louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01540747: Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: intrafollicular melatonin
PCOS
embryos quality
oocytes quality
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2012-02-29
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF) outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).

Detailed description: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The ROS generation from mononuclear cells is elevated in women with PCOS and a significant increment of lipid peroxidation products in women with PCOS has been reported.

Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant. It has been observed that a non-PCOS group co-treated with inositol, folic acid, and melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte quality history when compared to treatment only with inositol and folic acid (Inofolic by LO.LI.Pharma).

The aim of the study is to evaluate the possible effects of melatonin supplementation on the main IVF outcomes during ovarian stimulation of patients with PCOS.

From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in this prospective randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* diagnosis of PCOS
* irregular menstrual cycle (\> than 28-30 days)
* normal uterine cavity
* body mass index of 20 to 26 Kg/m2
* first IVF treatment

Exclusion Criteria:

* presence of tubal, uterine, genetics and male causes of infertility
* diagnosis of cancer
* hormonal treatment in the last six months

Primary outcomes:
measure: Number of mature oocytes
measure: embryo quality
measure: Pregnancy rate
measure: Implantation rate
Secondary outcomes:
measure: Total dose of FSH administered
measure: Number of days of stimulation
measure: Serum estradiol levels
measure: Endometrial thickness
measure: Cancellation rate
measure: Incidence of moderate or severe ovaric hyperstimulation syndrome (OHSS)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Praxi Pro Vita Centro di Fertilità
Study officials:
References:
Clinical trial NCT04469647: COVID 19 Seroprevalence Amongst Healthcare Workers in JHAH
Official title: COVID 19 Antibody Seroprevalence Amongst Healthcare Workers in Johns Hopkins Aramco Healthcare
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID 19
Keywords: COVID 19
Coronavirus
SARS-CoV-2
Lead sponsor: Johns Hopkins Aramco Healthcare
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare workers, divided into two groups (High-risk and Low-risk).

Brief summary: Healthcare workers play a critical role in fighting the pandemic, not only by managing the patients' health clinically, but also by implementing adequate measures for infection prevention and control in healthcare facilities. This puts healthcare workers at a greater risk of acquiring the disease. COVID-19 is caused by Severe Acute Respiratory Syndrome Coronavirus -2 (SARS-CoV-2) and many people can be infected with it asymptomatically and undetectably.

Serology is an antibody test that provides additional information to polymerase chain-reaction (PCR) testing as it is the only way to reliably establish the fraction of the population that was infected . Seroconversion is the development of antibodies in the blood which can confirm suspected cases after the fact and reveal who was infected but asymptomatic and never realized it. Antibodies are specific proteins created as the body's response to the infection and this test is essential for detecting infected individuals with few or no symptoms at all.


Eligibility criteria: Inclusion Criteria:

1. Adult.
2. JHAH employee
3. Housekeepers (this group of staff are outsourced at JHAH)

Exclusion Criteria:

1. Any participant exhibiting COVID 19 symptoms

Primary outcomes:
measure: Seroconversion status
timeFrame: 6 Months
Secondary outcomes:
measure: The proportion of asymptomatic infections among staff who have seroconverted
timeFrame: 6 Months
measure: The durability of COVID 19 seroconversion in asymptomatic healthcare workers at JHAH
timeFrame: 6 Months
measure: Identification of risk factors for COVID 19 seroconversion in asymptomatic healthcare workers
timeFrame: 6 Months
Other outcomes:
Locations:
city: Dhahran
country: Saudi Arabia
facility: Johns Hopkins Aramco Healthcare
state: Eastern
Study officials:
References:
citation: Mushcab H, Al-Tawfiq JA, Ghamdi M, Babgi A, Amir A, Sheikh SS, Darwisheh A, Alobaid A, Jebakumar AZ, Qahtani S, Al Sagheir A. A Cohort Study of Seroprevalence of Antibodies Against SARS-CoV-2 Infection Among Healthcare Workers at a Tertiary Hospital in Saudi Arabia. Infect Drug Resist. 2022 Aug 10;15:4393-4406. doi: 10.2147/IDR.S369755. eCollection 2022.
Clinical trial NCT01716247: Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer
Official title: Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women at Increased Risk for Developing Breast Carcinoma
Keywords: Mammography (CESM)
MRI
Breast screening
12-214
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.


Eligibility criteria: Inclusion Criteria:

* Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of \>15%due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI.
* Women who have a screening digital mammogram on the day of CESM or within 365 days prior

Exclusion Criteria:

* Women under 21.
* Pregnant or possibly pregnant.
* Women who have a contraindication to the intravenous use of iodinated - contrast agent (i.e., allergy to iodinated contrastor severely impaired renal function with a creatinine level \> or = to 1.3).
* Women with breast implants.
* Women with pacemakers.
* Women with aneurysm clips that don't allow for MRI.
* Women too claustrophobic to undergo MRI.

Primary outcomes:
measure: compare the sensitivity and specificity CESM
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Maxine Jochelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010647: Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee
Official title: Cost-Effectiveness of and Long-Term Outcomes Following Acupuncture Treatment for Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-03-25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate the cost-effectiveness of acupuncture and to determine the long-term outcomes and health care utilization of people with osteoarthritis (OA) of the knee.

Detailed description: Osteoarthritis (OA) makes up a large proportion of the disability and economic costs in the U.S. The knee is the most common site of OA and is a common cause of disability and the leading indication of total knee replacement in the elderly. There are presently no curative therapies for OA. Recently, increased attention has focused on the use of complementary and alternative medicine (CAM) therapies, such as acupuncture, especially for patients who have failed to respond to more standard therapy. Little is known of the long-term health services utilization and outcomes of patients with knee OA. This study will evaluate the cost effectiveness and overall outcomes of acupuncture for OA treatment.

Participants in this study will be randomly assigned to receive either acupuncture or placebo. Surveys and questionnaires will be used to assess participants. Data will be collected on the short- and long-term utilization of health services as well as on pain and physical function.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of osteoarthritis (OA)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland Osteoporosis Clinic
name: Dr. Marc C. Hochberg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10. doi: 10.7326/0003-4819-141-12-200412210-00006.
Clinical trial NCT00000347: Risperidone for Treatment of Cocaine Dependence in Outpatients - 12
Official title: Risperidone for Treatment of Cocaine Dependence in Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacological efficacy and clinical safety of risperidone in the treatment of cocaine and amphetamine dependence.


Eligibility criteria: Inclusion Criteria:

M/F ages 21-50 . Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03514147: Pelvic Floor Muscle Training on the Quality of Life in Women With Urinary Incontinence
Official title: The Effect of Pelvic Floor Muscle Training on the Quality of Life and Functionality in Women With Urinary Incontinence: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Quality of Life
Keywords: Women
Pelvic Floor Muscles
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 56
Sex: FEMALE
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: Aim: To assess the influence of pelvic floor muscles group training in the quality of life and functionality of these muscles in women with UI.

Study design: This is a randomized controlled trial.

Detailed description: Search location: Urogynecology Ambulatory Care of Porto Alegre Clinical Hospital (HCPA)

Patients or participants: Women will be included in aged 35-70 years who have had sexual intercourse in the last 12 months and who are able to understand the instruments, besides signing an informed consent form. Women will be excluded with latex allergy, who have made pelvic radiotherapy, or be undergoing chemotherapy, puerperal a year, or who use antidepressants and / or anxiolytics.

Intervention and measures: The evaluation consists of a medical history form, which will include personal data; the assessment of the MAP function is performed by the pressure biofeedback; for assessment of quality of life will use the questionnaire ICQI-SF and sexual function the PISQ-12 before and after Pelvic Floor Muscle Training.

Expected results: To estimate effectiveness of Pelvic Floor Muscle Training in the quality of life and functionality of these muscles in women with urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* Female;
* Have urinary incontinence;
* Age between 35 and 70 years;
* Have sexual intercourse in the last 6 months;
* Participants should understand the instruments used in the research;
* Accept to participate in the study and sign the Term of Free and Informed Consent.

Exclusion Criteria:

* Latex allergy;
* Have performed or are undergoing pelvic radiotherapy;
* Be performing chemotherapy treatment;
* Women who delivered during the last 12 months;
* Have participated in individual or group MAP training in the last 6 months;
* Have contraction of the pelvic floor muscles grade zero (0).

Primary outcomes:
measure: Quality of life in women with urinary incontinence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: José Geraldo Lopes Ramos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03566147: Treatment of RP and LCA by Primary RPE Transplantation
Official title: Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Leber Congenital Amaurosis, Retinitis Pigmentosa
Lead sponsor: Eyecure Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tongren Hospital
First posted: 2018-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of RP or LCA;
2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters or visual field of less than 10 degree;
3. Patient understand and sign the consent form.

Exclusion Criteria:

1. Blood routine examination is abnormal (hemoglobin\<10gm/dL; blood platelet count\<100k/mm³; neutrophil count\<1000/mm³)
2. Blood biochemistry is abnormal (ALT／AST\>1.5; creatinine\>1.3mg/dL)
3. Experimental eye has optic nerve atrophy caused by glaucoma
4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
5. Patients with uveitis and other endophthalmitis
6. Patients with other ocular disease affecting vision.
7. Patients have participated in clinical study of ocular or systemic drug use in recent 6 months.
8. Patients with medical history of malignant cancer (except resected basal cell carcinoma and squamous-cell carcinoma).
9. Patients with medical history of myocardial infarction
10. Patient with diabetes
11. Patient with Parkinson disease or Alzheimer's disease
12. Patients are under the treatment of immunosuppressive agent (except intermittent, low-dose corticosteroid treatment).
13. Patients with other medical conditions that restricts the compliance and safety of patients, or affects experimental results.

Primary outcomes:
measure: best-corrected visual acuity (BCVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
affiliation: Beijing Tongren Hospital
name: Ningli Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04160247: Angulated Screw-retained Crowns Following Immediate Implant Placement
Official title: Clinical Evaluation of Cemented and Angulated Screw-retained Crowns Following Immediate Implant Placement: a Randomized Controlled Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth Diseases
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 40
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: There are two choices of restorations and implant abutments connection now: cemented and screw-retained.The excess cement, which would be difficult to completely remove, might lead to series of biological complications. The angulated screw channel (ASC) abutments, which recently introduced by Nobel Biocare , largely address the problem with visible screw access that may compromise esthetics. However, all of the present studies were clinical reports, thus the clinical efficacy of ASC abutments still needs the verification of evidence-based medicine with larger sample. Therefore, we designed a randomized controlled clinical trial study, aiming to verify the clinical efficacy of the ASC abutments by comparing screw-retained (with ASC abutments) single implant crowns with cemented ones in esthetic region.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years old and in good health;
2. Single tooth implant (type 1) in the esthetic region;
3. Patients with natural teeth adjacent to single implant crowns;
4. Patients with periodontal treatment before implant surgery;
5. The implants are from Nobel Biocare system with tapered link and the permanent restoration is a single crown and all-ceramic;
6. Soft tissue in the implanting-and-adjacent areas is healthy and free of infection

Exclusion Criteria:

1. Multiple implants in the esthetic region, or the restoration is a bridge
2. Patients with bone augmentation procedures;
3. Heavy smokers (\>10 cigarettes/day);
4. Medically compromised patients (American Society of Anesthesiologists (ASA) classification III-IV);
5. Implants in an incorrect three-dimensional position (definition according to ITI VOL1);
6. Uncontrolled diabetes mellitus;
7. Unwilling to participate in the present study.

Primary outcomes:
measure: BOP%
timeFrame: from baseline to 1-year follow-up
Secondary outcomes:
measure: PPD
timeFrame: from baseline to 1-year follow-up
measure: MBL
timeFrame: from baseline to 1-year follow-up
measure: PES
timeFrame: from baseline to 1-year follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai NinthPeoples' Hospital
Study officials:
References:
Clinical trial NCT00613847: Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab
Official title: Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: PET Scan
Invasive Solid Tumors
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.


Eligibility criteria: Inclusion Criteria:

* Registered patient at MSKCC
* Age ≥ or = to 18 years
* Patients with invasive solid tumors.
* Measurable or evaluable disease
* Patients must have had routine disease staging studies with CT scan, FDG PET/CT scan, bone scan and/or MRI within 8 weeks of enrollment onto this trial
* Karnofsky Performance Score ≥ or = to 60
* Signed informed consent

Exclusion Criteria:

* Claustrophobia/pain or any other disability leading to inability to lie still for the duration of the scanning procedure.
* Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
* Patients with known sensitivity or contraindication to Herceptin.
* Inability to provide written informed consent.

Primary outcomes:
measure: the safety & feasibility of PET imaging with radiolabeled 68Ga-F(ab')2-trastuzumab fragments in pts w invasive solid tumors; by using the organ/tissue & body rt dosimetry inform following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments (HERScan)
timeFrame: conclusion of study
Secondary outcomes:
measure: determine the organ/tissue and tumor uptake and localization following i.v. injection of 68Ga-F(ab')2-trastuzumab fragments.
timeFrame: conclusion of study
measure: An exploratory objective will be to serially determine tumor uptake of 68Ga-F(ab')2-trastuzumab fragments in a subset of patients with positive scans.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jorge Carrasquillo, MD
role: PRINCIPAL_INVESTIGATOR
References: