biofilm Composition, Architecture and Metabolism
Official title: The Effect of Arginine on Biofilm Composition, Architecture and Metabolism in Caries-active Patients: a Split-mouth in Situ Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Dental Plaque
Microbial Colonization
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split-mouth design
Primary purpose: PREVENTION

Brief summary: Arginine is an adjunct to oral health care that has the potential to modulate the composition and activity of the microbial community of dental biofilms towards a health-related status without harmful effects for the resident oral microbiota. The aim of the study is to investigate the effects of arginine treatment compared to placebo on the composition, metabolism, and microarchitecture of biofilms grown in situ in the oral cavity of caries-active participants.


Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 18 years old.
* Three or more active carious lesions.
* Anatomically possible to manufacture an intraoral lower-jaw splint.
* Able to understand and follow instructions, as well as to read and sign the informed consent form.

Exclusion Criteria:

* History of allergies towards any of the ingredients in the test products
* Self-reported pregnant or nursing
* Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
* Orthodontic appliances, including retainers, or removable partial dentures.
* Self-reported serious medical conditions.

Primary outcomes:
measure: Biofilm pH
timeFrame: Measured after in situ biofilm growth
Secondary outcomes:
measure: Biofilm microbial composition
timeFrame: Analyzed after in situ biofilm growth
measure: Biofilm matrix architecture
timeFrame: Analyzed after of in situ biofilm growth
measure: Biofilm thickness
timeFrame: Measured after in situ biofilm growth
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Sebastian Schlafer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229892: Incisions for Cardiac Surgery
Official title: Small Incisions for Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiac Surgery
Cardiac Diseases
Keywords: pediatric health
cardiac
small incisions
operations
minimally invasive
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children who have undergone cardiac surgery at Children's, Egleston, before 11.1.2004

Brief summary: The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.

Detailed description: There is a trend in surgery, in general, toward minimal invasion. This includes the transition to laparoscopy/thoracoscopy from open procedures, as well as the reduction in incision size for open procedures. The goal of minimally invasive techniques is to reduce morbidity and length of hospital stay, with a consequent reduction in hospital cost.

There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy.

Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs.

Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes.

We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.

Eligibility criteria: Inclusion Criteria:

* Children who have undergone cardiac surgery at Children's Healthcare of Atlanta
* Surgery before November 1, 2004

Exclusion Criteria;

those who do not fall under the above inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00407992: An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
Official title: An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Keywords: Headache
Migraine
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2006-12-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache


Eligibility criteria: Inclusion Criteria:

* patients with migraine
* patients 18 years aged or above

Exclusion Criteria:

* patients which participated within the last 30 days or plan to participate during this study in another device or drug trial
* patients pregnant or planning on becoming pregnant during the study period

Primary outcomes:
measure: Number and the type of adverse events
timeFrame: Study period
measure: Reduction of headache frequency and intensity
timeFrame: Study period
Secondary outcomes:
measure: Reduction in drug intake
timeFrame: Study period
measure: Changes in QoL and interference in everyday activities
timeFrame: Study period
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore - Don Calabria
state: Verona
Study officials:
affiliation: IRCCS Sacro Cuore Don Calabria di Negrar
name: Gerardo Serra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.