louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001210: Prediction and Testing of Antigenic Sites of the AIDS Virus, HTLV-III Recognized by T Lymphocytes for the Development of Synthetic Vaccines
Official title: Prediction and Testing of Antigenic Sites of the AIDS Virus, HTLV-III Recognized by T Lymphocytes for the Development of Synthetic Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Healthy
Keywords: Blood Donors
Epitopes
HIV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Subjects are healthy adult volunteers either at high risk for HIV infection or already known to be seropositive, who will donate blood for in vitro tests of T-cell function and in vitro responses to synthetic peptides corresponding to sequences from HIV proteins.

Detailed description: Subjects are healthy adult volunteers either at high risk for HIV infection or already known to be seropositive, who will donate blood for in vitro tests of T-cell function and in vitro responses to synthetic peptides corresponding to sequences from HIV proteins.

Eligibility criteria: Inclusion criteria for the at risk group will be a statement from the donor that he is an active homosexual or bisexual.

Homosexual donors must not have AIDS.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
citation: Clerici M, Stocks NI, Zajac RA, Boswell RN, Bernstein DC, Mann DL, Shearer GM, Berzofsky JA. Interleukin-2 production used to detect antigenic peptide recognition by T-helper lymphocytes from asymptomatic HIV-seropositive individuals. Nature. 1989 Jun 1;339(6223):383-5. doi: 10.1038/339383a0.
citation: Clerici M, Lucey DR, Berzofsky JA, Pinto LA, Wynn TA, Blatt SP, Dolan MJ, Hendrix CW, Wolf SF, Shearer GM. Restoration of HIV-specific cell-mediated immune responses by interleukin-12 in vitro. Science. 1993 Dec 10;262(5140):1721-4. doi: 10.1126/science.7903123.
citation: Pinto LA, Sullivan J, Berzofsky JA, Clerici M, Kessler HA, Landay AL, Shearer GM. ENV-specific cytotoxic T lymphocyte responses in HIV seronegative health care workers occupationally exposed to HIV-contaminated body fluids. J Clin Invest. 1995 Aug;96(2):867-76. doi: 10.1172/JCI118133.
Clinical trial NCT02361710: Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
Official title: Comparing the Serum Vitamin D Levels and Pregnancy Rates in Women Undergoing Elective Frozen Embryo Transfer (eFET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Vitamin D
pregnancy rate
eFET
Lead sponsor: Bahceci Clinic
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women undergoing a frozen ET with 1 Day 5 (blastocyst stage) embryo

Brief summary: The aim of this study is determining the affects of serum vitamin D levels to implantation and clinical pregnancy rates in women undergoing elective vitrified/thawed embryo transfer. Two groups will be identified according to the serum vitamin D levels on eFET transfer day and later on implantation, clinical pregnancy and ongoing pregnancy rates will be compared between those groups

Detailed description: In the last decade there have been growing evidence about Vitamin D receptors and their role in female genital tract. But these studies are yet not well designed and the results should be interpreted cautiously. Although some of these studies advocating the Vitamin D deficiency as an negative circumstance on pregnancy rates some of the others don't agree. According to contradictory results understanding the actual role of those receptors needs more observation.

Latest retrospective analyse postulated that, vitamin D deficiency in fresh single embryo transfer cycles may reduce pregnancy rates mediated by endometrium or ovarian reserve and stimulation characteristics.

For this reason the investigators aimed to explore the effect of serum Vitamin D levels on pregnancy rates in infertile population undergoing frozen embryo transfer.

Eligibility criteria: Inclusion Criteria:

* 18 years to 35 years age, a frozen ET with 1 Day 5 (blastocyst stage) embryo
* Infertile women undergoing ICSI (intracytoplasmic sperm injection) cycle
* Factors affecting fertility are Tubal
* Unexplained or ovulatory disturbances,

Exclusion Criteria:

* Need to do Preimplantation Genetic Diagnosis
* Presence of endometriosis and adenomyosis
* Severe male factor infertility

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
measure: implantation rates
timeFrame: 3 weeks after embryo transfer
measure: ongoing pregnancy rates
timeFrame: 18 weeks after embryo transfer
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceci Fulya IVF Center
state: Fulya
Study officials:
affiliation: bahceci Fulya IVF center
name: mustafa bahceci
role: STUDY_DIRECTOR
References:
citation: Rudick B, Ingles S, Chung K, Stanczyk F, Paulson R, Bendikson K. Characterizing the influence of vitamin D levels on IVF outcomes. Hum Reprod. 2012 Nov;27(11):3321-7. doi: 10.1093/humrep/des280. Epub 2012 Aug 21.
Clinical trial NCT06646510: Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease
Official title: Effect of Sensory Electrical Stimulation on Resting Tremors in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease is one of the most prevalent motor disorders in the world . The disease is progressive and has no known treatment. In addition to a number of psychological and autonomic issues, the disease also cause movement abnormalities which are the most challenging problem because management is still limited by medication or traditional physiotherapy the most effective way to treat symptoms is through an interprofessional new modalities as sensory stimulation , this study will be the first of its type to measure the effect of sensory stimulation on static tremors. Also, this study is the first of its type to make a continues treatment protocol for patient with static tremors.

SO the purpose of these study will To investigate the effect of sensory electrical stimulation on resting tremors in Parkinson's patients.


Eligibility criteria: Inclusion Criteria:

* Age between 45 and 60
* Diagnosed with idiopathic Parkinson's disease with Magnetic resonance imaging of the brain
* All the patients will have mild to moderate symptoms based on (the Unified Parkinson's Disease Rating Scale UPDRS) ≥ 3
* Static tremors have been present at the hand and wrist
* Absence of other disorders that cause similar symptoms like dystonia

Exclusion Criteria:

* History of hand trauma causes stiffness
* Presence of other neurological problems interferes with diagnosis as hemiplegic stroke
* Secondary parkinsonism (drug-induced or vascular ) which has very low tremor magnitude which can not be detected The patient has a severe visual problem that does not allow following the instructions.
* The patient educational level does not allow for following the instructions.

Primary outcomes:
measure: triaxial gyrosensor (accelerator)
timeFrame: 3 weeks
measure: Fahn-tolosa- marin clinical rating scale
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Outpatient clinics, Faculty of Physical Therapy, Cairo University
Study officials:
References:
Clinical trial NCT05449210: Urdu Version of Parkinson's Disease Questionnaire: Reliability and Validity Study
Official title: Reliability and Validity of Urdu Version of Parkinson's Disease Questionnaire in Pakistani Parkinson's Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Parkinson's Disease Questionnaire-39
Parkinson's Disease
Reliability
Validity
Urdu Version
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 195
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson Disease in advanced age along tremors, rigidity and bradykinesia and postural abnormalities.will be recruited in this study.

Brief summary: In the study , the researchers will investigate the reliability and validity of Urdu version Parkinson's Disease Questionnaire in Pakistani population having Parkinsonism

Detailed description: The study is aimed to translate and culturally adapt Parkinson's Disease Questionnaire-39 into Urdu language and to investigate validity and reliability of Parkinson's Disease Questionnaire-39 in Parkinson's diseased patient among Pakistani population.The study will be a cross sectional survey in which non-probability purposive sampling technique will be used to enroll the participants into the study as per criteria.

The results of the study will help to establish an understanding of validity and reliability of Urdu version of Parkinson's Disease Questionnaire-39 with quality of life of Parkinson's Disease patients in Pakistani population having Parkinson's Disease. Reliability of the scale will be checked through internal consistency and test-retest methods. Cronbach's alpha value will be used to analyze internal consistency and for analyzing test-retest reliability an intraclass correlation coefficient with 195 patients will be used

Eligibility criteria: Inclusion Criteria:

1. Idiopathic Parkinson's Disease
2. Minimum age of 40 years
3. Minimum level of 5 years of education
4. A score equal to or greater than 23 on the Mini-Mental State Examination
5. Patient experiencing at least two of the three cardinal symptoms of idiopathic Pairkinson Disease (rigidity, resting tremor, and bradykinesia.)

Exclusion Criteria:

1. Patients with non-idiopathic Parkinsonian variants
2. Patients with a history of drug or alcohol abuse in the last two years
3. Patients with unstable medical problems that may place the patient at increased risk or may interfere with the assessment or treatment of Parkinson's
4. Neurological operation on the brain within one year prior to study entry

Primary outcomes:
measure: Parkinson's Disease Questionnaire
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT00000110: Influence of Diet and Endurance Running on Intramuscular Lipids Measured at 4.1 TESLA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: exercise
exertion
physical fitness
lipids
nutrition
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-01-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot investigation is to use 1 H Magnetic Resonance Spectroscopy (MRS) to 1) document the change in intra-muscular lipid stores (IML) before and after a prolonged bout of endurance running and, 2) determine the pattern (time course) of IML replenishment following an extremely low-fat diet (10% of energy from fat) and a moderate-fat diet (35% of energy from fat). Specifically, the study will evaluate the change in IML following a 2-hour training run and the recovery of IML in response to the post-exercise low-fat or moderate-fat diet in 10 endurance trained athletes who will consume both diets in a randomly assigned cross-over fashion. We hypothesize that IML will be depleted with prolonged endurance exercise, and that replenishment of IML will be impaired by an extremely low-fat diet compared to a moderate-fat diet. Results of this pilot study will be used to apply for extramural grant support from NIH or the US Armed Forces to investigate the effect of dietary fat on the health and performance of individuals performing heavy physical training. It is anticipated that this methodology could also be employed in obesity research to delineate, longitudinally, the reported cross-sectional relationships among IML stores, insulin resistance and obesity.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (developmental phase)
* Healthy endurance-trained subjects
* Maximum age for males is 39
* Maximum age for females is 49

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham Nutrition Sciences Department
state: Alabama
Study officials:
References:
Clinical trial NCT05420610: Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution and Severe Burn Injury
Official title: Early Goal-Directed Therapy Utilizing Transpulmonary Thermodilution for Treating Adult Patients With Severe Burn Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2011 to June 2019, all adult patients (age \> 18 years) suffered from major burn,23 defined as total burned surface area (TBSA) \> 20% with at least second degree burn depth were admitted to the intensive care unit (ICU) of the Burn Center at a tertiary medical center were retrospectively reviewed.

Brief summary: This study aimed to optimize fluid resuscitation with transpulmonary thermodilution (TPTD)-guided protocol and to lower the mortality rate of the severely burned.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age \> 18 years).
* Major burn (as total burned surface area (TBSA) \> 20% with at least second degree burn depth).
* Admitted to the intensive care unit (ICU) of the Burn Center.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients with severe cardiopulmonary diseases, or associated with other major trauma.
* Patient with incomplete data.

Primary outcomes:
measure: Patient mortality
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT03265210: A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Official title: "Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
Keywords: Middle-aged and Older Adults
Primary Care
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-08-29
Enrollment: 73
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pain and depression frequently co-exist in late and mid-life and contribute to increased disability, high health care costs, psychiatric comorbidity, and suicide. The investigators will recruit 60 adults from Weill Cornell Medical Associates primary care practices; participants will be randomized to either Relief (a 9 session behavioral intervention) or usual care/referral for mental health care. Research assessments are conducted with both groups at study entry (Baseline), 6, 9, and 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Age 50 years
* PHQ-9 greater than or equal to 10
* Non-cancer related chronic pain, defined as pain during most days over the past 3 months by patient report
* Capacity to consent

Exclusion Criteria:

* DSM-5 Axis 1 other than depression and anxiety disorders
* Montreal Cognitive Assessment (MoCA) \< 24
* Active suicidal ideation, i.e. MADRS Suicide Item greater than or equal to 4
* Severe or life-threatening medical illness.
* Patients on psychotropics, opioids or benzodiazepines will be included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance abuse disorders

Primary outcomes:
measure: Change in Clinically Significant Depressive Symptoms, as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Change in Pain-related Disability, as Measured by the Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline, 6, 9, and 12 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Mood, as Measured by the Daily Photographic Affect Meter (PAM)
timeFrame: Daily for 12 weeks
measure: Activities Monitoring
timeFrame: Daily for 12 weeks
measure: Activities Monitoring
timeFrame: Daily for 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Internal Medicine Associates (WCIMA)
state: New York
city: New York
country: United States
facility: Iris Cantor Men's & Women's Health Centers
state: New York
city: New York
country: United States
facility: Irving Sherwood Wright Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507910: The Development of Flat Foot After Ankle Fractures
Official title: Pes Planus After Weber B and C Ankle Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pes Planus
Keywords: ankle fracture
pes planus
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: In this study we are trying to determine the incidence of flat foot (also called pes planus) among patients who have had an ankle fracture. As compared to the general population, it is predicted that the incidence of pes planus will be higher among people who have fractured their ankle.

Detailed description: Pes planus may develop following ankle fractures due to additional injuries that are sustained at the time of ankle fracture. If this study can demonstrate an association, further research would investigate how to effectively treat the pes planus early to prevent it from becoming a symptomatic problem.

Eligibility criteria: Inclusion Criteria:

Patients will be considered eligible if:

* They have sustained Weber type B or C ankle fractures and needed open reduction
* They are 18 years of age or older
* They are expected to be full weight bearing for at least 4 months to allow the potential of supporting structures to stretch and pes planus to develop

Exclusion Criteria:

* Patients will be excluded if they already have flat foot in their non-fractured foot.
* Patients with bilateral ankle fractures
* Patients who are not competent to sign a consent form
* A second fracture to the ankle
* Pathological fractures
* Patients with underlying cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Alan Giachino
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542410: Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Official title: Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Surgically confirmed endometriosis
* Age between 15-40 y, and premenopausal
* Pelvic pain score ≥3 on a Visual Analog Scaleover the last month

Exclusion Criteria:

* Use of other concurrent hormone medications (such as birth control pills)
* Impaired liver function (ALT \> 2x normal) or liver disease (cirrhosis, hepatitis)
* Pregnancy
* Breast cancer
* Active thromboembolic disease
* Uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders

Primary outcomes:
measure: Change in Score in Worst Pain Over the Last Month
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Changes in Pain Interference Scores
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References:
citation: DiVasta AD, Stamoulis C, Gallagher JS, Laufer MR, Anchan R, Hornstein MD. Nonhormonal therapy for endometriosis: a randomized, placebo-controlled, pilot study of cabergoline versus norethindrone acetate. F S Rep. 2021 Jul 24;2(4):454-461. doi: 10.1016/j.xfre.2021.07.003. eCollection 2021 Dec.