louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00361400: Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
Official title: Combined Hormonal Contraceptive Use in High Risk Women: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
hormonal contraception
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-08-08
Enrollment: 1387
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned Parenthood patients who present to start a hormonal birth control for the first time.

Brief summary: This study is an examination of "high risk" young women, 15-24 years of age, who initiate first time use of vaginal ring, oral contraceptives, contraceptive path, or Depo-provera.

Detailed description: Approximately 1600 young women will be enrolled in a 12 month, observation study of their contraceptive use. They will complete surveys at baseline, 3, 6 and 12 months. They will also undergo pregnancy testing at baseline, 6 and 12 month visits. The study is examining such things are the relationship between partnerships, parental and peer influences, and contraceptive choice; Factors associated with long term continuation of contraceptive methods; Attributes of new hormonal contraceptive associated with user satisfaction and long-term continuation; And the extent to which high-risk women who use these methods are also condom users and determine the characteristics of these users.

Eligibility criteria: Inclusion Criteria:

- 15-24 years old, English or spanish speaking, Starting ring, pill, patch, or Depo for first time, Sexually active, Single, Not pregnant, Living in Bay Area for next 12 months

Exclusion Criteria:

Past user of method, Married, Pregnant, Moving out of area, Not sexually active

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Planned Parenthood-Golden Gate
state: California
city: Oakland
country: United States
facility: Planned Parenthood-Golden Gate
state: California
city: Richmond
country: United States
facility: Planned Parenthood - Shasta Diablo
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Vallejo
country: United States
facility: Planned Parenthood - Shasta Diablo
state: California
Study officials:
affiliation: University of California, San Francisco
name: Tina R Raine, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Cynthia Harper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02915900: Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
Official title: Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: In vitro fertilization
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.

Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.

In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.

The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.


Eligibility criteria: Inclusion Criteria:

* Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
* Pre-selected starting dose \<110 IU or \>270 IU FSH

Exclusion Criteria:

* Risk for hyperstimulation
* Polycystic ovary syndrome
* Endometriosis stage \>III
* BMI\>33
* Anti-mullerian hormone value missing

Primary outcomes:
measure: Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
timeFrame: The day of follicle aspiration.
measure: Consistency of optimal ovarian response during stimulation.
timeFrame: The day of follicle aspiration.
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Reproductive Medicine, Oslo University Hospital
Study officials:
affiliation: OUS-HF
name: Peter Fedorcsak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05201300: Remimazolam and Propofol Anesthesia in Elderly Patients
Official title: Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamics
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.

A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.

The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA I, II patients over 65 years old undergoing general anesthesia

Exclusion Criteria:

* cardiac surgery
* neurosurgery
* liver surgery
* uncontrolled hypertension
* bronchial asthma
* body mass index ≥ 30 kg/m2
* severe heart, liver, kidney disease

Primary outcomes:
measure: difference in the decreased mean arterial pressure
timeFrame: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04897100: Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
Official title: Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Club Foot
Achilles Tendon Surgery
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 244
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Achilles tendon tenotomy is an integral part of the Ponseti method, aimed at correcting residual equinus after correction of the adductus deformity. Tenotomy rates ranging from 63-95% after full cycle of castings have been reported in literature. Percutaneous tenotomy is the gold standard, which can usually be performed in an out-patient setting under local anesthesia using a scalpel blade. A complication rate of 2% (mainly neurovascular injury)has been reported in literature, with accidental sectioning of the peroneal artery being the most common. Development of a pseudo-aneurysm after accidental sectioning of the peroneal artery has been reported in a case report; this delayed further clubfoot treatment.

Percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age. This technique use a large-gauge (16-19 G) needle to percutaneously cut the Achilles tendon. Although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique, no major complications have been reported as yet using the needle technique.

We would like to compare the clinical outcomes and complication rates of both techniques, supporting our hypothesis that both techniques are equally safe and have the same success rate.


Eligibility criteria: Inclusion Criteria:

* Idiopathic clubfoot.
* Age less than or equal to 36 months at the time of tenotomy.
* Enrolled at the Pehla Qadam clinic at The Indus Hospital in Karachi.
* Fully corrected Adductus deformity with residual equinus after a full casting cycle.
* Completing routine follow up for 3 months post tenotomy.

Exclusion Criteria:

* Refusal of parents to enroll child into this study.
* Syndromic clubfoot.
* Previous treatment for clubfoot (surgical or non-surgical) received.
* Underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon

Primary outcomes:
measure: Dorsiflexion
timeFrame: 3 months
Secondary outcomes:
measure: Complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Indus Hospital
state: Sindh
Study officials:
affiliation: Indus Hospital and Health Network
name: Mansoor Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04890600: COVID-19 and Psycological Well-being in Healthcare Workers
Official title: Investigation on Psycological Well-being in Healthcare Workers of San Raffaele Institution During COVID-19 Emergency Context
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distress, Emotional
Coping Behavior
Keywords: COVID-19, resilience, depression, healthcare workers
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: nurses, medical doctors, therapists, researchers, administrative workers

Brief summary: Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.

After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules.

No personal data are required.

Detailed description: Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.

Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19.

Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.

Eligibility criteria: Inclusion Criteria:

* Healthworkers of San Raffaele Institution
* age\>18

Exclusion Criteria:

* all those who do not agree

Primary outcomes:
measure: Levels of anxiety and depression
timeFrame: 6 months
measure: Coping strategies
timeFrame: 6 months
measure: Levels of resilience
timeFrame: 6 months
measure: Levels of fear of COVID-19
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS San Raffaele Roma
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Stefano Bonassi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317600: Postamputation Pain: Peripheral Mechanisms
Official title: Postamputation Pain: Peripheral Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Amputation, Traumatic
Nerve Block
Phantom Limb Pain
Stump Pain
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2017-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.


Eligibility criteria: Inclusion Criteria:

* Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).

Exclusion Criteria:

* Severe somatic or psychiatric diseases
* Other peripheral neuropathy
* Lack of ability to cooperate to the clinical examination
* Allergy to Lidocaine or similar analgetics

Primary outcomes:
measure: Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
timeFrame: From 0 minutes until 120 minutes after injection
Secondary outcomes:
measure: Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
timeFrame: From 0 minutes until 120 minutes after injection
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT01153100: Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Official title: Effectiveness of a Subcutaneously Administered Long-acting Insulin Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Diabetes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators anticipate that the use of Glargine will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.


Eligibility criteria: Inclusion Criteria:

* Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre- and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutrition requiring insulin drip.
* Patients with type 1 and type 2 diabetes mellitus (DM) will be included.
* Patients with both types of diabetes will be among those treated with the insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition.
* Patients will be of age 19 to 80.

Exclusion Criteria:

* Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drip 2 weeks and longer, pregnancy, Lantus allergy, and concurrent sulfonamide treatment

Primary outcomes:
measure: Reduction in rebound hyperglycemia (blood glucose levels over 180 mg/dl)
timeFrame: within 48 hours of discontinuation
Secondary outcomes:
measure: Reduction in duration of insulin drip therapy and reduction in total and average per hour insulin drip dose
timeFrame: within one week of insulin drip therapy
measure: Reduction in ICU length of stay
timeFrame: within two weeks of hospitalization
measure: Equal or improved diabetes control
timeFrame: within two weeks of hospitalization
measure: Reduction in time to get back to control of glycemia (140-180 mg/dl) if rebound hyperglycemia occurs
timeFrame: within one week post insulin drip
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Univesity of Colorado
name: Boris Draznin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03203200: A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Sex Workers
Official title: A Cognitive Behavioral And Structural HIV Prevention Intervention for Young Ugandan Women Engaging in High Risk Sexual Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infection
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: MRC/UVRI and LSHTM Uganda Research Unit
name: National Institute of Mental Health (NIMH)
First posted: 2017-06-29
Enrollment: 640
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study develops and tests a behavioural and structural intervention to prevent unprotected sex among young female sex workers. Half the participants will receive the intervention and half will receive the standard of care.


Eligibility criteria: Inclusion Criteria:

* HIV-uninfected women, aged 15-24 years, being sexually active and having engaged in any form of transactional sex at least once in the last 3 months, agreeing to participate in all intervention sessions and to all study procedures and interviews planned over 18 months of follow-up.

Exclusion Criteria:

* presence of any physical or mental condition likely to cause inability to provide consent or hinder study participation; HIV infection

Primary outcomes:
measure: Unprotected Sex
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Entebbe
country: Uganda
facility: Uganda Virus Research Institute
Study officials:
affiliation: University of California, San Francisco
name: Rachel King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King R, Muhanguzi E, Nakitto M, Mirembe M, Kasujja FX, Bagiire D, Seeley J. Mobility study of young women who exchange sex for money or commodities using Google Maps and qualitative methods in Kampala, Uganda. BMJ Open. 2021 May 19;11(5):e043078. doi: 10.1136/bmjopen-2020-043078.
Clinical trial NCT01625000: Safety and Efficacy of MP-214 in Patients With Schizophrenia
Official title: A Double-Blind, Placebo-Controlled Study of MP-214 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Acute Schizophrenia
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Risperidone
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 512
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient before the initiation of any study-specific procedures
* Patients diagnosed with schizophrenia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* Patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change in the Clinical Global Impression-Severity (CGI-S) Score at Week 6
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Seoul
country: Korea, Republic of
city: Taipei
country: Taiwan
Study officials:
References: