louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06501924: Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
Official title: Clinical Study of DA-002 and DA-005 As a Treatment for Hair Loss
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Androgenetic Alopecia
Female Pattern Baldness
Male Pattern Baldness
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Follea International Limited
name: Daniel Alain, Inc.
First posted: 2024-07-15
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the safety and efficacy of DA-005 and DA-002 as a treatment for hair loss (androgenetic alopecia).

Detailed description: DA-005 is a botanical supplement with demonstrated HIF-1a inhibitory action. The ingredients were tested in-vitro and have demonstrated the HIF-1a inhibitory effect. The primary aim of the study is to compare DA-005 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

DA-002 is a topical alpha 1 agonist. The ingredients were tested in-vitro and have demonstrated hair growth effects. The secondary aim of the study is to compare DA-002 to topical minoxidil in the treatment of hair loss (also known as androgenetic alopecia).

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosed with androgenetic alopecia
* Willing and able to apply the treatment as directed, comply with study
* Otherwise healthy
* Able to give informed consent

Exclusion Criteria:

* A medical history that may interfere with study objectives
* Women who are pregnant, lactating, or planning to become pregnant during the study period
* Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc)
* Subjects who have known allergies to any excipient in DA-002 or DA-005
* Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device in the treatment area within 30 days prior to study treatment initiation
* Subjects who have used any topical prescription medications in the treatment area within 30 days prior to study treatment initiation
* Subjects who have had a dermatological procedure such as surgery in the treatment area within 30 days prior to study treatment initiation
* Subject is unable to provide consent or make the allotted clinical visits

Primary outcomes:
measure: Target Area Hair Counts
timeFrame: Week [0,12]
measure: Target Area Hair Counts
timeFrame: Week [0,24]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rome G. Marconi
name: Andy Goren, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06030024: Efficacy of Repetitive Transcranial Magnetic Stimulation in Adult Attention Deficit Disorder
Official title: An Open-lable Investigation of the Effect of rTMS on Attention in an Adult Sample Suffering From ADD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder
ADHD
Keywords: rTMS
ADHD
ADD
fMRI
Lead sponsor: University of Tehran
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the current open-lable study was to use low-frequency repetitive transcranial magnetic stimulation (rTMS) to improve the attention deficits in a sample of adult patients suffering from attention deficit disorder. Participants received 10 sessions of rTMS over Fz (located using the EEG 10-20 international system) and underwent assessments of their attentional capacity using the gradCPT task in an fMRI scanner, before and after the intervention. Other behavioral assessments of their attention symptoms have also been conducted.


Eligibility criteria: Inclusion Criteria:

* Normal intelligence level (\>90)
* Diagnosis of ADD by a psychiatrist using the ADHD-RS-IV with Adult Prompts

Exclusion Criteria:

* Scores of 21 or more on BDI and/or BAI
* History of head trauma
* History of a major psychological or neurological condition
* Presence of metal in the head
* History of seizures
* Serious cardiovascular disease
* Use of medications with an impact on cognitive functions during the treatment window (patients with a constant and stable dose were included)
* Recent use of alcohol or substance abuse

Primary outcomes:
measure: Change in performance
timeFrame: Up to 10 days, i.e., before and after the completion of the 10 sessions of rTMS
Secondary outcomes:
measure: Change in self-report attention scores
timeFrame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range= 0-6; Higher scores represent worse outcome
measure: Change in investigator-rated attention scores
timeFrame: Baseline, after 5 days of stimulation, after 10 days of stimulation; Range:0 - 54; Higher scores represent worse outcome
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Brain Mapping Lab
Study officials:
affiliation: University of Tehran
name: Reza Rostami, M.D
role: STUDY_DIRECTOR
affiliation: University of Tehran
name: Fatemeh Soltani, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04317924: Pneumostasis With Use of Bio-absorbable Mesh and Fibrin Sealant in Lung Resection
Official title: Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Air Leak From Lung
Keywords: Pneumostasis
Bio-absorbable mesh
Lung resection
Neoveil
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Gunze Limited
First posted: 2020-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified block randomization will be done using known predictors of prolonged air leak: 1) surgical procedure (wedge vs lobectomy) and 2) presence of pulmonary comorbidities (chronic obstructive pulmonary disease and emphysema).
Primary purpose: PREVENTION

Brief summary: Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.

NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.

This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective lung resection at BMC
* Intra-operative diagnosis of air leak

Exclusion Criteria:

* Patients undergoing emergency lung resection

Primary outcomes:
measure: Time to removal of chest tubes
timeFrame: 2 years
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 2 years
measure: Number of participants with additional interventions for air leak
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Kei Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914524: Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Official title: An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Glomerulonephritis
Diabetic Nephropathy
Keywords: Chronic Glomerulonephritis
Diabetic Nephropathy
Angiotensin II Receptor Blocker
Urinary Protein
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).


Eligibility criteria: Inclusion Criteria:

* urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range
* normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg

Exclusion Criteria:

* treatment with corticosteroids or immunosuppressants
* treatment with antihypertensives (other than ARBs and ACE inhibitors)
* serum potassium level of 5.5 mEq/l or above
* serum creatinine level of 2.0 mg/dl or above

Primary outcomes:
measure: The change in the urinary protein/creatinine ratio from baseline to the end of treatment.
timeFrame: baseline to 16 weeks
Secondary outcomes:
measure: The change of creatinine clearance
timeFrame: baseline to 16 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT06365424: Fenofibrate in Patients with Primary Biliary Cholangitis (PBC)
Official title: An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Primary Biliary Cholangitis
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)


Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent (signed and dated)
* Participated in the PBC study with fenofibrate (NCT02823353)
* Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

* Treatment-related adverse event (AE) leading to fenofibrate discontinuation
* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
* Known history of other liver diseases
* For females, pregnancy or breast-feeding
* Long-term use of immunosuppressive agents
* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Primary outcomes:
measure: Treatment emergent adverse events (TEAEs)
timeFrame: Through study completion, up to 120 Months
measure: Percentage of patients with biochemical response
timeFrame: Through study completion, up to 120 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT06790524: Comparative Evaluation Between One-piece and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full-arch Prosthesis on Peri-implant Bone Changes.
Official title: Evaluation of Peri-implant Bone Changes Around One-piece Implant and Two-piece Implants Supporting Mandibular Screw-retained All-On-Four Full Arch Prosthesis: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Marginal Bone Loss
One-piece Implants Versus Two-piece Implants During the Osseointegration Phase
Keywords: one-piece implants , All-On-Four, Marginal bone loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 22
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: Evaluating the bone changing after receiving one-piece implants supported full arch prosthesis compared to the conventional two-piece implants.

Detailed description: Studying the difference between one-piece and two-piece implants and their effect on bone loss. This will help in simplifying the surgical procedure for full arch implant-supported prosthesis rehabilitation using one-piece implants, eliminating the disturbance of the gum tissue around the implants, potentially reducing the risk of bacterial colonization and inflammation.

Eligibility criteria: Inclusion Criteria:

* Completely edentulous patients, who can sign an informed consent will be considered eligible for this trial.
* Residual bone height should have sufficient volume and quality for implant placement with a minimum of 12-14 mm in height and 6 mm in width.
* Patients who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, technical problems concerning denture design and/or occlusion are found, or who are dissatisfied with the retention and stability of their technically satisfactory mandibular dentures.

Exclusion Criteria:

* - Patients with conditions that may contraindicate implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino bisphosphonates, patients undergoing radiotherapy to the head and neck region).
* Inadequate mouth opening
* Heavy smokers, more than 10 cigarettes/day
* Patients with poor oral hygiene and motivation.
* Pregnancy or nursing.
* Drug abusers.
* Psychiatric problems or unrealistic expectations.
* Patients with infection and or inflammation in the area intended for implant placement.

Primary outcomes:
measure: Peri-implant marginal bone loss
timeFrame: From implant placement (baseline) and After 3 months (after the osseointegration phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo University
Study officials:
References:
Clinical trial NCT02088424: the Insulin Resistance in Recurrent Miscarriage IN RECURRENT ABORTION
Official title: Insulin Resistance and Recurrent Abortion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrent Abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Women in the child bearing period between 23-40 years.
2. All patients are pregnant.
3. The gestational age of both groups 6-13 weeks

Brief summary: THE INSULIN RESISTANCE IN RECURRENT ABORTION

Detailed description: THE ROLE OF INSULIN RESISTANCE IN RECURRENT ABORTION

Eligibility criteria: Inclusion Criteria:

1. Women in the child bearing period between 23-40 years.
2. All patients are pregnant.
3. The gestational age of both groups 6-13 weeks

Exclusion Criteria:

1. Patients with gestational diabetes and gestational impaired glucose tolerance.
2. The patients who took medication that could affect glucose metabolism at the time of the study
3. Patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and TORCH syndrome).
4. Patients with PCOS.
5. Obese patients(BMI\>30)

Primary outcomes:
measure: fasting blood glucose
timeFrame: 3 month
Secondary outcomes:
measure: fasting Insulin
timeFrame: 3 month
Other outcomes:
measure: oral glucose tolerance test
timeFrame: 3 month
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity hospital
Study officials:
References:
Clinical trial NCT00364624: Adrenal Function in Patients With Newly Diagnosed Lung Cancer
Official title: Adrenal Cortical Function in Patients With Newly Diagnosed Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Adrenal Insufficiency
Keywords: lung cancer
adrenal insufficiency
Lead sponsor: Princess Margaret Hospital, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2006-08-15
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed, histologically confirmed primary lung cancer

Brief summary: Patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either from tumour metastasis or other mechanisms. Since lung cancer patient may have to undergo stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be hazardous. Knowledge of the size of the problem may help determine whether routine check is warranted.


Eligibility criteria: Inclusion Criteria:

* Histologically proven primary lung cancer
* Newly diagnosed
* No specific treatment given
* No active infection in the previous week
* No general anesthesia in the previous week

Exclusion Criteria:

* Known adrenal disease
* Receiving exogenous systemic corticosteroids
* Concomitant illness known to affect adrenal function. e.g. active TB

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kowloon
country: China
facility: Department of Medicine, Princess Margaret Hospital
state: Hong Kong SAR
Study officials:
affiliation: Princess Margaret Hospital, Hong Kong
name: Wai C YU, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05842824: An Observational Study of Patients With Autoimmune Disease
Official title: An Observational Study of Patients With Autoimmune Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autoimmune Diseases
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adults who are being managed for autoimmune disease

Brief summary: TARGET-AUTOIMMUNE is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .


Eligibility criteria: Disease Cohort

Inclusion Criteria:

- Adult patients at the time of enrollment with a diagnosis autoimmune disease by select ICD-10 codes in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* Adult patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Primary outcomes:
measure: To characterize the natural history of disease in patients with autoimmune disease of various etiologies.
timeFrame: 15 Years
measure: To assess safety and effectiveness of autoimmune disease treatments and treatments for complications of any related conditions
timeFrame: 20 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients with autoimmune diseases
timeFrame: 15 Years
measure: To evaluate longitudinal and patient reported outcomes in patients with autoimmune diseases
timeFrame: 15 Years
measure: To select and evaluate quality of care measures for patients with autoimmune diseases
timeFrame: 15 Years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06306924: UNC Metastatic Cancer Radiation Therapy Registry
Official title: UNC Metastatic Cancer Radiation Therapy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Metastatic Cancer
Keywords: radiation therapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with metastatic cancer receiving palliative radiation therapy at the University of North Carolina Chapel Hill.

Brief summary: The purpose of this registry is to collect clinical data from participants attending UNC Hospitals who present with metastatic cancer and are evaluated to receive radiation therapy as part of their standard of care treatment. The goal of this study is to provide a foundation for studies designed to identify projects across the translational continuum related to metastatic cancer and radiation therapy treatment. The relevant clinical data will be linked to patient-reported outcomes (PROs) thus allowing for a unique and robust dataset. Ultimately, this registry will provide current and future studies with the ability to analyze the correlation of radiation therapy regimens with metastatic cancer outcomes.


Eligibility criteria: Inclusion Criteria:

Written informed consent was obtained to participate in the study and HIPAA

Authorization for release of personal health information. Ability to understand and willingness to sign informed consent

Diagnosed with or is suspected to have metastatic cancer.

Age ≥ 18 years at the time of consent.

Evaluated to receive radiation therapy as part of their standard-of-care treatment plan.

Exclusion Criteria:

All participants must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

Any serious medical or psychiatric disorder that would interfere with the participant's ability to give informed consent.

Primary outcomes:
measure: Clinical Data
timeFrame: Up to 1 month
Secondary outcomes:
measure: Patient reported outcomes (PRO)
timeFrame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Shivani Sud, MD
role: PRINCIPAL_INVESTIGATOR
References: