louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06729749: Effect of Bioptron on Primary Dysmenorrhea
Official title: Effect of Bioptron on Primary Dysmenorrhea: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to determine the effect of bioptron on PD through the assessment of serum progesterone level, and pain level measured by pressure algometry in addition to evaluation of the symptoms of PD and its effect on girl's quality of life through valid and reliable questionnaires which will be of valuable benefits in the women's health fields.

Detailed description: All females will be randomly divided into two equal groups:

Group A (control group):

lt will include 28 participants suffering from PD taking vitamin D (vitamin D) supplements for three consecutive menstrual cycles.

Group B (study group):

lt will include 28 participants suffering from PD who will take vitamin D (vitamin D) supplementations as in group A in addition to Bioptron for 20 min daily for 7 days before the menstrual cycle along with the first three days of menstrual flow for three consecutive menstrual cycles.

All females will be given a full explanation of the study protocol and a consent form will be signed by each female before entry in the study

Eligibility criteria: Inclusion Criteria:

All females will be clinically diagnosed by the gynecologist with primary dysmenorrhea.

* Self-reported history of PD, at least moderate pain due to menstrual cramps (\>4 on VAS)
* They have moderate symptoms of PD on the WaILDD questionnaire, (5-12) Teheran et al., 2018).
* Their ages will be ranged from 18-24 years old.
* Their BMI will be less than 30 kg/m².
* Being a virgin.
* Having regular menstruation for the last 6 months (every 28-30 days with no intermittent bleeding).
* Voluntary acceptance to participate in the study.

B) Exclusion Criteria:

Participants will be excluded if they have:

* Musculoskeletal or neurological disorders.
* Patients with a history of phototherapy allergy.
* Professional athletes (Jill et al., 2012).
* Secondary dysmenorrhea pathology such as (endometriosis, fibroids, adenomyosis, and pelvic inflammatory disease)
* Menstrual irregularity.
* Using hormonal contraception (such as contraceptives or injections).

Primary outcomes:
measure: Pain intensity
timeFrame: Three months
measure: Pressure pain threshold (PPT)
timeFrame: three months
Secondary outcomes:
measure: Plasma Progesterone level
timeFrame: Three months
measure: Assessment of menstrual symptoms
timeFrame: Three months
measure: Quality of life enjoyment and satisfaction
timeFrame: Three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Doaa A Osman
role: STUDY_CHAIR
References:
Clinical trial NCT01542749: Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer
Official title: Pilot Research Study to Asses Total Body Albumin Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoalbuminemia
Heart Failure
Nephrosis
Cirrhosis
Shock
Keywords: BVA-100 Blood volume analyzer
Human serum albumin labeled with Iodine 131
Lead sponsor: Daxor Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male and female volunteers

Brief summary: The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.

Detailed description: Twenty adult individuals underwent a standard blood volume measurement. The specimens for this determination are normally collected over a period of approximately 40 minutes. For the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. Calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. The ratio of albumin in the intravascular to the extravascular space is available in the medical literature. The total volume in which the tracer is distributed can be determined from the dilution determined. A calculation of total body albumin is therefore possible. Computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. The purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

Eligibility criteria: Inclusion Criteria:

* Normal adult males and females.
* Females in the childbearing age group to have test to exclude pregnancy

Exclusion Criteria:

* Children,
* pregnant females

Primary outcomes:
measure: Total Body Albumin
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Daxor Corporation
name: Joseph Feldschuh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720849: Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
EDSS 4-7
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.

Brief summary: The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue, micturation and walking impairment under 3 months of Fampyra treatment


Eligibility criteria: Inclusion Criteria:

All patients who according to the compound's Norwegian prescription guidelines are deemed eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS 4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or difficulties micturating.

Exclusion Criteria:

MS patients with contraindications to the compound according to the prescription guidelines.

Patients who have been exposed to Fampyra in the past Patients with an MS attack within last 3 months

Primary outcomes:
measure: change from baseline in visual evoked potential after 2 weeks and 3 months
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Helseforetak
Study officials:
References:
Clinical trial NCT01891149: Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
Official title: Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Fistula
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: American College of Obstetricians and Gynecologists
First posted: 2013-07-02
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We will be enrolling 100 Malawian women with obstetric fistula and 10 Malawian women without obstetric fistula.

Brief summary: This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula.

Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula.

Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.

Detailed description: This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.

Eligibility criteria: Inclusion Criteria:

1. Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
2. Ability to consent for study participation in Chichewa
3. Female aged 18-45 years
4. Willingness to undergo pelvic ultrasound for assessment of pelvic organs

Exclusion Criteria:

1. No history of pregnancy
2. History of hysterectomy
3. Current pregnancy or pregnancy within the past six weeks
4. Seriously or terminally ill

Primary outcomes:
measure: Cervical length
timeFrame: baseline
Secondary outcomes:
measure: Hormonal levels
timeFrame: baseline
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Fistula Care Centre
Study officials:
affiliation: University of North Carolina
name: Jeffrey Wilkinson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02875249: Intestinal Microbiome and Chemotherapy
Official title: Chemotherapy-driven Dysbiosis in the Intestinal Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Keywords: post-antibiotic diarrhea
intestinal microbiome
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, men and women, 18 to 65, who receive intravenous antibiotics broad spectrum (Tazocilline (piperacillin tazobactam) and Amiklin (amikacin)) in support of the context of febrile neutropenia following a autologous stem cells.

Brief summary: Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI mucositis pathophysiology are generally silent on the role of the intestinal microbiome.

The aim of the study is to identify functional mechanisms by which the intestinal microbiome may play a key role in the pathophysiology of GI mucositis, the investigators applied high throughput DNA-sequencing analysis to identify microbes and microbial functions that are modulated following chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Participants with non-Hodgkin's lymphoma
* Participants receiving the same myeloablative conditioning regimen for five consecutive days, including high-dose Carmustine (Bis-chloroethylnitrosourea), Etoposide, Aracytine and Melphalan.

Exclusion Criteria:

* Patients with a history of Inflammatory Bowel Diseases (IBD), exposed to probiotics, prebiotics or broad-spectrum antibiotics, or administered nasal-tube feeding or parenteral nutrition in the month prior to initiation of the study.

Primary outcomes:
measure: analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
timeFrame: baseline
measure: analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
timeFrame: at day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nantes Univetsity Hospital
name: Emmanuel Montassier, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205049: Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
Official title: A Pilot Study of Pentoxifylline-Therapy for Acute Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatitis, Alcoholic
Keywords: acute alcoholic hepatitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

Detailed description: The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

This study never moved forward due to funding issues.

Eligibility criteria: Inclusion Criteria:

* Inpatient with acute alcoholic hepatitis
* Model for End-Stage Liver Disease (MELD) of 15 or greater
* Recent alcohol abuse

Exclusion Criteria:

* Recent infection
* Other life threatening disease
* Severe coagulopathy
* Another non-alcoholic cause of liver disease

Primary outcomes:
measure: Survival at 28 Days
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael R Lucey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299449: Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement
Official title: Clinical and Radiographic Outcomes of Computer Guided Immediate Implant Placement Utilizing Artificial Intelligence Assisted Socket Shield Approach: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Implant Complication
Dental Implant Failed
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

Detailed description: Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.

Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.

Eligibility criteria: Inclusion Criteria:

* above the age of 18years
* presence of non-restorable maxillary anterior tooth
* had intact socket walls following tooth extraction
* the gingival biotype was thick.

Exclusion Criteria:

* history of systemic condition
* history of using bisphosphonates or other drugs that might impact bone turnover
* a history of smoking during the previous five years,
* a history of any acute infections at the surgical site,
* teeth having root resorptions

Primary outcomes:
measure: Stability Quotient of dental implant
timeFrame: 9-month.
measure: pink esthetic score
timeFrame: 9-month.
measure: Midfacial Mucosal Alterations
timeFrame: 9-month.
measure: facial marginal bone level
timeFrame: 9-month
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of dentistry, kafrelsheikh University
state: Kafrelsheikh
Study officials:
affiliation: Faculty of Oral and Dental Medicine, Kafrelsheikh University
name: Walid AH Elamrousy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06406049: Finishing HIV Project
Official title: FINISHING HIV: an Ending the HIV Epidemic (EHE) Model for Latinx Integrating One-Stop-Shop Pre-Exposure Prophylaxis (PrEP) Services, a Social Network Support Program and a National Pharmacy Chain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-05-09
Enrollment: 624
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.


Eligibility criteria: Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Being 18 to 54 years of age
4. Being a cis-gender male
5. Self-report one or more of the following behaviors and health conditions in the last 6 months which meet the Centers for Disease Control and Prevention (CDC) clinical guidelines for PrEP eligibility

   * Diagnosed with bacterial sexually transmitted infection (e.g., syphilis, gonorrhea, or chlamydia)
   * Sex with a partner who is living with HIV
   * Sex without a condom with two or more partners whose HIV status were unknown
   * Injection drug use and sharing injection equipment
6. Self-reported status as HIV negative
7. Willing to be tested for HIV

Exclusion Criteria

1. Display diminished capacity to consent because of:

   * An inability to provide informed consent (e.g., cognitive impairment)
   * Severe psychiatric symptoms (e.g., mania, psychosis) that impair capacity to provide informed consent, as assessed by interviewers with Collaborative Institutional Training Initiative (CITI) Human Subjects Research and National Institutes of Health (NIH) Good Clinical Practice training
2. \<18 years old or \>54 years old
3. Self-reported living with HIV
4. Reactive HIV test (for "Amigx" seeds or "Yo Quiero" control participants)
5. Refusal of HIV test
6. Identifies as Non-Latinx
7. Individuals enrolled in other PrEP initiation interventions
8. Individuals with an active PrEP prescription in the last 6-months (oral or injectable)

Primary outcomes:
measure: Number of participants that report using PrEP
timeFrame: Up to 12-months
measure: Number of Dried Blood Spot (DBS) tests that report PrEP use
timeFrame: Up to 12-months
measure: Number of participants that bring a proof of PrEP prescription
timeFrame: Up to 12-months
Secondary outcomes:
measure: PrEP knowledge measured by PrEP knowledge question
timeFrame: Up to 12-months
measure: Number of Dried Blood Spot (DBS) tests that report adequate PrEP adherence
timeFrame: Up to 12-months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Mariano Kanamori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03756649: Mayo Clinic IBD Biobank
Official title: Mayo Clinic IBD Biobank
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Inflammatory Bowel Diseases
Keywords: IBD
Ulcerative colitis
Crohn's
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment.

* The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening.
* Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
* Patients between the ages of 18 and 85 without history of IBD or colon cancer.

Brief summary: Researchers are collecting and storing blood, stool, and urine samples and medical information to better understand Inflammatory Bowel Disease (IBD) to improve disease outcome.

Detailed description: Subjects will be sent a letter detailing the proposed biobank and soliciting enrollment. Following the informed consent process, subjects will provide a blood sample (50 ml), urine sample (50 ml), and stool. The blood and urine samples will either be collected at the one of the Mayo Clinic outpatient laboratories or by a mail-out kit. Subjects will be asked to complete a questionnaire and 24-hour food recall questionnaire (completed online).

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease (IBD) who are between the ages of 18 and 85 at time of study enrollment.
* The diagnosis of IBD will be based on the standard IBD criteria including biochemical and colonoscopy screening.
* Women with inflammatory bowel disease of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
* Patients between the ages of 18 and 85 without history of IBD or colon cancer.

Exclusion Criteria:

* Patients with known liver disease.
* Patients unable to provide informed consent.
* Prisoners and institutionalized individuals.
* Patients with a history of colorectal cancer.

Primary outcomes:
measure: Study Participants
timeFrame: 50 years
Secondary outcomes:
measure: Urine Collection
timeFrame: 50 years
measure: Blood Collection
timeFrame: 50 years
measure: Stool Collection
timeFrame: 50 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Konstantinos N. Lazaridis, MD
role: PRINCIPAL_INVESTIGATOR
References: