louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04708665: Iron Deficiency Anemia and Non-iron Deficiency Anemia in Pregnancy in India
Official title: Iron-deficiency and Non-iron-deficiency Anemia in Pregnancy and Infant Health in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Anemia, Iron Deficiency
Anemia of Pregnancy
Keywords: Anemia of Pregnancy
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Lata Medical Research Foundation
First posted: 2021-01-14
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 pregnant women and their infants in Eastern Maharashtra, India. Mothers will be enrolled in the first trimester of pregnancy and mothers and infants will be followed up until 6 weeks post-partum.

Brief summary: This is a sub-study nested into the existing NICHD Global Network for Women's \& Children's Health Research Maternal Newborn Health (MNH) registry that is a prospective, observational population-based registry in Eastern Maharashtra, India. This study will assess the prevalence of iron deficiency anemia (IDA) and non-iron deficiency anemia (NIDA) in Eastern Maharashtra and will assess the association between both conditions and neo-natal and infant health outcomes (birth weight, gestational age at birth, weight-for-gestational-age z-score and infant hemoglobin concentration at 6 weeks). The investigators will also assess the relative strength of the association between anemia in the 1st trimester and 3rd trimester (after iron needs have increased but mothers may have been taking iron folic acid (IFA) supplements for several months) and infant health outcomes.


Eligibility criteria: Inclusion Criteria:

* A pregnant women in the first trimester of pregnancy
* Enrolled in the Maternal \& Newborn Health Registry
* At least 18 years of age
* Residing in the area of a selected Primary Health Center with the intention to remain in the area through child birth and 6-weeks post-partum

Exclusion Criteria:

* Having multiple fetuses

Primary outcomes:
measure: Birthweight
timeFrame: 0-48 hours
Secondary outcomes:
measure: gestational age at birth
timeFrame: <48 hours
measure: weight-for-gestational-age z-score
timeFrame: <48 hours
measure: infant hemoglobin at 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Lata Medical Research Foundation
state: Maharashtra
Study officials:
affiliation: Boston University
name: Lindsey M Locks, ScD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05661565: Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
Official title: Correlation of Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Study the Relationship Between Insulin Resistance With Hormonal and Ovarian Morphological Characteristics in Patients With Polycystic Ovarian Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with PCOS attending the outpatient clinic in Kasr Alainy Hospital in the reproductive age group (20:40 years)

Brief summary: We designed a study to determine if ovarian volume (OV) and/or follicle number (FN) are independently associated with abnormal metabolic findings in women diagnosed with PCOS. We hypothesized that ovarian morphology but not follicle number would be associated with a significantly higher odds of hyperinsulinemia among women with PCOS.


Eligibility criteria: Inclusion Criteria:

A-patients met the Rotterdam criteria of PCO with two out of three of the following:

1. oligo-or-anovulation
2. clinical and/or biochemical hyperandrogenism
3. the presence of 10 or more antral follicles in one ovary and/or a maximum ovarian volume \> 10cc B-reproductive age group (16:45 years) C-BMI \<40

Exclusion Criteria:

A-age \>40 years B-BMI\>40 C-previous ovarian surgery D-chronic medical disorders \[DM , HTN , ...\]

Primary outcomes:
measure: Correlation between the ovarian volume and Insulin resistance
timeFrame: January 2023- June 2023
measure: Correlation between the antral follicular count and insulin resistance
timeFrame: January 2023- June 2023
Secondary outcomes:
measure: Correlation between anti-mullerian hormone values and insulin resistance
timeFrame: January 2023- June 2023
measure: Correlation between FSH values and insulin resistance
timeFrame: January 2023- June 2023
measure: Correlation between LH values and insulin resistance
timeFrame: January 2023- June 2023
measure: Correlation between body mass index and insulin resistance
timeFrame: January 2023- June 2023
measure: Correlation between hirsutism and insulin resistance
timeFrame: January 2023- June 2023
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05448365: Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid
Official title: The Use of Vitamin D in Combination with Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women with Uterine Fibroid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uterine Fibroids
D-chiro-inositol
Inositol
Epigallocatechin Gallate
Vitamin D
Vitamin B6
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-07-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women with uterine fibroids
Primary purpose: TREATMENT

Brief summary: The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6.

The patients will be evaluated at baseline and after three months of treatment with placebo or product.


Eligibility criteria: Inclusion Criteria:

1. uterine fibroid with diameter greater than or equal to 4cm or multiple fibroids
2. eligible for surgery
3. symptoms like menometrorrhagia or pelvic pain

Exclusion Criteria:

1. BMI\>30
2. currently pregnant or breastfeeding
3. diabetic
4. suspect of malignancy
5. diagnosis of cancer

Primary outcomes:
measure: Diameter
timeFrame: 3 months
Secondary outcomes:
measure: Volume
timeFrame: 3 months
measure: Need for surgery
timeFrame: 3 months
measure: pVEGF-R
timeFrame: 3 months
measure: Marker of cellular proliferation
timeFrame: 3 months
Other outcomes:
Locations:
city: Francavilla Fontana
country: Italy
facility: Ospedale Dario camberlingo
state: Puglia
city: Scorrano
country: Italy
facility: Ospedale Veris Delli Ponti
state: Puglia
Study officials:
References:
Clinical trial NCT04898465: Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)
Official title: Improving Family's Adherence to Dental Care After Dental General Anaesthesia (DGA). Helsinki Early Childhood Caries - Child Abuse and Neglect-study. (HECC-CAN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries
Child Neglect
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 100
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Early childhood caries (ECC) is a common disease. Its prevalence is highest in poor, socially disadvantaged, and minority groups. Dental treatment under General Anaesthesia (DGA) is common, especially among the youngest patients. Parental adherence to child's post-DGA dental treatment is varying. Non-attendance to preventive care appointments and dental check-ups after the DGA is also common. The primary aim of this study is to explore if a multi-professional (paediatrician and social worker) intervention after the child's DGA can increase the adherence to post-DGA dental care. The secondary aim is to compare its possible influence on children's oral health 18 months after the DGA. Our hypothesis is that multi-professional counselling and support after the DGA will lead to better adherence to the scheduled preventive dental programme and better oral health for these children in the long run.

Detailed description: In an earlier Finnish study 26% of the children did not attend to their first scheduled appointment after the DGA and during a four years follow-up period 63% of the patients had one or more no-shows.

Based on the assumption that reducing the amount of no-shows to half of the reported earlier (60% vs. 30%) is a clinically relevant result, we need 42 patients for both groups (alpha 0.05, beta 0.2, power 0.8).

Eligibility criteria: Inclusion Criteria:

* reason for DGA is dental caries
* place of birth is Finland
* primary dentition

Exclusion Criteria:

* chronic disease which needs treatment in tertiary hospital

Primary outcomes:
measure: Number of uncancelled dental appointments after DGA
timeFrame: 0-18 months after the DGA
Secondary outcomes:
measure: Number of new decayed teeth after DGA
timeFrame: 0-18 months after the DGA
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: New Children's Hospital
Study officials:
affiliation: Consultant
name: Eeva Nikkola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savanheimo N, Vehkalahti MM. Five-year follow-up of children receiving comprehensive dental care under general anesthesia. BMC Oral Health. 2014 Dec 15;14:154. doi: 10.1186/1472-6831-14-154.
Clinical trial NCT05324865: The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia
Official title: The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenic Psychoses
Keywords: Schizophrenic
relaxation exercise
nursing
psychological symptoms
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired. Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment. For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.

Detailed description: Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired. Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment. For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.It is seen that the tension, the effects of stress, the state of anxiety, blood pressure, heart rate, lactic acid production, sensitivity to pain are reduced by performing relaxation exercises in a suitable environment, regularly and in accordance with the technique. Helps you think positively Studies involving patients with schizophrenia have also proven the beneficial effect of progressive relaxation, with positive changes observed through relieving anxiety, reducing psychological stress, and increasing psychological well-being.

Eligibility criteria: Inclusion Criteria:• Being 18 years or older,

* Having a confirmed diagnosis of schizophrenia for at least 6 months
* Having the ability to communicate and read,
* Volunteering to participate in the research.

Exclusion Criteria:• Being closed to communication,

* Not complying with the principle of voluntarism
* Patients in acute exacerbation period

Primary outcomes:
measure: Individual Introductory Information Form
timeFrame: 10 minute
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 15 minute
measure: Psychiatric Rating Scale(PRS)
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04726865: COVID-19 Pandemic and Medical Students
Official title: Effects of COVID-19 Pandemic on Medical Students in Jordanian Universities: A Multi-center Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Effect of COVID-19 Pandemic
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Aysha Alkhayat
name: Mariam Aljweesri
name: Reem Alharbi
name: Zahraa Aljazzaf
First posted: 2021-01-27
Enrollment: 415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students

Brief summary: Little is known about changes in levels of academic, financial, psychological, \& hygienic impact on medical students during this pandemic.

Detailed description: this is a cross-sectional, questionnaire-based study. It is conducted on a random targeted sample of medical students at medical schools in Universities of Jordan, classified by their academic years (from the 1st to the 6th academic year). A score of 10 points was constructed to reflect the perspective about the items in each group of variables. SPSS version 25.0 was used for the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Medical students in the basic and clinical years

Exclusion Criteria:

* Inability to complete the questionnaire

Primary outcomes:
measure: psychological stress and academic results
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Al-Husban University Naser
Study officials:
affiliation: The University of Jordan
name: Naser U Al-Husban
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765465: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Official title: Effect of Rowachol on Prevention of Postcholecystectomy Syndrome After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postcholecystectomy Syndrome
Keywords: postcholecystectomy syndrome
laparoscopic cholecystectomy
Rowachol
Lead sponsor: DongGuk University
Sponsor class: OTHER
Collaborators: name: Pharmbio Korea Co., Ltd.
First posted: 2013-01-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.

The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy


Eligibility criteria: Inclusion Criteria:

* Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Current immunosuppressive therapy
* Chemotherapy within 4 weeks before operation
* Radiotherapy completed longer than 4 weeks before operation
* Inability to follow the instructions given by the investigator
* Severe psychiatric or neurologic diseases
* Drug- and/or alcohol-abuse according to local standards
* Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
* Lack of compliance
* Lack of informed consent

Primary outcomes:
measure: the Number of the Participants Have Postoperative RUQ Pain
timeFrame: postoperative 3-month
Secondary outcomes:
measure: Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)
timeFrame: postoperative 3-month
measure: Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)
timeFrame: postoperative 3-month
measure: Laboratory Test Results of Postoperative 3-month(WBC Count)
timeFrame: postoperative 3-month
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: DongGuk University Ilsan Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: DongGuk University College of Medicine
name: In Woong Han, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781065: The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury
Official title: The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Spinal Cord Injury
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: 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 analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.

Detailed description: * anodal stimulation of the primary motor cortex (M1)
* anode electrode: C3 (EEG 10/20 system)
* cathode electrode: contralateral supraorbital area
* constant current of 2mA intensity for 20 min
* twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)

Eligibility criteria: Inclusion Criteria:

* elapsed time since spinal cord injury more than 6 months
* stable chronic pain for at least 3 preceding months
* pain that was not attributable to cause other that neuropathic pain
* pain that was resistant to various types of medications or physical or complementary medicine treatment

Exclusion Criteria:

* any kind of metal implant in the head
* heart disease including having a cardiac maker
* family or personal history of epilepsy, or neuropsychiatric illness

Primary outcomes:
measure: Numeric rating scale for average pain over the preceding 24h
timeFrame: before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
Secondary outcomes:
measure: Patient global impression of change for pain
timeFrame: before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation
Other outcomes:
measure: Pain interference in general daily life, mood and sleep
timeFrame: before the first tDCS session, and 1, 2, 4, 6, 8 wk after start of the stimulation
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyung Ik Shin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.
Clinical trial NCT00782665: Myometrial Biopsy for the Detection of Infection
Official title: Myometrial Biopsy for the Detection of Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection
Keywords: postoperative
infection
c-section
Lead sponsor: The Woman's Hospital of Texas
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to demonstrate that women in labor become infected without exhibiting any clinical signs or symptoms of infection.

Detailed description: The infection is a dynamic process probably beginning shortly after the onset of labor. This process continues and is enhanced during active uterine contractions, which result in bacteria from the vagina being drawn up into the uterine cavity. During labor, bacterial colonization of the amniotic fluid, the decidua, and even the fetus can occur, resulting in infection of the mother and the fetus.

Eligibility criteria: Inclusion Criteria:

1. Patients must be afebrile throughout labor.
2. Amniotic fluid must be not purulent; presence of meconium is not an exclusion.
3. Patients undergoing an elective cesarean section.
4. Patients who have labored with intact or ruptured amniotic membranes.

Exclusion Criteria:

1. Patient with a temperature of ≥ 100.4o F.
2. White blood cell count ≥ 24,000.
3. Suspicion of chorioamnionitis.
4. Suspicion of a urinary tract infection.
5. Presence of diarrhea (defined \> 4 liquid stools in a 24 hour period).
6. Patient currently taking therapeutic antibiotics.

Primary outcomes:
measure: Postoperative infection following rupture of amniotic membranes
timeFrame: Amount of time it takes to obtain culture result
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Woman's Hospital of Texas
state: Texas
Study officials:
affiliation: The Woman's Hospital of Texas
name: Sebastian Faro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: