louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06975527: Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women
Official title: Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.

Detailed description: Breastfeeding is a normal method of providing nutrition to young infant by breast milk. Breastfeeding is equally important and beneficial for not only infant but also for the mother.

Women with high BMI have delays in establishing lactation after giving birth. In addition, overweight and obesity increase the risk of early cessation of breastfeeding.

Aerobic exercises have positive effects on breastfeeding frequency and body weight of neonate and can increase blood flow to the chest which is effective in lactation performance.

So, this study will help to evaluate the efficacy of aerobic exercise in addition to guidelines for breastfeeding, nutrition and fluid intake on milk production, baby and mother weight.

Eligibility criteria: Inclusion Criteria:

* Multiparous obese mothers having number of parity ranges from two to four times.
* Lactating mothers within 2nd month after delivery.
* All of them diagnosed by gynecologist as having insufficient lactation
* Age will range from 25-35 years old.
* Body mass index: 30-40 Kg/m².

Exclusion Criteria:

* Lactating women suffering from postpartum hemorrhage
* Poor mammary development
* Cardio respiratory disease
* Diabetes mellitus
* Breast cancer
* Getting pregnant again during breast feeding period
* Mental disorders
* Previous surgeries in the chest, breast or the surrounding area
* Anemia
* Having twins or causes that hindering normal breast feeding as (mastitis, retracted, cracked, inflamed or inverted nipple)

Primary outcomes:
measure: Assessment of the degree of improvement in the flow of milk
timeFrame: 6 weeks
measure: Serum prolactin level
timeFrame: 6 weeks
measure: Weight of the baby
timeFrame: 6 weeks
measure: Weight of the mother
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beheira
country: Egypt
facility: Mai mohamed mohamed Elshafei
Study officials:
affiliation: Cairo University
name: Afaf Botla, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dalia Kamel, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01826227: Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Official title: Intraoperative Detection of Lesions Using PET (Positron Emission Tomography) Probe During Secondary Cytoreductive Surgery for Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Fallopian Tube
Primary Peritoneal
Keywords: PET (Positron Emission Tomography)
18F-FDG
Cytoreductive Surgery
13-017
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 5
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if Positron Emission Tomography (PET) probes make it easier for your surgeon to find cancer and remove it during your surgery. A PET probe is a wandlike device that can detect radioactivity.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven diagnosis of ovarian carcinoma, fallopian tube, or primary peritoneal not to include tumors of low malignant potential (all stage, grade, and histology)
* First recurrence
* Platinum sensitive as defined by disease free interval ≥ 6 months
* Radiological evidence of recurrent disease on preoperative PET/diagnostic CT
* Planned surgical secondary cytoreduction via laparotomy
* \>18 years old

Exclusion Criteria:

* Secondary cytoreduction via laparoscopy or robotically assisted laparoscopy
* Tumors of low malignant potential
* Beyond first recurrence
* With the exception of non-melanoma skin cancer, subjects with other invasive malignancies, who had (or have) any evidence of the other cancer present within the last 5 years, are excluded
* Active infection requiring parenteral antibiotics
* For subjects with diabetes mellitus, a blood sugar will be checked preoperatively and must be \<200 for participation in the study

Primary outcomes:
measure: Sensitivity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05265260: Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults
Official title: Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensorineural Hearing Loss, Bilateral
Keywords: Cochlear implant
Sentence recognition
Cognitive processing
Electrophysiology
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2022-03-03
Enrollment: 32
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: Adult Cochlear Implants recipients who are using currently a Nucleus cochlear implant with moderately severe to profound bilateral sensorineural hearing loss.

Brief summary: The aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a Nucleus cochlear implant.


Eligibility criteria: Inclusion Criteria:

* Adult subjects, 18 years or older
* Subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations.
* Subjects who have been implanted between January 2016 and December 2021.
* Subjects have received a Nucleus CI: CI512, CI522 or CI532 cochlear implants with non-rotating magnet, or CI600 series equivalent CI612, CI622 and CI632 with rotating magnet and external sound processors CP900 or CP1000 behind-the-ear, or Kanso or Kanso 2 off-the-ear types.
* Subjects who are fluent in French (language used in the questionnaire and speech tests)
* Subjects who are not opposed to participating in the study
* Subjects for who the medical record data is available throughout the defined data search period.

Exclusion Criteria:

* Subjects with single-sided deafness (SSD).
* Subjects who are not affiliated to the French Social Security.
* Subjects who are under legal protection.

Primary outcomes:
measure: Score of the French MBAA2 Sentence Recognition Test in Quiet
timeFrame: 1 month post activation
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Pierre-Paul Riquet, ORL, otoneurologie et ORL pédiatrique
Study officials:
affiliation: Hôpital Pierre-Paul Riquet
name: Mathieu Marx, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04018560: Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
Official title: Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 402
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders ("drinkers"). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs.

Detailed description: In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering.

Eligibility criteria: Inclusion Criteria:

1. the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol;
2. the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and
3. the drinker and CO can communicate in English. -

Exclusion Criteria:

1. the drinker is \<19 years old, not entering a treatment episode for alcohol use disorder;
2. the drinker does not sign a release for researchers to contact a CO;
3. the drinker and CO cannot communicate in English. -

Primary outcomes:
measure: Mental Health
timeFrame: The outcome measure will be assessed up to 1 year follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
citation: Timko C, Grant KM, Han X, Young LB, Cucciare MA. Al-Anon Intensive Referral to facilitate concerned others' participation in Al-Anon Family Groups: a randomized controlled trial. Addiction. 2022 Mar;117(3):590-599. doi: 10.1111/add.15670. Epub 2021 Oct 3.
Clinical trial NCT03772860: Defining the Sympathetic Skin Response of Migraineurs in the Facial Area
Official title: Defining the Sympathetic Skin Response of Migraineurs in the Facial Area During the Interictal State: Comparison of Migraine Patients Who Suffer Dominant Left/Right/Bilateral Pain.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine Disorders
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering migraine attending our Neurology Clinic and healthy volunteers

Brief summary: The aim of this study is to define the sympathetic skin response of migraineurs in the facial area. This will be achieved by exposing healthy volunteers and migraine patients to various stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge), and recording sympathetic skin response in the facial area.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with no history of any kind of recurrent headache
* Migraine patients according to ICH3 criteria
* Migraine patients with more than 1 attack per month

Exclusion Criteria:

* Patients with other heart or neurologic diseases
* Patients with hearing or visual decline
* Patients taking medication that effects the sympathetic system (except those taking beta blockers for migraine treatment)

Primary outcomes:
measure: Defining sympathetic skin response in migraineurs
timeFrame: One year
Secondary outcomes:
measure: Defining differences between sympathetic skin response in migraineurs
timeFrame: One year
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yaron River, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03534960: High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
Official title: High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.

Detailed description: Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Eligibility criteria: Inclusion Criteria:

1. Age ranges from 1 to 18 years
2. Hypercapnic respiratory failure:

   PaO2\<60mmHg and PaCO2 \>50 mmHg
3. Candidate for non-invasive respiratory support as a result of:

   1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
   2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support

Exclusion Criteria:

1. Participation in a concurrent study that prohibits the use of HHFNC
2. Active air leak syndrome
3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
5. PaCO2\<50mmHg

Primary outcomes:
measure: the number of patients in each group who require endotracheal intubation w
timeFrame: 24 hours
Secondary outcomes:
measure: mechanical ventilation-free to day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06671860: The Effects Of Oculomotor Exercises And Hands-On Protocol In Non-Specific Neck Pain
Official title: Investigation Of The Effects Of Oculomotor Exercises And Hands-On Protocol In Patients With Non-Specific Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain Musculoskeletal
Keywords: neck, non-specific neck pain, exercise, oculomotor exercises, myofascial release
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to evaluate the effectiveness of adding oculomotor techniques and hands-on treatments to routine exercise protocols for individuals with non-specific chronic neck pain (NSCNP).

Detailed description: A randomized controlled trial was performed at the orthopedic rehabilitation clinic. Ethical Standards in the 1946 Declaration of Helsinki, as revised in 2013, were followed, and the University Ethics Board approved the study (approval number 147). This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was conducted with individuals aged 18-65 who applied to a private clinic, received a doctor's diagnosis, met the inclusion criteria, and voluntarily agreed to participate in the study.

Participants A total of 38 subjects were calculated as the minimum required sample size determined by power analysis, and 38 subjects aged 18 to 65 years with a diagnosis of nonspecific neck pain who met the inclusion criteria and voluntarily agreed to participate were included in the study. Signed consent forms were obtained from the volunteers who agreed to participate in the study by face-to-face interview.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria included being between ages 18 and 65 old, having been diagnosed with nonspecific neck pain, being able to comply with exercise instructions and understand evaluation questions, and volunteering to participate in the research.

Exclusion Criteria:

History of acute or chronic musculoskeletal pain other than nonspecific neck pain, history of a rheumatological disease, sequestered or extruded disc herniation, having received physical therapy in the last three months, recent history of surgery, infectious and vascular diseases, and cooperation and communication problems presence were excluded.

Primary outcomes:
measure: Pain intensity
timeFrame: 6 week
Secondary outcomes:
measure: Proprioception
timeFrame: 6 week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Yeditepe university
Study officials:
References:
citation: Bier JD, Scholten-Peeters WGM, Staal JB, Pool J, van Tulder MW, Beekman E, Knoop J, Meerhoff G, Verhagen AP. Clinical Practice Guideline for Physical Therapy Assessment and Treatment in Patients With Nonspecific Neck Pain. Phys Ther. 2018 Mar 1;98(3):162-171. doi: 10.1093/ptj/pzx118.
Clinical trial NCT04712760: Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
Official title: Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Hypothyroidism
Keywords: eutopic thyroid gland
transient hypothyroidism
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 60
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with congenital hypothyroidism either detected by newborn screening or by a blood test done because of clinical suspicion of hypothyroidism, in Lorraine, between 1996 and 2017. All the patients with confirmed hypothyroidism underwent thyroid imaging. The children with eutopic gland and hemiagenesis are included in this study.

Brief summary: In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.


Eligibility criteria: Inclusion Criteria:

* Children with congenital hypothyroidism
* Eutopic thyroid gland or thyroid hemiagenesis
* Born between 1996 and 2017
* Treated at the Nancy Regional and University Hospital
* Follow-up of at least 3,5 years.

Exclusion Criteria:

* Polymalformative syndrome
* Thyroid dysgenesis except for thyroid hemiagenesis

Primary outcomes:
measure: Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.
timeFrame: 42 months
Secondary outcomes:
measure: Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up.
timeFrame: 6 months, 1 year, 2 years, 3 years
measure: Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.
timeFrame: 42 months
measure: Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).
timeFrame: 42 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Emeline Renard, MD
role: PRINCIPAL_INVESTIGATOR
References: