cyrilzakka/clinical-trials huggingface dataset:
Discovering the Gene(s) Causing Developmental Dysplasia of the Hip (DDH)

The primary objective of the study is to find the gene(s) responsible for causing DDH. The secondary objective of the study is to determine the mode of genetic transmission of DDH.

Developmental dysplasia of the hip (DDH), formerly known as Congenital Dislocation of the Hip (CDH) is a relatively common disorder that can lead to early onset arthritis of the hip. It is believed that DDH is the major cause of arthritis of the hip in young patients. The majority of patients with DDH are unaware of their condition. Only a very small number of these patients with the extremely severe form of the disease (dislocated hip) are identified at birth. The remaining patients usually seek help when severe arthritis is present and joint preservation treatment is not possible. The exact etiology of this condition remains elusive. Based on reports in the literature, DDH is believed to have a genetic basis.

Dr. Javad Parvizi at Rothman Institute (RT) in Philadelphia has extensive experience with this condition because their center provides joint preservation procedures such as pelvic and femoral osteotomy. They also have extensive experience with hip replacement in these patients. They are aware of some families with many affected individuals. Close history taking and examination of these patients has suggested that there may indeed be a genetic basis for DDH. Based on our findings so far, we believe that a dominant pattern of inheritance may exist, implying that this disorder may be inherited in a Mendelian manner (Single gene disorder).

Furthermore, Dr. Parvizi's group have documented a peculiar pattern of dominant inheritance in which all affected males give rise to only affected female children, suggesting that the disorder may be inherited as an X-linked dominant trait. X-linked dominant is the mode of inheritance in which a gene on the X chromosome is dominant. The X-linked dominant inheritance may in part account for the large number of females affected with the trait. Understanding the inheritance mechanism of this disease will allow better genetic counseling and monitoring of affected individuals and their families.

The reason behind this study is to investigate the possible genetic inheritance of the disease. Knowing this information will allow us to test patients for the disease early and before arthritis develops. In addition it is possible that better treatments may be designed based on this knowledge.

DDH is a relatively common condition. Although the most severe form of DDH is usually diagnosed during birth (dislocated hip), the majority (\>80%) of patients with this condition do not even know that they suffer from this disease and usually discover their condition when disabling arthritis of the hip develops in early adulthood.

Eligibility Criteria:
Inclusion Criteria:

* All patients with radiographic and clinical diagnosis of DDH will be included.

Exclusion Criteria:

* Other forms of arthritis:
* osteoarthritis
* inflammatory arthropathies
* vascular necrosis
Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.

OBJECTIVES:

* Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and irinotecan in patients with advanced cancer.
* Determine the objective antitumor responses in patients treated with this regimen.
* Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days 1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Sequential dose escalation of epirubicin is followed by sequential dose escalation of irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically documented incurable malignancy for which there is no beneficial standard therapy

  * Locally unresectable or metastatic disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 8 weeks

Hematopoietic:

* WBC at least 3,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.2 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2 times ULN

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* Ejection fraction at least 50% by MUGA scan
* No congestive heart failure

Other:

* Maintaining a reasonable state of nutrition
* No frequent vomiting or severe anorexia
* No weight loss greater than 10% of current body weight within the past 4 weeks
* No other concurrent medical illness that would preclude study
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy

Chemotherapy:

* Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2

Endocrine therapy:

* Not specified

Radiotherapy:

* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* Recovered from prior therapy
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach

A large body of medical research has shown that sleep deprivation adversely affects outcomes ranging from cognitive function to pain sensitivity and cardiovascular function. Much of this evidence comes from sleep labs in the developed world, where sleep can be carefully manipulated, and short-run physiological and cognitive outcomes precisely measured. In contrast, there is much less knowledge about how sleep deprivation affects the health of individuals in the developing world, coming from a lack of studies outside the lab and over longer periods. This project aims to fill this gap. The investigators will implement a randomized controlled trial (RCT) with 450 low-income adults in Chennai, India, providing the first objective measurement of sleep in a developing country. The investigators will also evaluate scalable interventions to improve the sleep of poor adults, such as providing home sleep-aid devices and a comfortable space for a 30-minute afternoon nap at the participants' work site. Finally, the study aims to assess the impact of improved sleep on health, with a primary focus on cardiovascular health and cognitive outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Unemployed and underemployed adult men and women of working age (see previous age limit) who have worked less than 5 days per week over the last month and earned less than Rs. 700 per day over that same period.
* Participants must live in Government board house or in a house with some kind of roof that protect the sleep aids from rain, such as a concrete or a metal or a Tarpaulin, ... roof.
* Have limited experience with typing, and limited knowledge of English.
* Participants need to speak Tamil, the local language, to be able to write numbers and to be able to commit easily to the office.

Exclusion Criteria:

* Participants who cannot commit to come to the office for the duration of the whole study.
* Participants who own more than three of the sleep aids that we provide in our sleep kit.
* Participants who have previously participated in the sleep study.
* Participants who have children younger than three years old.
Safety of Epidural Fentanyl and Adrenalin During Childbirth

Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural solution given to women in childbirth

Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet University Hospital, may be included. A randomized, placebocontrolled, double blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of pain relief, total amount of epidural solution injected, and plasma concentration of fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at term in active labor

Exclusion Criteria:

* age below 18 years
* BMI \> 40
* drug hypersensitivity
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses

The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Any race or ethnicity
* At least 35 years old
* Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria:

* Unable or unwilling to undergo informed consent
* Subjects who have breast implants
* Subjects who are unable or unwilling to tolerate compression
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are currently lactating
* Men
* Women less than 35 years old
* Women greater than 80 years old
* Subjects whose breasts are larger than the tomosynthesis detector
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women

The study will evaluate safety and effectiveness of the UriCap-F, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.

Following various disease conditions such as trauma, orthopaedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. For lack of a better solution for urinary management, indwelling catheter and diaper use is common in hospitalized patients. There is no externally applied urine collection device on the market today for women. In such situations an indwelling catheter is often placed to relieve patients while they are incapacitated, despite lack of urinary retention. Indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. In other cases diapers or absorbent pads may be used. These may be associated with skin irritation and infection.

The study will evaluate the UriCap-F, non-invasive urine collection devices for women, in hospitalized patients who are able to void or who are incontinent of urine

Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years old
* Empties the bladder completely on voiding
* A clinical indication for an indwelling catheter, use of pads or diapers
* Patient has signed an informed consent form, is cooperative and willing to complete all study procedures
* Absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition
* Agrees to genital hair removal.

Exclusion Criteria:

* Pregnant or breastfeeding
* Menstruation at time of enrolment
* Known allergy to silicon
* Dysuria
* Urinary retention - Post-void residual urine more than 300cc
* Hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement.
* Diagnosed with acute renal failure according, to investigator judgement.
* Serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the Investigator, would compromise the patient's well-being or successful participation in the study
* Participating in another clinical study.
* Financial interest in the Sponsor Company or a competitor company by patient or a family member
Effect of Vibration Massager Therapy on Non-Specific Low Back Pain

The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain.

This study will be conducted using a randomized controlled design. Volunteers between the ages of 18-65 with non-specific low back pain will be included in the study. Inclusion criteria are that participants do not have structural pathologies and agree to participate in the study voluntarily. Exclusion criteria include spinal deformities and exercise intolerance. Participants will be randomly divided into two groups. Individuals in the first group will receive vibratory massage therapy, while the second group will be evaluated with standard treatment methods as a control. Both groups will receive treatment 3 times a week for 8 weeks. Participants' quality of life, pain levels, range of motion, and muscle activity will be evaluated before and after treatment. Data will be collected using tools such as SF-36, Oswestry Low Back Pain Index, and VAS (Visual Analog Scale).

Eligibility Criteria:
Inclusion Criteria:

* Having back pain for the last 3 months VAS \>4
* Between 18-65 years of age.
* Volunteers for the study.
* Not having undergone surgical intervention in the last 6 months
* Individuals with structural amoli (e.g. spinal deformity).
* Having chronic bone disease

Exclusion Criteria:

* Not being able to cooperate
* Presence of psychological problems
* Use of sleeping pills,
* Presence of neurological and orthopedic diseases.
A Study to Help People Quit Smoking.

You are invited to participate in a research study at the VA Connecticut Healthcare System (West Haven campus) that examines whether a medication called galantamine can improve your learning and memory, and also help you to quit smoking. You have been invited to participate because you currently smoke cigarettes, and want to quit smoking. If you are eligible and agree to be in the study, your participation will last for approximately 8 weeks. To determine if galantamine (8 or 16 mg) is superior to placebo a) in reducing smoking self-administration in a human laboratory model and b) improving abstinence rates at the end of 4 weeks of treatment.

We propose a double-blind, placebo-controlled, outpatient study with a between-groups design. Seventy-two male and female smokers will be randomly assigned to one of the 3 treatment conditions: GAL (8 or 16 mg/day) or placebo. The dose of GAL will be gradually increased to the target doses over a 2-week period (Table 2). During Week 3, following overnight abstinence from smoking, participants will present for a laboratory Test Session in which they will have the option of cigarette self-administration. After this Test Session is completed, smokers will be maintained on their randomized medication condition for an additional 4-week period. Smokers will establish a quit date at the beginning of this Treatment Phase, and will receive brief weekly behavioral treatment for the 4 weeks of this phase. Additionally, at the beginning of Week 3, participants will be given a PDA that will administer EMA assessments. The study medication will be tapered after the end of Week 4 of the Treatment Phase. Participants will be contacted by phone at one week, and one month, after treatment termination to inquire about any adverse events and about their recent smoking status.

Eligibility Criteria:
Inclusion Criteria:

* Female and male smokers, aged 18 to 55 years;
* history of smoking daily for the past 12 months, at least 10 cigarettes daily;
* in good health as verified by medical history, screening examination, and screening laboratory tests;
* for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* History of GAL allergy;
* requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history (in the past 6 months);
* serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, or hepatic disorders;
* abuse of alcohol or any other illicit or prescription drugs;
* use of any other tobacco products, including smokeless tobacco and nicotine products; and
* inability to fulfill all scheduled visits and examination procedures throughout the study period.
Families Affected by Dementia: A Survey of Caregivers

The purpose of our study is to better understand how caregivers of individuals with dementia cope with their family member's illness. If you are eligible for the study and would like to participate, we will schedule a one-time phone interview, which will last approximately 2 hours for which you will be compensated for your time.

Eventually, results of this study will be used to develop treatments that will hopefully help caregivers cope more effectively with managing dementia in a loved one.

Eligibility Criteria:
Inclusion Criteria:

* Caregiver of individual with dementia
* Relative who is 60 years or older with dementia
* Live-in, unpaid caregiver
* Have a working telephone number
Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

The purpose of this study is to evaluate the feasibility, efficacy and safety of FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* • Chinese；

  * Stable vital signs, KPS≥60;
  * Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
  * Adequate fresh tumor tissue for genome sequencing and immuno- histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
  * At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
  * Life expectancy of more than 12 weeks;
  * Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\^9/L, neutrophils≥1.5×10\^9/L, platelets≥80×10\^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
  * Volunteer for this study, have written informed consent and have good Patient compliance;
  * Female patients of childbearing potential and their mates agree to avoid pregnancy.

Exclusion Criteria:

* Have received following treatment before this study:

  1. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
  2. lesions have been treated by irradiation;
  3. participate in other therapeutic or interventional clinical trials. - Page 5 of 5 \[DRAFT\] -
* Have central nervous system metastasis;
* History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
* Have symptomatic ascites and need for treatment;
* Have serious concurrent illness including, but not limited to

  1. uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure \>21.3 Kpa or diastolic blood pressure \>13.3 Kpa);
  2. ongoing or active serious infection;
  3. uncontrolled diabetes mellitus;
  4. psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
  5. HIV infection;
  6. other serious illness considered not suitable for this study by investigators.
* be allergic or have contraindications to target medicines involved in this study, gemcitabine or oxaliplatin.
My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care

The project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk.

The research programme is an ambitious and dedicated effort aiming at improvement of functioning and quality of life for individuals with persistent physical symptoms (PPS) and prevention of the development of chronic functional disorders and associated loss of working capacity and high use of health care. At present, access to specialized treatment of PPS is very limited and treatment capacity in general practice is restricted to brief consultations - often with poor opportunity to make a treatment plan for symptoms. As part of the research programme, the investigators have developed a web-based self-help programme for patient with PPS. This treatment programme is prescribed by the patient's general practitioner (GP). Only GPs who have participated in a short introduction course will be allowed for prescriptions.

The investigators have applied a high degree of user involvement (GPs and patients) in the development process but there is a need to evaluate how the new treatment programme is in fact adopted by GPs and patients.

With this study, the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs, patients and the health care system.

The project aims to evaluate the uptake and effects of the new self-help programme for PPS, the My Symptoms programme, prescribed and followed up by GPs.

Specific objectives are to:

1. Describe the use of the programme during routine care. This includes

   1. Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption)
   2. A description of how often the follow-up consultation is completed according to the patients.
2. Explore patient characteristics (appropriateness)
3. Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity)
4. Evaluate effects on patients' health, quality of life, functioning and satisfaction with care
5. Estimate effects on patients' use of health care services
6. Estimate effects on patients' work productivity
7. Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 (target population for the programme)
* The consultation targets symptom complaints
* Listed with participating practice.

Exclusion Criteria:

* Symptoms are acute (not persistent) and there is no need for this intervention
* Symptoms must primarily be treated by medicine or surgery
* Patient severely affected by other disease
* Not eligible due to language or cognitive problems