louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004649: Study of the Natural History and Genotype-Phenotype Correlations of Hereditary Hemorrhagic Telangiectasia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Hemorrhagic Telangiectasia
Keywords: genetic diseases and dysmorphic syndromes
hematologic disorders
hereditary hemorrhagic telangiectasia
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Collect data regarding the natural history of hereditary hemorrhagic telangiectasia (HHT).

II. Establish genotype-phenotype correlations in HHT. III. Create a database of information for researchers throughout the world.

Detailed description: PROTOCOL OUTLINE: Patients complete a self-administered natural history questionnaire in a multiple choice format. Questionnaire is completed by a population consisting of males and females of all ages and ethnic backgrounds.

Data are collected and made available to all researchers.

Eligibility criteria: * Diagnosed hereditary hemorrhagic telangiectasia (Osler-Rendu-Weber disease) with recurrent epistaxis, telangiectases, and visceral vascular anomalies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: Alan Guttmacher
role: STUDY_CHAIR
References:
Clinical trial NCT01975649: Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official title: Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopause
Sexual Abstinence
Keywords: postmenopausal
hypoactive
sexual disorder
androgen
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 44
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a reduction in circulating androgen levels. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.

Detailed description: Hypoactive Sexual Desire Disorder ( HSDD ) is the most prevalent female sexual dysfunction in society mainly in postmenopausal women, and is strongly linked to the quality of life of women . The androgen hormones decline over age in the premenopausal period, more sharply after menopause. Tribulus terrestris is a plant native to India , recommended in the treatment of infertility , low libido and impotence . Its main active ingredient is the protodioscin , which has been attributed to an increase in testosterone levels and improved sexual function . The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD .

Eligibility criteria: Inclusion Criteria:

* at least one year after last menstrual period
* with no use of hormonal replacement therapy within the last 3 months
* without any medication, drugs or alcohol.
* Healthy patients without systemic or psychiatric disease

Exclusion Criteria:

* Patient smoker (10 cigarettes per day).
* Patients with blood pressure \> 160/90 mm Hg.
* Patient with breast or endometrial carcinoma.
* Patients with a history of myocardial infarction.
* Patient with Diabetes.
* Patient with vaginal bleeding from any source.
* Patients with hepatic injury.
* Patients with active thrombophlebitis or thromboembolic disorders recent
* Patients with interpersonal relationship problems with your relationship or partner
* Patients with sexual problems from your partner

Primary outcomes:
measure: Sexual Desire
timeFrame: 120 days
Secondary outcomes:
measure: serum levels of prolactin and thyroid-stimulating hormone (TSH)
timeFrame: 120 days
Other outcomes:
measure: serum levels of testosterone and sex hormone-binding globulin (SHBG)
timeFrame: 120 days
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Selmo Geber, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865149: Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hydrocephalus
Keywords: Child
Optic nerve sheath diameter
Hydrocephalus
Intracranial hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with hydrocephalus

Brief summary: Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.


Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. aged between 1 and 19 year
3. hydrocephalus
4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve

Primary outcomes:
measure: both optic nerve sheath diameter (the posterior 3mm of the papilla)
timeFrame: For day 1 from induction of general anesthesia to average 15 min after recovery of general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute,
Study officials:
References:
Clinical trial NCT02612649: Special Drug Use Surveillance of Irribow in Female Patients
Official title: Special Drug Use Surveillance of Irribow® Tablets and Irribow® OD Tablets in Female Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
YM060
Ramosetron
Survey
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 793
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with diarrhea-predominant irritable bowel syndrome

Brief summary: The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.


Eligibility criteria: Inclusion Criteria:

* Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Incidences of Adverse Drug Reactions
timeFrame: Up to Week 52
Secondary outcomes:
measure: Change from baseline in frequency of bowel movements
timeFrame: Baseline to Week 52
measure: Change from baseline in form of stool
timeFrame: Baseline to Week 52
measure: Change from baseline in sensation of incomplete bowel evacuation
timeFrame: Baseline to Week 52
measure: Change from baseline in defecation urgency
timeFrame: Baseline to Week 52
measure: Change from baseline in abdominal pain or discomfort
timeFrame: Baseline to Week 52
measure: Change from baseline in melena
timeFrame: Baseline to Week 52
measure: Overall improvement
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Akita
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Gunma
country: Japan
city: Hiroshima
country: Japan
city: Hyogo
country: Japan
city: Ibaraki
country: Japan
city: Iwate
country: Japan
city: Kagoshima
country: Japan
city: Kanagawa
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyagi
country: Japan
city: Miyazaki
country: Japan
city: Nagano
country: Japan
city: Niigata
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Okinawa
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Shiga
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokyo
country: Japan
city: Tottori
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
city: Yamaguchi
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05200949: SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
Official title: IMPACT OF SURGICAL EXPERIENCE ON RENAL TRANSPLANT COMPLICATIONS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Failure
Keywords: Transplant
Kidney
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient who was treated with a kidney transplantation in CHU of Nice

Brief summary: Kidney transplantation (KT) failure could be due to surgery dependent factors and particularly surgeon's experience.

Objective: To assess the impact of the surgeon's experience on the post-operative outcomes to know if it safe for young surgeons to perform it.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent Kidney Transplant in CHU of Nice
* Patient for whom a minimum of 12 months follow up is possible.

Exclusion Criteria:

- Patients who underwent a dual Kidney Transplant or a multi-organ transplant

Primary outcomes:
measure: Complication post surgery
timeFrame: 1 month after transplant
Secondary outcomes:
measure: function of the transplanted kidney
timeFrame: within 1 year after surgery
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References:
Clinical trial NCT03525249: Clinical Trial on the Articular Pain of Diagnosed Patients of Arthrosis
Official title: Randomized Clinical Trial to Analyze the Efficacy of a Supplement Removed From the Internal Membrane of the Egg Shell on the Articular Pain of Diagnosed Patients of Arthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 87
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: Randomized, controlled, double-blind clinical trial of three parallel branches to analyze the efficacy of a supplement extracted from the internal membrane of the egg shell on the joint pain of patients diagnosed with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years.
* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
* Subjects must have persistent knee pain associated with osteoarthritis with an initial score of at least 30 mm in the assessment of pain according to the EVA scale.
* The subjects should not present in their treatment narcotic drugs or steroidal anti-inflammatory or immunosuppressive drugs.

Exclusion Criteria:

* Serious or terminal illnesses.
* Subjects who are currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrates or any supplement indicated for joint health.
* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
* Subjects with a body mass index above 32.
* Subjects with a known allergy to eggs.
* Pregnant or lactating women.
* Inability to understand informed consent.

Primary outcomes:
measure: Change in Pain from baseline at 8 weeks
timeFrame: The pain will be measured by a scale twice, at the beginning and at the end of the study (after an 8 week consumption).
Secondary outcomes:
measure: quality of life test
timeFrame: it will be measured twice, once at baseline or at the end of the study after 8 weeks of use
measure: functional test
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
measure: blood pressure
timeFrame: Twice, once at the beginning of the trial in basal conditions and once at the end after 8 weeks of consumption.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT04912349: Comparison of TUSP Versus TURP for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume
Official title: Comparison of Transurethral Split of the Prostate Versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia in a Small Prostate Volume: A Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 150
Sex: MALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of transurethral split of the prostate versus transurethral resection of the prostate for treatment of benign prostatic hyperplasia in a small prostate volume: A prospective controlled study

Detailed description: Transurethral resection of the prostate (TURP) was considered as the golden standard to treat benign prostatic hyperplasia (BPH) for decades. However, TURP was associated with low efficiency to alleviate the lower urinary tract symptoms and a significantly higher risk of bladder neck contracture (BNC) for patients with small-volume BPH. We aimed to compare the therapeutic effect of transurethral split of the prostate (TUSP) with TURP for patients with small-volume BPH (\<30 ml).

In this study, some selected small-volume BPH patients were randomly divided into two groups (TUSP and TURP group). The patient's baseline characteristics and perioperative outcomes were recorded. The follow-up was made at 6 months, 1 year and 2 years after surgical treatment.

Eligibility criteria: Inclusion Criteria:

* Benign prostatic hyperplasia patients with surgical indication
* Maximum flow rate \<12ml/s
* Prostate volume \<30ml
* The international prostate symptoms score\>21
* Medication of α-adrenergic blockers for at least 3 months

Exclusion Criteria:

* Acute prostatitis and urethritis
* Neurogenic bladder
* Abnormal prostate-specific antigen level
* Urethral injury history

Primary outcomes:
measure: international prostate symptoms score（IPSS）
timeFrame: within 24 months after surgery
measure: maximum urinary flow rate（Qmax）
timeFrame: within 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiaming Wen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05405049: Compared With Different Method for Postcesarean Section Analgesia
Official title: Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.

Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )

Detailed description: This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* 18-50 age
* ASA II
* Fullterm singular pregnancy

Exclusion Criteria:

* Neuraxial anesthesia is contraindicated,
* Allergy to the drugs to be used in the study,
* Refused to participate in the study,
* BMI\>35 kg/m2
* ASA≥3
* Diabetes
* Preeclampsia,
* Cardiovascular disease
* Chronic pain and neuropathic pain,
* Given opioids in the operation due to intraoperative pain,
* Switched to general anesthesia,
* Excessive bleeding during the operation,
* Uterine atony
* Drain placed in the area to be infiltrated,
* History of drug addiction and psychiatric illness,
* Understand Visual analog pain scale

Primary outcomes:
measure: The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
timeFrame: 2,4,6,12,and 24 hours postoperatively
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk üniversty medicine school
state: Yakuti̇ye
Study officials:
affiliation: Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine
name: ayşenur dostbil, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06378749: Previvors Recharge: A Resilience Program for Cancer Previvors
Official title: Previvors Recharge: A Resilience Program for Cancer Previvors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Cancer
Mental Health Issue
Keywords: Resilience
Coping
Previvor
well-being
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes to be examined will include pre-post changes on the Connor Davidson Resilience Scale.


Eligibility criteria: Inclusion Criteria:

1. Identified as having Hereditary Cancer Syndrome
2. Never having been diagnosed with cancer
3. Over 18 years of age
4. Living in the United States
5. English speaking
6. Having a score of 26 or below on the Connor Davidson Resilience Scale (10 Item)
7. Access to a mobile phone
8. Agree to receive text messages.

Primary outcomes:
measure: Connor Davidson Resilience Scale (CDRISC)
timeFrame: Baseline and 1 Month
Secondary outcomes:
measure: Acceptance and Action Questionnaire (AAQII)
timeFrame: Baseline and 1 Month
Other outcomes:
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline and 1 Month
measure: Generalized Anxiety Disorder-2 (GAD-2)
timeFrame: Baseline and 1 Month
measure: Cancer Behavior Inventory (CBI-B V2.0-12)
timeFrame: Baseline and 1 Month
Locations:
city: Narragansett
country: United States
facility: Pro-Change Behavior Systems
state: Rhode Island
Study officials:
References: