louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06124300: Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
Official title: A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Premenstrual Syndrome
Lead sponsor: Rael
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks


Eligibility criteria: Inclusion Criteria:

* Women aged between 18 - 55
* BMI less than 35
* Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
* Generally healthy - don't live with any uncontrolled chronic disease
* Self-reported symptoms of PCOS - irregular periods
* Self-reported concerns with hormonal skin issues

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone with known severe allergic reactions
* Anyone who is pregnant, breastfeeding, or attempting to become pregnant
* Unwilling to follow the study protocol

Primary outcomes:
measure: Changes in menstrual cycle regularity.
timeFrame: Baseline to Week 12
measure: Changes in hormonal acne.
timeFrame: Baseline to Week 12
measure: Changes in skin issues throughout the menstrual cycle.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Changes in overall mood.
timeFrame: Baseline to Week 12
measure: Changes in stress levels.
timeFrame: Baseline to Week 12
measure: Changes in food cravings.
timeFrame: Baseline to Week 12
measure: Changes in energy.
timeFrame: Baseline to Week 12
measure: Changes in menstrual cramps.
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT00399100: Is it Possible to Treat Cyanide Poisoning With HBO?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Poisoning From Fire Accidents
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: People who has been in a fire accident have been shown often to be cyanide poisoned as well as poisoned with carbon monoxide(CO). According to recommendations from the Danish Health Agency people who are CO poisoned must be treated with hyperbaric oxygen (HBO). We want to see if HBO treatment can also treat cyanide poisoning.

The hypothesis is that as cyanide binds the same place in the mitochondria as CO cyanide will be detached from the mitochondria like CO and diffuse back to the blood.This way it will be easier to treat with hydroxycobalamin.


Eligibility criteria: Inclusion Criteria:

* Going to receive HBO treatment for carbon monoxide poisoning from fire accidents

Exclusion Criteria:

* Under 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Lab. for hyperbar medicin, afs. 4092, Anæstesi og Operationsklinikken, HOC, Rigshospitalet
Study officials:
affiliation: Rigshospitalet HOC, Trykkammeret
name: Pia Lawson-Smith, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03630900: Sequential Versus Single O2 Levels on Human Embryo Development
Official title: 5% O2 or Lower is the Ideal Tension for Culturing Human Embryo Development From Day 3 Onward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Culture
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
First posted: 2018-08-15
Enrollment: 487
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Myriads of elements affect human embryo culture in vitro. These include, but not limited to, air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2 tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%. Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.


Eligibility criteria: Inclusion Criteria:

* ICSI cycles undergoing their first ICSI attempt

Exclusion Criteria:

* ICSI cycles with a previous failure

Primary outcomes:
measure: Ongoing Implantation rate
timeFrame: three months
Secondary outcomes:
measure: clinical and ongoing pregnancies
timeFrame: three months
measure: human embryo development in vitro
timeFrame: three months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT04239300: Efficiency and Safety of Water Birth
Official title: Efficiency and Safety of Water Birth in Maternity Hospitals in Uncomplicated Pregnancy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Water Birth
Keywords: water birth
Lead sponsor: Akusherstvo Pro
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 1080
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Water birth are not risks factors for newborns.

Detailed description: Investigators will study medical records of woman who have water birth and evaluate different parameters. Study lasts from February 2020 till April 2021. The questionnaire contain information about woman's expectations of labour Number of participant is approximately 500.

Eligibility criteria: Inclusion Criteria:

* delivery alive newborn in water
* age 18-45
* single pregnancy

Exclusion Criteria:

* antenatal death
* dead fetus
* age under 18 and up 45
* multiple pregnancy
* somatic diseases
* preeclampsia
* mental diseases

Primary outcomes:
measure: Perineal trauma
timeFrame: 1 day
Secondary outcomes:
measure: Episiotomy
timeFrame: 1 day
measure: Newborns wellbeing
timeFrame: 1 day
measure: Infections complications from newborns
timeFrame: 3 days
Other outcomes:
Locations:
city: Ufa
country: Russian Federation
facility: OOO MD proect 2010
state: Bashkortostan
city: Moscow
country: Russian Federation
facility: Schelkovo Perinatal Center
state: Moscow Region
Study officials:
References:
Clinical trial NCT02194400: Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus
Official title: A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: RSLV-132
Systemic Lupus Erythematosus
Lupus
SLE
Resolve
Lead sponsor: Resolve Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of RSLV-132 in subjects with inactive to mild SLE.


Eligibility criteria: Inclusion Criteria:

* Stable SLE with no anticipated change in medications for the next 60 days

Exclusion Criteria:

* Other biologic drugs

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Grand Rapids
country: United States
facility: West Michigan Rheumatology
state: Michigan
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research
state: Texas
Study officials:
affiliation: Resolve Therapeutics
name: James Posada, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06191900: Clinical Study of GT201 in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)
Official title: Single Arm Clinical Study of Autologous Tumor Infiltrating Lymphocyte Injection (GT201) in the Treatment of Advanced Gynecological Tumors (advanced Cervical Cancer)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult
Gynecological Tumors
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-01-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an early exploration clinical study with one arm.

The study consists of two stages, namely the dose escalation stage and the dose extension stage:


Eligibility criteria: Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
* 2. Arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 3.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 4. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 5.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);

Primary outcomes:
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06741800: Microbial Study of Sublingual Immunotherapy Tablets in Patients With Allergic Rhinitis
Official title: Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Tablets
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rhinitis, Allergic
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual tablet desensitization.

Brief summary: The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual tablet desensitization.

Exclusion Criteria:

* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.

Primary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 2024.2-2026.7
measure: Visual analogue scale (VAS)
timeFrame: 2024.2-2026.7
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 2024.2-2026.7
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lei Cheng, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01023100: A Study Of The Taste Of Different Oral Liquid Preparations Of CP-690,550 In Trained Adult Product Testers
Official title: A Study In Trained Taste Panel Healthy Adult Volunteers To Investigate The Palatability Of Select Formulations Of CP-690,550 Oral Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis, Rheumatoid
Keywords: taste study open label investigational drug oral therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will test the palatability of several different CP-690,550 oral preparations in trained product tester healthy volunteers.

Detailed description: To develop a palatable pediatric oral solution dosage form of CP-690,550.

Eligibility criteria: Inclusion Criteria:

* Trained healthy non-pregnant product testers, age 18-75

Exclusion Criteria:

* Severe acute or chronic medical conditions, including hepatitis or tuberculosis infections or clinically significant laboratory abnormalities.

Primary outcomes:
measure: A complete description of the sensory attributes of products (eg, aroma, flavor, texture, and mouthfeel).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Woburn
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02208700: Efficacy of Oxepa Enteral Feeding in LTAC (Long Term Acute Care Hospital) Patients on Chronic Ventilation- a Pilot Study
Official title: Efficacy of the Use of Enteral Feeding High in EPA,GLA and Antioxidants in LTAC Patients on Chronic Ventilation- a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Lung Injury
Mechanical Ventilation Complication
Dietary Modification
Lead sponsor: Grace Hospital, Cleveland, Ohio
Sponsor class: OTHER
Collaborators: name: Abbott Nutrition
First posted: 2014-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in EPA, GLA and antioxidants were fed to patients in the critical care setting.

LTAC Patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in EPA, GLA and antioxidants compared to an isotonic high fiber enteral nutrition product.


Eligibility criteria: Inclusion Criteria:

\>18 years old with Respiratory failure on mechanical ventilation with failure to wean Diagnosis of ARDS (Acute respiratory Distress Syndrome) Bilateral infiltrates -

Exclusion Criteria:

History Of pulmonary fibrosis, Terminal illness/ malignancies, \<28 day life expectancy, Hemodialysis, Active bleeding or bleeding disorder: DIC ( Disseminated intravascular Coagulation), Sickle Cell Anemia, Hemophilia Hemorrhagic or ischemic stroke, Liver failure, Head trauma with Glasgow coma scale score of \<5, Immunosuppression: WBC(White Blood Cell Count) \<5000, HIV positive, use of immunosuppressant drugs, Pregnancy, and Heart Failure with EF(Ejection Fraction) \<35%

-

Primary outcomes:
measure: Length of days on mechanical ventilation
timeFrame: 14 days from start of enteral feeding
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Grace Hospital
state: Ohio
Study officials:
affiliation: Grace Hospital
name: Basma Ricaurte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00741000: Cervical Stairstep and Effects on Range of Motion (ROM)
Official title: The Effects of Cervical Stairstep on Cervical Range of Motion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Range of Motion, Articular
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Observe the effects of Cervical Stairstep on Cervical Spine Range of Motion

Detailed description: The cervical spine can be affected in a number of ways due to its vulnerability to injury. These injuries can result from poor posture, sports or occupation and can lead to degenerative changes. Cervical range of motion (ROM) is also affected by these injuries. When active ROM is restricted, the injury is of muscular origin. Pain with passive ROM indicates ligamentous injury whereas restricted passive ROM indicates blockage within bone or soft tissue. The normal range of motion in the cervical spine is 80-90 degrees flexion, 70 degrees extension, 20-45 degrees lateral flexion and 90 degrees of rotation. A common mechanism of cervical spine injury is axial loading. Axial loading can create a buckling effect within the cervical spine and decrease its ability to move normally, creating a limited ROM.

Eligibility criteria: Inclusion Criteria:

* students and faculty between ages 18 and 50

Exclusion Criteria:

* current neck pain (as measured by the Neck Disability Index (NDI) and utilizing Jackson's and maximal foraminal compression tests to assess for radiating symptoms)
* severe recent head trauma
* acute exacerbations within the past 3 months
* known cervical disc problems
* surgical fusions within the cervical spine
* highly acute symptoms
* a positive valsalva test
* seizure disorder
* analgesics
* muscle relaxants
* medications with effects on the musculoskeletal system
* chiropractic manipulation within 48 hours of the study
* Other exclusions can be made based on investigator judgment

Primary outcomes:
measure: Cervical Range of Motion
timeFrame: Pre and post treatment
Secondary outcomes:
measure: Neck Disability Index
timeFrame: pre and post treatment
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT00124800: The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
Official title: The Effect of Tinnitus Retraining Therapy on Subjective and Objective Measures of Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: Tinnitus Research Consortium
Sponsor class: OTHER
First posted: 2005-07-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to examine the efficacy of tinnitus retraining therapy (TRT) as a treatment of chronic tinnitus in people with limited hearing loss. The study design is prospective, randomized, double-blind, with repeated measures. The null hypothesis states there will be no difference in subjective measures of tinnitus severity between subjects treated with standard TRT and subjects treated with sham TRT.

Detailed description: The specific aims of the study are to:

* Evaluate the efficacy of TRT in reducing the objective magnitude of tinnitus.
* Evaluate the efficacy of TRT in reducing the subjective awareness and impact of tinnitus.
* Determine the therapeutic time course of improvement in tinnitus.
* Determine the long-term improvement in tinnitus derived from TRT.

Eligibility criteria: Inclusion Criteria:

* Chronic non-pulsatile tinnitus

Exclusion Criteria:

* Hyperacusis
* Subjective hearing loss
* Objective hearing loss with pure tone average greater than 35 dB sound pressure level (SPL)
* Evidence of significant depression or suicidal ideation

Primary outcomes:
measure: Change in objective measure of tinnitus loudness using psychoacoustic matching task
timeFrame: 18 months
measure: Change in subjective handicap rating of tinnitus using a standardized questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Change in subjective ratings of tinnitus loudness, annoyance and awareness
timeFrame: 18 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Carol A Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References: